Merck's beleaguered R&D division wins its second 'breakthrough' title at FDA

Merck's beleaguered R&D group picked up another breakthrough therapy designation from the FDA. On the heels of a BTD for MK-3475, the pharma giant's closely watched cancer immunotherapy, Merck ($MRK) now has boasting rights for a combo therapy for hepatitis C, MK-5172 and MK-8742.

Now in a Phase IIb trial with interim data due out early next month, the FDA has carved out a preferred spot for the all-oral combination--an NS3/4a protease inhibitor and its NS5A inhibitor. The FDA started handing out its breakthrough drug designations at the beginning of this year, promising to make them a priority for regulators as they work closely with drug developers on the most promising new therapies.

It's early days yet in the process, but a BTD could theoretically shorten a drug's path at the FDA, leading to a more rapid approval. Gilead ($GILD), AbbVie ($ABBV) and Bristol-Myers Squibb ($BMY) have already racked up BTD status for their hep C programs, making new drugs for this disease a top priority at the FDA.

Merck's drugs are well behind a group of next-gen therapies that are angling for near-term approvals. Gilead's sofosbuvir will be in front of an FDA panel this week, just after Johnson and Johnson's ($JNJ) simeprevir gets a once-over. Sofosbuvir is widely expected to win approval and go on to be included in some of the new cocktails in development that will eliminate the need for interferon, which has a harsh impact on many patients. AbbVie and Bristol-Myers Squibb as well as Vertex ($VRTX) are hustling along their own programs, which promise to quickly eliminate current standards like Incivek and Merck's Victrelis (boceprevir).

Merck needs all the help it can get in reforming its R&D image. The company named Roger Perlmutter as its new R&D chief earlier in the year and then recently announced a major overhaul aimed at cutting more than $1 billion out of the company's $8 billion-plus research budget, axing thousands of workers from the staff. The company has one of the worst late-stage pipeline efforts in the industry, hit with delays and setbacks for some of its biggest Phase III therapies. This new hep C combo could help alleviate those woes.

"The designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic hepatitis C is an important milestone for Merck," Perlmutter said. "There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients."

Novartis ($NVS) is still the leader of the breakthrough drug club, with three separate BTDs to its credit. Ibrutinib from J&J and Pharmacyclics ($PCYC) has been given three BTDs in its own right.

- here's the press release

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