Market Newsdesk

December 11, 2020

• Consortium supports the development of additional 126 Megawatt capacity at wind farm in Finland
• Driving incremental production of renewable electricity in Europe, the deal is expected to add 330 Gigawatt hours of clean power to the electricity grid
• Netherlands-headquartered HEINEKEN, Nouryon, Philips and Signify committed to contracting renewable electricity from the wind farm for the first 10 years through a virtual Power Purchase Agreement (virtual PPA)

Amsterdam, the Netherlands – Royal Philips, HEINEKEN, Nouryon and Signify have formed the first consortium to sign a Pan-European green energy deal securing additional renewable electricity for Europe. The four companies have a shared vision to further reduce CO₂ emissions in support of the UN Paris Agreement and the European Green Deal objectives.

The companies joined forces to support the development of 35 wind turbines in the Mutkalampi municipality in Finland, which is scheduled for completion in 2023. The virtual PPA covers an expected output volume of 330 GWh per year – equivalent to the electricity consumption of 40,000 households. Compared to the average European electricity generation, this renewable electricity will help to avoid over 230,000 tons of CO₂ emissions per year.

The consortium has committed to contracting renewable electricity from the wind farm for the first 10 years through a virtual PPA. The electricity will be physically delivered to the Finnish grid while the four consortium partners benefit from the Guarantees of Origin. This provides income stability for the renewable project while guaranteeing clean energy benefits for the corporate buyers.

While the companies have signed PPAs for renewable electricity in the past, this is the first time such a consortium has formed a virtual PPA to drive incremental renewable electricity for Europe.

Through this consortium, HEINEKEN will source renewable electricity for an additional 31 of its European production sites [1], Nouryon will continue its progress in reducing CO₂ emissions by 25% by 2025, Philips secures renewable electricity supply to power its European operations for a 10-year period and Signify solidifies its leading position on 100% renewable electricity use and doubling the pace to reach the Paris Agreement over their value chain by 2025.

Jorge Paradela, Corporate Affairs Director Europe at HEINEKEN: “As part of our global CO₂ reduction program, Drop the C, we aim to significantly reduce emissions across our value chain and are committed to reaching 70% renewable energy in the production of our beers by 2030. This virtual PPA is another step towards our ambition and will provide the equivalent electricity needed to brew over 5 billion bottles of beer. Where possible, we aim to develop local PPAs for our Operating Companies. For example HEINEKEN Spain has signed a long term PPA involving the construction of a new solar photovoltaic plant. It is not always possible to build locally, therefore we are delighted to join forces on this virtual PPA to deliver significant renewable electricity for Europe. We firmly believe in the power of collaboration to help contribute to a greener world and greener future for us all.”

Marcel Galjee, Vice President Energy & New Business at Nouryon Industrial Chemicals: “As part of our commitment to a sustainable future, we have set a target to reduce carbon emissions by 25% between 2020 and 2025 and to increase our share of renewable and low-carbon energy to 60%. This virtual PPA combines the best of both worlds: additional renewable electricity is realized in Finland where there is space, both physically and on the grid, while we benefit from more sustainable energy for our operations.”

Robert Metzke, Global Head of Sustainability at Philips: “Climate change threatens our healthcare systems globally. This renewable electricity partnership raises the bar in how we can jointly increase green energy supply across Europe, in line with the UN Paris Agreement. With this agreement, we secure renewable electricity supply to power our global operations for a 10-year period, delivering real progress on our 2025 climate targets. By the end of this year, we will be carbon neutral in our own operations, and we aim to source over 75% of our total energy consumption from renewable sources by 2025.”

Nicola Kimm, Head of Sustainability, Environment, Health & Safety at Signify: “The world increasingly faces the challenges posed by climate change. The time to act is now. We already achieved carbon neutrality for all our global operations earlier this year and we source 100% renewable electricity. Now we are committing to double the pace we reach the Paris Agreement over our value chain by 2025. Joining forces to realize this Pan-European PPA will accelerate the transition to clean energy and supports our climate action ambitions. We hope to encourage others to follow so we can collectively reduce carbon emissions around the globe.”

