Interferon beta-1a(University Health Network)

DARMSTADT, Germany--(BUSINESS WIRE)-- Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients on evobrutinib and patients with less than 70 days exposure to study medication in the U.S. The ongoing, fully-enrolled Phase III EVOLUTION clinical trial program of evobrutinib in relapsing multiple sclerosis (RMS) will continue as planned with all participants remaining on treatment as all are beyond 70 days exposure to study medication. The Phase III clinical trial program of evobrutinib is on schedule to read out in the fourth quarter of 2023. The FDA action was based on their assessment of two recently reported cases of laboratory values suggestive of drug-induced liver injury that have been identified during the Phase III studies. Importantly, both patients were asymptomatic, did not require any medical intervention or hospitalization for this condition and their liver enzymes fully normalized after discontinuation of the study medication. The Phase III EVOLUTION clinical trial program of evobrutinib has been closely monitored by an Independent Data Monitoring Committee, including hepatologists, since initiation. In close collaboration with external experts as well as the Independent Data Monitoring Committee for the trials, Merck KGaA, Darmstadt, Germany is assessing the potential contributory role of predisposing factors to the liver injury. Merck KGaA, Darmstadt, Germany is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib. About Evobrutinib Evobrutinib is an oral, CNS-penetrating, highly selective inhibitor of Bruton’s tyrosine kinase (BTK) in clinical development as a potential treatment for relapsing multiple sclerosis (RMS). It is the first BTK inhibitor (BTKi) to demonstrate clinical efficacy in the largest Phase II study with follow-up beyond three years as well as demonstrate an impact on early biomarkers of ongoing central inflammation that correlate with disease progression, including slowly expanding lesions (SEL) volume and levels of blood neurofilament light chain protein (NfL). Evobrutinib is designed to modulate B cell responses such as proliferation and antibody and cytokine release, as well as modulate macrophage/microglia activation. During Phase II, the BTKi dose finding study demonstrated that BID dosing achieved maximal efficacy with >95% BTK occupancy maintained in 98% of patients before the next dose. Evobrutinib is currently under clinical investigation and is not approved for any use anywhere in the world. Merck KGaA, Darmstadt, Germany in Neurology and Immunology Merck KGaA, Darmstadt, Germany has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company’s current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine) tablets. Merck KGaA, Darmstadt, Germany aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck KGaA, Darmstadt, Germany’s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to to register for your online, change your selection or discontinue this service. About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. View source version on businesswire.com: Contacts Media Relations alice.mcgrail@emdserono.com Phone: +1-781-738-8791 Investor Relations investor.relations@emdgroup.com Phone: +49 6151 72-3321 Source: Merck KGaA View this news release online at:

Pictured: Biogen sign in front of an office building/courtesy of John Tlumacki/The Boston Globe via Getty Biogen is laying off an unspecified number of employees, according to a article published Monday by the Boston Business Journal. A Biogen spokesperson confirmed the layoffs in an email to BioSpace but declined to reveal the exact number of affected employees. In a LinkedIn post published in late March, Matt Winton, former senior vice president and head of the company’s U.S. multiple sclerosis franchise, announced that he was leaving Biogen. He wrote that he was proud of his team's work in the MS and SMA communities. Winton served Biogen for more than nine years. The Biogen spokesperson did not explicitly confirm to BioSpace whether the job cuts would primarily affect the company’s MS business. Christopher Viehbacher, president and CEO of Biogen, foreshadowed these job cuts in the company’s Q4 and full-year 2022 financial results presentation in February 2023, referring specifically to the “declining revenue base” of its MS business. Still, the company needs to be careful to “find the right balance” and not take too much from multiple sclerosis so as not to worsen already-declining sales, he said. For 2023, while Viehbacher expects to implement cost-reduction measures for its MS franchise, he said he anticipates some new investments, particularly as Biogen re-evaluates its general and administrative expenses for MS. The spokesperson said the MS franchise is an important part of Biogen’s base business and that the company would continue to invest as appropriate. “However, we will need to find the right balance across the entire portfolio to support the Leqembi and zuranolone launches [and] to sustain innovation in R&D," the spokesperson said. Monday’s layoffs follow a sweeping headcount reduction implemented throughout 2022 that saw the planned termination of as many as 1,000 employees. The cost-cutting initiative was meant to help Biogen recoup losses from the launch of its troubled Alzheimer’s medicine, Aduhelm. MS is Still Biogen’s Top Earner During the investor call, Viehbacher said the MS franchise still supports most of Biogen’s revenue. In 2022, Biogen’s MS business earned $5.43 billion dollars, accounting for nearly 68% of the company’s full-year revenue. Still, at constant currencies, MS sales dropped 9% from the year prior due to generic competition and pricing pressures. Of its MS assets, Tysabri (natalizumab) remains Biogen’s strongest seller, earning more than $2.3 billion in 2022. Approved in 2004, Tysabri is a monoclonal antibody that binds to T cells and prevents them from attacking nerves in the brain and spinal cord, a pathological hallmark of MS. Tecfidera (dimethyl fumarate), an activator of the Nrf2 pathway, is Biogen’s second-highest-selling MS asset, bringing in more than $1.4 billion in 2022. Tecfidera was approved in 2013. Biogen’s MS franchise also includes the fumarate-based oral drug Vumerity (diroximel fumarate), the interferon medicines Avonex (interferon beta-1a) and Plegridy (peginterferon beta-1a) and the oral drug Fampyra (fampridine), which is being marketed by Acorda Therapeutics as Ampyra in the U.S. Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com