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ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe

ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe

  • Marketing Authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets)
  • New treatment can enable people living with HIV to reduce the days they receive treatment from 365 to 12 or 6 per year
  • The long-acting injectable regimen was preferred by majority of clinical trial patients who tried the treatment over their previous daily oral therapy

LONDON–(BUSINESS WIRE)–
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced the authorisation of Vocabria (cabotegravir injection and tablets) in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed.1 Cabotegravir injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.

Dr Antonio Antela, University Hospital, Santiago de Compostela, Spain, said: “Daily antiretrovirals have transformed the lives of people living with HIV. However, taking daily medication can pose challenges for some people; it may act as a constant reminder of HIV or be a cause of fear that their HIV status will be disclosed. Following the oral initiation phase to assess the tolerability of the medicines, cabotegravir and rilpivirine injections could reduce the number of days of treatment per year from 365 down to 12 for the once-monthly, or 6 for the once every 2-months dosing regimen, representing a paradigm shift in how we are able to treat and manage the condition.The long-acting regimen of cabotegravir and rilpivirine was as effective as treatment with current daily antiviral therapy in the clinical trials in maintaining viral suppression, is generally well tolerated, and could change the treatment experience for some people living with HIV that may have challenges with daily HIV therapies.”

Outlining the need for a less frequent dosing regimen, the largest global HIV patient-reported outcomes study to date conducted by ViiV Healthcare, Positive Perspectives Wave 2, found that when participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% (n=1306/2389) would prefer not having to take medication every day, as long as their HIV stays suppressed.2 In addition, 58% (n=1394/2389) noted that taking daily HIV medication acts as a constant reminder of HIV in their lives, while up to 38% (n=906/2389) of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their HIV status to others.3

Deborah Waterhouse, CEO, ViiV Healthcare, said: “At ViiV Healthcare, we push the boundaries to provide new treatment options that will help make a difference to people’s lives. We saw from the patient reported outcomes in our pivotal clinical trials that approximately 9 out of 10 people who switched to the long-acting regimen preferred this over their previous daily oral tablets.4,5,6 It will potentially change the treatment experience for some people living with HIV by removing the need for daily HIV tablets. We are committed to pursuing innovative research to meet the diverse needs of the HIV community, and we won’t stop until we have more ways to treat, and hopefully one day cure, HIV.”

Marketing Authorisation is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies, which included more than 1,200 participants from 16 countries.4,5,6 Cabotegravir and rilpivirine are co-administered as two intramuscular (IM) injections in the buttocks by a Healthcare Professional at the same appointment.

ViiV Healthcare’s cabotegravir in combination with Janssen’s rilpivirine was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare’s industry-leading portfolio that is centered on delivering innovative medicines for the HIV community.

This announcement marks the second marketing authorisation of the long-acting regimen of cabotegravir and rilpivirine, with once-monthly dosing licensed by Health Canada under the brand name Cabenuva for the treatment of HIV-1 infection in adults who are virologically stable and suppressed. In July, ViiV Healthcare resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the US Food and Drug Administration (FDA), and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.

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Notes to editor

About cabotegravir

Cabotegravir is an INI developed by ViiV Healthcare for the treatment of HIV-1 in virologically suppressed adults. It is being evaluated in combination with injectable rilpivirine as a long-acting formulation.

INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

About rilpivirine and rilpivirine long-acting

The oral formulation of rilpivirine is also authorised for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with a viral load ≤ 100,000 HIV RNA copies/mL.

Rilpivirine long-acting is a prolonged-release suspension for IM injection being developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

Administration and dosing of cabotegravir and rilpivirine

Cabotegravir injection used in combination with rilpivirine injection will be the first complete long-acting regimen dosed once-monthly or once every 2-months, for virologically suppressed people living with HIV-1. Cabotegravir and rilpivirine injections are administered as two IM injections in the buttocks by a Healthcare Professional at the same appointment. Prior to the initiation of the injections, cabotegravir and rilpivirine oral tablets are taken for approximately one month (at least 28 days) to assess tolerability to the medicines.

Important Safety Information (ISI)

The following Important Safety Information is based on the Summary of Product Characteristics for Vocabria. Please consult the full Summary of Product Characteristics for all the safety information.

Vocabria (cabotegravir)injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.

Vocabria injection is indicated for the treatment of HIV-1 in combination with rilpivirine injection, therefore, the prescribing information for rilpivirine injection should be consulted for recommended dosing.

Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:

  • oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
  • oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.

Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing.

Prior to starting Vocabria injection, healthcare professionals should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.

Following discontinuation of Vocabria and rilpivirine injection, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of Vocabria when dosed monthly and no later than two months after the final injection of Vocabria when dosed every 2 months.

Elderly (≥65 years of age): No dose adjustment is required in elderly patients. There are limited data available on the use of cabotegravir in patients aged 65 years and over.

Paediatrics (<18 years of age): The safety and efficacy of Vocabria in children and adolescents aged under 18 years have not been established. No data are available.

Contraindications

Hypersensitivity to cabotegravir or rilpivirine or to any of the excipients.

Concomitant use with: rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin or phenobarbital.

Special Warnings and Precautions for Use

Vocabria injection

Risk of resistance following treatment discontinuation

To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of Vocabria when dosed monthly and no later than two months after the final injection of Vocabria when dosed every 2 months.

Residual concentrations of cabotegravir may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer), therefore, physicians should take the prolonged release characteristics of Vocabria injection into consideration when the medicinal product is discontinued.

If virologic failure is suspected, an alternative regimen should be adopted as soon as possible.

Baseline factors associated with virological failure

Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI ≥30 kg/m2. In patients with an incomplete or uncertain treatment history without pre-treatment resistance analyses, caution is warranted in the presence of either BMI ≥30 kg/m2 or HIV-1 A6/A1 subtype.

Hypersensitivity reactions

Hypersensitivity reactions have been reported in association with other integrase inhibitors. These reactions were characterised by rash, constitutional findings and sometimes organ dysfunction, including liver injury. While no such reactions have been observed to date in association with Vocabria, physicians should remain vigilant and should discontinue Vocabria and other suspected medicinal products immediately, should signs or symptoms of hypersensitivity develop (including, but not limited to, severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia or angioedema). Clinical status, including liver aminotransferases should be monitored and appropriate therapy initiated. Administration of oral lead-in is recommended to help identify patients who may be at risk of a hypersensitivity reaction.

Hepatoxicity

Hepatotoxicity has been reported in a limited number of patients receiving Vocabria with or without known pre-existing hepatic disease.

Monitoring of liver chemistries is recommended and treatment with Vocabria should be discontinued if hepatotoxicity is suspected.

HBV/HCV co-infection

Patients with hepatitis B co-infection were excluded from studies with Vocabria. It is not recommended to initiate Vocabria in patients with hepatitis B co-infection. Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.

Limited data is available in patients with hepatitis C co-infection. Monitoring of liver function is recommended in patients with hepatitis C co-infection.

Interactions with medicinal products

Caution should be given to prescribing Vocabria injection and tablets with medicinal products that may reduce its exposure.

Concomitant use of Vocabria injection with rifabutin is not recommended.

Polyvalent cation containing antacids are recommended to be taken at least 2 hours before and 4 hours after taking Vocabria tablets.

Effect of other medicinal products on the pharmacokinetics of cabotegravir

Cabotegravir is primarily metabolised by uridine diphosphate glucuronosyl transferase (UGT) 1A1 and to a lesser extent by UGT1A9. Medicinal products which are strong inducers of UGT1A1 or UGT1A9 are expected to decrease cabotegravir plasma concentrations leading to lack of efficacy.

Undesirable effects

Summary of the safety profile

The most frequently reported adverse reactions (ARs) from monthly dosing studies were injection site reactions (up to 84%), headache (up to 12%) and pyrexia* (10%).

The most frequently reported ARs from ATLAS-2M every 2-month dosing were injection site reactions (76%), headache (7%) and pyrexia* (7%).

*Pyrexia includes the following: feeling hot, body temperature increased.

Description of selected adverse reactions

Local injection site reactions (ISRs)

Up to 1% of subjects discontinued treatment with Vocabria plus rilpivirine because of ISRs. When dosing monthly, up to 84% of subjects reported injection site reactions; out of 30393 injections, 6815 ISRs were reported. When dosing every 2 months, 76% of patients reported injection site reactions; out of 8470 injections, 2507 ISRs were reported.

The severity of reactions was generally mild (Grade 1, 70%-75% of subjects) or moderate (Grade 2, 27%-36% of subjects). 3-4% of subjects experienced severe (Grade 3) ISRs. The median duration of overall ISR events was 3 days. The percentage of subjects reporting ISRs decreased over time.

Weight increased

At the Week 48 time point, subjects in studies FLAIR and ATLAS, who received Vocabria plus rilpivirine gained a median of 1.5 kg in weight subjects continuing on their current antiretroviral therapy (CAR) gained a median of 1.0 kg (pooled analysis). In the individual studies FLAIR and ATLAS, the median weight gains in the Vocabria plus rilpivirine arms were 1.3 kg and 1.8 kg respectively, compared to 1.5 kg and 0.3 kg in the CAR arms.