The new wind farm will be realized by Neoen, an independent French producer of renewable energy. The four parties were advised on the consortium by Schneider Electric.

[1] Across 13 of its European Operating Companies in Romania, Portugal, Belgium, Bulgaria, Croatia, Czech Republic, Greece, Hungary, Ireland, Serbia, Slovakia, Slovenia and Switzerland.

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

About Heineken

HEINEKEN is the world’s most international brewer. It is the leading developer and marketer of premium beer and cider brands. Led by the Heineken® brand, the Group has a portfolio of more than 300 international, regional, local and specialty beers and ciders. HEINEKEN is committed to innovation, long-term brand investment, disciplined sales execution and focused cost management. Through “Brewing a Better World”, sustainability is embedded in the business. HEINEKEN has a well-balanced geographic footprint with leadership positions in both developed and developing markets. It employs over 85,000 employees and operates breweries, malteries, cider plants and other production facilities in more than 70 countries. Heineken N.V. and Heineken Holding N.V. shares trade on the Euronext in Amsterdam. Prices for the ordinary shares may be accessed on Bloomberg under the symbols HEIA NA and HEIO NA and on Reuters under HEIN.AS and HEIO.AS. HEINEKEN has two sponsored level 1 American Depositary Receipt (ADR) programmes: Heineken N.V. (OTCQX: HEINY) and Heineken Holding N.V. (OTCQX: HKHHY). Most recent information is available on HEINEKEN’s website: www.theHEINEKENcompany.com and follow us via @HEINEKENCorp.

About Nouryon

We are a global specialty chemicals leader. Markets worldwide rely on our essential chemistry in the manufacture of everyday products, such as paper, plastics, building materials, food, pharmaceuticals, and personal care items. Building on our nearly 400-year history, the dedication of our 10,000 employees, and our shared commitment to business growth, strong financial performance, safety, sustainability, and innovation, we have established a world-class business and built strong partnerships with our customers. We operate in over 80 countries around the world and our portfolio of industry-leading brands includes Eka, Dissolvine, Trigonox and Berol. Visit our website and follow us @Nouryon and on LinkedIn.

About Signify


Signify
(Euronext: LIGHT) is the world leader in lighting for professionals and consumers and lighting for the Internet of Things. Our Philips products, Interact connected lighting systems and data-enabled services, deliver business value and transform life in homes, buildings and public spaces. With 2019 sales of EUR 6.2 billion, we have approximately 37,000 employees and are present in over 70 countries. We unlock the extraordinary potential of light for brighter lives and a better world. We achieved carbon neutrality in 2020, have been in the Dow Jones Sustainability World Index since our IPO for four consecutive years and were named Industry Leader in 2017, 2018 and 2019. News from Signify is located at the Newsroom, Twitter, LinkedIn and Instagram. Information for investors can be found on the Investor Relations page.

 

Attachment

• First Pan-European consortium for future wind farm

FALCON OIL & GAS LTD.

(“Falcon”)

Results of Annual General & Special Shareholders Meeting

11 December 2020 – Falcon Oil & Gas Ltd. (TSXV: FO, AIM: FOG) held its Annual General & Special Shareholders meeting via conference call yesterday, 10 December 2020.

All resolutions considered and voted upon by the shareholders were approved. The full text of each resolution was included in the Management Information Circular communicated in advance of the meeting to shareholders.

The Annual General & Special Shareholders meeting presentation is available on the Falcon website at https://falconoilandgas.com/.

For further information, please contact:

CONTACT DETAILS:

Falcon Oil & Gas Ltd.	+353 1 676 8702
Philip O’Quigley, CEO	+353 87 814 7042
Anne Flynn, CFO	+353 1 676 9162
Cenkos Securities plc (NOMAD & Broker)
Neil McDonald / Derrick Lee	+44 131 220 9771

About Falcon Oil & Gas Ltd.

Falcon Oil & Gas Ltd is an international oil & gas company engaged in the exploration and development of unconventional oil and gas assets, with the current portfolio focused in Australia, South Africa and Hungary. Falcon Oil & Gas Ltd is incorporated in British Columbia, Canada and headquartered in Dublin, Ireland with a technical team based in Budapest, Hungary.

