UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 12, 2009
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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000-51863
(Commission File No.)
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03-0491827
(IRS Employer Identification No.) |
9605 Medical Center Drive
Suite 300
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (240) 599-4500
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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| Item 1.01. |
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Entry into a Material Definitive Agreement. |
On October 12, 2009, Vanda
Pharmaceuticals Inc. (“Vanda”) announced that it had entered into an Amended
and Restated Sublicense Agreement (the “Agreement”) with Novartis Pharma AG (“Novartis”). The
parties had originally entered into a sublicense agreement on June 4, 2004 (as amended, the
“Original Agreement”) pursuant to which Vanda obtained certain worldwide exclusive licenses from
Novartis relating to a compound known as iloperidone. On May 6, 2009, the U.S. Food and Drug
Administration (“FDA”) granted marketing approval of the oral formulation of iloperidone for the
acute treatment of adult patients with schizophrenia pursuant to Vanda’s New Drug Application (the
“NDA”).
Pursuant to the Agreement, Novartis will have exclusive commercialization rights to all
formulations of iloperidone (“Fanapt™”) in the United States and Canada (the “Territory”). 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 Territory, including the development and commercialization of a long—acting
injectible (or depot) formulation of Fanapt™. In connection with such rights, Vanda granted
Novartis an exclusive license to all know-how owned or licensed by Vanda that may be necessary or
useful in the development or commercialization of Fanapt™ for the Territory, as well as an
exclusive license to the trademark Fanapt™ for use in the Territory. In addition, Vanda assigned
the NDA to Novartis and agreed that all future regulatory interactions with the FDA would be the
exclusive responsibility of Novartis.
Pursuant to the terms of the Agreement, Vanda will be entitled to an upfront payment of $200
million and will be eligible for additional payments totaling up to $265 million upon the
achievement of certain commercial and development milestones for Fanapt™ in the Territory. Vanda
will also receive royalties, which, as a percentage of net sales, are in the low
double-digits, on net sales of Fanapt™ in the Territory. In addition, Vanda will
no longer be required to make the future milestone and royalty payments that were contemplated in
the Original Agreement with respect to sales of Fanapt™ in the Territory.
Vanda retains exclusive rights to Fanapt™ outside the Territory and Vanda will have exclusive
rights to use any of Novartis’ data for Fanapt™ for developing and commercializing Fanapt™ outside
the Territory. At Novartis’ option, the parties will enter into good faith discussions relating to
the co-commercialization of Fanapt™ outside of the Territory or, alternatively, Novartis will
receive a royalty on net sales of Fanapt™ outside of the Territory.
The Agreement is subject to customary regulatory approvals.