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Eligard

TOLMAR, Inc.

Drug Names(s): leuprolide acetate, SOT-375

Description: Eligard is a sterile polymeric matrix formulation of leuprolide acetate for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one month therapeutic period. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. Thus, Eligard is an GnRH agonist designed to reduce the amount of testosterone in the body by reducing testicular production of testosterone.

The liquid Eligard product, using Atrix's proprietary Atrigel sustained-release drug delivery technology, is injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.

Deal Structure: Sosei and QLT USA
Sosei in-licensed the exclusive rights to SOT-375 from its U.S.-based manufacturer, QLT USA. This agreement was signed in January 2003 andgrants Sosei rights to develop and commercialize this product in Japan. Sosei has a collaborative strategy agreement with Nippon Organon K.K. to co-promote the product in Japan.

sanofi, Astellas and QLT USA
Sanofi-Synthelabo has an exclusive North American marketing agreement for Eligard with QLT and Astellas Pharma markets the Eligard one-, three- and four-month formulations in Europe.

MediGene and Atrix (TOLMAR)
MediGene acquired the licence for pan-European commercialization of Eligard from Atrix Laboratories (now TOLMAR) in April 2001.

TOLMAR and QLT USA
In October 2009, QLT announced that it has completed the sale of all of the shares of its wholly-owned U.S. subsidiary, QLT USA, to TOLMAR Holding for up to an aggregate US$230 million pursuant to a Stock Purchase Agreement...See full deal structure in Biomedtracker

Partners: Sanofi Sosei Co., Ltd Astellas Pharma, Inc. MediGene AG


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