Genzyme diarrhea drug may be blockbuster

By Toni Clarke

BOSTON (Reuters) - Genzyme Corp. (GENZ.O: Quote, Profile, Research, Stock Buzz) said on Wednesday that an experimental drug it is developing to treat hospital-acquired diarrhea could generate annual sales of nearly $1 billion, if approved.

Speaking at the Reuters Biotechnology Summit in Boston, the company's chief executive, Henri Termeer, said he expects results from two late-stage trials of the drug, Tolevamer, for the treatment of Clostridium difficile-associated diarrhea, to be available in the first half of next year, with a potential approval in 2008.

If successful, the drug could add to an increasingly diverse stable of products from a company that five years ago was heavily reliant on the drug Cerezyme for Gaucher disease, a condition that causes enlargement of the liver and spleen.

Within the next two months, Cambridge, Massachusetts-based Genzyme expects to receive approval in Europe and the United States for Myozyme, its experimental treatment for Pompe disease, a potentially fatal muscular disorder.

Termeer said sales of Myozyme will not amount to much in 2006 but will be "material" in 2007. He said he sees the drug following a similar growth trajectory as its drug Fabrazyme for Fabry disease, a condition which causes fats to build up in blood vessels. The company expects sales of the drug to reach as much as $390 million this year.

Eventually Myozyme could become as big a product as Cerezyme, which will generate sales of nearly $1 billion this year and has been on the market for more than a decade, Termeer said.

Genzyme, which built itself into the fourth-biggest U.S. biotech by concentrating on developing high-priced drugs for diseases with tiny populations, is expanding. It is determined to build a cancer drug portfolio and is developing its cancer drug Campath to treat multiple sclerosis.

The company had halted mid-stage trials of Campath in multiple sclerosis after safety data turned up three cases of idiopathic thrombocytopenic purpura, or ITP, a severe autoimmune disorder. The company expects to be able to resume testing shortly, after submitting a safety monitoring plan to U.S. regulators.  Continued...