Merck & Co. (MRK) said Friday it would delay beyond 2007 its filing for regulatory approval of a new combination drug that raises good cholesterol while lowering bad cholesterol, saying it's still working on the formulation.
The Whitehouse Station, N.J., drug maker said it still expected to file for regulatory approval of a second, related cholesterol drug in 2007.
Merck shares dropped 10 cents to $41.96 on light volume. The news, however, sent shares of Kos Pharmaceuticals Inc. (KOSP) up $2.86, or 6%, to $49.84 because Kos sells a drug, Niaspan, whose sales could be hurt if Merck successfully brings its new drugs to market.
Merck said in December it was developing two combination drugs, and would apply for regulatory approval of both in 2007. One drug, MK-0524A, is a combination of the drug niacin and another compound designed to inhibit flushing, a skin-related side effect of niacin. The second drug, MK-0524B, would those two compounds with Zocor, Merck's cholesterol-lowering drug that's already on the market.
Merck said the new compounds would not only lower bad cholesterol as Zocor does, but also boost levels of good cholesterol. Doctors believe raising good cholesterol while cutting bad cholesterol can further reduce the incidence of heart disease beyond what drugs such as Zocor have accomplished.
But in March, Merck said it had experienced a "formulation issue" in developing MK-0524B, which combines Zocor, niacin and the flushing-inhibiting compound. Merck said at the time it would proceed with clinical trials of MK-0524B, but Zocor and MK-0524A would be co-administered, not given in a single pill. The co-administration will continue as Merck tries to develop a fixed-dose combination formulation, Merck said Friday.
Now, Merck no longer plans to file an application for MK-0524B in 2007, citing the formulation issue. It still plans, however, to file for approval of MK-0524A in 2007. If MK-0524A is approved, it's possible doctors would prescribe it in combination with Zocor or another cholesterol-lowering drug, rather than wait for MK-0524B to come to market in a single pill.
Merck said it hasn't determined a new projected filing date for MK-0524B.
Merck is counting on the new cholesterol to become big sellers and help fill the void left by the loss of Vioxx, which Merck withdrew over safety concerns, and the expiration of patents for key drugs such as Zocor. The recent launch of generic Zocor has cut into sales of the branded drug.
Kos Pharmaceuticals spokesman John Howarth said the company had no comment on Merck's news. Kos has applied for FDA approval for a new version of its Niaspan designed to reduce flushing, the niacin-related side effect that Merck also hopes to reduce with its proposed drugs. Kos expects FDA action on the application by the middle of the fourth quarter, Howarth said.
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