MAP Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office (USPTO) issued to the company US 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.
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.