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Roche Holding AG

Drug Names(s): TNX-901, Hu-901

Description: Like Xolair, TNX-901 is a monoclonal antibody that targets immunoglobulin (Ig) E. Tanox is developing TNX-901 as a treatment for peanut allergies. Approximately 3 million people in the U.S. are allergic to peanuts or tree nuts, and the incidence of peanut allergy and peanut-induced anaphylactic reactions among infants and young children is rapidly rising. Approximately 125 people die annually from food allergies, typically to peanuts, compared to approximately 50 deaths from allergic reactions to bee stings.

Tanox has likely been focusing on TNX-901 for peanut allergy more for commercial than scientific reasons. Xolair’s mechanism of action and pharmacologic profile suggests that it also can be developed for the management of food allergies. As arbitration between Novartis and Tanox resolves the role of these two companies in the development of both TNX-901 and Xolair, we expect that Novartis and Tanox will choose to develop only one of these drugs for peanut allergies. Given that Xolair is very likely to be approved in 2003 for the treatment of asthma, it is more likely that the companies will develop Xolair for the treatment of food allergy.

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

Tanox partnered with Genentech and Novartis to develop Xolair and, potentially, other anti-IgE antibodies. In 1999, Tanox indicated that it wished to develop TNX-901 without these partners. Lawsuits and arbitration regarding the right of Tanox to develop TNX-901 independently are ongoing, and Tanox cannot begin phase III development without Novartis until this issue is resolved.

In August 2007, Genentech completed its acquisition of Tanox.

In March 2009, Roche and Genentech announced that they signed a merger agreement under which Roche will acquire the outstanding publicly held interest in Genentech for US95.00 per share in cash, or a total payment of approximately US$46.8 billion to equity holders of Genentech other than Roche. The acquisition was completed on March 26, 2009.

Partners: Novartis AG

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