Theratechnologies (TSX: TH) announced today that the U.S. Food and Drug Administration ("FDA") has approved EGRIFTATM (tesamorelin for injection) as the first and only treatment indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy (abdominal lipohypertrophy). EGRIFTATM(tesamorelin for injection) was developed by Theratechnologies and will be exclusively commercialized in the U.S. by EMD Serono, Inc. ("EMD Serono"), an affiliate of Merck KGaA, of Darmstadt, Germany, under the terms of a collaboration and licensing agreement.
There are limitations of use associated with EGRIFTATM (tesamorelin for injection). Since the long-term cardiovascular safety and potential long-term cardiovascular benefit of EGRIFTATM (tesamorelin for injection) treatment have not been studied and are not known, careful consideration should be given whether to continue EGRIFTATM (tesamorelin for injection) treatment in patients who do not show a clear efficacy response as judged by the degree of reduction in visceral adipose tissue ("VAT") measured by waist circumference ("WC") or CT scan. EGRIFTATM (tesamorelin for injection) is not indicated for weight loss management (weight neutral effect). There are no data to support improved compliance with antiretroviral therapies in HIV-positive patients taking EGRIFTATM (tesamorelin for injection).
"Theratechnologies is very pleased to receive marketing approval for EGRIFTATM from the FDA. We are one of the very few Canadian biotechnology companies to have successfully discovered, developed and brought a drug to the market on our own. This milestone represents a significant achievement which will benefit both patients and our shareholders," commented Yves Rosconi, President and CEO of Theratechnologies.
"We are confident that EMD Serono will successfully commercialize EGRIFTATM in the United States, given their track record and expertise with other metabolic disorders," noted Paul Pommier, Chairman of the Board of Directors of Theratechnologies. "Theratechnologies will continue to focus on signing partnerships outside of the United States in order to access additional markets for EGRIFTATM in HIV-infected patients with excess abdominal fat associated with lipodystrophy," Mr. Pommier concluded.
"While antiretroviral therapy is extremely important in the management of patients with HIV infection, some patients are experiencing excess abdominal fat associated with lipodystrophy, which can be difficult to manage," said Fereydoun Firouz, President and CEO, EMD Serono. "EMD Serono has maintained a commitment to advancing science and medicine in this area of unmet medical need, and it will continue to remain a focus for the organization. We are committed to making a difference in people's lives, and look forward to making EGRIFTATM available for patients as soon as possible. "
In 2008, Theratechnologies entered into a collaboration and licensing agreement with EMD Serono, for the exclusive commercialization rights to EGRIFTATM (tesamorelin for injection) in the United States for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Under the terms of this agreement, the FDA marketing approval is associated with milestone payments totaling US$25 million (approximately CAN$25 million). EGRIFTATM is the proposed brand name to be used globally.
The efficacy and safety of EGRIFTATM (tesamorelin for injection) was evaluated in two Phase 3 multi-center, randomized, double-blind, placebo-controlled clinical trials, which demonstrated statistically significant decreases in VAT and WC versus placebo in HIV-infected patients who suffer from excess abdominal fat associated with lipodystrophy.
The FDA has requested the following three post-marketing requirements: a long-term observational safety study for tesamorelin acetate (EGRIFTATM), a single vial formulation - the development of a new presentation of the same formulation, and a clinical trial to assess whether EGRIFTATM (tesamorelin for injection) has an impact on diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy and excess abdominal fat.
"Having a FDA-approved treatment available for this condition is an important goal for the HIV population," said Steven Grinspoon, M.D., Professor of Medicine at Harvard Medical School, Director of the Massachusetts General Hospital Program in Nutritional Metabolism, and lead investigator for EGRIFTATM(tesamorelin for injection) trials in the U.S. "Although lifestyle modification could be a valuable first step for HIV patients with abdominal fat accumulation, results to date from lifestyle and exercise studies have been inconsistent with respect to the reduction in abdominal lipohypertrophy. Until today, physicians did not have access to approved drug options to treat this complication," added Dr. Grinspoon. "Having been involved in the clinical development of EGRIFTATM over the past 7 years, I am pleased that we have published data demonstrating that EGRIFTATM reduces VAT, with no adverse effects on subcutaneous adipose tissue. It is also important to monitor IGF-1 levels and impaired glucose tolerance in patients receiving EGRIFTATM. I am encouraged that, for the first time, patients in the United States with this serious condition will have a FDA-approved treatment option available to them," concluded Dr. Grinspoon.
