Full Press Release Details
Pharmaceuticals Provides Corporate Update on Hedrin and Management
NEW YORK, NY JUN 18, 2009 -
Manhattan Pharmaceuticals, Inc. (OTCBB: MHAN) today provided an update on its
ongoing development programs. The Company also announced it has initiated a
management restructuring that is intended to extend the Company's resources and
allow it to continue working toward its near-term corporate objectives and to
maximize the value of its assets.
Product for the Treatment of Pediculosis (head lice)
a next generation, non-pesticide treatment for head lice and is currently being
developed as a 1-hour head lice treatment by and through a joint venture with
Nordic Biotech. Hedrin was designated as a Class III medical device by the
Food and Drug Administration ("FDA"), and we expect that the joint venture will
have to complete a clinical study in order to obtain a product approval.
The joint venture has requested a meeting with the FDA to confirm a study is
necessary and to determine the trial design and the number of patients required.
We expect that the joint venture will commence a clinical study shortly after
receiving FDA feedback.
to maximize the commercial value of Hedrin, the joint venture is seeking a
marketing and distribution partner with a strong, established presence in the
relevant markets. Under its management agreement with the joint venture,
Manhattan Pharmaceuticals, on behalf of the joint venture, intends to secure a
commercialization and marketing partner for Hedrin and discussions are currently
ongoing with potential partners for both the United States and
currently marketed in 27 countries and is the top selling head lice product in
the United Kingdom and France. Across Europe, Hedrin achieved 2008 annual sales
of $48 million (USD). To date, Hedrin has been clinically studied in 350+
subjects in studies conducted outside of the United States and has demonstrated
clinical equivalence to widely used pesticide head lice treatments.
June 16, 2009, Douglas Abel was appointed Chairman of the Manhattan
Pharmaceuticals Board of Directors and stepped down from his positions as Chief
Executive Officer and President of Manhattan Pharmaceuticals, Inc. In
addition to his role as Chairman of the Board, Mr. Abel has been retained as a
consultant to the Company and he will continue to work toward securing FDA
approval and a commercialization and marketing partner for Hedrin in both the
United States and Canada.
G. McGuinness, Chief Operating and Financial Officer, will assume day-to-day
leadership responsibilities and Mary Spellman, M.D., a consultant to the
Company, will remain as Head of Dermatology and Drug
current market conditions we find it necessary to reduce the Company's burn rate
as much as possible while we continue partnership discussions for Hedrin,"
stated Douglas Abel. "I remain committed to the Company and will continue to
work closely with Michael McGuinness and Mary Spellman to achieve our strategic
Manhattan Pharmaceuticals, Inc.
Pharmaceuticals, Inc. is a specialty healthcare company focused on developing
and commercializing innovative treatments for underserved patient populations
primarily in the areas of dermatologic disorders. Manhattan Pharmaceuticals,
Inc. (through a strategic joint venture partnership with Nordic Biotech) is
currently developing Hedrin, a novel, non-pesticide treatment for pediculosis
(head lice) and has a topical GEL product candidate for the treatment of
psoriasis. The Company is currently exploring several options to
commercialize the GEL product candidate.
Regarding Forward-Looking Statements
press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements involve risks
and uncertainties that could cause Manhattan Pharmaceuticals, Inc.'s actual
results to differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are often, but
not always, made through the use of words or phrases such as "intends,"
"anticipates," "expects," "plans," "believes," "intends," "will," and similar
words or phrases. These statements are based on Manhattan Pharmaceuticals,
Inc.'s current expectations, forecasts and assumptions, which are subject to
risks and uncertainties, which could cause actual outcomes and results to differ
materially from these statements. Among other things, there can be no assurances
that Manhattan Pharmaceuticals, Inc.'s (or its joint venture with Nordic's)
development or commercialization efforts relating to Hedrin, topical
GEL, or any other current or future product candidates will be successful,
that any clinical study will be completed or will return positive results. Other
risks that may affect forward-looking information contained in this press
release include the company's extremely limited capital resources, an
arbitration award in favor of Swiss Pharma which Swiss Pharma is in the process
of enforcing in the United States, the possibility of being unable to
obtain regulatory approval of Hedrin, the risk that the results of clinical
trials may not support the company's or its joint venture's claims, the
risk that the company's product candidates may not achieve market acceptance in
North America or elsewhere, the company's reliance on third-party researchers to
develop its product candidates, availability of patent protection, the risk that
sufficient capital may not be available to develop and commercialize the
company's product candidates, and the company's lack of experience in developing
and commercializing pharmaceutical products. Additional risks are described in
the company's filings with the Securities and Exchange Commission, including its
Annual Report on Form 10-K for the year ended December 31, 2008. Manhattan
Pharmaceuticals, Inc. assumes no obligation to update these statements, whether
as a result of new information, future events, or otherwise, except as required
Pharmaceuticals, Inc.
G. McGuinness, Chief Operating