Merck to seek OK for 2 new drugs
Drugmaker to ask FDA to approve weight loss and cholesterol drugs in 2008; backs financial outlook.
WHITEHOUSE STATION, N.J. (CNNMoney.com) -- The drugmaker Merck & Co. said Tuesday that it will seek federal approval for two new experimental drugs next year, adding that it's on track to meet its sales targets.
Merck, in a meeting with analysts at its headquarters, unveiled plans to ask the Food and Drug Administration to approve an experimental combination drug that controls cholesterol, as well as a weight-loss medication.
Merck also backed its guidance for 2007 and 2008. As previously stated, Merck projects earnings per share in 2007 of $3.08 to $3.14, excluding certain charges including the Vioxx settlement, or an EPS of $1.45 to $1.51 with the charges. Merck expects EPS of $3.28 to $3.38 for 2008, excluding a $2.5 billion payment from a deal with AstraZeneca, as well as certain charges. Including the charges and the payment, Merck projects EPS for 2008 of $3.96 to $4.06.
The experimental cholesterol drug for which Merck is seeking FDA approval raises a beneficial type of cholesterol called high-density lipoprotein, while lowering harmful types like triglycerides and low-density lipoprotein. The combo drug, which is not yet named, includes Zocor, a former blockbuster whose patent expired in 2006.
Merck said it also plans to begin late-stage studies of another experimental cholesterol drug, called anacetrapib. This drug would also aim to raise beneficial cholesterol and lower harmful low-density lipoprotein, without raising blood pressure.
The weight-loss medication that Merck wants approval for is similar to the drug rimonabant by Sanofi-Aventis (Charts). Rimonabant has been approved for sale in Europe under the name Zimulti. But Sanofi-Aventis withdrew its FDA application for rimonabant in June after an advisory panel voted not to recommend its approval because of reports it provoked suicidal thoughts in its users. The drug class appears to have other potential uses and has been studied as a treatment for diabetes and smoking cessation.
Dr. Peter Kim, president of Merck Research Laboratories, said that early-stage studies with the weight-loss drug excluded patients on anti-depressants and those with a history of depression. Nonetheless, certain "psychiatric adverse events" were observed in some of these patients, depending on how much of the drug they took.
The current, late-stage drug study includes patients taking a single anti-depressant, but excludes those on multiple anti-depressants. Dr. Kim said the new study will go into more detail on the effects of different dosages.
"We are going to be meeting or beating the FDA requirements for submission of an obesity drug," said Dr. Kim, referring the planned submission of the drug, also called taranabant, for next year.
Merck was also working on an HIV vaccine, but the experiments were stopped recently when the vaccine was found to be ineffective. Fielding questions from analysts, Dr. Kim said the failure of the HIV vaccine "was indeed a blow to the world."
In addition to seeking regulatory approval on the new cholesterol and weight-loss drugs, Merck expects decisions next year on two other products that it already has submitted to the FDA: the cholesterol drug Cordaptive and the injectable treatment Emend for nausea related to chemotherapy. Cordaptive is experimental, but Emend is already available in a capsule form.
Merck Chief Executive Richard Clark said the company's growth has been driven by fast-growing new products, such as the cervical cancer vaccine Gardasil and the diabetes drug Januvia.
In the past two years, Merck has launched seven new drugs and vaccines, including the newly-launched HIV treatment Isentress. The company is also conducting late-stage testing of an experimental heart failure drug - which it acquired when it bought NovaCadia earlier this year - and a migraine treatment and may seek FDA approval of them in 2009.
The FDA is reviewing Gardasil for the additional use of preventing vaginal and vulvar cancers. In addition, the vaccine, approved in girls and women ages 9 to 26, is being considered for women up to age 45. Isentress, which is approved for patients with drug-resistant HIV strains, is now being considered for patients who have not been previously treated.
Clark said the company is "firmly on track" to deliver its goal of growing sales of 4 to 6 percent annually between 2005 and 2010. The company is also increasing its per-share earnings by double-digit percentages each year, he said.
Merck's (Charts, Fortune 500) stock has surged about 44 percent this year, as the company finally seems to be leaving behind its problems related to Vioxx, the arthritis painkiller blockbuster that was pulled from the market in 2004 after a study showed increased risk of heart attack and stroke.
On Nov. 9, Merck announced a $4.85 billion settlement covering 27,000 of the lawsuits, triggering a surge in the company's stock price. During the opening portion of their morning presentation, Clark and other Merck executives did not mention Vioxx.