LevadexTreatment for Migraine
MAP Pharmaceuticals Issued U.S. Patent for Methods of Achieving Rapid Relief of Migraine and Minimizing Side Effects Based Upon Pharmacokinetic Profile
MOUNTAIN VIEW, Calif., Aug. 11, 2011 /PRNewswire/ -- MAP Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (USPTO) issued to the Company U.S. Patent No. 7,994,197, titled "Method of Therapeutic Administration of DHE to Enable Rapid Relief of Migraine while Minimizing Side Effect Profile." The patent, which expires in 2028, results from the Company's discovery that dihydroergotamine (DHE) can be administered to achieve pharmacokinetic profiles that result in both rapid efficacy and minimal side effects. Levadex, which contains the Company's proprietary formulation of DHE, is an orally inhaled investigational drug for the potential acute treatment of migraine in adults that targets the pharmacokinetic profiles described in this patent.
"We have designed Levadex to overcome the limitations of currently available migraine therapies by combining our novel formulation capabilities with our proprietary TEMPO inhaler, and to target an optimal pharmacokinetic profile for rapid relief of migraine while minimizing side effects," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "The issuance of this patent strengthens MAP Pharmaceuticals' patent estate relating to our Levadex product candidate."
The issuance of this patent follows the recent company announcement that the Levadex New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA), with a user fee goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA). In accordance with the Company's collaboration agreement with Allergan, Inc., the FDA's acceptance for filing of the NDA triggers a $20 million milestone payment to MAP Pharmaceuticals. In addition to these significant achievements, the Company also recently announced the appointment of Frederick Graff to the newly created position of Vice President, Commercial Operations and announced that Allergan executed its option to co-promote Levadex to neurologists and pain specialists in Canada.
About MAP Pharmaceuticals
MAP Pharmaceuticals is an emerging biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology. The Company is developing Levadex, an orally inhaled investigational drug for the acute treatment of migraine. The U.S. Food and Drug Administration has accepted for filing the New Drug Application for Levadex for the potential acute treatment of migraine in adults. MAP Pharmaceuticals has entered into a collaboration agreement with Allergan, Inc. to co-promote Levadex to neurologists and pain specialists in the U.S. and Canada. The Company also applies its proprietary drug particle and inhalation technologies to generate new pipeline opportunities by enhancing the therapeutic benefits of proven drugs, while minimizing risk by capitalizing on their known safety, efficacy and commercialization history. Additional information about MAP Pharmaceuticals can be found at http://www.mappharma.com.
Levadex has not been approved for marketing in the United States or any other country for any indication.
In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to MAP Pharmaceuticals' Levadex product candidate. Actual results may differ materially from current expectations based on risks and uncertainties affecting the company's business, including, without limitation, risks and uncertainties relating to the regulatory approval process for the Company's Levadex product candidate and relating to the Company's patent rights. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals' results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, available at http://edgar.sec.gov.
MAP Pharmaceuticals, Inc.
SOURCE MAP Pharmaceuticals, Inc.
Posted: August 2011
- Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Levadex (dihydroergotamine) New Drug Application - April 16, 2013
- MAP Pharmaceuticals Resubmits New Drug Application to FDA for Levadex Orally Inhaled Migraine Drug - October 16, 2012
- MAP Pharmaceuticals Provides Update Following Meeting with FDA for Levadex (dihydroergotamine) New Drug Application - June 25, 2012
- MAP Pharmaceuticals Provides Update on Levadex Program - April 12, 2012
- MAP Pharmaceuticals Receives Complete Response Letter from FDA for Levadex (dihydroergotamine) NDA - March 26, 2012
- MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA for Levadex - August 2, 2011
- MAP Pharmaceuticals Submits New Drug Application to FDA for Levadex Orally Inhaled Migraine Drug - May 27, 2011
- MAP Pharmaceuticals Announces FDA Will Not Require a Second Pivotal Efficacy Study for Levadex NDA Submission - January 11, 2010