A federal court invalidated the patent for a blockbuster osteoporosis drug made by Merck yesterday, sending Merck shares plunging but offering...
TRENTON, N.J. — A federal court invalidated the patent for a blockbuster osteoporosis drug made by Merck yesterday, sending Merck shares plunging but offering patients with the brittle-bone disease the possibility of cheaper pills in a few years.
The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated the patent for the once-a-week version of Merck’s Fosamax, which dominates the market for osteoporosis drugs. Under the ruling, generic competition could begin as soon as early 2008, instead of 2018.
Fosamax is the No. 2 drug for Merck. The company already is beleaguered by its voluntary withdrawal of arthritis blockbuster Vioxx, which is expected to cost the company billions of dollars to settle lawsuits by patients claiming it caused heart attacks, strokes and other serious medical problems.
Merck reported sales of $3.16 billion for Fosamax last year, more than 90 percent of which were for the once-a-week version, according to company spokesman Tony Plohoros.
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“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,” he said.
Merck shares were down $3.34, or 10.7 percent, to $27.84 yesterday.
“It’s a big deal,” said Barbara Ryan, a managing director at Deutsche Bank Securities. “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.
Merck’s primary Fosamax patent, covering both the daily and weekly versions, is to expire in February 2018, according to Plohoros. Both versions cost about $80 for a month’s supply.
The once-a-week patent had been challenged by generic drug maker Teva Pharmaceuticals USA.
SEC starts inquiry into Vioxx handling
Merck said the Securities and Exchange Commission (SEC) has started a formal inquiry into its handling of Vioxx, the painkiller pulled from the market Sept. 30 because of its link to heart attacks and strokes.
The SEC’s decision wasn’t unexpected, the company said in a statement yesterday. A formal investigation gives the SEC staff the power to issue subpoenas for documents or testimony.
Merck wouldn’t comment on the SEC matter beyond the press release, company spokesman Tony Plohoros said. SEC spokesman John Heine declined to comment on the investigation. Merck shares fell.
Vioxx may have caused as many as 140,000 heart attacks in the U.S. between its 1999 introduction and the recall, Food and Drug Administration safety reviewer David Graham said in a study published this week by the U.K. medical journal Lancet. As of Dec. 31, Merck said 575 lawsuits had been filed by 1,400 plaintiffs’ groups alleging injuries linked to Vioxx, including heart attacks and kidney damage.
The Department of Justice and certain congressional committees also are investigating.