Fingolimod Lauryl Sulfate

Meeting program to feature latest clinical findings for GA Depot and showcase commitment to improving care for people living with multiple sclerosis (MS) PITTSBURGH, April 24, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Mapi Pharma today announced that recent data from ongoing studies of GA Depot 40 mg will be presented at the American Academy of Neurology (AAN) 75th Annual Meeting in Boston taking place April 22-27. Data will include results from the pivotal Phase III clinical trial exploring the efficacy and safety of GA Depot – a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS). "Viatris' commitment to developing GA Depot as a potential treatment for multiple sclerosis (MS) patients is driven by our belief that access is fundamental to empowering people worldwide to live healthier at every stage of life," said Abhijit Barve, Chief Medical Officer, Viatris. "Through this ongoing research, we are applying our industry-leading expertise and experience to develop novel treatment options that support and more holistically address the needs of the MS community. That's why we are excited to be back at the American Academy of Neurology meeting this year and proud to partner with Mapi Pharma to showcase the latest clinical data on GA Depot." "The American Academy of Neurology meeting is an important forum to share with the neurology community the results of the study which show the potential of GA Depot 40 mg to offer patients with relapsing forms of multiple sclerosis an effective treatment option," said Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma. Visit Viatris at AAN at booth #761 to learn more about the study and how the company supports the needs of the MS community. GA Depot data will be presented during the following poster session: Results of a Phase III, Multinational, Double-blind, Placebo-controlled Study in Subjects with Relapsing Forms of Multiple Sclerosis (RMS) to Assess the Efficacy, Safety, and Tolerability of GA Depot, a Long-Acting IM Injection of Glatiramer Acetate, Administered Once Every Four Weeks Speaker: Aaron E. Miller, MD, FAAN April 24th, 5:30 – 6:30 p.m. EST Poster Session P6, Poster #014 Boston Convention and Exhibition Center, Exhibit Hall B2, Neighborhood 3 Abstract: Full session details and abstracts for the 2023 Annual Meeting can be found at the American Academy of Neurology's website at . About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, and a variety of over-the-counter consumer products. With approximately 37,000 colleagues globally, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube. About Mapi Pharma Mapi Pharma is a clinical stage pharmaceutical company, engaged in development of high barrier-to-entry and high added-value life cycle management ("LCM") products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients ("APIs") and formulations. Mapi Pharma partnered with Viatris for GA Depot in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for relapsing forms of multiple sclerosis. The Company is also marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific geographic markets. Mapi's portfolio also includes a leading development of Depot drugs for Schizophrenia, GLP-1 for diabetes, weight control, Parkinson's disease and potentially Alzheimer's with innovative intellectual property. Mapi is built on strong chemical and pharmaceutical R&D capabilities, a deep understanding of the global market and of regulatory needs. Mapi is headquartered in Israel, with R&D facilities in Israel and China, and an API production facility, and an aseptic manufacturing and a Fill & Finish facility for injectable Finished Dosage Forms, all in Israel. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations. For more information, please visit . Forward-looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements about the outcome of clinical trials and development of products. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that the Company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with acquisitions, divestitures, or its global restructuring program, within the expected timeframe or at all; impairment charges or other losses related to the divestiture or sale of businesses or assets; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by COVID-19; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this release other than as required by law. SOURCE Viatris Inc.

Vyne anticipates it has enough money to fund operations into the fourth quarter. Vyne Therapeutics is putting its mash-up of Pfizer’s Xeljanz and Novartis’ Gilenya on the back burner. After sifting through the data from a failed midphase eczema trial, the biotech has begun searching for a partner for the program to free up its own cash for development of its BET inhibitors.  New Jersey-based Vyne, formerly known as Menlo Therapeutics, developed the topical combination of the approved drugs tofacitinib and fingolimod in the belief the combination of a JAK inhibitor and an S1P modulator would reduce inflammation from two different angles. However, the hypothesis took a hit last year when the formulation, FMX114, failed a phase 2a trial in mild to moderate atopic dermatitis. In response to the setback, Vyne outlined plans to reevaluate its pipeline and priorities. Initially, the firm made the case for FMX114, telling investors that additional analyses showed FMX114 was statistically superior to the control at weeks 1, 2 and 3. The problem was it failed to beat control at Week 4. Yet, in the months since that update, which made the case that FMX114 may be more effective in people with moderate to severe atopic dermatitis, Vyne has decided against committing more of its own cash to the program. Instead, the biotech is “evaluating partnering opportunities for this program” and putting its money into a pair of BET inhibitors.    Vyne delivered phase 1a safety data on one of its BET inhibitors, the locally administered VYN201, last month. Initial results from a phase 1b trial of the candidate, which is in development as a treatment for vitiligo, are due around the middle of the year. Vyne’s second, oral BET inhibitor is in preclinical development for the treatment of immuno-inflammatory indications.  The biotech has limited cash to commit to the programs. Having ended last year with $31 million in the bank, Vyne anticipates it has enough money to fund operations into the fourth quarter. Using FMX114 to land a deal could give Vyne some more money and buy it more time.