Market Newsdesk

KELOWNA, B.C., Nov. 17, 2020 /PRNewswire/ – The Valens Company Inc. (TSX: VLNS) (OTCQX: VLNCF) (the “Company” or “The Valens Company”), a global leader in the end-to-end development and manufacturing of innovative, cannabinoid-based products, today announced the addition of SōRSE Clear, a stable, clear emulsion with a minimal sensory profile, to the SōRSE by Valens offering for CBD isolate product formats.

SōRSE Technology is a water-soluble emulsion technology designed for product developers to provide consumers with a more consistent cannabinoid experience with user-controlled dosing, demonstrated shelf-stability, and safe ingredients. The Valens Company has been leveraging this emulsion technology to transform cannabis extracts into water-soluble forms and to infuse beverages, edibles and topicals without a cannabis aroma and after-taste.

“As the exclusive partner for the development and custom manufacturing of best-in-class cannabis derivative products in Canada, having access to the highest quality cannabinoid emulsion technology is critically important,” said Tyler Robson, Chief Executive Officer of The Valens Company. “We have made great strides revolutionizing many of our product lines with SōRSE by Valens, including more mature formats such as tinctures, and the addition of SōRSE Clear will only deepen our ability to innovate a diverse portfolio of products for the forthcoming 3.0 market.”

SōRSE Clear is currently available in a liquid format and contains safe, vegan, allergen-free ingredients. The new emulsion offering features multiple benefits including stability, safety, improved sensory experience, homogeneity, and seamless integration. SōRSE Clear also complies with all the main safety and testing protocols, including Good Manufacturing Practices (GMP) and The Global Safety Food Initiative (GFSI).

Howard Lee, Chief Executive Officer of SōRSE, said, “We believe that SōRSE Clear is a game-changer for the cannabis industry and we have no doubt that The Valens Company will harness this technology to continue to formulate the most innovative, premium cannabis-infused products for Canadian consumers.”

About The Valens Company

The Valens Company is a global leader in the end-to-end development and manufacturing of innovative, cannabinoid-based products. The Company is focused on being the partner of choice for leading Canadian and international cannabis brands by providing best-in-class, proprietary services including CO2, ethanol, hydrocarbon, solvent-less and terpene extraction, analytical testing, formulation and product development and custom manufacturing. The Valens Company is the largest manufacturer of derivative products in Canada with an annual capacity of 425,000 kg of dried cannabis and hemp biomass at our purpose-built facility in Kelowna, British Columbia which is in the process of becoming European Union (EU) Good Manufacturing Practices (GMP) compliant. The Valens Company currently offers a wide range of product formats, including tinctures, two-piece caps, soft gels, oral sprays and vape pens as well as beverages, concentrates, topicals, edibles, injectables, natural health products and has a strong pipeline of next-generation products in development for future release. Finally, The Valens Company’s wholly-owned subsidiary Valens Labs is a Health Canada licensed ISO 17025 accredited cannabis testing lab providing sector-leading analytical services and has partnered with Thermo Fisher Scientific to develop a Centre of Excellence in Plant-Based Science. For more information, please visit http://thevalenscompany.com. The Valens Company’s investor deck can be found specifically at http://thevalenscompany.com/investors/. 

About SōRSE Technology

SōRSE Technology Corporation is a water-soluble emulsion technology designed for product developers to provide consumers with a better, more consistent cannabinoid experience with greater bioavailability, near-perfect dosing, shelf-stability, and safe ingredients. Its patent-pending technology converts oil into SōRSE, a proprietary water-soluble emulsion, for infusing CBD and other functional ingredients into beverages, food items, topicals, and medical applications. SōRSE Technology currently powers more than 45 leading products in the CBD space.

Notice regarding Forward Looking Statements

All information included in this press release, including any information as to the future financial or operating performance and other statements of The Valens Company that express management’s expectations or estimates of future performance, other than statements of historical fact, constitute forward-looking information or forward-looking statements within the meaning of applicable securities laws and are based on expectations, estimates and projections as of the date hereof. Forward-looking statements are included for the purpose of providing information about management’s current expectations and plans relating to the future. Wherever possible, words such as “plans”, “expects”, “scheduled”, “trends”, “indications”, “potential”, “estimates”, “predicts”, “anticipate”, “to establish”, “believe”, “intend”, “ability to”, or statements that certain actions, events or results “may”, “could”, “would”, “might”, “will”, or are “likely” to be taken, occur or be achieved, or the negative of these words or other variations thereof, have been used to identify such forward-looking information. Specific forward-looking statements include, without limitation, all disclosure regarding future results of operations, economic conditions and anticipated courses of action. Investors and other parties are advised that there is not necessarily any correlation between the number of SKUs manufactured and shipped and revenue and profit, and undue reliance should not be placed on such information.

