News Feature | May 9, 2014

Merck Could Have 6 New Drugs Approved By FDA This Year

By Marcus Johnson

During a briefing on Merck’s business this week, company executives announced that Merck & Co could get as many as 6 new drugs approved by the FDA this year. The company has already had two drugs approved earlier this year—quick dissolving immunotherapy tablets used to treat seasonal allergies. In addition, the company will be applying for regulatory approval of two other drugs.

The four Merck drugs being reviewed by the FDA include Zontivity, which treats patients with blood clots; V503, which protects against various strains of the human papilloma virus; MK-3475, which is an advanced melanoma treatment; and Suvorexant, which treats patients with insomnia. The two drugs the company will seek regulatory approval for later this year — Odanacatib and Sugammadex — treat osteoporosis and reverse the effects of anesthesia, respectively.

Merck aspires to be an industry leader in a new area of cancer research and treatment called immuno-oncology. Immuno-oncology treatments are different than traditional cancer drugs; instead of designing a drug from scratch to treat a specific cancer, immuno-oncology treatments stimulate the immune system to identify and attack cancer cells.

Merck is also in the midst of late-stage clinical trials for experimental drugs for HIV and hepatitis C. Merck’s hepatitis C treatment, which is a two drug combination, has already shown to have a 98 percent cure rate during clinical trials. The drug’s entrance into the market could offer competition to Gilead Sciences, which is currently selling its hepatitis C drug, Sovaldi, for $1,000 per day. The expensive nature of the Gilead hepatitis C drug has forced a number of governments to seek other options, and Merck could stand to benefit if its hepatitis C treatment receives regulatory approval.

The company was recently in the news for selling its consumer health business to Bayer for $14.2 billion. Through this agreement, Bayer will gain Merck’s Claritin allergy pills, Coppertone sun-care line, and Dr. Scholl’s foot-care products line. The company expects that this move will enable more research to occur on prescription drugs.