Manhattan Pharmaceuticals Achieves Ariston Merger Milestone
January 31 2011 - 12:11PM
Manhattan Pharmaceuticals, Inc. (OTCBB:MHAN) announced today that
the company's Board of Directors has decided to continue
development of AST-915, an orally delivered treatment for essential
tremor. This decision was made following the announcement of
favorable clinical results from a Phase 1/2 clinical study of
AST-915 conducted by the National Institute of Neurological
Disorders and Stroke (NINDS) at the National Institutes of Health
(NIH) under a CRADA agreement between the NIH and Ariston
Pharmaceuticals, Inc., a wholly owned subsidiary of Manhattan
Pharmaceuticals, Inc. Data from this study, previously announced on
December 16, 2010, demonstrated that AST-915 was safe and well
tolerated and demonstrated a clear effect on tremor power. The
company intends to continue to work with the NIH and to proceed
toward Phase 2 with the AST-915 development program.
Under the terms of the merger agreement between Manhattan
Pharmaceuticals, Inc. and Ariston Pharmaceuticals, Inc., the
achievement of this milestone requires the company to issue
8,828,029 shares of its common stock to debt holders and former
shareholders of Ariston.
About Essential Tremor
Essential tremor is a common movement disorder that is
characterized by involuntary shaking of the hands, arms, head,
voice and upper body. The most disabling tremors occur during
voluntary movement affecting common skills such as writing, eating
and drinking and body care. According to the International
Essential Tremor Foundation, an estimated 10 million Americans have
essential tremor. The condition is most common among people over
60, but it also occurs in children, adolescents and the
middle-aged. There is no curative treatment for essential tremor
and current therapy is inadequately effective in a large portion of
patients and/or limited by side effects. Manhattan Pharmaceuticals
owns worldwide rights to AST-915 and believes it may provide a new
treatment option for this serious and prevalent disorder.
About Manhattan Pharmaceuticals, Inc.
Manhattan Pharmaceuticals, Inc. is a specialty healthcare
product company focused on the development and commercialization of
innovative treatments for underserved patient populations. The
company is currently focused on two programs: AST-726, a nasally
delivered vitamin B12 remediation treatment, and AST-915, an orally
delivered product candidate for the treatment of essential tremor.
The company also has an equity ownership position in HedrinĀ®, a
non-insecticide treatment for head lice currently being developed
by Nordic Biotech for the North American market.
Note Regarding Forward-Looking Statements
This 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, 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, 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, the risk that sufficient capital may not be
available to develop and commercialize the company's product
candidates or permit the company's continuing business operations,
the risk that $1,315,000 of aggregate principal amount of the
company's outstanding indebtedness is now past due and to date the
lenders thereof have not waived events of default or extended the
maturity date of such indebtedness, the risk that any financing
transaction or restructuring of indebtedness that the company may
pursue would likely result in substantial dilution to the company's
equityholders, 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, 2009. Manhattan Pharmaceuticals, Inc. assumes no
obligation to update these statements, whether as a result of new
information, future events, or otherwise, except as required by
law.
CONTACT: Manhattan Pharmaceuticals, Inc.
Michelle Y. Carroll, Vice President, Corporate Development
(212) 582-3950