At the 48 week timepoint, in ATLAS-2M the median weight gain in both the monthly and 2-monthly CAB+RPV dosing arms was 1.0 kg.

Pregnancy

There are a limited amount of data from the use of cabotegravir in pregnant women. The effect of Vocabria on human pregnancy is unknown.

Cabotegravir was not teratogenic when studied in pregnant rats and rabbits but, exposures higher than the therapeutic dose showed reproductive toxicity in animals. The relevance to human pregnancy is unknown.

Vocabria injection is not recommended during pregnancy unless the expected benefit justifies the potential risk to the foetus.

Cabotegravir has been detected in systemic circulation for up to 12 months or longer after an injection.

Breast-feeding

It is expected that cabotegravir will be secreted into human milk based on animal data, although this has not been confirmed in humans. Cabotegravir may be present in human milk for up to 12 months or longer after the last cabotegravir injection.

It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

REKAMBYS (rilpivirine injection) ISI

The following Important Safety Information is based on the Summary of Product Characteristics for REKAMBYS (rilpivirine injection). Please consult the full Summary of Product Characteristics for all the safety information.

REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class

REKAMBYS should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing.

Prior to the initiation of REKAMBYS, rilpivirine oral tablets, together with cabotegravir oral tablets, should be taken for approximately 1 month (at least 28 days) to assess tolerability to rilpivirine and cabotegravir. One rilpivirine 25‑mg tablet should be taken with a meal with one cabotegravir 30‑mg tablet once daily.

Prior to starting REKAMBYS, the healthcare professional should carefully select patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance associated with missed doses.

Following discontinuation of REKAMBYS in combination with cabotegravir injection, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the last every 1 month injection of REKAMBYS or two months after the last every 2 months injection of REKAMBYS.

Elderly: There is limited information regarding the use of REKAMBYS in patients > 65 years of age. No dose adjustment of REKAMBYS is required in older patients.

Paediatric Patients: The safety and efficacy of REKAMBYS in children and adolescents aged < 18 years have not been established. No data are available.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

REKAMBYS must not be co‑administered with the following medicinal products, which may result in loss of therapeutic effect of REKAMBYS:

  • the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • the antimycobacterials rifabutin, rifampicin, rifapentine
  • the systemic glucocorticoid dexamethasone, except as a single dose treatment
  • St John’s wort (Hypericum perforatum).

Special Warnings and Precautions for Use

Risk of resistance following treatment discontinuation

To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the last every 1 month injection of REKAMBYS or two months after the last every 2 months injection of REKAMBYS.

 

Long-acting properties of rilpivirine injection

Residual concentrations of rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 4 years in some patients) and should be considered upon discontinuation of REKAMBYS.

Baseline factors associated with virological failure

Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI ≥30 kg/m2. In patients with an incomplete or uncertain treatment history without pre-treatment resistance analyses, caution is warranted in the presence of BMI ≥30 kg/m2 and/or HIV‑1 subtype A6/A1.

Post-injection reactions

Partial intravenous administration may result in AEs due to temporarily high plasma concentrations. In clinical studies, serious post-injection reactions were reported within minutes after the injection of rilpivirine, including dyspnoea, agitation, abdominal cramping, flushing, sweating, oral numbness, and changes in blood pressure. These events were very rare and began to resolve within a few minutes after the injection.

Carefully follow the Instructions for Use when preparing and administering REKAMBYS to avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a patient experiences a post-injection reaction, monitor and treat as clinically indicated.

Cardiovascular

REKAMBYS should be used with caution when co‑administered with a medicinal product with a known risk of Torsade de Pointes. At supra‑therapeutic doses (75 and 300 mg once daily), oral rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG). Oral rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. Plasma rilpivirine concentrations after REKAMBYS injections are comparable to those during such oral rilpivirine therapy.

HBV/HCV co-infection

Patients with hepatitis B co-infection were excluded from studies with REKAMBYS. It is not recommended to initiate REKAMBYS in patients with hepatitis B co-infection. In patients co‑infected with hepatitis B receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis B co‑infected. Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.

Limited data is available in patients with hepatitis C co-infection. In patients co‑infected with hepatitis C receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis C co‑infected. The pharmacokinetic exposure of oral and injectable rilpivirine in co‑infected patients was comparable to that in patients without hepatitis C co‑infection. Monitoring of liver function is recommended in patients with hepatitis C co-infection.

Interactions with other medicinal products

REKAMBYS should not be administered with other antiretroviral medicinal products, except for cabotegravir injection for the treatment of HIV-1 infection.

Pregnancy

There are limited data of REKAMBYS in pregnant women. REKAMBYS is not recommended during pregnancy unless the expected benefit justifies the potential risk. Lower exposures of oral rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. In the Phase 3 studies with oral rilpivirine, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely. Alternatively, switching to another ART regimen could be considered.

Undesirable effects

The most frequently reported ARs from every 1 month dosing studies were injection site reactions (up to 84%), headache (up to 12%) and pyrexia (10%).

The most frequently reported ARs from every 2 months dosing were injection site reactions (76%), headache (7%) and pyrexia (7%).

Tabulated list of adverse reactions is available in the full information leaflet.

Description of selected adverse reactions

Local Injection Site Reactions (ISRs)

Up to 1% of subjects discontinued treatment with rilpivirine and cabotegravir injections because of ISRs. When dosing every 1 month in ATLAS, FLAIR, and ATLAS-2M (Q4W arm), up to 84% of subjects reported injections site reactions; out of 30393 injections, 6815 ISRs were reported. When dosing every 2 months in ATLAS-2M (Q8W arm), 76% of subjects reported injection site reactions; out of 8470 injections, 2507 ISRs were reported.

Injection site reactions were generally mild (Grade 1, 70%-75% of subjects) or moderate (Grade 2, 27%-36% of subjects). 3-4% of subjects experienced severe (Grade 3) ISRs. The median duration of ISR events was 3 days. The percentage of subjects reporting ISRs decreased over time.

Weight increased

At the Week 48 time point, subjects in Phase 3 Studies FLAIR and ATLAS, who received rilpivirine plus cabotegravir gained a median of 1.5 kg in weight; subjects continuing on their current antiretroviral regimen (CAR) group gained a median of 1.0 kg (pooled analysis). In the individual studies FLAIR and ATLAS, the median weight gains in the rilpivirine plus cabotegravir arms were 1.3 kg and 1.8 kg respectively, compared to 1.5 kg and 0.3 kg in the CAR arms.

At the 48 week timepoint, in ATLAS-2M the median weight gain in both the monthly and every 2 months rilpivirine + cabotegravir dosing arms was 1.0 kg.

Pregnancy

The effect of REKAMBYS on human pregnancy is unknown. A moderate amount of data with oral rilpivirine in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or foetal/neonatal toxicity of rilpivirine. A study of 19 pregnant women treated with oral rilpivirine in combination with a background regimen during the second and third trimesters, and postpartum, showed lower exposures of oral rilpivirine during pregnancy, therefore viral load should be monitored closely if REKAMBYS is used during pregnancy.

Animal studies do not indicate reproductive toxicity. REKAMBYS is not recommended during pregnancy unless the expected benefit justifies the potential risk.

An alternative oral regimen should be considered in line with current treatment guidelines. After discontinuation of REKAMBYS, rilpivirine may remain in systemic circulation for up to 4 years in some patients.

Breast-feeding

It is expected that rilpivirine will be secreted into human milk based on animal data, although this has not been confirmed in humans. Rilpivirine may be present in human milk for up to 4 years in some patients after discontinuation of REKAMBYS.

It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

EDURANT (rilpivirine tablet) ISI

Please refer to the full Summary of Product Characteristics for full prescribing information for EDURANT® (rilpivirine): https://www.medicines.org.uk/emc/product/4968/smpc

Important Safety Information (ISI)

The following Important Safety Information is based on the Summary of Product Characteristics for EDURANT® Please consult the full Summary of Product Characteristics for all the safety information.

EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in antiretroviral treatment‑naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV‑1 RNA copies/ml. Genotypic resistance testing should guide the use of EDURANT.

The recommended dose of EDURANT is one 25 mg tablet taken once daily. EDURANT must be taken with a meal.

Elderly: There is limited information regarding the use of EDURANT in patients > 65 years of age. No dose adjustment of EDURANT is required in older patients. EDURANT should be used with caution in this population.

Paediatric population: The safety and efficacy of EDURANT in children aged < 12 years have not yet been established. No data are available.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

EDURANT should not be co‑administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT:

  • the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • the antimycobacterials rifampicin, rifapentine
  • proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole
  • the systemic glucocorticoid dexamethasone, except as a single dose treatment
  • St John’s wort (Hypericum perforatum).

Special Warnings and Precautions for Use

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.

Virologic failure and development of resistance

EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.

