MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA
Resubmission for LEVADEX®
MOUNTAIN VIEW, Calif.,
Nov. 21, 2012 /PRNewswire/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that its New
Drug Application (NDA) resubmission for LEVADEX® orally inhaled
migraine drug for the potential acute treatment of migraine in
adults has been accepted for filing by the U.S. Food and Drug
Administration (FDA). The FDA has classified the resubmission
as a complete, Class 2 response to the FDA's March 26, 2012 action letter and has set a goal
date of April 15, 2013 under the
Prescription Drug User Fee Act.
"The acceptance of our LEVADEX resubmission is an important
milestone for the company," said Timothy S.
Nelson, president and chief executive officer of MAP
Pharmaceuticals. "We will continue to work closely with the FDA
through the review process, with the goal of providing the
underserved migraine patient population with a potential new
treatment option in 2013."
About MAP Pharmaceuticals
MAP Pharmaceuticals is a 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 New Drug Application for LEVADEX is currently under
review by the U.S. Food and Drug Administration. 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.
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 the FDA goal date for 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. 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 most recent Quarterly Report on Form 10-Q,
available at http://edgar.sec.gov.
MAP Pharmaceuticals Contact:
Lisa Borland (media),
650-386-3122
Chris Chai (investors),
650-386-3107
SOURCE MAP Pharmaceuticals, Inc.