For further information on Falcon Oil & Gas Ltd. please visit www.falconoilandgas.com

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.

Certain information in this press release may constitute forward-looking information. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict. Actual results might differ materially from results suggested in any forward-looking statements. Falcon assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward looking-statements unless and until required by securities laws applicable to Falcon. Additional information identifying risks and uncertainties is contained in Falcon’s filings with the Canadian securities regulators, which filings are available at www.sedar.com.

Zaandam, the Netherlands, 
December 11
, 20
20 – Ahold Delhaize today announces that it has successfully closed a €1 billion, Sustainability-linked Revolving Credit Facility (the ‘Facility’), refinancing its existing 2015-dated €1 billion facility. The Facility is an important milestone that highlights how Ahold Delhaize is reinforcing the alignment of its funding strategy and its commitments laid out in its Healthy & Sustainable ambition, which can be found here  

Through this Facility, Ahold Delhaize draws a connection between its cost of borrowing and the achievement of the following ambitions: 

1. Food waste reduction: as measured by percentage reduction in tons of food waste per million Euro food sales and supporting the UN SDG 12.3; 

2. Carbon emission reduction: as measured by percentage reduction of Scope 1 and Scope 2 CO2-equivalent emissions and aligned with Ahold Delhaize SBTi-certified 2030 targets; 

3. Promotion of healthier eating: as measured by percentage of own brand food sales from healthy products.  

Ahold Delhaize will report on the progress on these ambitions in the company’s annual report.  

Natalie Knight, Chief Financial Officer, said: “This is an important facility for Ahold Delhaize that ensures we maintain our financial flexibility. After having issued the first euro-denominated Sustainability Bond in the Retail industry in June 2019, we believe that linking this facility with our significant Healthy & Sustainable ambition will deliver a positive outcome for all stakeholders.” 

The new Facility has a maturity of three years with two one-year extension options. The Facility also includes a mechanism allowing the company to anticipate the discontinuation of the US dollar interbank benchmark interest rate. A syndicate of 16 relationship banks participate in the Facility. 

ABN AMRO and Société Générale acted as Coordinators and Sustainability Coordinators on the Facility. 

Cautionary notice 
This communication includes forward-looking statements. All statements other than statements of historical facts may be forward-looking statements. Words such as reinforcing, alignment, strategy, commitments, ambition(s), reduction, promotion, progress, ensures, maintain, believe, deliver, outcome, maturity, options, anticipate, discontinuation or other similar words or expressions are typically used to identify forward-looking statements.  

Forward-looking statements are subject to risks, uncertainties and other factors that are difficult to predict and that may cause actual results of Koninklijke Ahold Delhaize N.V. (the “Company”) to differ materially from future results expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the risk factors set forth in the Company’s public filings and other disclosures. Forward-looking statements reflect the current views of the Company’s management and assumptions based on information currently available to the Company’s management. Forward-looking statements speak only as of the date they are made and the Company does not assume any obligation to update such statements, except as required by law. 

