MOUNTAIN VIEW, Calif.,
June 25, 2012 /PRNewswire/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the
Company completed an End-of-Review meeting with the United States
Food and Drug Administration (FDA) for its New Drug Application
(NDA) for LEVADEX® (dihydroergotamine) inhalation aerosol. MAP
Pharmaceuticals requested the End-of-Review meeting following
receipt of a Complete Response letter (CRL) on March 26, 2012. The Company is seeking approval
of LEVADEX for the acute treatment of migraine in adults.
"Based on our meeting with the FDA, we believe that we have
clarity on what is needed to address the issues in the Complete
Response letter, and we are encouraged by the FDA's collaborative
dialogue in providing guidance that will help us move forward with
our resubmission process. We plan to resubmit to the FDA in the
late third quarter/early fourth quarter 2012 timeframe," said
Timothy S. Nelson, president and
chief executive officer of MAP Pharmaceuticals. "We believe LEVADEX
has the potential to be an important new therapy for people who
experience migraine and look forward to being able to provide it to
patients whose needs are not being met by currently available
treatments."
Based on the meeting, the Company believes that no new studies
need to be conducted for inclusion in the resubmission. The FDA
will determine the type of resubmission (Class 1 or Class 2) and
the resulting review timeline after the resubmission has been
accepted for filing.
In the CRL, the FDA requested that the Company address issues
relating to chemistry, manufacturing and controls (CMC) and
observations from a 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 CMC issues are focused on commercial product specifications
and justification of process controls to reflect the product
specifications. The Company believes it has all data necessary to
respond and confirmed at the FDA meeting its approach to address
these issues. The FDA also agreed with the Company's proposal to
include recently completed 24 month stability data on LEVADEX in
the resubmission.
The FDA provided clarity on the steps necessary for the
Company's third party manufacturer to address observations related
to the implementation and documentation of manufacturing process
controls cited during a facility inspection. The Company is working
closely with its third party manufacturer. The third party
manufacturer provided responses to the observations to the FDA, and
the Company believes the observations cited by the FDA either have
been resolved or will be addressed in conjunction with the
resubmission.
With respect to inhaler usability information, the FDA has
requested that the Company provide information on patient
experience related to inhaler usability from the existing clinical
data set to augment the information previously provided. The
Company believes it has the data necessary to provide this
additional information.
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 U.S. Food and Drug Administration (FDA) reviewed the
New Drug Application (NDA) for LEVADEX and on March 26, 2012, the Company received a Complete
Response letter with respect to this NDA. 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 process and timing for
responding to the FDA's Complete Response letter with respect to
the Company's LEVADEX product candidate, and the Company's belief
that no new studies will need to be conducted for inclusion in the
resubmission. 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 process to have the
Company's LEVADEX product candidate approved for commercial use,
including the possibility that the preparation of the resubmission
may take longer than anticipated, or that the FDA may determine
that the Company's data does not provide a full response and
request that the Company conduct additional studies, which may
delay the approval of the LEVADEX NDA and require additional time,
resources and capital. 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
March 31, 2012, available at
http://edgar.sec.gov.
MAP Pharmaceuticals Contact:
Lisa Borland, 650-386-3122
Nicole Foderaro, 415-946-1058
(media)
SOURCE MAP Pharmaceuticals, Inc.