Merck to Seek U.S. Approval of 3 Drugs in 2007

Posted 13 December 2006 @ 08:17 am EET     Print     Reprint     E-Mail     Comments

NEW YORK (Reuters) - Merck & Co. expects to seek U.S. approval in 2007 for drugs to treat HIV, cholesterol and insomnia, and it aims to have another four products in late-stage trials by mid-year, the company said on Tuesday.

The products due to be in late-stage trials are MK-524B, which raises "good" HDL cholesterol; weight loss drug MK-364, which works through the same mechanism as Sanofi-Aventis' Acomplia; MK-974 for migraine headaches; and MK-822, which treats osteoporosis by blocking a protein called Cathepsin K.

Merck also reviewed its drugs in earlier-stage trials, as the company aims to restore double-digit earnings growth by 2010 following recent patent expirations on older medicines and the withdrawal two years ago of its Vioxx arthritis treatment.

The U.S. drugmaker laid out its plans in a meeting with investors, but Merck shares slipped about 1 percent amid a perceived lack of excitement at the annual event. "There really wasn't much surprise," Natexis Bleichroeder analyst Jon LeCroy said of the main portion of the meeting on drug research. "It's a relatively uneventful meeting."

OrbiMed Advisors analyst Trevor Polischuk said he took a "negative" overall view of the presentations on Merck's experimental drugs because side effects or disadvantages were seen among many of them. "Every sort of compound you can come up with has some negative baggage," Polischuk said, referring to highlighted Merck drugs.

For example, Polischuk said Merck predicted its insomnia drug, gaboxadol, would be a controlled substance because of its abuse potential, eliminating a potential advantage over rival drugs. Merck research chief Peter Kim said one of the company's most promising experimental drugs is its HIV medicine MK-518, which blocks an enzyme called integrase. It works faster than perhaps any other class of medicines to reduce HIV levels, he said.

"The speed in knocking down HIV ... and its ability to inhibit (drug) resistant HIV is very impressive," Kim said at the meeting, held at company headquarters in Whitehouse Station, New Jersey. Kim also put the spotlight on MK-364, but noted the weight-loss drug was linked to psychiatric side effects in clinical trials. He noted that Sanofi's Acomplia had been associated with depression in its own trials.

The research chief expressed enthusiasm for MK-859, another Merck HDL-raising drugs, which works the same way as Pfizer Inc.'s torcetrapib, for which trials were halted early this month on safety concerns.

He said MK-859 raised levels of HDL by more than half in trials and cut levels of "bad" LDL cholesterol by more than 20 percent, without raising blood pressure or causing serious cardiovascular side effects.

Torcetrapib, by contrast, was discontinued after being linked to elevated blood pressure and a worrisome number of deaths. Merck also singled out cancer drug, MK-457, now in mid-stage trials against a wide variety of tumors, which blocks a protein called Aurora kinase.

Merck, which last week maintained its forecast for flat 2006 earnings and slightly higher 2007 results, largely pegged its financial goals to revenue from three recently launched new vaccines and a new diabetes drug called Januvia. Company officials also stressed the importance of a continuing restructuring plan meant to produce cumulative savings of up to $5 billion from 2006 through 2010.

"Fundamentally rebuilding our business model will lead us to a place where other companies will (need) years to catch up with us," Peter Loescher, Merck's president of global human health, said after the meeting.