In the pooled efficacy analysis from the Phase III trials in adults through 96 weeks, patients treated with rilpivirine with a baseline viral load > 100,000 HIV‑1 RNA copies/ml had a greater risk of virologic failure (18.2% with rilpivirine versus 7.9% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV‑1 RNA copies/ml (5.7% with rilpivirine versus 3.6% with efavirenz). The greater risk of virologic failure for patients in the rilpivirine arm was observed in the first 48 weeks of these trials. Patients with a baseline viral load > 100,000 HIV‑1 RNA copies/ml who experienced virologic failure exhibited a higher rate of treatment‑emergent resistance to the non‑nucleoside reverse transcriptase inhibitor (NNRTI) class. More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance.

As with other antiretroviral medicinal products, resistance testing should guide the use of rilpivirine.

Cardiovascular

At supra‑therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG). EDURANT at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. EDURANT should be used with caution when co‑administered with medicinal products with a known risk of Torsade de Pointes.

Immune reactivation syndrome

In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms. Typically, such reactions have been observed within the first weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.

Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

Pregnancy

Edurant should be used during pregnancy only if the potential benefit justifies the potential risk. Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. In the Phase III studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely. Alternatively, switching to another ART regimen could be considered.

Important information about some of the ingredients of EDURANT

EDURANT contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose‑galactose malabsorption should not take this medicinal product.

Undesirable effects

During the clinical development program (1,368 patients in the Phase III controlled trials TMC278‑C209 (ECHO) and TMC278‑C215 (THRIVE)), 55.7% of subjects experienced at least one adverse drug reaction. The most frequently reported adverse drug reactions (ADRs) (≥ 2%) that were at least of moderate intensity were depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%), and abdominal pain (2.0%). The most frequent serious treatment-related ADRs were reported in 7 (1.0%) patients receiving rilpivirine. The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was 104.3 and 104.1 weeks, respectively. Most ADRs occurred in the first 48 weeks of treatment.

Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, reported in EDURANT treated patients were increased pancreatic amylase (3.8%), increased AST (2.3%), increased ALT (1.6%), increased LDL cholesterol (fasted, 1.5%), decreased white blood cell count (1.2%), increased lipase (0.9%), increased bilirubin (0.7%), increased triglycerides (fasted, 0.6%), decreased haemoglobin (0.1%), decreased platelet count (0.1%), and increased total cholesterol (fasted, 0.1%).

Tabulated list of adverse reactions is available in the full information leaflet.

Description of selected adverse reactions

Immune reactivation syndrome

In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

Breast-feeding

It is not known whether rilpivirine is excreted in human milk. Rilpivirine is excreted in the milk of rats. Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breast‑feed if they are receiving rilpivirine.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk Factors” in the company’s Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q3 Results and any impacts of the COVID-19 pandemic.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

References

 

1 Vocabria EU Summary of Product Characteristics.

2 De Los Rios P, Okoli C, Castellanos C et al. Treatment aspirations and attitudes towards innovative medications among people living with HIV in 25 countries. Popul. Med. 2020;2(July):23

3 De Los Rios P, Okoli C, Castellanos C et al. Physical, Emotional and Psychosocial Challenges Associated with Daily Dosing of HIV Medications and Their Impact on Indicators of Quality of Life: Findings from the Positive Perspectives Study. AIDS and Behavior. 2020

4 Swindells S, Andrade-Villanueva J-F, Richmond G, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. DOI: 10.1056/ NEJMoa1904398

5 Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. DOI: 10.1056/ NEJMoa1909512

6 Overton ET et. al. Cabotegravir and rilpivirine every 2 months is non inferior to monthly: ATLAS-2M study. Presented at CROI 2020: Available at: https://www.croiconference.org/abstract/cabotegravir-rilpivirine-every-2-months-is-noninferior-to-monthly-atlas-2m-study/. Accessed September 2020

ViiV Healthcare media enquires:

Sofia Kalish

+44 (0) 7341 079531

(London)

GSK enquiries:

Media enquiries:

Simon Steel

+44 (0) 20 8047 5502

(London)

Tim Foley

+44 (0) 20 8047 5502

(London)

Kristen Neese

+1 804 217 8147

(Philadelphia)

Kathleen Quinn

+1 202 603 5003

(Washington DC)

Analyst/Investor enquiries:

Sarah Elton-Farr

+44 (0) 20 8047 5194

(London)

Sonya Ghobrial

+44 (0) 7392 784784

(Consumer)

James Dodwell

+44 (0) 20 8047 2406

(London)

Jeff McLaughlin

+1 215 751 7002

(Philadelphia)

Frannie DeFranco

+1 215 751 4855

(Philadelphia)

KEYWORDS: United Kingdom Europe

INDUSTRY KEYWORDS: AIDS Health Infectious Diseases Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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NEXE Strengthens Advisory Board to Complement Board of Directors

PR Newswire

VANCOUVER, BC, Dec. 21, 2020 /PRNewswire/ – NEXE INNOVATIONS INC. (TSXV: NEXE) (the “Company” or “NEXE”) is pleased to announce that it has strengthened its advisory board by appointing seasoned product marketing, automation and financial advisors to complement the Board of Directors.  The Company is an advanced materials company which has commercially developed a fully compostable (plant-based) single-serve coffee pod for use in Keurig Brewing Systems and will continue its innovation strategy by creating other high value plant-based products with sustainability as a primary focus.

“NEXE has undergone several phases of growth since inception, but there is no phase bigger than our transition into commercialization as a public company.  With growth rates in our core business accelerating, the need to attract top talent is a key requirement in driving value to our stakeholders.  Being amongst the largest shareholders of the Company, the management, board, and advisory board are fully aligned with the interests of our investors and fully committed to ‘best-of-breed’ in all facets of the business.  We believe that NEXE now has the right mix of experienced and independent board members to guide, to shape, and to support strategy, all while ensuring solid execution.  We would like thank everyone for their commitment to this point and believe that the best is coming soon,” said Ash Guglani, Co-Founder, Director and President.

The Board of Directors, Officers & Advisory Team are comprised of the following members:


Darren Footz, CEO, Director, Co-Founder

A serial entrepreneur, Mr. Footz is the past President of Granville Island Coffee, a company he built in 5 years from a small artisan roaster to a national brand. He is the innovative mind behind the 100% plant-based and fully compostable NEXE POD. His expertise, dedication and pioneering ideas are the backbone of our organization.


Rajwant Kang, CPA, CMA, Chief Financial Officer & Corporate Secretary

Mr. Kang has over 25 years of accounting and finance experience with public companies is the founder & president of RSK Management Consulting Inc. a company that provides management services. He has proficient knowledge of capital markets, raising capital, M&A and corporate regulation of publicly listed companies.


Ashvani Guglani, President, Director, Co-Founder

Mr. Guglani spent 12 years in capital markets with a national investment bank in Vancouver. As an original founder of NEXE, he plays an integral role in helping NEXE in all capacities across financing (public, private and government), operations, and marketing.


Haytham Hodaly, Independent Director

Mr. Hodaly is currently the Senior Vice President, Corporate Development of Wheaton Precious Metals and brings with him more than 23 years of experience in analyzing mining opportunities. Prior to joining Wheaton Precious Metals, Mr. Hodaly had spent more than 16 years in the North American securities industry, most recently as Director and Mining Analyst, Global Mining Research, at RBC Capital Markets. Mr. Hodaly is an engineer with a Bachelor of Applied Science in Mining and Mineral Processing Engineering and a Master of Engineering, specializing in Mineral Economics, both obtained from the University of British Columbia.


Killian Ruby, Independent Director

Mr. Ruby is the president and chief executive officer of Malaspina Consultants Inc. in Vancouver, and focuses on clients in the resource and junior public sector. Mr. Ruby advises clients on matters related to financial management and public company reporting, and is particularly adept at handling complex issues and multiple stakeholders with a collaborative, team-based approach. Prior to joining Malaspina, Mr. Ruby was an assurance partner at Wolrige Mahon LLP (now Baker Tilly Canada) working predominantly with resource and other junior public companies, and formerly was a senior manager with KPMG LLP working on a range of public companies and reporting issuers.


Graham Gilley, Independent Director

Mr. Gilley is currently a Director of Enterprise Risk Management and Data Protection at Mulgrave School – The International School of Vancouver. For the past 15 years, he has been responsible for the leadership, innovation, governance, and management of the school’s operational, financial, and strategic risks. By developing tools, practices, and policies that analyze and report enterprise risks, he has been able to create and implement an enterprise risk management framework in compliance with applicable regulations and strategic priorities. Previously, Graham was Executive Director of Ideation & Development with Cloud9 Secure Digital Services, where he drove the creation of applications to help power mobile online banking in the Canadian market.


Anthony Rosenfeld, Advisor

Anthony holds 20 years of experience in marketing, strategy and business development. He joined Vega where he built a 50-member team that developed a leading marketing program overseeing consumer, trade, PR, creative and digital marketing.


Paul Bhogal, Advisor

Paul has over 20 years of manufacturing and automation experience. He grew a small family Hamilton-based machine shop into a Tier 1 & 2 automotive production machining/assembly/testing facility with two locations in Ontario and one in Saltillo, Mexico. Paul will be focused on defining, sourcing and implementing manufacturing capacity at G-PAK to ensure fulfilment of customer requirements in a timely, cost-effective, and quality sensitive manner.


