PHARMACY

Researcher speaks out on risks of Lilly’s prasugrel

BY Alaric DeArment

NEW ORLEANS A leading cardiologist has said researchers have underestimated the risks of Eli Lilly’s blood-thinning drug prasugrel, according to published reports.

On the one hand, prasugrel was more effective than Bristol-Myers Squibb’s Plavix (clopidogrel bisulfate) at preventing blood clots, but it also caused much more serious bleeding.

The cardiologist, Sanjay Kaul, said the risk of serious bleeding in high-risk patients was 42 percent higher among those using prasugrel than among those using Plavix.

Lilly is developing the drug with Daiichi Sankyo, though the Food and Drug Administration has delayed approval of the drug twice.

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FDA raises questions about efficacy of pain medication tamper-proofing

BY Alaric DeArment

NEW YORK Questions have arisen as to whether a pill by Pain Therapeutics and King Pharmaceuticals is resistant to tampering.

A memo by the Food and Drug Administration Monday concerns the drug Remoxy, a formulation of oxycodone that uses liquid capsule drug-delivery technology designed to prevent misuse of the drug. Some people have abused oxycodone tablets by crushing them, dissolving it in water and then injecting it for its opiate-like effects.

The FDA’s memo said that Pain Therapeutics did not sufficiently conduct long-term tests of Remoxy to determine whether the oxycodone could be extracted and diverted, though Pain Therapeutics disputes that claim.

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Titan releases earnings report for Q3 2008

BY Alaric DeArment

SOUTH SAN FRANCISCO, Calif. Titan Pharmaceuticals has released financial results for third quarter 2008.

Total operating costs for the quarter, which ended Sept. 30, were $6 million, compared with $4.6 million for third quarter 2007, the company said. Net loss for the quarter was $5.9 million, compared to $4.3 million last year; losses in both cases totaled 10 cents a share. The increase in operating costs resulted mostly from an increase in research and development funding related to development of the opiate addiction treatment Probuphine (buprenorphine) and a slight increase in general and administrative costs.

“We have continued to streamline our expenses and focus our resources on the phase 3 clinical development of Probuphine,” Titan president and chief executive Marc Rubin said. “During the third quarter, we have engaged in discussions with several potential partners both in the U.S. and Europe, and we are continuing these efforts as we evaluate strategic alternatives for the company.”

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