Press Release
Nicox’s Partner Fera Pharmaceuticals to Investigate Naproxcinod as Potential Covid-19 Adjuvant Treatment
December 11, 2020 – release at 7:30 am CET Sophia Antipolis, France   Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Fera Pharmaceuticals, a privately-held, U.S. specialty pharmaceutical company, announced today that Fera will evaluate naproxcinod as a potential adjuvant treatment for patients with COVID-19 infection.  Subject to successful completion of the ongoing manufacturing of naproxcinod test material, Fera plans to initiate pre-clinical proof-of-concept studies in models of COVID-19 infection in early 2021. Naproxcinod, a Cyclooxygenase-Inhibiting Nitric Oxide (NO)-Donating (CINOD) naproxen, is a non-steroidal anti-inflammatory product candidate engineered to release NO and naproxen, originally discovered and developed by Nicox.  Nicox and Fera entered into an agreement in December 2015 which granted Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market.  Nicox and Fera are amending their existing agreement to include COVID-19 as an indication, and Nicox will grant to Fera warrants1 to acquire 10,000 Nicox shares. Michele Garufi, Chief Executive Officer and Chairman of Nicox, said: “There is a strongscientific rationale for using naproxcinod in the treatment of the inflammatory symptoms of COVID-19 infections, and potentially against the virus itself.  In collaboration with Fera we will be testing this scientific rationale in relevant pre-clinical models and whilst this research is at an early stage, any potential future human trial would benefit from the extensive naproxcinod clinical data previously generated by Nicox for the treatment of signs and symptoms of osteoarthritis.” Rationale for naproxcinod in COVID-19 treatment Most outcomes of COVID-19 are associated with high levels of inflammation and dysfunction of the vascular system leading to thrombotic events2.  Naproxcinod, a Cox-Inhibiting Nitric Oxide Donor (CINOD), would potentially treat multiple aspects of COVID-19 infection including fever, pain, inflammation and platelet aggregation, thus decreasing the risk of thrombus formation.  In addition, NO donation might increase vasodilation and restore normal vascular functions.  Moreover, NO has specifically been demonstrated to inhibit replication of the COVID-19 virus by two distinct mechanisms3. As an oral capsule formulation, naproxcinod could be easily administered to patients at the first signs of infection. Once Fera has received the newly manufactured naproxcinod, they plan to initiate proof-of-concept pre-clinical tests in models of COVID-19 infection.  Should the results of these studies prove positive, Fera plans to meet with the U.S. Food and Drug Administration (FDA) to identify the clinical trials that would be required to submit a New Drug Application (NDA) for naproxcinod in the treatment of COVID-19 infection.  Under the terms of the naproxcinod agreement with Nicox, Fera is responsible for all clinical development, manufacturing, regulatory and commercialization activities in the U.S.  Nicox retains all rights to naproxcinod outside the U.S., subject to the payment of royalties to Fera, if intellectual property developed under the agreement is used outside the U.S. Fera continues to review non-COVID-19 development options for naproxcinod, including addressing the U.S. FDA refusal letter concerning Fera’s application for Orphan Drug Designation (ODD) of naproxcinod in sickle-cell disease.
About naproxcinod
Naproxcinod is a nitric oxide (NO)-donating naproxen combining the cyclooxygenase (COX) inhibitory activity of naproxen with that of NO (COX-inhibiting NO donor, CINOD).  While the inhibitory COX component provides the analgesic and anti-inflammatory efficacy, the NO part may play a significant role in maintaining vascular endothelial cell function and integrity, blood pressure homeostasis and microvascular circulation.  A broad clinical package already exists for naproxcinod in osteoarthritis, including three phase 3 trials with over 2,700 patients.
About Fera Pharmaceuticals
Fera Pharmaceuticals is a privately held company.  The company goal is to realize opportunities via acquisitions, in-licensing, developing and marketing abbreviated new drug applications (ANDAs), new drug applications (NDAs) and 505(b)(2) NDA products.  Areas of interest include products that could benefit from lifecycle management with a special focus on niche markets.  For more information visit www.ferapharma.com.
About Nicox
Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  Nicox’s lead program in clinical development is NCX 470, a novel, second-generation nitric oxide-donating bimatoprost analog, for lowering intraocular pressure in patients with glaucoma.  The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis.  Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE™ in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets.  Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes. For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
Analyst coverage
Bryan, Garnier & Co        Victor Floc’h           Paris, France Cantor Fitzgerald             Louise Chen           New York, U.S. H.C. Wainwright & Co      Yi Chen                   New York, U.S. Kepler Cheuvreux            Damien Choplain   Paris, France Oppenheimer & Co          Hartaj Singh            New York, U.S.
The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current.  Nicox disavows any obligation to correct or to update the information contained in analyst reports.
Contacts
Nicox Gavin Spencer Executive Vice President, Chief Business Officer & Head of Corporate Development  T +33 (0)4 97 24 53 00 [email protected]
Investors & Media United States & Europe LifeSci Advisors, LLC Mary-Ann Chang T +44 7483 284 853 [email protected]	Media France LifeSci Advisors, LLC Sophie Baumont M +33 (0)6 27 74 74 49 [email protected]
Forward-Looking Statements
The information contained in this document may be modified without prior notice.  This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance.  These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.  Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements. Risks factors which are likely to have a material effect on Nicox’s business are presented (i) in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website (www.nicox.com) and (ii) as restated in the 4th chapter of the half yearly financial report as of June 30, 2020, which is also available on Nicox’s website.
Nicox S.A. Drakkar 2 Bât D, 2405 route des Dolines CS 10313, Sophia Antipolis 06560 Valbonne, France T +33 (0)4 97 24 53 00 F +33 (0)4 97 24 53 99