Don Chisholm, Advisor

For over 30 years, Don Chisholm has been working at the intersection of business and design. With a unique skillset that balances creativity with innovation and strategy with operations, Don is passionate about working closely with entrepreneurs, executives and marketers to transform businesses and generate results.


Leonard Clough, Advisor

Leonard began his career at RBC Dominion Securities in 1998 and spent 13 years in investment management. In 2013, he founded Toro Pacific Management Inc, a capital markets advisory firm focusing on high growth, early-stage companies looking to access the Canadian capital markets. Mr. Clough has extensive public company experience, has worked in senior management roles including CEO, has served as a Director of several public companies, has structured transactions and executed several capital formation mandate over a variety of sectors.

Finally, the NEXE Innovations team would like to wish Season’s Greetings to all of its stakeholders, team members and partners. This past year has been a difficult one for many and we would like to wish a safe, happy, and prosperous 2021 filled with good health.

We will be updating our initiatives to our stakeholders in the coming weeks with our corporate update.

About NEXE Innovations Inc.

NEXE Innovations Inc. is a well financed, British Columbia-based advanced materials company which has developed a fully compostable (plant-based) single-serve coffee pod for use in Keurig Brewing Systems. The Company purchased its facility in Surrey, British Columbia in 2016. In addition, the Company has developed custom automation through its European and Canadian partners enabling the Company to commercialize its proprietary capsules. The Company believes that the NEXE POD can eventually eradicate the waste created by single serve capsules. The Company’s goal is to attract and sustain a significant portion of the single serve market, as there is a growing demand for environmentally friendly and sustainable products.

For additional information, please contact:

Ash Guglani, President at (604) 359-4725
or visit: nexeinnovations.com

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this release are forward-looking statements or information, which include the proposed use of proceeds, commercialization of the NEXE PODs and increase production capacity, create other environmentally friendly compostable packaging opportunities, the date of trading of the Company’s common shares on the Exchange, development of technologies, the potential of the Company’s technology, future plans, regulatory approvals and other matters. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such information can generally be identified by the use of forwarding-looking wording such as “may”, “expect”, “estimate”, “anticipate”, “intend”, “believe” and “continue” or the negative thereof or similar variations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including but not limited to, business, economic and capital market conditions, the ability to manage operating expenses, consumer demand for and sentiment towards the Company’s products, security threats, and dependence on key personnel. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the demand for its products, anticipated costs, and the ability to achieve goals. Factors that could cause the actual results to differ materially from those in forward-looking statements include, failure to obtain regulatory approval, the continued availability of capital and financing, equipment failures, litigation, increase in operating costs, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, competition, failure of counterparties to perform their contractual obligations, government regulations, loss of key employees and consultants, and general economic, market or business conditions.  Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The reader is cautioned not to place undue reliance on any forward-looking information.

The forward-looking statements contained in this news release are made as of the date of this news release.  Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

 

Cision View original content:http://www.prnewswire.com/news-releases/nexe-strengthens-advisory-board-to-complement-board-of-directors-301196554.html

SOURCE Nexe Innovations Inc.

Posted on

Takeda Furthers Innovation-Focused Strategy in China with Sale of Select Non-Core Assets to Hasten for $322 million USD

Takeda Furthers Innovation-Focused Strategy in China with Sale of Select Non-Core Assets to Hasten for $322 million USD

− Takeda continues to execute on global strategy focused on life-transforming treatments for patients living with complex and rare diseases

− Fast tracks innovative medicines to patients in China in key business areas

OSAKA, Japan–(BUSINESS WIRE)–
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has entered into an agreement to divest a portfolio of non-core prescription pharmaceutical products sold in China to Hasten Biopharmaceutic Co., Ltd. (China) (“Hasten”), a company funded by Feidong County of Hefei City, China and established by Ray Capital Management Limited (“Ray Capital”)1 Takeda will receive $322 million USD, subject to customary legal and regulatory closing conditions.

The portfolio to be divested to Hasten includes cardiovascular and metabolism products sold in mainland China. The portfolio generated FY2019 net sales of approximately $109.5 million USD, driven by strong sales of cardiovascular products such as Ebrantil®. While the products included in the sale continue to play important roles in meeting patient needs in the country, they are outside of Takeda’s chosen business areas – Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience – that are core to its global long-term growth strategy.

“China is an important market for Takeda in our efforts to accelerate the availability of our highly innovative medicines to patients living with complex and rare diseases,” said Ricardo Marek, President, Growth & Emerging Markets Business Unit, Takeda. “This sale will further sharpen Takeda’s focus and resources in fast tracking innovation in China, and the Emerging Markets. At the same time, we are confident that under Ray Capital, Hasten will be well-positioned to provide continued patient access to these trusted products in China.”

“This announcement marks continued progress on our commitment to simplify our global portfolio and remain focused on investing in our growth drivers, and research and development pipeline,” said Costa Saroukos, Chief Financial Officer, Takeda. “We remain committed to expansion in China with more than 15 planned approvals over the next five years. By continuing to execute and deliver on Takeda’s financial commitments, including paying down debt and focusing on our highly innovative portfolio, we can sustain our long-term growth and continue to deliver life-transforming treatments for patients worldwide.”

Takeda intends to use the proceeds from its divestitures to continue to reduce its debt and accelerate deleveraging toward its target of 2x net debt/adjusted EBITDA within FY2021 – FY2023.

Takeda has sustained momentum in its divestiture strategy in 2020 and exceeded its $10 billion non-core asset divestiture target, announcing 10 deals since January 2019 to date for a total aggregate value of up to ~$11.3 billion, including agreements to divest:

  • Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates for a total value of approximately JPY 242.0 billion ($2.3 billion USD).
  • Other non-core portfolio assets within the Growth & Emerging Markets Business Unit, totaling up to approximately ~$2 billion with four separate buyers.2
  • Select OTC and non-core assets in Europe to Orifarm for up to approximately $670 million.
  • Non-core assets in Europe and Canada to Cheplapharm for approximately $562 million.
  • The TachoSil Fibrin Sealant Patch to Corza Health, Inc. for €350 million.

Transactions still pending are expected to close by March 31, 2021, subject to customary legal and regulatory closing conditions.

Transaction Details

Takeda has entered into an agreement to sell a portfolio of five select non-core prescription pharmaceutical assets sold in mainland China to Hasten for $322 million USD.

Under the terms of the agreement, Hasten will acquire the rights, title and interest to the products in the portfolio exclusive to China. Employees who are dedicated to the commercial support of these products today will be transferred to Hasten. Takeda and Hasten have also entered into a manufacturing and supply agreement under which Takeda will continue to manufacture the portfolio of divested products and supply them to Hasten.

The agreement is expected to close by June 30, 2021, subject to the satisfaction of customary closing conditions, receipt of required regulatory clearances and, where applicable, satisfaction of local works council requirements. Until then, Takeda remains the owner of these products.

Takeda is being advised by BofA Securities as its financial advisor and White & Case is its legal advisor in this transaction.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company

Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

1 Ray Capital is a biopharmaceutical investment company established by the Government of Hefei Municipality.

2Includes agreement with Hypera S.A. for the sale of select non-core products in Latin America which remains subject to close; and, completed sales of non-core assets in the Russia-CIS region to STADA, the Near East, Middle East and Africa region to Acino, and Asia Pacific to Celltrion Inc.

Investor Relations

Christopher O’Reilly

[email protected]
+81 (0) 3-3278-2306

Media Contacts:

Japanese Media

Kazumi Kobayashi

[email protected]

+81 (0) 3-3278-2095

Media outside Japan

Justine Grosvenor

[email protected]

+1 872-226-6701

KEYWORDS: Japan Asia Pacific

INDUSTRY KEYWORDS: Biotechnology General Health Other Health Health Pharmaceutical

MEDIA:

Posted on

Shell fourth quarter 2020 update note

The Hague, December 21, 2020 − This is an update to the fourth quarter 2020 outlook provided in the third quarter results announcement on October 29, 2020. The impacts presented here may vary from the actual results and are subject to finalisation of the fourth quarter 2020 results.

This update note is presented based on prevailing commodity prices and forward curves, further movements and volatility till the end of the year are likely to impact earnings and CFFO.

Unless otherwise indicated, presented impacts relate to Adjusted Earnings on a post-tax basis.

INTEGRATED GAS

  • Production is expected to be between 900 and 940 thousand barrels of oil equivalent per day. Despite increased production compared with the third quarter 2020, earnings impact is limited due to PSC effects.
  • LNG liquefaction volumes are expected to be between 8.0 and 8.6 million tonnes.
  • Trading and optimisation results are expected to be below average.
  • Approximately 80% of our term sales of LNG in 2020 have been oil price linked with a price-lag of up to 6 months.
  • Significant margining outflows have impacted CFFO in the fourth quarter so far, compared with margining related inflows at the end of the third quarter 2020. The full quarter impact is subject to movements in commodity prices and forward curves up until the last day of the quarter.