The risks and uncertainties that may affect forward-looking statements include, among others,  regulatory risk, United States border crossing and travel bans, reliance on licenses, expansion of facilities, competition, dependence on supply of cannabis and reliance on other key inputs, dependence on senior management and key personnel, general business risk and liability, regulation of the cannabis industry, change in laws, regulations and guidelines, compliance with laws, reliance on a single facility, limited operating history, vulnerability to rising energy costs, unfavourable publicity or consumer perception, product liability, risks related to intellectual property, product recalls, difficulties with forecasts, management of growth and litigation, many of which are beyond the control of The Valens Company. For a more comprehensive discussion of the risks faced by The Valens Company, and which may cause the actual financial results, performance or achievements of The Valens Company to be materially different from estimated future results, performance or achievements expressed or implied by forward-looking information or forward-looking statements, please refer to The Valens Company’s latest Annual Information Form filed with Canadian securities regulatory authorities at www.sedar.com or on The Valens Company’s website at www.thevalenscompany.com. The risks described in such Annual Information Form are hereby incorporated by reference herein. Although the forward-looking statements contained herein reflect management’s current beliefs and reasonable assumptions based upon information available to management as of the date hereof, The Valens Company cannot be certain that actual results will be consistent with such forward-looking information. The Valens Company cautions you not to place undue reliance upon any such forward-looking statements. The Valens Company disclaims any intention or 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. Nothing herein should be construed as either an offer to sell or a solicitation to buy or sell securities of The Valens Company.

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SOURCE The Valens Company Inc.

Novel, Plant-based Complete Nutrition for Toddlers to hit retail shelves in coming weeks

VANCOUVER, BC, Nov. 17, 2020 /PRNewswire/ – ELSE NUTRITION HOLDINGS INC. (TSXV: BABY) (OTCQB: BABYF) (FSE: 0YL) (“Else” or the “Company”) the plant-based baby, toddler and children nutrition company, is pleased to announce that as part of its mission to ensure its novel, plant-based toddler nutrition products will be accessible to health conscious families across North America, that it has now commenced shipping its Plant-Based Complete Nutrition for Toddlers to retail stores across the U.S.. The Company and its distribution partner, KeHE Distributors, has thus far activated five distribution centers in various regions across the U.S. This distribution will enable Else’s first product to very quickly be on the shelves of numerous U.S. retail stores, including a soon-to-be announced, national major grocery chain.

“We are so pleased that Else will be available to consumers on their favourite store shelves in advance of the Christmas holiday,” said Mrs. Hamutal Yitzhak, CEO and Co-Founder of Else. “We are making strong headway now, adding brick and mortar as a core sales vertical, to be complemented by our already-growing e-commerce and Amazon business verticals. We continue to extend our appreciation to KeHE Distributors for its early support of our brand, and anticipate early success and aggressive listings in 2021, as we develop our core retail accounts,” she added.

KeHE Distributors has nearly 70 years of experience servicing store owners and today has a network of over 16 distribution centers across North America. KeHE is one of the largest and most well regarded national fresh, natural and organic and specialty food distributors in North America. Else Nutrition’s agreement with KeHE Distributors secures a retail distribution path of Else’s ground-breaking plant-based toddler nutrition products to thousands of store shelves in the United States, and millions of consumers seeking plant-based alternatives for their children.

About Else Nutrition Holdings Inc.

Else Nutrition GH Ltd. is an Israel-based food and nutrition company focused on developing innovative, clean and plant-based food and nutrition products for infants, toddlers, children, and adults. Its revolutionary, plant-based, non-soy, formula is a clean-ingredient alternative to dairy-based formula. Else Nutrition (formerly INDI) won the “2017 Best Health and Diet Solutions” award at the Global Food Innovation Summit in Milan. The holding company, Else Nutrition Holdings Inc., is a publicly traded company, listed as TSX Venture Exchange under the trading symbol BABY and is quoted on the US OTC Markets QX board under the trading symbol BABYF and on the Frankfurt Exchange under the symbol 0YL. Else’s Executives includes leaders hailing from leading infant nutrition companies. Many of Else advisory board members had past executive roles in companies such as Mead Johnson, Abbott Nutrition, Plum Organics and leading infant nutrition Societies, and some of them currently serve in different roles in leading medical centers and academic institutes such as Boston Children’s Hospital, Pediatrics at Harvard Medical School, USA, Tel Aviv University, Schneider Children’s Medical Center of Israel, Rambam Medical Center and Technion, Israel and University Hospital Brussels, Belgium.

For more information, visit: elsenutrition.com or @elsenutrition on Facebook and Instagram.

TSX Venture Exchange

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.

Caution Regarding Forward-Looking Statements

This press release contains statements that may constitute “forward-looking statements” within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as “will” or similar expressions. Forward-looking statements in this press release include statements with respect to the anticipated dates for filing the Company’s financial disclosure documents.  Such forward-looking statements reflect current estimates, beliefs and assumptions, which are based on management’s perception of current conditions and expected future developments, as well as other factors management believes are appropriate in the circumstances. No assurance can be given that the foregoing will prove to be correct. Forward-looking statements made in this press release assume, among others, the expectation that there will be no interruptions or supply chain failures as a result of COVID 19 and that the manufacturing, broker and supply logistic agreement with the Company do not terminate.  Actual results may differ from the estimates, beliefs and assumptions expressed or implied in the forward-looking statements.  Readers are cautioned not to place undue reliance on any forward-looking statements, which reflect management’s expectations only as of the date of this press release. The Company disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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SOURCE Else Nutrition Holdings Inc.

