MOUNTAIN VIEW, Calif.,
April 12, 2012 /PRNewswire/
-- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today provided an
update on LEVADEX®, the Company's investigational orally inhaled
drug for the potential acute treatment of migraine in adults.
- The Company submitted a request to the U.S. Food and Drug
Administration (FDA) for a meeting to discuss the Complete Response
letter received on March 26, 2012.
The Company announced that the FDA has scheduled a meeting with the
Company, to occur in the second quarter.
- On April 3, 2012, the United
States Patent and Trademark Office (USPTO) issued to the Company
U.S. Patent No. 8,148,377, titled "Method of Therapeutic
Administration of DHE to Enable Rapid Relief of Migraine While
Minimizing Side Effect Profile." This new patent, which expires in
2028, is the third in a series of patents issued to the Company
relating to the pharmacokinetics of LEVADEX. The new patent results
from the Company's discovery that dihydroergotamine (DHE) can be
administered to achieve pharmacokinetic profiles of DHE that result
in rapid efficacy while minimizing side effects that are typically
seen with other migraine drugs.
"We are pleased that the FDA has scheduled a meeting with us to
discuss the issues contained in the Complete Response letter for
LEVADEX," said Timothy S. Nelson,
president and chief executive officer of MAP Pharmaceuticals. "We
continue to work closely together with our partner, Allergan, as we
seek to resolve the issues in the Complete Response letter as
quickly as possible."
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 potential acute
treatment of migraine. The U.S. Food and Drug Administration
reviewed the New Drug Application for LEVADEX and on March 26, 2012, the Company received a Complete
Response letter. 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 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-K for the year ended
December 31, 2011, available at
http://edgar.sec.gov.
CONTACT:
Christopher Chai, 650-386-3107
(investors)
Lisa Borland, 650-386-3122
(media)
Denise Powell 510-703-9491
(media)
SOURCE MAP Pharmaceuticals, Inc.