UPSTREAM

  • Adjusted Earnings are expected to show a loss in the current price environment.
  • Production is expected to be between 2,275 and 2,350 thousand barrels of oil equivalent per day, reflecting hurricane impacts in the US Gulf of Mexico (between 60 and 70 thousand barrels of oil equivalent per day) and the effect of mild weather in Northern Europe in the first half of the fourth quarter.
  • Realised Upstream gas prices are expected to trend in line with Henry Hub.
  • Depreciation is expected to be $100 to $200 million higher compared with the third quarter 2020. 
  • Tax charge in the range of $600 million and $900 million is expected to negatively impact Adjusted Earnings in the fourth quarter. This includes unfavourable movements in deferred tax positions.
  • Despite the expected earnings loss, CFFO is not expected to reflect a comparable cash tax effect due to the build-up of deferred tax positions in a number of countries.
  • CFFO is expected to be negatively impacted by the settlement of previously booked provisions in the range of $400 to $500 million.

OIL PRODUCTS

  • Refinery utilisation is expected to be between 72% and 76%.
  • Realised gross refining margins are expected to be slightly improved compared with the third quarter 2020.
  • Sales volumes are expected to be between 4,000 and 5,000 thousand barrels per day.
  • Marketing results are expected to be in line with the fourth quarter 2019 while significantly lower compared with the record third quarter 2020 due to lower volumes driven by seasonal trends.
  • Trading and optimisation results are expected to be significantly lower compared with the third quarter 2020.
  • Significant derivatives related outflows have impacted CFFO in the fourth quarter so far, compared with derivatives related inflows at the end of the third quarter 2020. The full quarter impact is subject to movements in commodity prices and forward curves up until the last day of the quarter.
  • Working capital movements are typically impacted by movements between the quarter opening and closing price of crude along with changes in inventory volume.

CHEMICALS

  • Chemicals manufacturing plant utilisation is expected to be between 77% and 81%.
  • Chemicals sales volumes are expected to between 3,600 and 3,900 thousand tonnes.
  • Chemicals base and intermediate margins are expected to improve compared with the third quarter 2020.

CORPORATE

  • Corporate segment Adjusted Earnings are expected to be a net expense of $900 to $975 million for the fourth quarter, impacted by unfavourable movements in deferred tax positions. This excludes the impact of currency exchange effects.

OTHER

  • Higher underlying operating expenses due to increased activity compared to the third quarter 2020 are expected to impact Adjusted Earnings across the businesses.
  • As per previous disclosures, CFFO price sensitivity at Shell Group level is estimated to be $6 billion per annum for each $10 per barrel Brent price movement.
  • Note that this price sensitivity is indicative and is most applicable to smaller price changes than those in the current environment and in relation to the full-year results. This excludes the short-term impacts from working capital movements and cost-of-sales adjustments.
  • Post-tax charges, in aggregate, between $3.5 to $4.5 billion in relation to impairments, asset restructuring and onerous contracts are expected in the fourth quarter. These expected charges, reported as identified items, relate to Upstream (including partial impairment of Appomattox asset in the US Gulf of Mexico due to subsurface updates), Oil Products (including charges related to announced transformation of the refinery portfolio) and Integrated Gas (onerous contracts). As per accounting standards, charges linked to Reshape organisational restructuring  are expected to be recognised in 2021.
  • Shell will provide a strategy update on 11 February 2021.


Consensus

The consensus collection for quarterly Adjusted Earnings and CFFO excluding working capital movements, managed by VARA research, is scheduled to be opened for submission on 13 January 2021, closed on 27 January 2021, and made public on 28 January 2021.


Contacts

Media International: +44 (0) 207 934 5550

Media Americas: +1 832 337 4355


Cautionary Note

The companies in which Royal Dutch Shell plc directly and indirectly owns investments are separate legal entities. In this announcement “Shell”, “Shell Group” and “Royal Dutch Shell” are sometimes used for convenience where references are made to Royal Dutch Shell plc and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to Royal Dutch Shell plc and its subsidiaries in general or to those who work for them. These terms are also used where no useful purpose is served by identifying the particular entity or entities. ‘‘Subsidiaries’’, “Shell subsidiaries” and “Shell companies” as used in this announcement refer to entities over which Royal Dutch Shell plc either directly or indirectly has control. Entities and unincorporated arrangements over which Shell has joint control are generally referred to as “joint ventures” and “joint operations”, respectively. Entities over which Shell has significant influence but neither control nor joint control are referred to as “associates”. The term “Shell interest” is used for convenience to indicate the direct and/or indirect ownership interest held by Shell in an entity or unincorporated joint arrangement, after exclusion of all third-party interest. This announcement contains the following forward-looking Non-GAAP measure: Adjusted Earnings. We are unable to provide a reconciliation of the above forward-looking Non-GAAP measures to the most comparable GAAP financial measures because certain information needed to reconcile the above Non-GAAP measure to the most comparable GAAP financial measure is dependent on future events some which are outside the control of the company, such as oil and gas prices, interest rates and exchange rates. Moreover, estimating such GAAP measures consistent with the company accounting policies and the required precision necessary to provide a meaningful reconciliation is extremely difficult and could not be accomplished without unreasonable effort. Non-GAAP measures in respect of future periods which cannot be reconciled to the most comparable GAAP financial measure are calculated in a manner which is consistent with the accounting policies applied in Royal Dutch Shell plc’s financial statements.

This announcement contains forward-looking statements (within the meaning of the U.S. Private Securities Litigation Reform Act of 1995) concerning the financial condition, results of operations and businesses of Royal Dutch Shell. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in these statements. Forward-looking statements include, among other things, statements concerning the potential exposure of Royal Dutch Shell to market risks and statements expressing management’s expectations, beliefs, estimates, forecasts, projections and assumptions. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. There are a number of factors that could affect the future operations of Royal Dutch Shell and could cause those results to differ materially from those expressed in the forward-looking statements included in this announcement, including (without limitation): (a) price fluctuations in crude oil and natural gas; (b) changes in demand for Shell’s products; (c) currency fluctuations; (d) drilling and production results; (e) reserves estimates; (f) loss of market share and industry competition; (g) environmental and physical risks; (h) risks associated with the identification of suitable potential acquisition properties and targets, and successful negotiation and completion of such transactions; (i) the risk of doing business in developing countries and countries subject to international sanctions; (j) legislative, fiscal and regulatory developments including regulatory measures addressing climate change; (k) economic and financial market conditions in various countries and regions; (l) political risks, including the risks of expropriation and renegotiation of the terms of contracts with governmental entities, delays or advancements in the approval of projects and delays in the reimbursement for shared costs; (m) risks associated with the impact of pandemics, such as the COVID-19 (coronavirus) outbreak; and (n) changes in trading conditions. No assurance is provided that future dividend payments will match or exceed previous dividend payments. All forward-looking statements contained in this announcement are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Additional risk factors that may affect future results are contained in Royal Dutch Shell’s Form 20-F for the year ended December 31, 2019 (available at www.shell.com/investor and www.sec.gov). These risk factors also expressly qualify all forward-looking statements contained in this announcement and should be considered by the reader. Each forward-looking statement speaks only as of the date of this announcement, December 21, 2020. Neither Royal Dutch Shell plc nor any of its subsidiaries undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information. In light of these risks, results could differ materially from those stated, implied or inferred from the forward-looking statements contained in this announcement.

We may have used certain terms, such as resources, in this announcement that the United States Securities and Exchange Commission (SEC) strictly prohibits us from including in our filings with the SEC. Investors are urged to consider closely the disclosure in our Form 20-F, File No 1-32575, available on the SEC website www.sec.gov.

LEI number of Royal Dutch Shell plc: 21380068P1DRHMJ8KU70



Posted on

Mkango Appoints Bacchus Capital as Strategic and Financial Adviser

LONDON and VANCOUVER, British Columbia, Dec. 21, 2020 (GLOBE NEWSWIRE) — Mkango Resources Ltd. (AIM/TSX-V: MKA) (the “Company” or “Mkango”) is pleased to announce the appointment of Bacchus Capital Advisers Limited (“Bacchus Capital”) as strategic and financial adviser, encompassing mergers and acquisitions, takeover defence, strategic and other financial advice.

Bacchus Capital is a London-based independent investment and merchant banking boutique. The Bacchus Capital team members have been involved in building some of the world’s most successful mining companies from the earliest stages and have played a key role in many of the metals and mining industry’s most significant transactions in recent decades.

William Dawes, Chief Executive of Mkango stated:
“We are very pleased to appoint Bacchus Capital as strategic and financial adviser. This comes at a critical time in Mkango’s development, against the backdrop of transformational changes in the rare earths sector, and we look forward to working with Bacchus Capital to best position the company for new opportunities and to increase value for shareholders.”

Richard Allan, Managing Director and COO of Bacchus Capital stated: “We are excited to begin working with Mkango at a time when the wider market is starting to appreciate the material structural supply deficit facing critical materials, such as rare earths. Mkango will play an important role in supplying the increasing demand for the rare earths required to support a global shift towards a sustainable economy, specifically in light of the increased demand for electric vehicles and wind power.”

Under the terms of the advisory agreement, Bacchus Capital will receive a fee of US$30,000 and, subject to TSX Venture Exchange approval, 325,000 shares on 31 January 2021, and a further 625,000 shares on 18 December 2021 should its engagement continue with the Company until such date.

