Theratechnologies announced today that it has sold the rights to sell the experimental lipodystrophy drug tesamorelin in the United States—if the drug is approved by the U.S. Food and Drug Administration—to EMD Serono. Tesamorlin prompts the body to produce more growth hormone and has been shown to reduce some of the fat accumulation seen in people with HIV-related lipodystrophy.
Serono also makes Serostim, a manufactured form of human growth hormone approved to treat HIV-related wasting syndrome. Serostim has been studied for treating fat accumulation in people living with HIV, but Serono has been unable to secure approval for this indication due to side effect concerns and limited long-term safety and effectiveness results.
Tesamorelin is currently being evaluated in a second yearlong Phase III study and has been shown to be just as effective with less toxicity—including effects on sugar (glucose) levels in the blood—than Serostim.
Theratechnologies will receive an up-front payment of $30 million dollars and will ultimately be paid $215 million or more over time.
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