MOUNTAIN VIEW, Calif.,
March 26, 2012 /PRNewswire/
-- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced
that the United States Food and Drug Administration (FDA) has
issued a Complete Response letter to its New Drug Application (NDA)
for LEVADEX® (dihydroergotamine) inhalation aerosol.
In the Complete Response letter, the FDA requested that the
Company address issues relating to chemistry, manufacturing and
controls (CMC) and observations from a recent facility inspection
of a third party manufacturer. The FDA also indicated that it had
not been able to complete review of inhaler usability information
requested late in the review cycle by the FDA.
The FDA did not cite any clinical safety or efficacy issues, nor
did the FDA request that any additional clinical studies be
conducted prior to approval. The Company is pleased with the
FDA-provided revisions to product labeling and packaging, including
correct use of the LEVADEX trade name. The Company continues to
pursue approval of LEVADEX for the acute treatment of migraine in
adults.
MAP Pharmaceuticals plans to request a meeting with the FDA to
discuss the issues raised in the Complete Response letter.
"MAP is committed to making this important new therapy available
to people who experience migraine. We will continue to work closely
with the FDA to finalize our product labeling and to address the
issues raised in the Complete Response letter as quickly as
possible," said Timothy S. Nelson,
President and Chief Executive Officer of MAP Pharmaceuticals.
Conference Call Information
MAP Pharmaceuticals management will host a conference call on
Tuesday, March 27, 2012 at
8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) and individuals may
participate in the conference call by dialing (877) 291-1367
(domestic) or (253) 237-1128 (international). To access the
webcast, please visit the Company's website at www.mappharma.com
and go to the Investor Relations page. A replay of the
webcast will be available approximately two hours after the
call.
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.
LEVADEX and TEMPO are trademarks of MAP Pharmaceuticals,
Inc.
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. 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 September 30, 2011,
available at http://edgar.sec.gov.
MAP Pharmaceuticals Contact:
Christopher Chai, 650-386-3107
(investors)
Lisa Borland, 650-386-3122
(media)
Denise Powell 510-703-9491
(media)
SOURCE MAP Pharmaceuticals, Inc.