BREDA, the Netherlands and GHENT, Belgium, Nov. 17, 2020 /PRNewswire/ — argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced the release of a new docuseries, A Mystery to Me, which depicts the experiences of people living with myasthenia gravis (MG), a rare and often unpredictable, chronic autoimmune disease.¹

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8789351-argenx-premieres-a-mystery-to-me-docuseries-myasthenia-gravis-patient-experience/

“At argenx, we listen to and learn from people with rare diseases so that we can better address the real-life challenges they face,” said Tim Van Hauwermeiren, Chief Executive Officer at argenx. “The strength and resilience of the MG community humbles us every day, and we felt compelled to tell the stories of these remarkable individuals to a broader audience. We’re proud to present A Mystery to Me to unite the MG community in raising awareness of a disease that is often misunderstood and inspire compassion in those who watch it.”

MG causes a person’s immune system to attack the junction where the nerve meets the muscle, often leading to debilitating and potentially life-threatening muscle weakness and fatigue.² People with MG often experience difficulty in performing daily tasks like speaking, chewing or swallowing food, moving one’s eyes, and even breathing.² MG affects an estimated 65,000 people in the United States.¹

“The Myasthenia Gravis Foundation of America is excited for the launch of this important docuseries, which provides a new sense of connection among our patient community, particularly during the COVID-19 pandemic,” said Samantha Masterson, CEO of the Myasthenia Gravis Foundation of America. “Living with MG can feel isolating, especially since every person who has MG experiences the disease differently. We are hopeful that A Mystery to Me will educate the general public not just about the physical implications of MG, but also the emotional toll it can have on a person’s life.”

A Mystery to Me, which was produced by award-winning Sarofsky Productions, illustrates the perseverance of three individuals as they navigate the challenges of living with MG. Glenn Phillips, Teresa Hill Putnam, and Vanetta Drummer Fenton have all adapted their lives and those of their families to accommodate this debilitating illness. In doing so, they strive to hold on to the parts of life that make them who they are – a mother, father, partner, athlete, daughter, son, friend, hometown hero.

“As I listened to Glenn, Teresa, and Vanetta describe their experiences in managing MG, I started to identify the commonalities we can all relate to and wanted to tell their stories. These are extraordinary people exhibiting great strength to address a formidable obstacle in their paths, while also navigating the highs and lows that life can bring us. The stories of these three incredible people are about confronting challenges that may seem impossible to surmount and finding the emotional strength to learn from and apply them to how we live our lives going forward,” said docuseries director Ben Strang.

A Mystery to Me will debut in the U.S. on November 17, 2020 at 6:00PM ET on MG-United.com, an online platform that provides clear and credible resources for people with MG and their support communities, such as symptom tracking, emotional support, and real life stories. The docuseries will be made available to all viewers following the premiere on the MG United website.

About A Mystery to Me

A Mystery to Me is a three-part docuseries that features the moving stories of three people living with myasthenia gravis, a rare, chronic and often unpredictable autoimmune disease. The films explore how three unique individuals have persevered in their own lives despite living with a challenging and sometimes debilitating disease. Sponsored by argenx and produced amid the coronavirus pandemic by Sarofsky Productions, the docuseries was created using an innovative, contactless production technique to complete the films, making this a uniquely “2020” film production. The documentary is available on MG-United.com, an online platform for MG patients and their support communities. For more information, follow MG United on social media at https://www.facebook.com/MGUnitedOfficial/ and https://www.instagram.com/mgunited_official/.

About Myasthenia Gravis

Myasthenia gravis (MG) is a rare and chronic autoimmune disease, often causing debilitating and potentially life-threatening muscle weakness.^1,2 More than 85% of people with MG progress to generalized MG (gMG) within 18 months, where muscles throughout the body may be affected, resulting in extreme fatigue and difficulties with facial expression, speech, swallowing and mobility.³ In more life-threatening cases, MG can affect the muscles responsible for breathing.² There are approximately 65,000 people in the United States and 20,000 people in Japan living with the disease.^1,4

About Sarofsky

Sarofsky is a Chicago-based, internationally heralded production company chosen by brand and entertainment titans to lead their artful storytelling projects. Sarofsky, in addition to producing their own entertainment content, is well known for their work on Captain America: The Winter Soldier, Guardians of the Galaxy, Shameless, and Apple’s iMac Pro artists series.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. argenx has the goal of translating immunology discoveries into potential new medicines. argenx has offices in Belgium, the United States and Japan. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/.

For further information, please contact:

Beth DelGiacco, Vice President, Investor Relations
+1 518 424 4980
[email protected]

Joke Comijn, Director Corporate Communications & Investor Relations (EU)
+32 (0)477 77 29 44
+32 (0)9 310 34 19
[email protected]

Forward-looking Statements
 
The contents of this announcement include statements that are, or may be deemed to be, forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms believes, estimates, anticipates, expects, intends, may, will, or should, and include statements argenx makes concerning its business and financial outlook and related plans, the intended benefit of its partnerships, sponsorships or collaborations, the prevalence of MG in the U.S. and Japan and the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

¹ Gilhus N. Myasthenia gravis — autoantibody characteristics and their implications for therapy. Nature Reviews Neurology. 2016. 12:259-269.