 

---

¹ The warrants will be issued at no cost.  The subscription price of the new shares to be obtained by exercising the warrants will be equal to the VWAP calculated on the 3-days trading prior to the Board meeting that will decide on the issuance of the warrants.

² Bikdeli et al., COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020; 75(23):2950-2973.

³ S. Akerstrom et al., Dual effect of nitric oxide on SARS-CoV replication: Viral RNA production and palmitoylation of the S protein are affected. Journal of Virology 2009; 395:1–9.

 

 

Attachment

• EN_FeraNaproxcinodCOVID_PR_F

ALLSCHWIL, Switzerland, Dec. 11, 2020 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN) today announced the extension of its existing grant agreement with CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global partnership led by Boston University dedicated to supporting the development of antibacterial products to diagnose, prevent and treat drug-resistant infections. The grant will support the development of Polyphor’s novel OMPTA (Outer Membrane Protein Targeting Antibiotics) BamA program. The OMPTA-BamA program addresses the deadliest and most resistant Gram-negative bacterial pathogens, potentially active against all three critical priority 1 pathogens in the World Health Organization (WHO) list.

Under the extension of the 2019 agreement, CARB-X is committing to Polyphor additional funding of up to USD 2.3 million, bringing potential funding for this contractual stage to USD 5.1 million. Polyphor may also receive up to USD 13 million in future option stages that could take the program through a first-in-human program if certain project milestones are met.

“We are delighted to extend our partnership with CARB-X on our OMPTA-BamA program, which has the potential to be a major breakthrough in addressing carbapenem resistance potentially covering all WHO priority 1 pathogens”, said Gokhan Batur, Chief Executive Officer of Polyphor. “This is another important endorsement of Polyphor’s OMPTA program, following the award by CARB-X in October for our OMPTA Thanatin Derivatives program.”

Polyphor’s novel OMPTA antibiotics target the highest priority Gram-negative ESKAPE pathogens (Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa), which are the leading cause of severe and often deadly infections throughout the world, such as bloodstream infections, urinary tract infections and pneumonia. Importantly, this new class of antibiotics is active against strains which have become resistant to most commonly used antibiotics including the “last resort workhorse” carbapenems.

For further information please contact:

For Investors:

Hernan Levett Chief Financial Officer Polyphor Ltd. +41 61 567 16 00 [email protected]

Mary-Ann Chang LifeSci Advisors Tel: +44 7483 284 853 [email protected]

For Media:

Bernhard Schmid LifeSci Advisors +41 44 447 12 21 [email protected]



About Polyphor
Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance leveraging the company’s leading macrocyclic peptide technology platform. Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria. The company’s lead OMPTA program is an inhaled formulation of murepavadin for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.

Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor’s results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Research reported in

this news release

is supported by CARB-X. CARB-X’s funding for this project is sponsored by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly

• Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years
• Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups
• Companies plan a Phase 2b study with an improved antigen formulation
• With support from BARDA as part of Operation Warp Speed, study to start in February 2021, including a proposed comparison with an authorized COVID-19 vaccine
• Product availability now expected in Q4 2021 pending successful completion of the development plan  

PARIS and LONDON – December 11, 2020 – Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.

A recent challenge study in non-human primates performed with an improved antigen formulation demonstrated that the vaccine candidate could protect against lung pathology and lead to rapid viral clearance from the nasal passages and lungs, within 2 to 4 days. These results increase the Companies confidence in the capacity of the adjuvanted recombinant platform to deliver a highly efficient vaccine for all adults.

