Monday, October 12, 2009 6:06:15 PM
Press Release
Source: Vanda Pharmaceuticals Inc.
On 6:00 pm EDT, Monday October 12, 2009
Companies:Vanda Pharmaceuticals, Inc.
ROCKVILLE, Md., Oct. 12 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA - News) announced today that it has entered into an agreement with Novartis Pharma AG to commercialize and develop Fanapt(TM) (iloperidone), Vanda's anti-psychotic, in the U.S. and Canada. Fanapt(TM) was approved by the U.S. Food and Drug Administration on May 6, 2009 for the acute treatment of schizophrenia in adults. Fanapt((TM)) is a mixed dopamine D2 / serotonin 5HT2A receptor antagonist. The U.S. anti-psychotic market is approximately $14 billion.
Under the terms of the agreement, which amended and restated a prior agreement among the parties, Novartis will have exclusive commercialization rights to Fanapt(TM) for the U.S. and Canada. Novartis will be responsible for the further clinical development activities in these territories, including the development and commercialization of a long-acting injectable (or depot) formulation of Fanapt(TM). Vanda will retain rights to commercialize Fanapt(TM) oral and depot formulations outside the U.S. and Canada. At Novartis' option, the parties will enter into good faith discussions relating to an agreement for the co-commercialization of Fanapt(TM) outside of the U.S. and Canada or, alternatively, Novartis will receive a royalty on net sales.
Under the agreement, Vanda will receive an upfront payment of $200 million and will be eligible for additional payments totaling up to $265 million upon the achievement of certain development and commercial milestones for Fanapt(TM) in the U.S. and Canada. Vanda will also receive royalties on the U.S. and Canadian net sales of Fanapt(TM). The consummation of the transaction is subject to the receipt of customary regulatory approvals, which are expected by the end of 2009.
"I am very excited about our agreement with Novartis, as we now have one of the premier pharmaceutical companies in the world to commercialize the oral formulation and further develop and commercialize the depot formulation of Fanapt(TM) in the U.S. and Canada," said Mihael H. Polymeropoulos, M.D., Vanda's Chief Executive Officer. "This agreement allows Vanda to utilize current and future data generated by Novartis on the oral and depot formulations to pursue regulatory approvals outside the U.S. and Canada."
Cowen and Company, LLC acted as financial advisor to Vanda.
Recent VNDA News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/13/2024 08:38:04 PM
- Vanda Pharmaceuticals Confirms Receipt of Revised Unsolicited Takeover Proposal from Future Pak • PR Newswire (US) • 06/13/2024 02:02:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/06/2024 08:30:57 PM
- Vanda Pharmaceuticals Confirms Receipt of Unsolicited, Non-Binding Indication of Interest from Cycle Group Holdings Ltd. • PR Newswire (US) • 06/06/2024 01:24:00 PM
- Vanda Pharmaceuticals Announces Participation in the Jefferies 2024 Global Healthcare Conference • PR Newswire (US) • 05/30/2024 09:20:00 PM
- Vanda Pharmaceuticals Announces Completion of Transfer of FDA Marketing Authorization for PONVORY® • PR Newswire (US) • 05/30/2024 08:48:00 PM
- Vanda Pharmaceuticals Announces Presentations at SLEEP 2024 • PR Newswire (US) • 05/29/2024 06:17:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 08:49:41 PM
- Vanda Pharmaceuticals Board of Directors Determines that Revised Unsolicited Takeover Proposal is Not in the Best Interests of the Company and its Shareholders • PR Newswire (US) • 05/24/2024 08:46:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/24/2024 08:43:11 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/24/2024 08:31:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 08:55:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 08:53:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 08:52:54 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/21/2024 08:34:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/20/2024 09:26:51 PM
- Vanda Pharmaceuticals Reports Positive Results from a Second Phase III Study of Tradipitant in Motion Sickness • PR Newswire (US) • 05/15/2024 12:45:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/13/2024 08:15:59 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/09/2024 09:15:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 11:07:02 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 08:06:04 PM
- Vanda Pharmaceuticals Reports First Quarter 2024 Financial Results • PR Newswire (US) • 05/08/2024 08:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2024 08:51:10 PM
- Vanda Pharmaceuticals Confirms Receipt of Revised Unsolicited Takeover Proposal from Future Pak • PR Newswire (US) • 05/07/2024 03:16:00 PM
- Vanda Pharmaceuticals to Announce First Quarter 2024 Financial Results on May 8, 2024 • PR Newswire (US) • 04/30/2024 08:30:00 PM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • CAFI • Jun 13, 2024 8:45 AM
Snakes & Lattes Opens Pop-Up Location at The Wellington Market in Toronto: A New Destination for Fun and Games - Thanks 'The Well', PepsiCo, Indie Pale House & All Sponsors & Partners for Their Commitment & Assistance Throughout The Process • FUNN • Jun 13, 2024 8:18 AM
HealthLynked Introduces Innovative Online Medical Record Request Form Using DocuSign • HLYK • Jun 12, 2024 8:00 AM
Ubiquitech Software Corp (OTC:UBQU) Posts $624,585 Quarterly Revenue - Largest Quarter Since 2018 • UBQU • Jun 11, 2024 10:13 AM