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Mkango’s primary business is exploration for rare earth elements and associated minerals in the Republic of Malawi, a country whose hospitable people have earned it a reputation as “the warm heart of Africa”. The Company holds interests in four exclusive prospecting licenses in Malawi: the Phalombe licence, the Thambani licence, the Chimimbe Hill licence and the Mchinji licence.

The main exploration target in the 51% held Phalombe licence is the Songwe Hill rare earths deposit. This features carbonatite-hosted rare earth mineralisation and was subject to previous exploration in the late 1980s. Mkango completed an updated Pre-Feasibility Study for the project in November 2015 and a Feasibility Study is currently underway, the initial phases of which included a 10,900 metre drilling programme and an updated mineral resource estimate, announced in February 2019. In March 2019, the Company announced receipt of a £7 million (C$12.3 million) investment from Talaxis to fund completion of the Feasibility Study. Following completion of the Feasibility Study, Talaxis has an option to acquire a further 26% interest in Songwe by arranging financing for project development including funding the equity component thereof.

The main exploration targets in Mkango’s remaining three 100% held licences are, in the Thambani licence, uranium, niobium, tantalum and zircon, in the Chimimbe Hill licence, nickel and cobalt, and in the Mchinji licence, rutile, nickel, cobalt, base metals and graphite. Mkango recently completed an extensive exploration program following a new rutile discovery within the Mchinji licence.

Mkango also holds a 75.5% interest in Maginito (www.maginito.com) with the balance owned by Talaxis. Maginito was established by Mkango and Talaxis to pursue downstream green technology opportunities in the rare earths supply chain, encompassing neodymium (NdFeB) magnet recycling as well as innovative rare earth alloy, magnet and separation technologies.

Maginito’s strategy is underpinned by offtake rights for sustainably sourced primary and secondary raw materials, and geared to accelerating growth in the electric vehicle sector, wind power generation and other industries driven by decarbonization of the economy.

For more information, please visit www.mkango.ca.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement may have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the release of this announcement.

Cautionary Note Regarding Forward-Looking Statements

This news release contains forward-looking statements (within the meaning of that term under applicable securities laws) with respect to Mkango, its business and the Project. Generally, forward looking statements can be identified by the use of words such as “plans”, “expects” or “is expected”, “scheduled”, “estimates” “intends”, “anticipates”, “believes”, or variations of such words and phrases, or statements that certain actions, events or results “can”, “may”, “could”, “would”, “should”, “might” or “will”, occur or be achieved, or the negative connotations thereof. Forward looking statements in this news release include statements with respect to the global market for rare earth metals the Company is exploring for, completion of the feasibility study for Songwe. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. Such factors and risks include, without limiting the foregoing, governmental action relating to COVID-19, COVID-19 and other market effects on global demand for the metals and associated downstream products for which Mkango is exploring, researching and developing, the positive results of a feasibility study on the Project and delays in obtaining financing or governmental or stock exchange approvals. The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made by, third parties in respect of the matters discussed above.

For further information on Mkango, please contact:

Mkango Resources Limited  
William Dawes Alexander Lemon
Chief Executive Officer President

[email protected]
[email protected]
Canada: +1 403 444 5979  
   

www.mkango.ca
 		 
@MkangoResources  
   
Blytheweigh  
Financial Public Relations  
Tim Blythe  
UK: +44 207 138 3204  
   
SP Angel Corporate Finance LLP  
Nominated Adviser and Joint Broker  
Jeff Keating, Caroline Rowe  
UK: +44 20 3470 0470  
   
Alternative Resource Capital  
Joint Broker  
Alex Wood  
UK: +44 20 7186 9004  
   
Bacchus Capital Advisers  
Strategic and Financial Adviser  
Richard Allan  
UK: +44 20 3848 1642  


The TSX Venture Exchange has neither approved nor disapproved the contents of this press release. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any equity or other securities of the Company in the United States. The securities of the Company will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) and may not be offered or sold within the United States to, or for the account or benefit of, U.S. persons except in certain transactions exempt from the registration requirements of the U.S. Securities Act.



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BetterLife Closes Acquisition of Second Generation Psychedelic Assets of Transcend Biodynamics LLC

VANCOUVER, Dec. 20, 2020 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU) is pleased to announce that further to its press release of December 8, 2020, the Company has completed its acquisition to acquire 100% of the assets in Transcend Biodynamics LLC (“Transcend”) in an all-stock transaction, for a total of 13,333,333 common shares at $0.75 per share, with the transaction valued at $10 million.

“We are very pleased to close our acquisition of Transcend. It is our continual objective to broaden our product scope, and Transcend, with its experienced management team, is a perfect foothold for us in the fast-growing market for psychedelics molecules and complements our existing pipeline of treatments. We are excited to bring such a promising brand under the BetterLife umbrella, especially in such a fast-growing and exciting sector,’’ said Dr. Ahmad Doroudian, CEO of BetterLife.

“With this acquisition we are expanding our product pipeline to include psychedelic therapeutics, incorporating elements of our IP around drug delivery technology in which we already have prototypes developed, which we believe will propel us towards clinical studies relatively quickly.  We see great promise in delivering psychedelic-based medicines to treat various diseases and disorders and look forward to unveiling clinical study designs,’’ he continued.

Transcend is a research driven biotechnology company committed to addressing unmet mental health needs through the development of patented next generation psychedelic therapeutics including the Lysergic Acid Diethylamide (“LSD”) derivative BOL-148.

BOL-148 is a nontoxic second-generation LSD-derived molecule that mimics the therapeutic potential of LSD, without the psychedelic effects or hallucinations. Transcend’s patented process allows for cost-effective manufacturing of BOL-148 without the need to make LSD. This makes BetterLife the only entity with the ability to synthesize BOL-148 without the regulatory hurdles of handling a Schedule 1 controlled substance.

“We are excited to work with BetterLife to build out our product line and conduct further R&D to develop an exciting IP portfolio surrounding LSD based pharmaceutical treatments,” said Transcend CEO, Justin Kirkland.  “Both companies have similar values and complementary strengths, which make this a strong corporate and cultural fit.”

BetterLife also announces that it has engaged GRA Enterprises LLC (the “Consultant”) to provide investor relations services pursuant to a consulting agreement dated December 15, 2020. Services will include the production and publication of investor bulletins, distribution of investor bulletins to the Consultant’s e-mail list, and posts via the Consultant’s blogs and social media accounts. In consideration of these services, the Company has paid the Consultant a fee of US$50,000 for a 6-month contract. The Consultant is an arm’s length party to the Company and may purchase securities in the Company from time to time for investment purposes.

About BetterLife Pharma Inc.

BetterLife Pharma Inc. is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies. BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumours to treat specific types of cancer.

For further information please visit www.abetterlifepharma.com.

About Transcend Biodynamics LLC

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Transcend is focused on developing second generation psychedelic compounds, peptides, pro-drugs, and nutraceuticals to address unmet needs within mental health, wellness and anti-aging industries.

Contact Information:

Ahmad Doroudian, Chief Executive Officer
Email: [email protected]
Phone: 604-221-0595

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.



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Allecra Therapeutics and Shanghai Haini Pharmaceutical Announce Exclusive Licensing Agreement for Cefepime/enmetazobactam for Greater China

  • Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties
  • Shanghai Haini gains exclusive manufacturing, development and commercial rights for the licensed territory

SAINT-LOUIS, France and WEIL AM RHEIN, Germany and SHANGHAI, China, Dec. 21, 2020 (GLOBE NEWSWIRE) — Shanghai Haini Pharmaceutical Co., Ltd. (Shanghai Haini), the subsidiary of Yangtze River Pharmaceutical Group (YRPG), and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive licensing agreement under which Shanghai Haini will manufacture, develop and commercialize cefepime/enmetazobactam within Greater China, including Mainland China with Hong Kong and Macau, and Taiwan.

Under the terms of the agreement, Shanghai Haini will be responsible for manufacturing, development and commercialization of cefepime/enmetazobactam, including commercial manufacturing, and all associated costs, within the licensed territory. Subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, Allecra is to receive an upfront cash payment at signing and is eligible to receive further development and sales milestones for cefepime/enmetazobactam with an overall deal value of $78 million, as well as tiered royalties on sales within the licensed territory.

The consummation of the licensing transaction is subject to regulatory approval and other customary conditions precedent.

Mr. Iain Buchanan, on behalf of the Allecra Therapeutics board, said: “We are very pleased to sign this agreement with Shanghai Haini. They are one of the top pharmaceutical firms in China and are considered a market leader in the antibiotics space. With their extensive experience and outstanding development and commercialization capabilities, Shanghai Haini is the ideal partner to maximize the opportunity for cefepime/enmetazobactam for this large and important market region.”

Mr. Tan Pengfei, the General Manager of Shanghai Haini, commented: “We are pleased to in-license cefepime/enmetazobactam and advance its development for Greater China. There is an urgent need in China, and indeed, globally, to bring new antibiotics to the market that can address critical resistance issues. Cefepime/enmetazobactam will be a welcome addition to the tools that doctors have to help their patients, and we look forward to introducing this antibiotic to hospitals and achieving a win-win collaboration.”

