Navigation Links
Vanda Pharmaceuticals Announces Commencement of Clinical Study of Long-Acting Injectable Formulation of Fanapt®

ROCKVILLE, Md., April 11, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced today that Novartis Pharmaceuticals Corporation, an affiliate of Vanda's sublicensor Novartis Pharma AG, has initiated a clinical study to evaluate the long-acting injectable (or depot) formulation of Fanapt® (iloperidone).  This is a Phase I study that will evaluate the safety and pharmacokinetic profiles of two different long-acting formulations of Fanapt® in patients with schizophrenia.

Under a 2009 agreement, Novartis has exclusive rights to the depot formulation of Fanapt® in the U.S. and Canada.  Vanda has exclusive rights to the depot formulation outside the U.S. and Canada, but Novartis has the option to enter into discussions with Vanda to co-commercialize Fanapt® or receive sales royalties for such territory.

"We are very excited with the advance of the Fanapt® depot formulation into clinical studies," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO.  "A long-acting injectable formulation could offer a potential new option for patients with schizophrenia who might benefit from less frequent dosing compared to an oral medication."

About Schizophrenia

Schizophrenia is a chronic, severe and disabling mental disorder, characterized by profound disruptions in thinking, affecting language, perception, and the sense of self. It often includes psychotic experiences, such as hearing voices or delusions. Schizophrenia typically begins in late adolescence or early adulthood and affects 2.4 million Americans or 1.1% of the U.S. adult population.

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders. For more on Vanda, please visit

Cautionary Note Regarding Forward-Looking Statements

Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," and "could," and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the company's forward-looking statements include, among others: the extent and effectiveness of the development, sales and marketing and distribution support Fanapt® receives; Vanda's ability to successfully commercialize Fanapt® outside of the U.S. and Canada; delays in the completion of Vanda's clinical trials; a failure of Vanda's products to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements for its products; a lack of acceptance of Vanda's products in the marketplace, or a failure to become or remain profitable; Vanda's expectations regarding trends with respect to its costs and expenses; Vanda's inability to obtain the capital necessary to fund additional research and development activities; Vanda's failure to identify or obtain rights to new products; Vanda's failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; limitations on Vanda's ability to utilize some or all of its prior net operating losses and research and development credits; a loss of any of Vanda's key scientists or management personnel; losses incurred from product liability claims made against Vanda; a loss of rights to develop and commercialize Vanda's products under its license and sublicense agreements and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2010, which is on file with the SEC and available on the SEC's website at  In addition to the risks described above and in Vanda's annual report on Form 10-K, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Media/Investor Inquiries
Cristina Murphy

SOURCE Vanda Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vanda Pharmaceuticals to Evaluate Tasimelteon in Major Depression
2. Vanda Pharmaceuticals Receives Orphan Drug Designation in Europe for tasimelteon
3. Vanda Pharmaceuticals Files Shelf Registration Statement
4. Vanda Pharmaceuticals Appoints Chief Financial Officer
5. Vanda Pharmaceuticals Reports Third Quarter 2010 Results
6. Vanda Pharmaceuticals to Announce Third Quarter 2010 Financial Results on November 3, 2010
7. Vanda Pharmaceuticals Initiates Phase III Clinical Study Aimed at Resetting the Body Clock
8. Vanda Pharmaceuticals Adds Former U.S. Surgeon General, Steven Galson, to its Board of Directors
9. Vanda Pharmaceuticals Announces Date of Annual Meeting of Stockholders
10. Vanda Pharmaceuticals Announces U.S. Patent Allowance for a Long-Acting Injectable Formulation of Fanapt(TM) (iloperidone) in the U.S.
11. Vanda Pharmaceuticals Announces Expiration of Hart-Scott -Rodino Waiting Period for Exclusive License of Fanapt(TM)
Post Your Comments:
(Date:11/26/2015)... Research and Markets ( ) ... Future Horizons and Growth Strategies in the Italian ... Segment Forecasts, Competitive Intelligence, Emerging Opportunities" report ... --> This new 247-page report ... drug monitoring market, including emerging tests, technologies, instrumentation, ...
(Date:11/25/2015)... , Nov. 25, 2015 ... addition of the "Global Brain Monitoring ... offering. --> ) has ... Brain Monitoring Devices Market 2015-2019" report ... and Markets ( ) has announced ...
(Date:11/25/2015)... WASHINGTON , Nov. 25, 2015  The ... Obstetricians and Gynecologists (ACOG), and the March of ... bipartisan Protecting Our Infants Act of 2015 ... the number of newborns born exposed to drugs, ... Since the bill,s introduction, all three organizations have ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... Bayco Products, Inc today announced the introduction of three Nightstick® brand ... choice of three different colors; red ( NSP-1632 ), yellow ( NSP-1634 ) and blue ... hours in constant-on mode, or 27 hours in blinking strobe mode using a fresh set ...
(Date:11/29/2015)... ... November 30, 2015 , ... Gift ideas ... Sublime Beauty NATURALS®. All products are available on Amazon or its webstore. , ... facial serums and USDA Certified Organic Sesame Oil for Oil Pulling," says Kathy ...
(Date:11/29/2015)... Michigan (PRWEB) , ... November 29, 2015 , ... "I ... games. Things that as a Mother and Wife would love to do, I missed. ... that I just happened to call Dr. Zaidan first. They have changed my life ...
(Date:11/29/2015)... (PRWEB) , ... November 29, 2015 , ... NewsWatch featured ... technology products available to consumers. Amanda Forstrom, a technology expert and special reporter for ... be a reality in the future. , It’s the future because flying cars are ...
(Date:11/29/2015)... ... November 29, 2015 , ... While conventional walkers afford considerable help with ... to exercise weights. Fortunately, an inventor from Uniontown, Pa., has found a way to ... the benefits of a standard walker to improve the user’s quality of life. To ...
Breaking Medicine News(10 mins):