Merck seeks to be leader in generic biotech drugs

WHITEHOUSE STATION, N.J. - Drugmaker Merck & Co. Inc. said yesterday that it was moving to become a leader in generic biotechnology drugs and sales in emerging markets.

The company also said it was diversifying its research through partnerships and new technologies and was working to maximize long-term sales of key products.

Merck has major operations in the Philadelphia area, primarily in West Point.

The maker of respiratory drug Singulair and cholesterol drugs Vytorin and Zetia, which have been dogged by efficacy and safety questions, plans to seek U.S. approval for three new drugs next year, has seven more in late-stage testing, and will start late-stage tests on six others in 2009.

Also, Merck is launching a division called Merck BioVentures to make new and follow-on, or generic, biotech drugs, management told analysts gathered at its headquarters. Such generic biologic drugs, while starting to arrive in Europe, are not yet allowed in the United States - but that is likely to be a hot issue in Washington next year.

The unit will use new science to speed up drug development, including glycoengineering, a technology Merck obtained with a 2006 acquisition that allows rapidly making antibodies and other proteins for drugs in yeast, rather than the mammalian cells other companies use.

Peter Kim, president of Merck Research Laboratories, said the unit would invest $1.5 billion in research by 2015, develop a facility by 2012 in Elkton, Va., and aim to launch six or more generic biotech products from 2012 through 2017, a period when some major biotech drugs lose patent protection.

Marketing chief Kenneth Frazier said "this will be a tremendous commercial opportunity for Merck."

"This is also our entree into novel biologics," Frazier added.

Kim said Merck would apply next year to sell three drugs in the United States: for migraines, acute heart failure and hardening of the arteries. He also discussed several promising compounds in late development - including drugs for asthma, diabetes and osteoporosis and a vaccine to prevent costly, sometimes deadly, staph infections.