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Vanda Pharmaceuticals Reports Third Quarter 2009 Results
Date:11/2/2009

r 12, 2009, Vanda entered into an amended and restated sublicense agreement with Novartis Pharma AG (Novartis). The parties had originally entered into a sublicense agreement on June 4, 2004 pursuant to which Vanda obtained certain worldwide exclusive licenses from Novartis relating to Fanapt(TM). The agreement is subject to, and will become effective upon, clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), which is expected by the end of 2009.

Pursuant to the agreement, Novartis will have exclusive commercialization rights to all formulations of Fanapt(TM) in the U.S. and Canada. Except for two post-approval studies started by Vanda prior to the execution date of the agreement, which Vanda is obligated to complete, Novartis will be responsible for the further clinical development activities in the U.S. and Canada, including the development of a long-acting injectable (or depot) formulation of Fanapt(TM).

Pursuant to the terms of the agreement, Vanda will be entitled to an upfront payment of $200 million, which it expects to receive within 30 days after the effective date of the agreement. Vanda will be eligible for additional payments totaling up to $265 million upon the achievement of certain commercial and development milestones for Fanapt(TM) in the U.S. and Canada. Vanda will also receive royalties, which, as a percentage of net sales, are in the low double-digits, on net sales of Fanapt(TM) in the U.S. and Canada. In addition, Vanda will no longer be required to make any future milestone payments with respect to sales of Fanapt(TM) or any future royalty payments with respect to sales of Fanapt(TM) in the U.S. and Canada.

Vanda retains exclusive rights to Fanapt(TM) outside the U.S. and Canada and Vanda will have exclusive rights to use any of Novartis' data for Fanapt(TM) for developing and commercializing Fanapt(TM) outside the U.S. and Canada. At Novartis' option, the parties will enter int
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SOURCE Vanda Pharmaceuticals Inc.
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