Welcome to the latest edition of our weekly EuroBiotech Report. The past 7 days brought mixed news for the Danish biotech sector. On the upside, Genmab’s Johnson & Johnson-partnered CD38 monoclonal antibody secured an FDA breakthrough therapy designation, reaffirming its status as a hot prospect and setting the groundwork for a quickie approval later this year. ALK-Abello, which is based a short drive from Genmab, had a less rosy week. Following sluggish sales, Merck decided to hand back rights to ALK’s sublingual allergy immunotherapies, leaving the Danish drugmaker without a North American partner at a time when one of the assets is nearing a regulatory approval decision date. The Netherlands’ uniQure and Switzerland’s Cassiopea has difficulties of their own. UniQure’s stock briefly hit a new low following the release of data on its hemophilia B gene therapy. And dermatology specialist Cassiopea was forced to seize control of a Phase II trial after its Israeli partner closed its doors midstudy. The FDA designated Morphochem’s MCB3837 as a Qualified Infectious Disease Product. And more. Nick Taylor
Merck ($MRK) has shocked ALK-Abello (CPH:ALK-B) and its investors by returning the rights to three sublingual allergy immunotherapy tablets. The decision, which comes partway through a clinical trial and regulatory approval process, leaves ALK without a partner in the U.S. and triggered an 18% drop in its share price.
Shares in uniQure ($QURE) briefly hit a new low following a negative knee-jerk reaction to fresh data on its hemophilia B gene therapy. The sharp slide, which was quickly reversed, was triggered by data showing that, for better or worse, the 9-month data on hemophilia B gene therapy AMT-060 were comparable to results generated after 6 months.
Cassiopea (SWX:SKIN) has taken control of a Phase II trial after the Israeli biotech it licensed the drug from shut down midstudy. The difficulties mean the genital wart trial has enrolled 27 patients almost three years after the protocol was filed with ClinicalTrials.gov, a situation that has forced Cassiopea to step in to prevent further delays to the study.
The FDA has designated Morphochem’s MCB3837 as a Qualified Infectious Disease Product (QIDP) and simultaneously put the antibiotic on its regulatory fast-track program. The regulatory rulings give Morphochem the opportunity to liaise more frequently with the FDA at a time when it is gearing up for the start of a Phase II trial.