² Myasthenia gravis fact sheet. National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/disorders/patient-caregiver-education/fact-sheets/Myasthenia-gravis-fact-sheet#2. Accessed October 2020.

³ Hehir M. Generalized myasthenia gravis: classification, clinical presentation, natural history, and epidemiology, Neurol Clin. 2018; 36: 253–260.

⁴ Carr AS. Generalized myasthenia gravis. BMC Neurol. 2019; 10:46-54.

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SOURCE argenx

TAIPEI and MILPITAS, Calif., Nov. 17, 2020 /PRNewswire/ — Silicon Motion Technology Corporation (NasdaqGS: SIMO) (“Silicon Motion”), a global leader in designing and marketing NAND flash controllers for solid-state storage devices, today announced the SM8266, a complete enterprise-grade 16-channel PCIe 4.0 NVMe hardware plus firmware turnkey SSD controller solution.  Customers can rapidly develop and bring to market enterprise SSDs for data centers by using our complete development platform that includes a turnkey NVMe firmware stack and hardware reference design kit.

“Our solution is the only complete PCIe Gen4 turnkey solution available today from an established merchant controller supplier,” said Nelson Duann, Silicon Motion’s Senior Vice President of Marketing and R&D.  “Since the introduction of our PCIe Gen3 turnkey solution, we have established a longer track record of supplying turnkey solutions in terms of customer adoption and sale volume than any other company.  Our Shannon Systems team is already custom designing enterprise-grade NVMe, Open-Channel and Key-Value SSDs using SM8266 for hyperscale customers’ data centers with production expected in 2021.”

Advanced turnkey enterprise SSD controller solution

The SM8266 controller solution features Silicon Motion’s state-of-the-art firmware and hardware technology to provide consistent, low latency QoS domains.  Offering capacity up to 16TB with 16 NAND flash channels, the SM8266 is designed to support the latest 3D TLC and QLC NAND flash technologies.  To ensure enterprise level reliability, data integrity and retention at PCIe Gen4 performance, the SM8266 is equipped with Silicon Motion’s proprietary technologies including:

• 6^th generation NANDXtend™ technology, which incorporates machine learning algorithms supporting Silicon Motion’s proprietary high-performance LDPC error correction code (ECC) engine with RAID, ensuring better data integrity even in extreme operating environments.
• End-to-end data path protection, which applies ECC to the SSD’s SRAM and DRAM buffers as well as to the primary NAND flash memory array. This maintains data integrity as data is transmitted between the host and the SSD, and between buffer memories and NAND flash.
• Power loss protection, which eliminates the risk of data loss in the event of an unexpected power outage.

Other features of SM8266 include:

• High performance PCIe Gen4 x4 & NVMe 1.4 compliance
• Turnkey stacks enable standard NVMe SSD as well as proprietary Open-Channel and Key-Value SSD implementations
• Support for up to 16TB of physical NAND capacity
• Low and consistent latency enabled by physical and logical isolation
• Ultra-high sequential read performance of up to 6.5GB/s and 950K sustained random read IOPS
• Data security with AES 256-bit hardware supporting SED, Secure Boot and TCG Opal

Silicon Motion will showcase SM8266 at SC Virtual from November 17 to 19. https://cdmcd.co/5YAKp6 

SM8266 video: https://www.youtube.com/watch?v=GM_OLtymubw

About Silicon Motion:

We are the global leader in supplying NAND flash controllers for solid state storage devices and the merchant leader in supplying SSD controllers.  We have the broadest portfolio of controller technologies and our controllers are widely used in storage products such as SSDs and eMMC+UFS devices, which are found in data centers, PCs, smartphones, and commercial and industrial applications. We have shipped over six billion NAND controllers in the last ten years, more than any other company in the world.  We also supply customized high-performance hyperscale data center and industrial SSD solutions.  Our customers include most of the NAND flash vendors, storage device module makers and leading OEMs.  For further information on Silicon Motion, visit us at www.siliconmotion.com.

Corporate Media Contact:  

Minnie Lin    
Director of Marketing Communication      
Tel: +886 2 2219 6688 x3010    
E-mail: [email protected]

Sales & Marketing Communications Contact:

Robert Fan

President of SMI USA
Tel: +1 408 519 7219
E-mail: [email protected]

Investor Contact:

Chris Chaney

Director, Investor Relations & Strategy
Tel: +1 561 866-9173
E-mail: [email protected]

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SOURCE Silicon Motion Technology Corporation

TEL AVIV, Israel and RALEIGH, N.C., Nov. 17, 2020 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase 2/3 study evaluating orally administered RHB-107 (upamostat)[1] in patients with symptomatic COVID-19 who do not require hospitalization.

“This is a significant milestone in our efforts to combat the effects of the COVID-19 pandemic. The ability to treat patients earlier in the course of COVID-19 disease, using an oral therapy that enables treatment outside of a hospital setting, is of critical importance given the large proportion of patients that are not hospitalized but are still very much at risk of disease progression,” said Terry F. Plasse MD, Medical Director at RedHill. “With RHB-107 and opaganib[2], RedHill has two novel, late-stage, oral therapeutic candidates with potential to reduce the impact of COVID-19 disease, both of which target host cell components, potentially minimizing the likelihood of resistance due to emergence of viral mutations.”

RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action make it a promising candidate for evaluation as a treatment for COVID-19 disease. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial cell model and its safety profile has been demonstrated in approximately 200 people, including in Phase 2 studies in oncology indications. RedHill licensed RHB-107 (formerly Mesupron) from Heidelberg Pharma AG (FWB: HPHA, formerly Wilex AG).

The randomized, parallel-group double-blind Phase 2/3 study is expected to start enrolling patients early next year. The study will enroll patients with symptomatic diagnostically confirmed COVID-19 who do not require inpatient care. RHB-107 will be administered once daily for 14 days, with patients receiving follow-up for eight weeks from first dosing. The primary endpoints will be time to recovery from symptomatic illness compared to placebo, as well as safety and tolerability of RHB-107. Several secondary and exploratory endpoints will also be assessed.

The late-stage development program for RedHill’s other COVID-19 candidate, opaganib, in patients with severe COVID-19 pneumonia includes: The U.S. Phase 2 study (NCT04414618) is now fully enrolled and expected to report topline data in the coming weeks; and the global Phase 2/3 study (NCT04467840) which is more than 50% enrolled and is on track to enroll up to 270 patients and report topline data in support of potential emergency use applications in the first quarter of 2021. Both studies are randomized, double-blind, parallel-arm, placebo-controlled trials with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

About RHB-107 (upamostat)

RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action make it a strong candidate for evaluation as a treatment for COVID-19 disease. In addition, RHB-107 has potential in targeting cancer, inflammatory lung diseases and gastrointestinal diseases, and has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany’s Heidelberg Pharmaceuticals (formerly WILEX AG) for all indications.

About RedHill Biopharma    

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik^® for opioid-induced constipation in adults with non-cancer pain^[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults^[4], and Aemcolo^® for the treatment of travelers’ diarrhea in adults^[5]. RedHill’s key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva^®), a first–in–class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (iv) RHB-102 (Bekinda^®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB–106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

 This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that enrollment in the company’s Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, the risk that the Company’s Phase 2/3 development program evaluating opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the data from this clinical study will be delayed if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia^®; (v) the Company’s ability to successfully commercialize and promote Movantik^®, Talicia^® and Aemcolo^®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

[1] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.

[2] Opaganib is an investigational new drug, not available for commercial distribution

[3] Full prescribing information for Movantik^® (naloxegol) is available at: www.Movantik.com.  

[4] Full prescribing information for Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

[5] Full prescribing information for Aemcolo^® (rifamycin) is available at: www.Aemcolo.com.

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SOURCE RedHill Biopharma Ltd.

INDIANAPOLIS and INCHEON, South Korea, Nov. 17, 2020 /PRNewswire/ — Samsung Biologics’ partnership with Eli Lilly and Company is expected to greatly accelerate the global supply for Lilly’s COVID-19 antibody therapies through a long-term manufacturing agreement, with the ultimate goal of making antibody treatments more globally accessible for patients.

Lilly’s success in developing neutralizing antibodies against COVID-19, augmented with Samsung Biologics’ manufacturing scale, signals a major move forward in delivering important treatments to patients suffering from the deadly pandemic.  

“Neutralizing antibodies are proving to be a potentially important tool in the fight against COVID-19, and the biopharmaceutical industry is collaborating quickly and effectively to increase the global manufacturing supply,” said David A. Ricks, Lilly’s chairman and CEO. “This agreement with Samsung supplements Lilly’s own internal manufacturing capacity and greatly expands our ability to deliver Lilly antibody therapies to patients around the world.”

Lilly and Samsung Biologics entered into the manufacturing partnership agreement in May of 2020 to address the increasingly urgent demand for COVID-19 treatments worldwide. Despite the global challenges of securing stable supply of raw materials amid the pandemic, Samsung was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API) meeting Good Manufacturing Practices (GMP) and regulatory expectations within 5 months of contract signing by leveraging the full force of both companies’ collaborative efforts. In addition, the timeline for tech transfer was reduced dramatically to less than 3 months, due in large part to close communications and coordination between technical, quality, supply chain, and regulatory experts from both companies.

“We are very pleased to deliver this product to our client Lilly in record breaking speed to aid in the war against the COVID-19 pandemic,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “Thanks to Lilly’s ongoing scientific efforts, patients suffering from this devastating disease are gaining new hope. Samsung Biologics is proud to be Lilly’s CDMO partner and will continue to work relentlessly and collaboratively with them to bring COVID-19 treatments to patients who need them the most, wherever they are.”

About Eli Lilly and Company
 

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity at a single site, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.

Lilly Forward Looking Statements

This press release contains forward-looking statements about the supply and use of Lilly antibodies to treat or prevent COVID-19 and reflects Lilly’s current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Lilly antibodies will prove to be safe and effective to treat or prevent COVID-19, that Lilly antibodies will receive regulatory approval, or that Lilly can provide an adequate supply of Lilly antibodies in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, please see Lilly’s most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Samsung Biologics Forward Looking Statements

This press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics’ objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.

