Not wishing to make December all about numbers, Merck (NYSE:MRK) hosted its 2007 Annual Business Briefing yesterday and spent much of the time highlighting its research-stage drugs.
Merck is expecting the FDA to make decisions on two new drugs next year. Building on the cholesterol drug franchise that it's created with Schering-Plough (NYSE:SGP), Merck is going at it alone with CORDAPTIVE. It's also expecting a decision about an injectable form of EMEND, which received an approvable letter earlier this month. EMEND is used to treat chemotherapy-induced nausea.
Clinical trial data should be available next year for cholesterol-lowering drug MK-0524B and weight-loss drug taranabant, which, if positive, would allow Merck to submit marketing applications with the FDA. The latter should be interesting because it targets the same molecule as Sanofi-Aventis' (NYSE:SNY) Acomplia, which was rejected by an FDA advisory panel last year due to worries over psychiatric side effects.
Merck will also make two supplemental filings with the FDA in 2008: one for HIV drug ISENTRESS and another for its human papillomavirus (HPV) vaccine, GARDASIL. While the expansion of ISENTRESS' label so that it's approved as a front-line treatment is crucial for it to have meaningful sales, I'm not convinced that the GARDASIL approval for use in older women would be enough to combat competition from GlaxoSmithKline's (NYSE:GSK) Cervarix.
Merck currently has seven drug candidates in phase 3 trials. After it showed promising results in phase 2 trials, the company expects another cholesterol drug, anacetrapib, to enter phase 3 trials next year. The drug is in the same class as Pfizer's (NYSE:PFE) torcetrapib, which was stopped in its tracks after its phase 3 trial showed the drug caused patients' blood pressure to rise. Clinical data also showed more deaths and cardiovascular events occurring among patients who took the drug.
Merck hasn't seen any sign of problems yet, but it won't know that it's out of the woods until it runs the larger and longer phase 3 trial.
With a nice solid pipeline -- much of which was developed internally, unlike some of its big pharma brethren -- Merck is on its way to its goal of double-digit EPS growth through 2010.
