I’m in Whitehouse Station, N.J., today to get a birds-eye view of Merck’s overhauled pipeline following last year’s merger with Schering-Plough. The company is unveiling its pipeline as part of an overall business briefing for investors. Here are a few highlights after the R&D segment of today’s meeting:
–The company has jettisoned what had been expected to be its first biosimilars product, MK-2578, a pegylated form of erythropoietin that would have gone up against Amgen’s Aranesp. The product has been developed using technology acquired for $400 million in 2006 from GlycoFi, which figured out how to coax yeast into make homogeneous glycoforms. Peter Kim, president of Merck Research Laboratories, said that regulatory authorities indicated that given the safety concerns over erythopoeitin stimulating agents, the company would have to conduct a cardiovascular assessment for MK-2578. The delay—and one can assume the cost—caused the company to ditch the project. Merck BioVentures, its biologics business, still has two biosimilars in the clinic, and plans to have five in Phase III trials by 2012.
–Merck devoted a lot of time to its cardiovascular business, which seems to be almost an even distribution of legacy Schering-Plough and Merck products. Vorapaxar (Schering-Plough), in Phase III; betrixaban (Merck), expected to enter Phase III trials next year; Brinavess (Merck), a novel multi-ion channel blocker under regulatory review in Europe; Acadesine (Schering-Plough), an adenosine-regulating molecule in Phase III trials; Tredaptive (Merck), extended-release niacin combined with laropiprant, a compound that prevents flushing, expected to be submitted for regulatory approval in 2012; and anacetrapib (Merck), a reversible inhibitor of CETP in Phase III studies.
–Kim came out swinging in a discussion of boceprevir, a protease inhibitor for Hepatitis C compound that he called “potentially the most impactful near-term product” for Merck. Without ever mentioning boceprevir’s biggest potential competitor, Vertex Pharmaceutical’s telaprevir, by name, Kim went through a point-by-point discussion of areas where boceprevir might have an advantage over telaprevir. Neither Vertex nor Merck have unveiled Phase III data on their drugs, but as discussed in last week’s magazine, analysts have given telaprevir an edge over boceprevir on several fronts: its side effect profile appears milder (telaprevir causes a rash, boceprevir exacerbates anemia already caused by ribavirin, one of the two drugs given as the current standard of care) and, importantly, it appears to decrease treatment time to 24 weeks from 48 weeks. Kim described a “post-hoc” analysis of Phase II data for boceprevir that suggests it could also be effective after just 24 weeks. A Phase III study for boceprevir plus standard of care includes a “response-guided therapy” arm, which means that patients who have undetectable levels of the virus at four weeks after boceprevir treatment will stop standard of care therapy after 24 weeks. Merck expects to submit for regulatory approval for boceprevir later this year.
–Kim also walked through the differences between Odanacatib, the cathepsin K inhibitor in Phase III trials for osteoporosis, and Fosomax, its osteoporosis drug that has already lost patent protection. On the tolerability front, he pointed out that Odanacatib appears to have milder gastrointestinal side effects than Fosamax. The new drug appears to be just as effective at decreasing bone resorption as Fosamax, but offers improvements on the bone formation front.
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