Media Contacts:

Eli Lilly
 and Company

Mark E. Taylor; [email protected] 

Samsung Biologics

Claire Kim; [email protected] 

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SOURCE Samsung Biologics

ARLINGTON, Va., Nov. 17, 2020 /PRNewswire/ — The AES Corporation (NYSE: AES) today announced an agreement with Alberta Investment Management Corporation (AIMCo) to merge the sPower development platform, a leading independent solar developer in the US, with AES’ US-based clean energy development business to accelerate the safe, reliable transition to cleaner energy solutions in the country. AES’ wholly-owned clean energy development business includes AES Distributed Energy and a wind development team formerly part of Advance Energy. The merged business will represent one of the top renewables growth platforms. 

As states, communities and organizations of all types make commitments and plans to reduce their carbon footprints, renewables are on track to be the fastest-growing source of electricity generation in the US in 2020. AES is working with its customers to co-create and deliver the smarter, greener energy solutions that meet their needs, including 24/7 carbon-free energy.

“We share our customers’ commitments to a more sustainable energy future. Together, we can create a safe, resilient and carbon-free grid,” said Andrés Gluski, AES President and Chief Executive Officer. “The merger of sPower with AES’ clean energy business will benefit customers by providing access to a broader portfolio of product offerings as well as an expanded highly skilled and experienced team to drive innovation at scale.”  

“sPower has been one of our key infrastructure platforms since our initial investment made in partnership with AES in 2017,” stated Kevin Uebelein, Chief Executive Officer of AIMCo. “Our experience working with AES has shown that they are a world leader in delivering on customers’ sustainable energy needs, and the formation of this new renewables platform in the US will take that capability to an even higher level. On behalf of our clients and consistent with our investment mandate, we are excited about the value the next phase of our partnership will bring to our many stakeholders.”

The merged renewables platform will bring together sPower’s and AES’ differentiated capabilities in solar, wind and energy storage to accelerate our customers’ energy transitions.

“This platform will bring tremendous value to our customers as they pursue their business objectives and climate commitments,” said Leo Moreno, AES Clean Energy President.  “Our expanded portfolio of innovative solutions based on cutting-edge technologies will enable us to work together with our customers to power their energy transitions while making a carbon-free future possible.”

Future projects developed from the combined 12 gigawatts (GW) development pipeline will be owned 75% by AES and 25% by AIMCo, leveraging our successful partnership at sPower. Although there is no change in ownership of operating assets and backlog, the newly formed platform will manage the 2.5 GW of operating assets and the existing 2.6 GW contracted backlog. The transaction is expected to close in the next few months upon successful completion of customary closing conditions. 

More information about the available jobs in AES’ clean energy business is available at aesrenewablejobs.com.

About AES
The AES Corporation (NYSE: AES) is a Fortune 500 global energy company accelerating the future of energy. Together with our many stakeholders, we’re improving lives by delivering the greener, smarter energy solutions the world needs. Our diverse workforce is committed to continuous innovation and operational excellence, while partnering with our customers on their strategic energy transitions and continuing to meet their energy needs today. For more information, visit www.aes.com.

About AIMCo
AIMCo is one of Canada’s largest and most diversified institutional investment managers with more than $115 billion of assets under management. AIMCo was established on January 1, 2008 with a mandate to provide superior long-term investment results for its clients. AIMCo operates at arms-length from the Government of Alberta and invests globally on behalf of 31 pension, endowment and government funds in the Province of Alberta.

AIMCo’s Infrastructure and Renewable Resources group manages a portfolio of nearly $10 billion in infrastructure investments, comprised primarily of long-term equity positions in OECD-based infrastructure assets. These assets typically provide essential services to the public and are either regulated or have highly contracted revenues with the potential for long-term capital appreciation. AIMCo infrastructure investments are intended to match long duration real return asset characteristics with inflation-indexed pension liabilities.

For more information on AIMCo please visit www.aimco.ca.

About sPower
Headquartered in Salt Lake City, Utah, sPower is a leading independent power producer (IPP) that owns and operates a wind, solar, and storage portfolio. sPower is owned by a joint venture partnership between The AES Corporation (NYSE: AES), a Fortune 500 global power company, and the Alberta Investment Management Corporation (AIMCo), one of Canada’s largest and most diversified institutional investment managers.

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SOURCE The AES Corporation

TORONTO, Nov. 17, 2020 /PRNewswire/ – Corus Entertainment Inc. (TSX: CJR.B) announced today that its Board of Directors has declared quarterly dividends of $0.06 per Class B Share and $0.05875 per Class A Share payable on December 30, 2020, to shareholders of record at the close of business on December 15, 2020.

The foregoing dividends are designated as “eligible” dividends for the purpose of the Income Tax Act (Canada) and any similar provincial legislation.

Corus’ Board of Directors reviews the dividend on a quarterly basis. Shareholders are entitled to receive dividends only when any such dividends are declared by Corus’ Board of Directors and there is no entitlement to any dividend prior thereto.