Sanofi’s recombinant technology and GSK’s pandemic adjuvant are established vaccine platforms that have proven successful against influenza. The recombinant technology offers the advantages of stability at temperatures used for routine vaccines, the ability to generate high and sustained immune responses, and the potential to prevent virus transmission.

“We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data. We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine. Following these results and the latest encouraging new preclinical data, we will now work to further optimize our candidate to achieve this goal,” said Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur. “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”

Roger Connor, President of GSK Vaccines added: “The results of the study are not as we hoped. Based on previous experience and other collaborations, we are confident that GSK’s pandemic adjuvant system, when coupled with a COVID-19 antigen, can elicit a robust immune response with an acceptable reactogenicity profile. It is also clear that multiple vaccines will be needed to contain the pandemic. Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to preventing COVID-19.”

The Companies plan a Phase 2b study expected to start in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) under contract W15QKN-16-9-1002. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global Phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.

Sanofi and GSK adjuvanted recombinant protein-based vaccine candidate was selected in July 2020 by U.S. government’s Operation Warp Speed in order to accelerate its development and manufacturing.

The Companies have updated Governments and the European Commission where a contractual commitment to purchase the vaccine has been made.

Phase 1/2 study

The interim Phase 1/2 results showed a level of neutralizing antibody titers after two doses comparable to sera from patients who recovered from COVID-19, a balanced cellular response in adults aged 18 to 49 years, but insufficient neutralizing antibody titers in adults over the age of 50. The candidate showed transient but higher than expected levels of reactogenicity likely due to the suboptimal antigen formulation, with no serious adverse events related to the vaccine candidate. The most favorable results were observed in the group which tested the highest antigen concentration, combined with the GSK adjuvant, showing neutralization titers in 88% of participants. Seroconversion was observed in 89.6% of the 18 to 49 age group; 85% in the >50 age group; and 62.5% in the >60 age group.

The Phase 1/2 clinical study is a randomized, double blind and placebo-controlled study designed to evaluate the safety, reactogenicity and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 441 healthy adults participated in the study, across 10 investigational sites in the United States. The participants received one or two doses of the vaccine candidate, or placebo at 21 days apart.

Full results of the Phase 1/2 study will be published as soon as all data are available, following peer-reviewed publication process.

Latest preclinical results

A recent preclinical study using a highly virulent challenge in non-human primates, showed high ability for the vaccine to protect against lung pathology and reduce virus in the nose and lungs within 2 to 4 days. Results from this pre-clinical study confirm strong ability of the vaccine candidate to stop the replication of the virus with an optimal antigen formulation.

These data are being prepared for submission to a peer-reviewed publication.

On the front lines in the fight against COVID-19

In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/2 study to start in Q1 2021, with earliest potential approval in the second half of 2021.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally. For further information please visit www.gsk.com

About Sanofi   Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.   With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.   Sanofi, Empowering Life
Sanofi Media Relations Quentin Vivant Tel.: +33 (0)1 53 77 46 46 [email protected]   Ashleigh Koss Tel.: +1 (908) 205-2572 [email protected]   Nicolas Kressmann Tel.: +1 (732) 532 53-18 [email protected]	Sanofi Investor Relations – Paris Eva Schaefer-Jansen Arnaud Delepine Yvonne Naughton   Sanofi Investor Relations – North America Felix Lauscher Fara Berkowitz Suzanne Greco   IR Main Line: Tel.: +33 (0)1 53 77 45 45 [email protected]
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  Innate
  
  
  will
  
  
  no longer
  
  
  pursue Lumoxiti
  
  
  commercialization
  
  
  activities
  
  
  in US or E
  
  
  U
  
  
  ;
  
  
  Company
  
  
  to
  
  
  re
  
  
  -focus
  
  
  investments
  
  
  in
  
  
  its
  
  
  R&D p
  
  
  ortfolio 

  
  

