Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules
Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed.
Biocryst said Friday it is selling the European business of its hereditary angioedema drug Orladeyo to Italy’s Neopharmed Gentili for $250 million upfront. The deal, which transfers BioCryst’s European sales organization to Neopharmed, promises $14 million in additional milestone payments associated with sales in central and eastern Europe. Biocryst said it will use the proceeds to pay off about $249 million in term debt owed to Pharmakon Advisors, which it said will save $70 million in interest. Sale of the European organization will save an additional $50 million in annual operating costs. The company now expects to end 2027 with $700 million in cash, an increase of $400 million from previous guidance. — Jonathan Gardner
The Food and Drug Administration is overstepping its authority over vaccination practices with new rules that will limit who can receive annual COVID-19 shots, according to a New England Journal of Medicine commentary authored by Peter Marks, the former head of the FDA division that reviews vaccines. Marks left the FDA’s vaccine review division following disagreements with health secretary Robert F. Kennedy Jr. The FDA’s new rules require any new COVID-19 booster for healthy, non-elderly adults and children must be supported by a large, randomized controlled trial evaluating death or hospitalization before approval, a policy that could make it difficult for any new vaccines to gain wide approval. Marks wrote that the FDA has “taken on aspects of policymaking that have previously been in the domain” of the Centers for Disease Control and Prevention. Moreover, it did so without a public discussion of the changes or consulting with outside public health experts who advise the FDA and CDC. In addition, he said the changes ignore the existing safety data for the COVID-19 shots and the continued hospitalizations and deaths caused by the virus. — Jonathan Gardner
Experimental liver disease drug pemvidutide met one of the two main goals of a Phase 2 trial in MASH, resolving the inflammatory disorder and stabilizing fibrosis in significantly more participants than did placebo after 24 weeks of treatment, its developer, Altimmune, said Thursday. In the trial, 59% of people who got a 1.2 milligram weekly shot of pemvidutide saw MASH resolution and no increase in fibrosis score, as did 52% of people who got a 1.8 milligram shot, the company said. Of those who received a placebo, 19% saw MASH resolution and no fibrosis increase. The drug missed on a second goal, fibrosis improvement with no worsening of MASH. Altimmune shares fell by more than half following the news. — Jonathan Gardner
Belgian drugmaker UCB plans to submit fenfluramine, one of the two drugs that made up the scandal-ridden “fen-phen” diet regimen, for approval in a new setting, now that it has positive results from a late-stage study. The company didn’t release any detailed data, but said the drug, which was tested as an add-on therapy for patients with a rare genetic disorder that gravely impairs brain development, hit the study’s main goal for effectiveness. It was also “generally well tolerated,” according to UCB, which wants to file it with regulatory agencies “as soon as possible.” An oral solution of fenfluramine is already cleared in the U.S. to treat Dravet syndrome and Lennox-Gastaut syndrome, two other uncommon, severe diseases characterized by persistent seizures. — Jacob Bell
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