Registered shareholders who are residents of Canada and who are not currently participating in Corus’ Dividend Reinvestment Plan (“the Plan”) may elect to participate in the Plan through the completion of an enrollment form which can be obtained from the Company’s plan administrator, AST Trust Company (Canada), on their website at www.astfinancial.com/ca-en or by calling 1.800.387.0825. The Plan allows eligible holders of Class A Shares and Class B Shares to acquire additional Class B Shares through reinvestment of the cash dividends paid on their respective shareholdings. Non-registered beneficial shareholders who are residents of Canada and who wish to join the Plan should consult their broker, financial institution or other intermediary through which they hold Class A Shares or Class B Shares.

Corus’ Board of Directors confirms that the Company will distribute shares purchased on the open market at no discount from the average market price to the Plan participants of record, as determined pursuant to the terms of the Plan.

There were 3,412,392 Class A Voting Shares and 204,954,666 Class B Non-Voting Shares outstanding on October 31, 2020.

Corus Entertainment Inc. reports in Canadian dollars.

About Corus Entertainment Inc.
Corus Entertainment Inc. (TSX: CJR.B) is a leading media and content company that develops and delivers high quality brands and content across platforms for audiences around the world.  Engaging audiences since 1999, the company’s portfolio of multimedia offerings encompass 34 specialty television services, 39 radio stations, 15 conventional television stations, a suite of digital assets, animation software, technology and media services. Corus is an established creator of globally distributed content through Nelvana animation studio, Corus Studios, and children’s book publishing house Kids Can Press. The company also owns innovative full-service social digital agency so.da, and lifestyle entertainment company Kin Community Canada. Corus’ roster of premium brands includes Global Television, W Network, HGTV Canada, Food Network Canada, HISTORY®, Showcase, Adult Swim, National Geographic, Disney Channel Canada, YTV, Global News, Globalnews.ca, Q107, Country 105, and CFOX. Visit Corus at www.corusent.com.

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SOURCE Corus Entertainment Inc.

ATLANTA, Nov. 17, 2020 /PRNewswire/ — UCB, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VIMPAT^® (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and VIMPAT injection for intravenous use in children four years of age and older.¹ PGTCS is a type of seizure that occurs all over the brain, affecting both sides of the brain from the start, causing muscles to stiffen and convulsions to occur for up to a few minutes.²

“These approvals underscore UCB’s commitment to people living with epilepsy and our focus on finding solutions for specific unmet needs within the epilepsy community,” said Mike Davis, Head of U.S. Neurology at UCB. “We are pleased that VIMPAT is now available as a treatment option for people living with primary generalized tonic-clonic seizures on their journey to seizure control.”

The PGTCS approval is based, in part, on results of a Phase 3 study recently published in the Journal of Neurology, Neurosurgery & Psychiatry.³  Adjunctive treatment with VIMPAT resulted in a significantly lower risk of developing a second PGTCS during the 24-week treatment period, with the corresponding risk reduction being 45% (p=0.001), and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo (31.3% vs 17.2%, p=0.011).

People living with generalized tonic-clonic seizures have an increased risk of injury⁴ and those who experienced three or more in one year had a fifteen-fold increased risk of sudden unexpected death in epilepsy.⁵

“The treatment of primary generalized tonic-clonic (convulsive) seizures is challenging, with about one-third of patients still being refractory while on therapy,” said David Vossler, MD, FAAN FACNS FAES, Department of Neurology, University of Washington, Seattle, USA. “Bolstered by a wealth of data demonstrating the efficacy and safety of VIMPAT, this new indication gives people suffering from PGTCS a chance at freedom from these seizures, which many have never experienced.”

Results from the Phase 3 study showed that VIMPAT was generally tolerated in patients with Idiopathic Generalized Epilepsy (IGE) and PGTCS. The most common adverse reactions (≥10%) reported in patients treated with VIMPAT were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo.

Regarding the expanded pediatric population, VIMPAT tablets and oral solution were already approved to treat partial-onset seizures in adults and children four years and older as monotherapy and adjunctive therapy. VIMPAT injection was previously approved for the treatment of partial-onset seizures only in adult patients (17 years of age and older).

In October 2020, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIMPAT  as adjunctive therapy in the treatment of PGTCS in adults, adolescents and children from four years of age with idiopathic generalized epilepsy.⁶ Regulatory reviews for use of VIMPAT in the treatment of PGTCS are also underway in Japan and Australia.

About Epilepsy

Epilepsy is the main symptom of a variety of chronic disorders of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked epileptic seizures with a risk of further seizures.⁷

About UCB in Epilepsy

UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies, and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About UCB

UCB, Brussels, Belgium (www.ucb-usa.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or the central nervous system. With more than 7,600 people in approximately 40 countries, the company generated revenue of €4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

About VIMPAT^® (lacosamide) CV in the U.S.

¹

VIMPAT^® was approved in the U.S. in 2008 as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. VIMPAT was approved as monotherapy for adults in August 2014, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2017. VIMPAT is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.

INDICATION

VIMPAT^® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

• Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including VIMPAT, increase the risk of suicidal behavior and ideation. Monitor patients taking VIMPAT for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to the healthcare provider.
• Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia in adult and pediatric patients. In adult clinical trials for partial-onset seizures, the onset of dizziness and ataxia was most commonly observed during titration. Advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they are familiar with the effects of VIMPAT on their ability to perform such activities.
• Cardiac Rhythm and Conduction Abnormalities

PR Interval Prolongation, Atrioventricular Block, and Ventricular Tachyarrhythmia

Dose-dependent prolongations in PR interval with VIMPAT have been observed in clinical studies in adult patients and in healthy volunteers. When VIMPAT is given with other drugs that prolong the PR interval, further PR prolongation is possible.

