UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported): January 31, 2011
Manhattan
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-32639
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36-3898269
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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48
Wall Street, Suite 1110
New
York, New York 10005
(Address
of principal executive offices) (Zip Code)
(212)
582-3950
(Registrant's
telephone number, including area code)
Not
applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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1
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Item
8.01
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Other
Events
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On
January 31, 2011 Manhattan Pharmaceuticals, Inc. announced that its company’s
Board of Directors has decided to continue development of AST-915, an orally
delivered treatment for essential tremor. 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.
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Item
9.01
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Financial
Statements and Exhibits
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(d)
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Exhibits
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Exhibit
No.
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Description
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99.1
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Press
release dated January 31, 2011.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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MANHATTAN
PHARMACEUTICALS, INC.
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Date: January 31,
2011
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By:
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/s/
Michael G. McGuinness
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Michael
G. McGuinness
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Chief
Operating and Financial Officer
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2
Manhattan
Pharmaceuticals Achieves Ariston Merger Milestone
AST-915
Development Program to Continue to Phase 2
NEW YORK, NY JAN 31, 2011 –
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 Hedrin®, 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