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Re: earlylight post# 85884

Thursday, 09/03/2009 7:58:12 PM

Thursday, September 03, 2009 7:58:12 PM

Post# of 91977
Lets go DEEEEEEEP! For about 2 months! Tell the bounce board to watch OSIR tomorrow...I can't post there while on a free sub...

UPDATE:Osiris Thera Drops On Fears Of Negative Prochymal DataLast update: 9/3/2009 5:05:06 PM(Updates with company comment in the fourth paragraph.)

By Shara Tibken
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Shares of Osiris Therapeutics Inc. (OSIR) tumbled as much as 22% on heavy volume Thursday as the market feared the company is going to report negative data for two Phase III trials for Prochymal, a stem-cell-based treatment for graft-versus-host disease. "The company said it would most likely release it this week," Wedbush Morgan analyst Duane Nash said in an interview. "The market is taking the approach that no news is bad news, but I think that's pretty rash." He added the company said it hasn't received the data yet from its contract research organization. In a statement, an Osiris company spokesperson reiterated the company's comments from its second-quarter earnings call, saying Osiris expects the data "to be released during the first week of September give or take a few days." Shares closed down 18% to $11.52 after earlier falling as low as $10.91 on five times the normal daily volume. Shares have varied widely in the last 12 months, down about 24% during the period. They traded as low as $10.80 in October and as high as $21.65 in December. According to FactSet, short interest was about 25% of float as of Thursday. Shares have been volatile in recent weeks in anticipation of results from the Prochymal trials. The current trials are evaluating the drug's ability to combat GvHD, a complication that can occur following bone marrow transplants when the transplanted material attacks the recipient's body. Analysts have said Prochymal would be the first therapy approved for GvHD, and it also could become the first stem-cell therapy approved in any indication. But more importantly, Prochymal could be used for other indications besides GvHD. The trial is "extraordinary important," Nash said. "The GvHD market is a small market - only about $150 million - but the same drug has the potential to bring in well over $1 billion a year in other indications. Everyone's looking at this data as a proxy to whether the same drug will work in other indications." Nash said some possible uses for Prochymal include Crohn's disease, heart attack and Type 1 diabetes. He said the company is conducting studies for the uses, but the data for GvHD is the first from large studies that are randomized. Meanwhile, Jefferies & Co. analyst Eun Yang said in a note Thursday she believes chances for success in GvHD are low. Interim data for the drug in other indications - like Crohn's disease and chronic obstructive pulmonary disease, or COPD - haven't been impressive, results that Yang says call into question Prochymal's "robustness in efficacy." In March, Osiris stopped enrollment in a late-stage trial to treat Chron's disease because a flaw in the trials design made it unlikely to succeed. And in June, the company said interim data from the COPD trial showed no significant improvement in lung function. Yang said the firm's experts view Prochymal in the Phase III trial for steroid-refractory GvHD as a "weak, non-specific immunosuppressive agent" based on likely high variability in placebo responses, lack of robustness of Prochymal and liberal definition of steroid-refractory in trial design. She added that the Phase III data for first-line GvHD has a better chance for success, but a tougher endpoint of complete response maintained for 28 days with no steroid dose increase, no second-line therapy requirement and survival for 90 days. -By Shara Tibken, Dow Jones Newswires; 212-416-2189; shara.tibken@dowjones.com; (Jon Kamp contributed to this report.) (END) Dow Jones NewswiresSeptember 03, 2009 17:05 ET (21:05 GMT)

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