In the postmarketing setting, there have been reports of cardiac arrhythmias in patients treated with VIMPAT, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death. Most, although not all, cases have occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval. These events have occurred with both oral and intravenous routes of administration and at prescribed doses as well as in the setting of overdose.

VIMPAT should be used with caution in patients with underlying proarrhythmic conditions such as known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block, and sick sinus syndrome without pacemaker), severe cardiac disease (such as myocardial ischemia or heart failure, or structural heart disease), and cardiac sodium channelopathies (e.g., Brugada Syndrome).

VIMPAT should also be used with caution in patients on concomitant medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state maintenance dose, is recommended. In addition, these patients should be closely monitored if they are administered VIMPAT through the intravenous route. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away.

Atrial Fibrillation and Atrial Flutter

VIMPAT administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease.

• Syncope: VIMPAT may cause syncope in adult and pediatric patients.
• Withdrawal of Antiepileptic Drugs: Gradually withdraw VIMPAT (over a minimum of 1 week) to minimize the potential of increased seizure frequency.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also known as multi- organ hypersensitivity, has been reported with antiepileptic drugs, including VIMPAT. Some of these events have been fatal or life-threatening. If signs or symptoms are present, immediately evaluate the patient. Discontinue VIMPAT if an alternative etiology for the signs and symptoms cannot be established.
• Risks in Patients with Phenylketonuria: VIMPAT oral solution contains aspartame, a source of phenylalanine, which can be harmful in patients with phenylketonuria (PKU). A 200 mg dose of VIMPAT oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Adverse Reactions

• Partial-Onset Seizures: In the adult adjunctive therapy placebo-controlled clinical trials for partial-onset seizures, the most frequently seen adverse reaction with VIMPAT was dizziness (31% vs 8% placebo). Other common adverse reactions occurring in ≥10 percent of VIMPAT-treated patients, and greater than placebo, were headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%).
• Primary Generalized Tonic-Clonic Seizures: In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizure placebo-controlled trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.
• Pediatric Patients: Adverse reactions reported in clinical studies of pediatric patients 4 to less than 17 years of age were similar to those seen in adult patients.
• Injection: In adult adjunctive therapy clinical trials for partial-onset seizures, adverse reactions with intravenous administration generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). When administering a loading dose, the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia, may be higher with 15-minute administration than over a 30- to 60-minute period. The adverse reactions associated with VIMPAT injection in adult patients with primary generalized tonic-clonic seizures are expected to be similar to those seen in adults with partial-onset seizures. The adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults. Infusion times less than 30 minutes were not adequately studied in pediatric patients.

Dosing Considerations

VIMPAT injection is for intravenous use only when oral administration is temporarily not feasible. The loading dose for adult patients should be administered with medical supervision considering the VIMPAT pharmacokinetics and increased incidence of CNS adverse reactions. The use of a loading dose in pediatric patients has not been studied. Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in patients with severe hepatic impairment is not recommended. Perform dose titration with caution in all patients with renal and/or hepatic impairment.

VIMPAT is a Schedule V controlled substance.

Please refer to full Prescribing Information.

For further information, UCB:

U.S. Neurology Communications
Erica Puntel,
U.S. Communications, UCB
T 404.938.5359, [email protected] 

Investor Relations

Antje Witte,
Investor Relations, UCB 
T +32.2.559.94.14, [email protected] 

Isabelle Ghellynck,
Investor Relations, UCB
T+32.2.559.9588, [email protected]

VIMPAT^® is a registered trademark used under license from Harris FRC Corporation.

©2020 UCB, Inc., Smyrna, GA 30080. All rights reserved.

Forward looking statements – UCB

This press release contains forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal  models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’ efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

References:

1. VIMPAT^® (lacosamide) CV. U.S. Prescribing Information

2. NIHR: National Institute for Health Research. Lacosamide for primary generalised tonic-clonic seizures – adjunctive therapy. http://www.io.nihr.ac.uk/wp-content/uploads/2019/07/27110-Lacosamide-for-Primary-Generalized-Tonic-Clonic-Seizures-V1.0-JULY2019-NON-CONF.pdf

3. Vossler DG, et al. Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomized, placebo-controlled trial. Neurol Neurosurg Psychiatry 2020; 91(10):1067-1075

4. Asadi-Pooya AA, Nikseresht A, Yaghoubi E, et al. Physical injuries in patients with epilepsy and their associated risk factors. Seizure 2012;21:165–8. 5

5. DeGiorgio CM, et al. Ranking the leading risk factors for sudden unexpected death in epilepsy. Front Neurol. 2017;8:473

6.  European Medicine Agency: Committee for Medicinal Products for Human Use (CHMP). https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vimpat-ws/1782_en.pdf

7. Epilepsy Foundation. Who gets epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Date Accessed 10 November 2020

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SOURCE UCB, Inc.