Merck bids for cholesterol market leadership
cholesterol-lowerting drug in a bid to wrestle control of the
cholesterol market away from Pfizer.
Merck's cholesterol franchise was blown open after it lost patent protection on its multibillion-dollar Zocor (simvastatin), which accounted for sales of over $4bn (€3.3bn) in 2005. Merck has since lost significant sales of Zocor to generic drug makers, such as Teva, and needs the new drug, currently in Phase III trials, to maintain revenues in its cardiovascular portfolio.
The new combination product aims to combine the HDL-C raising and triglyceride lowering effects of MK-0524A - a compound related to niacin - with the proven benefits of Zocor. Merck expect to file a new drug application (NDA) with the FDA in 2008 for the combination therapy, MK-0524B.
Merck also confirmed for the first time that it is developing a novel cholesterol in the CETP inhibitor class, MK-0859, that has reached the Phase II testing stage.
The announcement came 11 days after Pfizer had to withdraw its ownCETP inhibitor, torcetrapib, from clinical trials after safety concerns. Pfizer touted torcetrapib as its next blockbuster drug, after its US patent protection for the world's biggest selling drug Lipitor (atorvastatin), with sales of $12bn (€9bn), runs out in 2011.
The torcetrapib failure raised questions about other drugs in the CETP inhibitor class, but Dr Peter Kim, chief scientist at Merck, said that short-term studies of MK-0859 had shown no evidence of the blood pressure increases seen with torcetrapib.
In a Wall Street briefing, Richard Clark, CEO and President of Merck, said: "We've successfully launched five novel medicines and vaccines; advanced promising products through every phase of our pipeline; and driven the continued success of our in-line products. We've accomplished this even as we're executing on a new strategy, reinvesting to support our success and making our cost structure lean and flexible."
Building on the five FDA approvals Merck received in 2006, the company expects three FDA filings in 2007, including: a first-in-class HIV integrase inhibitor, MK-0518; an insomnia treatment developed in alliance with H.Lundbeck, gaboxadol; and an extended release niacin drug, MK-0524a, which improves HDL levels with a novel-flushing pathway inhibitor to remove the skin-reddening side effect.
Merck currently has three products currently under review by the FDA, including: a type-2 diabetes treatment Janumet (sitagliptin plus metformin); an intravenous formulation of its chemotherapy-induced nausea and vomiting drug Emend (aprepitant); and a selective COX-2 inhibitor for osteoarthritis, Arcoxia (etoricoxib), which is about to go to an FDA advisory committee meeting.
Merck needs to bolster its product portfolio at a time when it is still facing over 27,000 lawsuits, over its painkiller, Vioxx (rofecoxib), a former $2bn drug which was withdrawn two years ago.
Mr Clark added: "Of course, even as we change our business model, one thing remains the same. We are still a company whose mission is to discover and develop novel medicines and vaccines that address unmet medical needs and to get those products to the people who need them."
