MOUNTAIN VIEW, Calif.,
Aug. 11, 2011 /PRNewswire/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) 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.
Forward-Looking Statements
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.
CONTACTS:
Lisa Borland
MAP Pharmaceuticals, Inc.
650-386-3122
Nicole Foderaro
WCG
415-946-1058
nfoderaro@wcgworld.com
SOURCE MAP Pharmaceuticals, Inc.