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10 janvier, 2007 23:53 |
Pharmaceuticals
Merck Stands Tall
Matthew Herper, 12.12.06, 11:55 AM ET
WHITE HOUSE STATION, N.J., NJ -
At Merck's annual briefing for analysts here, Chief Executive Richard Clark pledged to return the drug giant to a leadership position in the pharmaceutical industry.
Merck is unveiling new experimental medicines to treat osteoporosis, heart disease and obesity, trying to convince Wall Street that it is emerging from the invention drought that has afflicted the entire drug business.
This year it has launched five new medicines and vaccines, including Januvia to treat diabetes and Gardasil to prevent the virus that causes cervical cancer. But the drug giant is still threatened by 20,000 or so lawsuits related to its withdrawn painkiller Vioxx. The lawsuits are likely to cost billions, but Merck has forestalled and perhaps reduced the damage with the strategy to fight out every case in court.
Already, some doctors are saying the drug giant's research labs seem to have reawakened. "I've been very impressed, scientifically, with what's gone on at Merck," says Christie Ballantyne, a cardiologist at the Baylor College of Medicine. "It seems they are energized and aggressively pursuing leads. They are back into taking risk."
Next year, Merck says, it will file three new drugs with the U.S. Food and Drug Administration and unveil late-stage results on four more. The drugs to be submitted to the FDA will include a first-of-its-kind AIDS treatment and a sleeping pill.
Also on tap, a new form of niacin, the only drug now available to raise HDL (the good cholesterol). The niacin pill will be paired with another drug to curtail niacin's main side effect of unpleasing flushing or an overheated feeling. Some doctors may want extra studies to be certain the anti-flushing drug is safe.
Other drugs expected to yield data next year also may face some doubts. Merck unveiled another kind of HDL-raiser, a drug to inhibit the cholesterol ester transfer protein (CETP). Last week a similar drug from Pfizer was canceled after disastrous clinical results in which it increased mortality by more than 60%. Pfizer's pill also raised blood pressure, an unwanted side effect that Merck's entrant does not have. But there is a real chance the drugs in this class simply won't work.
Another entrant that could be tarnished even before the final data is in: a new obesity pill that is similar to Acomplia, from Sanofi-Aventis. Acomplia has been delayed by the FDA until May 2007. Medicines in this class cause psychiatric side effects, potentially including mood changes and depression. Merck confirms there are "some adverse psychiatric experiences." Merck expects to file with the FDA in 2008.
Merck is also touting a medicine to treat migraines by an entirely new mechanism, and an osteoporosis drug that likewise works in an entirely new way. Merck expects to submit those drugs to the FDA in 2009 and 2011, respectively.
The company is also moving forward in cancer. One recently approved drug, Zolinza, is being tested in blood cancers. A second targets a biological pathway called Aurora kinase. Early studies indicate it spurs cancer cells to kill themselves. The drug is being developed with biotech firm Vertex of Cambridge, Mass.
