Drug Development

Protocols: Merck punts ALK allergy meds; Gene editing gets mixed reviews by a wary public

Just a few months ago, Merck capped a 9-year alliance with Denmark’s ALK on new allergy medicines by noting that the FDA had accepted its biologics application for a dust mite treatment, MK-8237. And that followed two approvals, including an OK for Grastek back in 2014. But now, after posting disappointing sales from the alliance’s new products, the pharma giant is simply walking away from the drugs they worked on together. ALK said that Merck has decided to hand back all rights to its sublingual allergy immunotherapy tablets (SLIT-tablets) against grass, ragweed and house dust mite. The change-up came after Merck — now heavily committed to immuno-oncology — completed a reprioritization of resources. “The timing of this move is unexpected. However, we understand that MSD’s decision was based on a prioritisation of resources,” noted CEO Steen Riisgaard. “Our belief that North America represents an important opportunity for ALK’s SLIT-tablets is unchanged. The sales performance over the past two years has been below expectations. Our view is that success there is likely to follow the path seen in Europe, where slow early adoption has now given way to sustained growth.”

Gene editing has emerged as one of the hottest fields in biotech, but a wary public has some decidedly mixed emotions about tinkering with genetic coding. Most would like to have it available to their children, but they draw they line at altering human embryos. And the more religious they feel, the less likely they are to support gene editing at all.

Shares of Malvern, PA-based Recro Pharma $REPH shot up 22% after it announced positive Phase III data for IV meloxicam (N1539) for the treatment of acute postoperative pain in patients following bunionectomy surgery.


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RAPS Regulatory Convergence 2017