Sunday, April 14, 2013

Anti-Infective Files: Merck Seeks FDA Approval Of Tablet Form Of Legacy Schering-Plough SCH-56592, Noxafil® (Posaconazole)

At the middle of last week, Whitehouse Station announced that FDA had accepted (for filing) its ANDA packet -- or an abbreviated new drug application -- to sell Noxafil® anti-fungal in tablet form. When approved, about seven months from now (unless something untoward appears), the tablet form will be, at best, a modest positive for Merck. The legacy Schering-Plough drug is already on the market, in an oral suspension -- in the fairly crowded triazole antifungal agent space.

On balance, I'd ask: Is an oral, once a day solid tablet form marginally more convenient (and patient-palatable) than a rather foul-tasting oral liquid suspension, by spoon? Yes. But is it a game-changer? No.

Even so, it is good to see at least one or two legacy Schering-Plough candidate programs make it to the FDA filing window. There have been so few of them, post the merger with Merck -- due not to any real fault of New Merck, but (in my opinion) due to the poor choices Ex-CEO Fred Hassan made -- in throwing resources behind the wrong programs. Thus, what is coming out of the drinking end of the legacy-Schering Plough pipe is only as good as the mistakes "Fast Fred" Hassan loaded into the pipe, at the well-head -- seven or eight years ago, now.

In any event, here's a bit from the press release:

. . . .Merck currently markets Noxafil Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as patients who have received hematopoietic stem cell transplants and have graft-versus-host disease, or patients with cancers of the blood who are experiencing prolonged low white blood cell counts (neutropenia) as a result of chemotherapy. . . .

Merck is seeking FDA approval of Noxafil tablets for once-daily administration (following a twice-a-day loading dose on the first day of therapy). The company has filed a marketing authorization application for Noxafil tablets with the European Medicines Agency (EMA) and plans to seek regulatory approval for the tablet formulation in other countries around the world. . . .
As ever, we will keep you posted, if/when FDA approves this new delivery method.

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