Merck offers peek into product pipeline

WHITEHOUSE STATION, N.J. (CNNMoney.com) -- Merck plans to submit three new drugs to the Food and Drug Administration in 2007 and said it will have four experimental drugs in late-stage testing, the company said Tuesday.

Merck's pipeline includes an HIV treatment, a weight loss drug and a cholesterol combination, the company said.

Merck, along with other Big Pharma companies like Pfizer (Charts), Eli Lilly (Charts), Wyeth (Charts) and Schering-Plough (Charts), is trying to appease investors by building up their new product pipeline to ensure future sales growth.

Merck (Charts) plans to submit a new antiviral treatment for HIV, known as MK-0518, and an insomnia treatment called Gaboxadol to the FDA for approval in 2007.

The company also plans to submit MK-0524A, a drug that increases HDL, or "good" cholesterol, while reducing facial flushing, a common side-effect with this type of drug, to the FDA for approval as well.

In addition to the three drugs submitted for approval in the upcoming year, Merck also expects to put four drugs into "phase 3" or the final stage of testing by mid-year 2007.

If all goes well in testing, the company intends to file its weight loss drug, MK-0364, for FDA approval in 2008.

Merck's late-stage drugs anticipated for next year also include MK-0974, an experimental treatment for migraines, which the company plans to file to the FDA in 2009.

Merck also has in its pipeline a drug that would prevent the breakdown of bones from osteoporosis. The company plans to file this drug, called MK-0822, to the FDA in 2011.

Finally, Merck plans on having an experimental combination drug MK-0524B in late-stage testing in 2007 as well. This combo drug would add the effect of MK-0524A with the effects of Zocor.

MK-0524A increases HDL while at the same time lowering triglycerides, a form of cholesterol that can be harmful. Zocor is a blockbluster cholesterol drug that lost patent protection in 2006.

"I think the cholesterol combo is a sleeper blockbuster," said Les Funtleyder, analyst for Miller Tabak. "A lot of people think it's a gimmicky drug, but I do not."

"If you can raise cholesterol without causing effects, the value of that is under-appreciated," Funtleyder said.

Merck plans on filing the cholesterol combo drug to the FDA in 2008.

If Merck is successful with its new cholesterol products it might help the company reclaim sales lost when its patent on Zocor expired in June of 2006.

When drug company patents run out, prices can drop as much as 80 percent as generic drugmakers jump into the fray, which hits Big Pharma's bottom line.

As a result, Big Pharma companies have renewed their focus on their product pipelines to try to secure new blockbusters for the future.

Pfizer played up its pipeline at a recent analyst meeting by focusing on its experimental drug torcetrapib, but that plan backfired when that drug was linked to deaths in clinical trials.

Merck's pipeline includes an experimental drug called MK-0859 that works in the same way as torcetrapib, which Pfizer recently yanked from studies because of a high mortality count.

But Dr. Peter Kim, president of Merck Research Labs, sought to separate Merck's experimental drug from Pfizer's. Kim told a gathering of analysts that "no serious cardiovascular disturbances have occurred" in phase 2 studies for MK-0859.

Kim also said that this drug increased HDL by 50 percent and decreased LDL, or "bad" cholesterol, by 20 percent, and did not affect blood pressure.

He also defended a recently announced study regarding Arcoxia, an experimental arthritis painkiller that is being reviewed by the FDA.

Arcoxia works the same way as Vioxx, a former blockbuster that was pulled from the market in 2004 after a study linked Vioxx to an increased risk of heart attacks and strokes.

Merck sought to distinguish Arcoxia from Vioxx in November when it unveiled a study showing Arcoxia to have the same cardiovascular risk as diclofenac.

It comes from the same class of NSAID painkillers as ibuprofen and naproxen.

Merck came under attack from some critics for choosing diclofenac for its comparison, because that drug is considered riskier than the other two NSAIDs.

"We compared our drug to the most widely prescribed NSAID in the world, and we did it in a multi-year 30,000-patient study," Kim said.

Funtleyder does not own shares of Merck's stock and Miller Tabak does not conduct business with the company.

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