Date: 2013-04-08
Type of information: Licensing agreement
Compound: tesamorelin
Company: Theratechnologies (Canada) Ferrer Internacional (Spain)
Therapeutic area: Metabolic diseases - Infectious diseases
Type agreement: distribution
licensing
Action mechanism: Tesamorelin is an analogue of the human growth hormone releasing factor (“GRF”) shown to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. GRF is a hypothalamic peptide that acts on the pituitary cells in the brain to stimulate the synthesis and release of endogenous growth hormone. Tesamorelin is approved for sale for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the United States alone and in no other country, including Canada. Tesamorelin is being exclusively commercialized in the United States by EMD Serono under the brand name EGRIFTA™.
Disease: excess abdominal fat in HIV-infected patients with lipodystrophy
Details: * On April 8, 2013, Theratechnologies has announced the termination of its distribution and licensing agreement with Ferrer Internacional for the commercialization of tesamorelin in Europe, Russia, South Korea, Taiwan and certain Asian countries for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Ferrer was also responsible for regulatory activities for tesamorelin in these territories. Last June, Ferrer Internacional has withdrawn the MAA filed with the EMA for tesamorelin. This decision has followed an oral explanation with the EMA’s Committee for Medicinal Products for Human Use (CHMP). The CHMP has indicated that the lack of data on cardiovascular risk markers did not allow the committee to conclude on a positive benefit/risk balance. “We have been working diligently to forge the most appropriate path for tesamorelin in Europe following the withdrawal of the application last June. Our work in this regard continues and, at this juncture, Ferrer and Theratechnologies have mutually agreed to terminate their agreement,” stated Luc Tanguay, President and CEO of Theratechnologies. The company is currently assessing a potential re-filing in Europe in 2013. As a result of the termination of this agreement,Theratechnologies, through its wholly-owned subsidiary, now holds 100%of the commercialization rights for tesamorelin in Europe, Russia, South Korea, Taiwanand certain Asian countries.
* On January 31, 2011, Theratechnologies and Ferrer have concluded a distribution and licensing agreement for the commercialization of tesamorelin in Europe, Russia, South Korea, Taiwan and certain Asian countries for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Under the terms of the agreement, Ferrer will be responsible for conducting all regulatory and commercialization activities in connection with tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in the territories subject to the agreement. Theratechnologies will be responsible for the manufacture and supply of tesamorelin to Ferrer. Ferrer will purchase tesamorelin at a transfer price equal to the higher of a significant percentage of the net selling price and a predetermined floor price. Theratechnologies has the option to co-promote tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy in the territories. Theratechnologies has kept all development rights to tesamorelin for other indications and will be responsible for conducting research and development for any additional programs. Ferrer has the option to enter into a co-development and commercialization agreement using tesamorelin relating to any such new indications. The terms and conditions of such a co-development and commercialization agreement will be negotiated based on any additional program chosen for development.
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