• 
  Companies
  
  
  will
  
  
  develop
  
  
  a
  
  
  transition
  
  
  plan
  
  
  with the goal of returning full commercialization
  
  
  responsibilities
  
  
  to
  
  
  AstraZeneca
  
  
  in
  
  
  2021
  

• 
  C
  
  
  ompanies
  
  
  will
  
  
  ensure availability of Lumoxiti to patients
  
  
  during transition period
  

• 
  C
  
  
  onference call to be held
  
  
  today
  
  
  at
  
  
  2 pm CET
  
  
  / 8 am ET
  

MARSEILLE, France, Dec. 11, 2020 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will return the US and EU commercialization rights of Lumoxiti (moxetumomab pasudotox-tdfk) to AstraZeneca¹. Innate licensed the US and EU rights to AstraZeneca’s FDA-approved Lumoxiti for certain patients with relapsed or refractory hairy cell leukemia in October 2018.

The companies will develop a transition plan, including costs and transfer of the US marketing authorization and distribution of Lumoxiti back to AstraZeneca in 2021. AstraZeneca will remain the marketing authorization applicant for the EU filing.

“Since in-licensing Lumoxiti from AstraZeneca, we have been committed to delivering this medicine to patients and healthcare professionals in the US, and moving towards commercialization in the EU.
However,
we’ve determined that there is low
strategic value
for us
in
main
taining
Lumoxiti in our portfolio
due to
lower than anticipated
product
sales
,
further compounded by the
ongoing
COVID-19 pandemic
. This
has
led
us to
ma
k
e the
decision to
re-
prioritize our investments in our R&D portfolio,”
s
aid
Mondher Mahjoubi, Chief Executive Officer of Innate Pharma
. 
“
W
e will
continue to embed a commercial mindset into our R&D programs,
which
is a key success factor
for
the development
and future commercialization
of our
pipeline
assets
.”

As part of this decision, Innate will immediately begin to reduce its US commercial operations; however, it will maintain the appropriate patient and customer support services, as well as product supply, during this transition period. In the EU, Innate will no longer progress Lumoxiti regulatory or commercial activities.   

The accounting impacts will be presented in the December 31, 2020 financial statements. As a reminder, the net book value of Lumoxiti intangible assets amounted to €45.2 million, as of June 30, 2020.  

All other agreements with AstraZeneca remain unchanged. 

About
Lumoxiti (moxetumomab pasudotox-tdfk):

Lumoxiti is a CD22-directed immunotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory (r/r) hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min). It comprises the CD22 binding portion of an antibody fused to a truncated pseudomonas exotoxin. The toxin inhibits protein synthesis and ultimately triggers apoptotic cell death. Lumoxiti received U.S. FDA approval in September 2018 and has been granted Orphan Drug Designation by the FDA and the EMA for the treatment of r/r HCL. AstraZeneca is the marketing authorization applicant for the EU filing.

A conference call will be held today at 2:00pm CET (8:00am ET)

Webcast access: https://edge.media-server.com/mmc/p/4mpdd99d

or Dial in numbers:

France: +33 (0)1 70 70 07 81      US only: + 1 877 870 9135

Standard International: +44 (0) 2071 928338

Conference ID: 9198932

The access to the live webcast will be available on Innate Pharma’s website 30 minutes ahead of the conference.

A replay will be available on Innate Pharma’s website after the conference call.

About Innate Pharma:
Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.

Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.

Innate has been a pioneer in the understanding of natural killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca.

Based in Marseille, France, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com

Information about Innate Pharma shares:

ISIN code Ticker code LEI

FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors
:

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995.The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts, the Company’s continued ability to raise capital to fund its development and the overall impact of the COVID-19 outbreak on the global healthcare system as well as the Company’s business, financial condition and results of operations. For an additional discussion of risks and uncertainties which could cause the company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

For additional information, please contact:

Investors Innate Pharma Tel.: +33 (0)4 30 30 30 30 [email protected]

Media Innate Pharma Tracy Rossin (Global/US) Tel.: +1 240 801 0076 [email protected] ATCG Press Marie Puvieux (France) Tel.: +33 (0)9 81 87 46 72 [email protected]

¹ Lumoxiti is licensed from MedImmune, a subsidiary of AstraZeneca.