Regeneron Pharmaceuticals has big plans for cancer immunotherapy Libtayo and it believes it can better execute on them if it has full control of the drug, currently partnered with Sanofi. Regeneron struck a deal to pay Sanofi $900 million, plus another $200 million in milestones, to secure full global rights to the asset.
Regeneron Pharmaceuticals is paying $250 million cash to acquire Checkmate Pharmaceuticals, a clinical-stage biotech developing drugs that activate the innate immune system. The biotech’s lead drug candidate is currently in pivotal testing in melanoma.
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Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans to seek full FDA approval of its antibody cocktail later this summer.
A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.
The FDA approval clears Regeneron's drug, Evkeeza, as a treatment for the rarer of two forms of an inherited disease that causes high cholesterol levels. The company already markets Praluent, which treats the more common form of familial hypercholesterolemia.
The company said that those who received the two-antibody cocktail REGN-COV2 showed a lower viral loads and faster alleviation of symptoms than those who received placebo.
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The deal brings Roche's considerable manufacturing heft to Regeneron's efforts to develop the two-antibody cocktail, REGN-COV2. Regeneron will distribute the drug in the U.S., while Roche will distribute it ex-U.S.
Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity Pivot Podcast.
The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.
The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.
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The U.S. district attorney for Massachusetts filed suit against the drugmaker this week, alleging that it paid tens of millions in kickbacks through a copay foundation for Eylea, a drug used to treat macular degeneration.
The company plans to test REGN-COV2 - consisting of the SARS-CoV-2-specific antibodies REGN10933 and REGN10987 - in four populations, including infected patients and uninfected people at high risk of infection.
The Phase III portion of the companies' trial of Kevzara will now only enroll critically ill patients and randomize them to receive the drug at 400mg or placebo, after the drug did not appear effective in severely ill patients.
An analyst wrote that while the data are positive, the bigger question is how the drug will be priced, based on another drug already on the market for the same disease, HoFH, which affects about 1,300 people in the U.S.
The companies also reported a European dermatitis approval and successful topline results from a Phase III study of the drug, Dupixent.