EuroBiotech Report: J&J-Genmab, Merck-ALK, uniQure, PhII misstep and Morphochem

europeGOOD

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

1. J&J, Genmab bag breakthrough status for Darzalex, shortening route to second-line use

FDA staffers have joined the long list of people to be impressed by data on Johnson & Johnson ($JNJ) and Genmab’s (CPH:GEN) cancer drug Darzalex. The regulator recently took a look at data from trials that gave Darzalex in combination with Celgene’s ($CELG) Revlimid and Takeda’s Velcade, after which it granted breakthrough therapy status to the drug as a second-line treatment for multiple myeloma.

2. Merck shocks ALK by returning rights to allergy immunotherapies

Virtual Roundtable

ESMO Post Show: Highlights From the Virtual Conference

Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields.

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.

3. UniQure yo-yos as data raise questions about its place in hem B gene therapy race

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.

4. Cassiopea seizes control of PhII trial after partner folds midstudy, delaying data

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.

5. FDA grants fast-track status to Morphochem’s antibiotic ahead of start of PhII

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.

And more articles of note>>

Suggested Articles

Chi-Med has detailed plans to seek approval from the FDA later this year in part on the strength of data from Chinese phase 3 trial.

The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder.

The role gives one of the driving forces behind Bristol Myers Squibb’s $74 billion takeover of Celgene the chance to help build biotechs.