Federal court invalidates patent for drug Fosamax

Saturday, January 29, 2005

TRENTON, N.J. -- A federal court invalidated the patent on Friday for Merck & Co.'s second-largest selling drug, the blockbuster osteoporosis treatment Fosamax, in a decision that offers millions of patients hope for a cheaper version sooner, but darkens the company's already clouded outlook.

The company also was hit with news that the federal Securities and Exchange Commission is starting a formal inquiry into its handling of arthritis blockbuster Vioxx, which it withdrew from the market last year after studies showed it increased the risk of heart attacks and strokes.

Merck's shares tumbled in heavy trading.

The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated the patent for the once-a-week version of Fosamax, which dominates the market for osteoporosis drugs. More than 3 million people in the United States afflicted with the brittle-bone disease take Fosamax.

Under the ruling, generic competition could begin as soon as early 2008, instead of 2018. The main patent for the daily 5 milligram and 10 milligram versions of the drug already was set to expire in February 2008.

Fosamax is the No. 2 drug for Whitehouse Station, N.J.-based Merck. It reported sales of $3.16 billion for Fosamax last year, more than 90 percent of which were for the 35 mg and 70 mg once-a-week versions, according to company spokesman Tony Plohoros.

Each version costs about $80 for a month's supply.

"Merck disagrees with the opinion of the court of appeals and is considering its options, including a request for reconsideration by the court of appeals," Plohoros said.

The court's ruling was a blow to Merck, which faces a dearth of new drugs to offer, slumping sales from major drugs losing patent protection, and lost revenues and a slew of lawsuits over its withdrawal of arthritis blockbuster Vioxx.

Merck shares closed down $3.16, or 10 percent, to $28.02 Friday on the New York Stock Exchange. Nearly 57 million shares were traded, or roughly six times normal daily volume for Merck.

"It's a big deal," said Barbara Ryan, a managing director at Deutsche Bank Securities Inc. "Merck obviously has a lot of issues facing it, including the withdrawal of Vioxx from the market and the loss of the Zocor patents in the middle of 2006."

Zocor, for high cholesterol, is Merck's biggest drug, with $5.2 billion in sales last year.

"The profit impact could be very severe," Ryan said of the Fosamax patent loss.

Merck in 2003 lost two major products in late-stage trials that could have eventually replaced Zocor, said pharmaceuticals analyst Albert Rauch of A. G. Edwards & Sons Inc.

"How are you going to replace those revenues? That's what people are worried about," Rauch said.

Pharmaceuticals analyst Tim Anderson of Prudential Financial predicted the Fosamax decision will leave Merck with flat earnings in 2008. A once-monthly osteoporosis treatment called Boniva, produced by Switzerland's Roche Group, is due out in several months and is "an underappreciated threat," he added.

The appeals court's 2-1 decision on Fosamax reversed an August 2003 ruling by the U.S. District Court in Delaware, which had upheld the patent.

The once-a-week patent had been challenged by generic drugmaker Teva Pharmaceuticals USA Inc. of North Wales, Pa., one of the country's largest generic drugmakers, with about 170 medicines on the market.

"We're very pleased with the court's decision," said Kevin Mannix, director of investor relations for Teva. He said the company expects to get final U.S. approval for a once-a-week version as early as 2008.

Meanwhile, Merck said Friday that the SEC notified it Thursday that it was starting a formal inquiry into Merck's handling of Vioxx, which had about $2.5 billion in annual sales.

Merck pulled the arthritis and acute pain drug from the market worldwide on Sept. 30, after its own study showed that Vioxx increased the risk of heart attacks and strokes after 18 months' use. Consumer groups and other critics have charged that Merck knew about the risks earlier but downplayed them.

Merck said Friday the SEC action was not unexpected and that it will continue to cooperate with the agency.

A day earlier, a panel of seven federal judges in Fort Myers, Fla., considered motions by Merck and plaintiffs' attorneys to consolidate hundreds of Vioxx personal injury lawsuits to one jurisdiction to streamline discovery and other pretrial steps. The panel is expected to decide the issue in several weeks.

Associated Press Writer Krista Larson contributed to this story.

On the Net: http://www.merck.com


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