Merck & Co. Inc. has signed a potential $1 billion research tie-up with Synthekine Inc. to develop engineered cytokines to fight autoimmune diseases, as its $11.5 billion merger with Acceleron Pharma Inc. hit a regulatory speed bump.
In the year’s second biggest M&A deal, Merck & Co. Inc. will take over pulmonary and hematologic specialist Acceleron Pharma Inc. for $11.5 billion. The acquisition brings Merck a pair of potential blockbuster drugs, one of them already marketed. There is sotatercept, in development for treating pulmonary hypertension (PH), and also Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent approved in the U.S., Europe and Canada for treating anemia in certain blood disorders.
With a phase IIb readout coming in the third quarter of 2020, Cambridge, Mass.-based Fulcrum Therapeutics Inc. might be set up for a win in facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder for which there’s no treatment.
Keros Therapeutics Inc. CEO Jasbir Seehra told BioWorld that he plans to use at his new company lessons learned as co-founder of Acceleron Pharma Inc., where work with receptors in the TGF-beta superfamily “taught me the potential of the biology and those molecules, but also the limitations” with regard to safety that need to be surmounted.
As Acceleron Pharma Inc.’s phase II trial of sotatercept hit its primary endpoint and some key secondary endpoints in significantly reducing pulmonary vascular resistance, the stock (NASDAQ:XLRN) reacted accordingly, gaining 50% on Jan. 28. The stock ended the day at $79.39, up $26.52.
Acceleron Pharma Inc. and Fulcrum Therapeutics Inc., two Cambridge, Mass.-based companies that have benefited from partnerships, agreed to an R&D collaboration and license agreement to identify small molecules for treating an undisclosed target in pulmonary disease.
Nearly a month ahead of the PDUFA date, red blood cell maturation drug luspatercept cleared the FDA for treating anemia in adults with beta-thalassemia who require regular red blood cell (RBC) transfusions. Branded Reblozyl, the drug, developed in a collaboration between Celgene Corp. and Acceleron Pharma Inc., is expected to be available in one week following approval.