**note - Glucophage/Metformin is an insulin-sensitizing drug used to treat Type 2 diabetes, Polycystic Ovarian Syndrome (PCOS), and other disorders of Insulin Resistance ......... Doreen

By Lisa Richwine

WASHINGTON, Oct 10 (Reuters) - Generic-drug makers are appealing to Congress to stop Bristol-Myers Squibb Co. in what they say would be a precedent-setting move to protect a key drug from cheaper rivals.

The New York-based drug maker is using legal maneuvers to try to keep generic versions of its blockbuster diabetes medicine Glucophage off the US market for three and a half more years, generic-drug companies say.

If successful, Bristol-Myers could reap hundreds of millions of dollars by maintaining sole rights to sell Glucophage.

The issue is tied to legislation that would renew incentives for studying medicines' effects on children. The measure is poised for Senate action and is set for a House committee vote on Thursday. Generic companies are feverishly lobbying for lawmakers to include in the bill language to block Bristol-Myers's moves.

"The impact for consumers on this one product is in the hundreds of millions of dollars," said Jake Hansen, a vice president for generic-drug maker Barr Laboratories. "And the potential impact is in the multibillions of dollars as other companies realize here is the key to a long monopoly extension."

The pediatrics law set for renewal awards 6 months of extra patent protection to products tested in children, an incentive for a long-neglected area of research. Bristol-Myers won the extra 6 months after completing a study on Glucophage's effectiveness in children aged 10 to 16.

But the company also is using that information to try to block competitors for an additional three and a half years, generic companies say. Another law grants that extra time if the Food and Drug Administration (FDA) approves a new indication for a product, usually information about another use.

Bristol-Myers is arguing that the FDA cannot clear any generic versions of Glucophage because the makers would not be allowed to include the protected pediatric language on their labels, according to generic companies. Generally, the FDA requires labels for generics to be identical to those for brand-name products.

Bristol-Myers said in a statement it had decided to "vigorously defend its intellectual property for Glucophage" and said its pediatric studies showed the drug had a clear benefit for children. The company declined to provide further comment on the drug.

Generic companies also said Bristol-Myers was trying to similarly shield anti-anxiety treatment BuSpar from more generic competition, but Bristol-Myers said that was untrue.

The FDA said it was still evaluating the issues regarding Glucophage and the pediatric study.

In the meantime, copies of Glucophage, known generically as metformin, are sitting in warehouses ready to go. Twelve generic firms have applied for FDA approval. They include Barr, Teva Pharmaceutical Industries Ltd., Mylan Laboratories Inc., Watson Pharmaceuticals Inc. and Andrx Corp.

With many competitors, the price of the medicine likely would drop quickly. A 3-month supply of 500-milligram tablets of Glucophage now costs about $63 US.

Generic makers are pressing lawmakers, who are concerned about rising drug costs, to write into the pediatric bill a prohibition against such use of pediatric studies, clearing the way for FDA approval of generic versions of Glucophage and preventing other companies from using the same tactic.

"A simple label change does not merit 3 years of exclusivity for Bristol and a multibillion-dollar penalty for the consumer," William Nixon, president of the Generic Pharmaceutical Association, said in a statement.

http://www.reutershealth.com/archiv...010elin029.html

I'm tired of the pharmaceutical market taking advantage of every possible loop-hole. Then again, its a tough market, and every edge helps I'm sure.

Mike