Theratechnologies' COPD program has completed itspreclinical and Phase I stages, and is in the early stages of Phase II. Musclewasting related to COPD, the company notes on its site, is "a decrease orthinning of the muscle mass…associated with several abnormalities, includingimpaired exercise capacity and functioning and decreased muscle strength." Itis "a common symptom in patients with moderate to severe COPD," the site adds,and is "an independent predictor of a COPD patient's functional deteriorationand mortality." Theratechnologies was investigating tesamorelin, a stabilizedanalogue of the growth hormone-releasing factor that induces growth hormoneproduction, as a treatment for this issue.
Tesamorelin is the focus of another therapy byTheratechnologies in Egrifta, tesamorelin as an injection for the treatment ofHIV-associated lipodystrophy, or changes of fat distribution in the body.Lipodystrophy can lead to abnormalities in body shape and excess abdominal fataccumulation, which tesamorelin is expected to treat by reducing visceral fat. Theratechnologieswill be focusing its efforts on this indication for the compound, which iscurrently under review with regulatory agencies in Europe, Canada, Mexico,Brazil, Israel and Argentina. The company will also accelerate the developmentof a second-generation growth hormone releasing factor for a range of potentialmedical indications.
Theratechnologies estimates that the program discontinuationand workforce reductions will result in cost savings of approximately $10million in 2012. The COPD program was estimated to have required an investmentof approximately $90 million over the next four years. Factoring in severancecosts and the termination of the clinical trial, the company expects charges ofapproximately $3 million, which will be registered in fiscal 2012.
The decisions were approved unanimously byTheratechnologies' board of directors, which is also aiming to lower its costsby approximately 50 percent through a reduction in the number of committees,number of members and a decrease in remuneration fees.
SOURCE: Theratechnologies press release