A cross-border team of Baker McKenzie life sciences lawyers led by Julia Braun advised Allecra Therapeutics on the legal aspects of the licensing. Staatz Business Development & Strategy acted as corporate finance and transaction adviser on the deal. JunHe LLP provided PRC legal service in connection with the licensing.

Delos Capital, an existing investor of Allecra and a global life sciences fund based in Hong Kong, was instrumental with its representatives serving on Allecra’s board in working with both parties in completing the transaction.

About cefepime/enmetazobactam  
Cefepime/enmetazobactam is a combination of enmetazobactam, a novel extended-spectrum β-lactamase inhibitor belonging to the penicillanic acid sulfone class, with the 4th generation cephalosporin cefepime. Cefepime/enmetazobactam has shown superiority over standard of care in patients with complicated urinary tract infections (cUTIs) in a randomized, controlled, double-blind, global Phase 3 trial. Based on these results, Allecra plans to submit, during the second half of 2021, this ß-lactam/ß-lactamase inhibitor combination for marketing approval in the U.S. and EU. Cefepime/enmetazobactam has been granted Qualified Infectious Disease Product and Fast Track designation by the U.S. Food and Drug Administration (FDA), which will provide five years additional market exclusivity and priority FDA review. The European Medicines Agency (EMA) has indicated that, due to the combination of enmetazobactam with the already-approved cefepime and in light of results obtained in an epithelial lining fluid penetration study with cefepime/enmetazobactam, Allecra Therapeutics is allowed to seek approval of cefepime/enmetazobactam for use in pneumonia, including hospital-acquired/ventilator-associated pneumonia (HAP/VAP), without conducting a Phase 3 study in this indication.

About Allecra Therapeutics

Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms. Lead product candidate, cefepime/enmetazobactam, has shown superiority over standard of care in patients with complicated urinary tract infections (cUTIs) in a randomized, controlled, double-blind, global Phase 3 trial, and the Company is preparing submissions for marketing approval in the U.S. and EU based on these results. The Company has significant patent protection covering proprietary enmetazobactam in major territories. Allecra’s investors are: Forbion, Andera Partners, Delos Capital, Xeraya Capital, EMBL Ventures, and BioMedPartners. Allecra’s wholly owned French subsidiary is a beneficiary of financial support from Bpifrance and the Région Alsace. Please visit www.allecra.com for further information and follow us on LinkedIn.

About YRPG

Yangtze River Pharmaceutical Group (YRPG) was founded in 1971, which is headquartered in Taizhou, China. It is a large-scale Chinese pharmaceutical company that integrates research, production and distribution. As a leading company in the pharmaceutical industry in China, Yangtze River Pharmaceutical Group has extensive marketing network, and adheres to the core values of “High quality, Benefits the people, Innovation, and Perfection”. It dedicates in the pharmaceutical industry and also implements the traditional Chinese medicine, chemical medicine, and biological medicine, which is known as the “Three Drives” strategy in order to provide the society with most effective medicines and health services, and to become one of the most respected pharmaceutical companies in the world. For more information, please visit our website, www.yangzijiang.com.

About Shanghai Haini

Shanghai Haini Pharmaceutical Co., Ltd. (Shanghai Haini) was founded in 2001. It is located in Pudong District, Shanghai, at Shanghai Zhangjiang Bio-pharmaceutical Industrial Park. Shanghai Haini is the first wholly-owned subsidiary established by YRPG outside Taizhou headquarter. After 20 years of development, it has become a leading company in the pharmaceutical industry in Shanghai and a rising star in the life and health industry in the “Yangtze River Delta” area.

Contact
 
Allecra Therapeutics GmbH
 
Andreas Kranzusch
Chief Financial Officer
[email protected]
 
Media inquiries
 
MC Services AG
   
Europe:

Raimund Gabriel
Tel.: +49 89 210 228 80		 U.S.:

Laurie Doyle
Tel.: +1 339 832 0752
[email protected]
  
 
Shanghai Haini Pharmaceutical Co., Ltd.
 
Chai Hao
Tel.: +86 21 6812 8999
[email protected]



Posted on

Changes in Supervisory Board

December 21, 2020

Mrs. Laurence Mulliez and Mr. Andy Brown will step down from the Supervisory Board.

After serving 6 years on the Supervisory Board, Mrs. Laurence Mulliez announced that she will step down at the time of the General Shareholder meeting on April 7, 2021.

Mr. Andy Brown will leave the board by year end 2020 to prepare for a role in another company in the course of 2021. Mr. Andy Brown joined the Supervisory Board in 2020.

Mr. Roeland Baan, Chairman of the Supervisory Board said:
“I thank both Laurence and Andy for their valuable contributions. Laurence has for many years contributed significantly in especially the development of the strategy of the Company in Renewables. Andy will be missed for his vast experience in the oil and gas industry. I wish both Laurence and Andy every success in the future.”

The Company has started the process to fill the vacancies in the Supervisory Board.

Corporate
Profile

The Company’s main activities are the design, supply, installation, operation and the life extension of floating production solutions for the offshore energy industry over the full lifecycle. The Company is market leading in leased floating production systems, with multiple units currently in operation.

As of December 31, 2019, the Company employs approximately 4,450 people worldwide spread over offices in our key markets, operational shore bases and the offshore fleet of vessels.

SBM Offshore N.V. is a listed holding company headquartered in Amsterdam, the Netherlands. It holds direct and indirect interests in other companies.

Where references are made to SBM Offshore N.V. and /or its subsidiaries in general, or where no useful purpose is served by identifying the particular company or companies “SBM Offshore” or “the Company” are sometimes used for convenience.

For further information, please visit our website at www.sbmoffshore.com.

The Management Board
Amsterdam, the Netherlands, December 21, 2020

Financial Calendar Date Year
Full Year 2020 Earnings – Press Release February 11 2021
Annual General Meeting of Shareholders April 7 2021
Trading Update 1Q 2021 – Press Release May 12 2021
Half Year 2021 Earnings – Press Release August 5 2021
Trading Update 3Q 2021 – Press Release November 11 2021

For further information, please contact:

Investor Relations

Bert-Jaap Dijkstra
Group Treasurer and IR

Telephone: +31 (0) 20 236 3222
Mobile: +31 (0) 6 21 14 10 17
E-mail: [email protected]
Website: www.sbmoffshore.com

Media Relations

Vincent Kempkes
Group Communications Director

Telephone: +31 (0) 20 236 3170
Mobile: +31 (0) 6 25 68 71 67
E-mail: [email protected]
Website: www.sbmoffshore.com

Disclaimer

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Some of the statements contained in this release that are not historical facts are statements of future expectations and other forward-looking statements based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those in such statements. Such forward-looking statements are subject to various risks and uncertainties, which may cause actual results and performance of the Company’s business to differ materially and adversely from the forward-looking statements. Certain such forward-looking statements can be identified by the use of forward-looking terminology such as “believes”, “may”, “will”, “should”, “would be”, “expects” or “anticipates” or similar expressions, or the negative thereof, or other variations thereof, or comparable terminology, or by discussions of strategy, plans, or intentions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this release as anticipated, believed, or expected. SBM Offshore NV does not intend, and does not assume any obligation, to update any industry information or forward-looking statements set forth in this release to reflect subsequent events or circumstances. Nothing in this press release shall be deemed an offer to sell, or a solicitation of an offer to buy, any securities.

 

Attachment



Posted on

SOL: Sasol – DIvestment Of Full Shareholding In Central Termica De Ressano Garcia S.A. (CTRG)

PR Newswire

JOHANNESBURG, Dec. 21, 2020 /PRNewswire/ — Sasol is pleased to announce that a Sale Securities Purchase Agreement has been signed with Azura Power Limited for the divestment of the Company’s full shareholding in CTRG, the gas-to-power plant located in Ressano Garcia, Mozambique.

The transaction is subject to a number of conditions precedent, which include regulatory approval and the waiver of pre-emption rights held by Electricidade de Mocambique (EDM), the Mozambican state-owned electricity company.

The consideration will be approximately USD145 million and covers the equity and other shareholder claims that Sasol holds in CTRG. This will be subject to any relevant closing adjustments, including those in relation to working capital.

This transaction is part of the Company’s ongoing, strategy aligned, asset divestment programme. Sasol remains fully committed to upstream operations in Mozambique, which continue to be integral to Sasol’s strategy.

