Theratechnologies shares hit by FDA findings

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Fw: NATAP: Theratechnologies Stock HitNATAP: Theratechnologies Stock HitWed May 26 2010 08:33:29 GMT-0500 (Central Daylight Time)From:"" <nataphcvhiv@...>To:"" <hiv@...>, "" <nataphcvhiv@...>, "" <natapindustry@...>Theratechnologies shares hit by FDA findings By Nicolas Van Praet, Financial Post May 25, 2010http://www.vancouversun.comMontreal -- Theratechnologies Inc. lost half its market value Tuesday after a review by the U.S. Food and Drug Administration said the Canadian biopharmaceutical company’s key drug reduced abdominal fat in patients with the Human Immunodeficiency Virus,

but might increase the risk of diabetes.Montreal-based Theratechnologies is trying to get market approval for the drug Egrifta, which treats excess abdominal fat in HIV-infected patients with lipodystrophy. A hearing of the FDA’s endocrinologic and metabolic drugs advisory committee is scheduled for Thursday to discuss the matter and hold a potential approval vote.In briefing materials released Tuesday ahead of the hearing, FDA doctors who tested the drug concluded that when injected at a daily dose of 2 mg, the drug did reduce fat tissue significantly compared with a placebo. The drug also had other metabolic effects, like an increase in lean body mass.But the researchers also found that Egrifta’s effectiveness stopped when therapy was discontinued, and that “it appears chronic therapy is necessary†to keep fat levels down. It also found a “statistically significant increase†in the number of patients with diabetes

using the drug.“[This] finding may affect unfavorably the potential cardiovascular benefit of this therapy,†the reviewers said in the briefing materials.The FDA has not yet made a final determination about the safety and effectiveness of the drug. But investors did not like the briefing materials, sending Theratechnologies shares down to $1.92, a 56% decline from the previous close in trading on the Toronto Stock Exchange.Company officials did not return an email seeking comment.Some 1.1 million people were believed to have HIV in the United States as of the end of 200. Successful anti-retroviral therapies in the mid 1990s reduced the number of people dying of the virus but also caused changes in body composition, like accumulating excess fat in the belly.Between 200,000 and 800,000 HIV-infected patients in the United States may experience such lipodystrophy and benefit from intervention, the FDA

estimates.Fw: NATAP: Tesamorelin FDA Briefing DocumentNATAP: Tesamorelin FDA Briefing DocumentWed May 26 2010 08:50:29 GMT-0500 (Central Daylight Time)From:"" <nataphcvhiv@...>To:"" <hiv@...>, "" <nataphcvhiv@...>, "" <natapindustry@...>Tesamorelin FDA Briefing Document pdf attachedGlucose metabolism – Summary and Conclusions:http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM213260.pdfDuring the Main Phase of the trials:• There were no

clinically meaningful changes in mean values for fasting blood glucose, fasting insulin, HOMA-IR and HbA1c at Week 26 between tesamorelin- and placebo-treated patients.• At post-baseline evaluations, there was a trend of worsening glucose status in individual patients treated with tesamorelin as indicated by the larger proportions of patients who shifted from normal fasting blood glucose or HbA1c to abnormal values (in the range of glucose intolerance, prediabetes, or DM) relative to placebo.• There was a statistically significant difference in the proportion of patients who developed DM in the tesamorelin group relative to placebo: Odds Ratio (95%CI) of 3.4 (1.3, 11.5) or 3.6 (1.5, 12.0) depending on whether baseline DM cases were excluded or not.During the Extension Phase of the trials there were no convincing data to indicate deterioration in the glucose status in patients who were continued on tesamorelin, while patients who were

switched to placebo seemed to remain stable or slightly improve. This observation has to take into consideration that the potential effect of dropouts is not known. Regards, Vergelpowerusa dot org