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Osiris Rises on European Stem-Cell Drug Title Decision

Osiris Therapeutics Inc. rose the most in eight months after European regulators transferred the orphan drug title for a stem cell therapy to the company, making it easier to seek a buyer or partner for the treatment.

Osiris gained 9 percent to $7.65 at the close in New York, its biggest intraday jump since June. The European Medicines Agency made the title transfer for the intravenous treatment Prochymal, which treats a disease that attacks bone marrow- transplant recipients, Columbia, Maryland-based Osiris said in a statement today.

The orphan designation provides 10 years of market exclusivity if the medicine is approved, and the simplifying of who holds the title “clears the way for a transaction” should Osiris opt to sell Prochymal to another company, said Edward Tenthoff, a senior analyst with Piper Jaffray & Co. in New York.

“They’ve started to get approvals for Prochymal,” said Tenthoff, who has a neutral rating on the stock. “There’s a way for them to monetize that.”

Tenthoff said Osiris’s former partner, Sanofi’s Genzyme unit, probably held Prochymal’s orphan drug title before. Osiris didn’t name the previous title holder in its statement.

Osiris had declined 22 percent this year through Feb. 15. An orphan drug typically targets rare diseases and is intended for a small number of patients with few treatment options.

Patent Challenge

Prochymal is the world’s first approved drug with a stem cell as its active ingredient, Osiris said.

Osiris said in a separate statement it won a patent challenge in Australia. Prochymal is approved in New Zealand and Canada to treat children with acute graft versus host disease, a bone marrow transplant complication that kills as many as 80 percent of children affected. It’s the first drug approved to treat the disease, the company said.

The drug is available in seven other countries, including the U.S., under an expanded access program, Osiris said. Such programs make investigational drugs available to treat patients with serious conditions or diseases who cannot participate in a controlled clinical trial.

The company hasn’t sought a U.S. Biologics License Application approval yet, which may be what has weighed on the stock this year, Tenthoff said.

Prochymal is being tested for refractory Crohn’s disease and acute myocardial infarction, the company said.

To contact the reporter on this story: Jeanna Smialek in Washington at jsmialek1@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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