For further information, please contact:

Sasol Investor Relations,
Tiffany Sydow, Investor Relations Officer
Telephone: +27 (0) 71 673 1929
[email protected]

Disclaimer – Forward-looking statements

Sasol may, in this document, make certain statements that are not historical facts and relate to analyses and other information which are based on forecasts of future results and estimates of amounts not yet determinable. These statements may also relate to our future prospects, expectations, developments and business strategies. Examples of such forward-looking statements include, but are not limited to, the impact of the novel coronavirus (COVID-19) pandemic on Sasol’s business, results of operations, financial condition and liquidity and statements regarding the effectiveness of any actions taken by Sasol to address or limit any impact of COVID-19 on its business; statements regarding exchange rate fluctuations, changing crude oil prices , volume growth, increases in market share, total shareholder return, executing our growth projects (including LCCP), oil and gas reserves, cost reductions, our climate change strategy and business performance outlook. Words such as “believe”, “anticipate”, “expect”, “intend”, “seek”, “will”, “plan”, “could”, “may”, “endeavour”, “target”, “forecast” and “project” and similar expressions are intended to identify such forward-looking statements, but are not the exclusive means of identifying such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and there are risks that the predictions, forecasts, projections and other forward-looking statements will not be achieved. If one or more of these risks materialise, or should underlying assumptions prove incorrect, our actual results may differ materially from those anticipated. You should understand that a number of important factors could cause actual results to differ materially from the plans, objectives, expectations, estimates and intentions expressed in such forward-looking statements. These factors and others are discussed more fully in our most recent annual report on Form 20-F filed on 24 August 2020 and in other filings with the United States Securities and Exchange Commission. The list of factors discussed therein is not exhaustive; when relying on forward-looking statements to make investment decisions, you should carefully consider both these factors and other uncertainties and events. Forward-looking statements apply only as of the date on which they are made, and we do not undertake any obligation to update or revise any of them, whether as a result of new information, future events or otherwise.

 

Cision View original content:http://www.prnewswire.com/news-releases/sol-sasol—divestment-of-full-shareholding-in-central-termica-de-ressano-garcia-sa-ctrg-301196561.html

SOURCE Sasol Limited

Posted on

European Commission Approves Aimmune’s PALFORZIA® as First-Ever Treatment for Peanut Allergy in the EU

European Commission Approves Aimmune’s PALFORZIA® as First-Ever Treatment for Peanut Allergy in the EU

— Peanut Allergy is One of the Most Common Food Allergies in Europe —

— Up to 1.6% of European Children Live with Potentially Life-Threatening Peanut Allergy —

VEVEY, Switzerland & LONDON–(BUSINESS WIRE)–
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, today announced that the European Commission (EC) has approved PALFORZIA® [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy. PALFORZIA is indicated in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet and may be continued in patients 18 years of age and older.

“Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allergy, and we are proud to bring PALFORZIA to patients in the EU who, until now, have not had an approved therapeutic option,” said Andrew Oxtoby, President and CEO of Aimmune Therapeutics. “We are grateful for the efforts of the peanut allergy community who contributed to the development program. Now we turn our efforts toward working with health authorities to ensure access of this first-of-kind treatment for those children with peanut allergy for whom our product is appropriate as we prepare to launch in Germany and the UK in May 2021.”

“Today’s news of the EC approval represents the first-ever treatment option approved for peanut allergy in the EU and underscores our vision of providing end-to-end solutions as a driver of wellness and treatment, including prescription medicines for food allergy,” said Greg Behar, CEO of Nestlé Health Science.

Food allergies affect around 17 million people across Europe.1 Peanut allergy is one of the most common food allergies in Europe, with the prevalence doubling among children between 2005 and 2015.1,2,3 The incidence of hospital admissions due to severe allergic reactions also increased seven-fold, and around two-thirds of schools in Europe have at least one child at risk of anaphylaxis.1 Analyses in multiple European countries estimate that around 1.6% of European children live with peanut allergy, with estimations ranging from 0.24% to 2% depending on the diagnostic methods used.4 Severe reactions, which can be life threatening, and the difficulty of avoidance create an urgent need for treatment.5

“Results from landmark Phase 3 clinical trials have shown more than half of patients treated with PALFORZIA were able to tolerate the equivalent of seven to eight peanut kernels after up to nine months of treatment. These compelling data highlight its potential to mitigate against severe allergic reactions, including anaphylaxis in the event of unintended exposure to peanut protein,” said Prof. George du Toit, M.B., B.Ch., Professor of Paediatric Allergy at Evelina London Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London and study investigator for the PALISADE and ARTEMIS trials. “Today’s announcement is a very important step and means that we are closer than ever before to being able to provide an approved treatment for patients with peanut allergy.”

The approval was based on a package of data including two pivotal Phase 3 clinical trials, PALISADE and ARTEMIS.6,7,8 In both studies, PALFORZIA treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo.7

“The incidence of peanut allergy has been increasing across Europe and the threat of accidental exposure is an everyday reality for people with peanut allergy as avoidance is difficult. As a result, many patients and their families suffer a daily toll of uncertainty, stress and fear of a severe reaction,” said Sabine Schnadt, food allergy and anaphylaxis expert at Deutscher Allergie und Asthmabund e.V. (DAAB), a German allergy advocacy organization. “A treatment option which provides an additional level of protection has long been awaited in the peanut allergy community and so we are thrilled with today’s news.”

About PALFORZIA

PALFORZIA is a complex biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research. With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, that can result in the ability to mitigate allergic reactions to the allergen over time. PALFORZIA is a rigorously developed, pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to assure the consistency of every dose, from 0.5 mg (equivalent to 1/600th of a peanut) to 300 mg.

PALFORZIA is not intended for, and does not provide, immediate relief of allergic symptoms. Therefore, this medicinal product is not to be used for emergency treatment of allergic reactions, including anaphylaxis. Self-injectable adrenaline (epinephrine) must be available to the patient at all times.

About the PALISADE and ARTEMIS Phase 3 Clinical Trials

PALISADE (Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization) and ARTEMIS (AR101 Trial in Europe Measuring Oral Immunotherapy Success) evaluated the efficacy and safety of PALFORZIA in 671 participants aged 4 to 17 with peanut allergy in North America and Europe.

Participants enrolled represented a highly allergic population with a high prevalence of comorbidities who reacted to low doses of peanut protein at the screening double-blind, placebo-controlled food challenge (DBPCFC). Participants underwent an initial dose escalation period for 20 to 40 weeks starting at 3 mg until the 300 mg dose was reached. Participants then underwent six months (PALISADE) or three months (ARTEMIS) of maintenance immunotherapy with 300 mg PALFORZIA or placebo until the end of the study.

The primary efficacy endpoint in both studies was the proportion of participants who tolerated a single highest dose of at least 1,000 mg peanut protein (equivalent to seven peanut kernels cumulatively) with no more than mild allergic symptoms at the exit challenge. Key secondary endpoints included desensitization response rates after single doses of 300 mg and 600 mg peanut protein and the maximum severity of symptoms at the exit challenge.7

Endpoint

PALISADE

ARTEMIS

PALFORZIA

n=372

Placebo

n=124

PALFORZIA

n=132

Placebo

n=43

Proportion of participants who tolerated 1,000 mg peanut protein (95% CI; P-value < 0.0001)

50.3%

(45.2, 55.3)

2.4%

(0.8, 6.9)

58.3%

(49.4, 66.8)

2.3%

(0.1, 12.3)

Proportion of participants who tolerated 600 mg peanut protein (95% CI; P-value < 0.0001)

67.2%

(62.3, 71.8)

4.0%

(1.7, 9.1)

68.2%

(59.5, 76.0)

9.3%

(2.6, 22.1)

Proportion of participants who tolerated 300 mg peanut protein (95% CI; P-value < 0.0001)

76.6%

(72.1, 80.6)

8.1%

(4.4, 14.2)

73.5%

(65.1, 80.8)

16.3%

(6.8, 30.7)

The safety profile was as expected for an oral desensitization therapy. The most common adverse reactions (of any severity) were abdominal pain (49.4%), throat irritation (40.7%), pruritus (33.7%), nausea (33.2%), vomiting (28.5%), urticaria (28.5%), oral pruritus (26.0%), abdominal discomfort (22.9%), and abdominal pain upper (22.8%).7

About Aimmune

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and other food-mediated conditions, including gastrointestinal conditions. Aimmune Therapeutics has one FDA- and EU-approved medicine for peanut allergy and other investigational therapies in development. For more information, please visit www.aimmune.co.uk.

About Nestlé Health Science

Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and vitamins, minerals and supplements (VMS) brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world who are committed to making a difference in people’s lives, for a healthier today and tomorrow. www.nestlehealthscience.com.

1 EAACI. Food Allergy & Anaphylaxis Public Declaration, 2015. Available at: http://dgaki.de/wp-content/uploads/2014/04/FoodAllergyAnaphylaxisPublicDeclarationCombined.pdf. Accessed: 13 Nov 2020

2 Du Toit G, et al. Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy. N Engl J Med 2015; 372: 803-13

3 Worldallergy.org. 2019. Food Allergy World Allergy Organization. Available at: https://www.worldallergy.org/education-and-programs/education/allergic-disease-resource-center/professionals/food-allergy

4 Nwaru BI, et al. The epidemiology of food allergy in Europe: a systematic review and meta-analysis. Allergy 2014; 69: 62–75.

5 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3.

6 PALFORZIA. Summary of Product Characteristics.

7 Vickery BP, et al. AR101 oral immunotherapy for peanut allergy. New Engl J Med 2018; DOI: 10.1056/NEJMoa1812856

8 Hourihane JO, et al. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child & Adolescent Health. 2020; 4:10: 728-739.

Global:

Jodi Sievers

+1 (628) 250-6849

[email protected]

Europe:

Sophie Shey

+44 7964 560008

[email protected]

KEYWORDS: Europe Switzerland United Kingdom

INDUSTRY KEYWORDS: Biotechnology General Health FDA Health Pharmaceutical

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