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): July 9, 2007
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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810
Seventh Avenue, 4th Floor
New
York, New York 10019
(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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Item
8.01 Other
Events
Manhattan
Pharmaceuticals, Inc.’s (the “Company”) press release dated July 9, 2007, which
announced the results of the Company’s Phase 2a studies for Oral Oleoyl-estrone
and information on accessing a management discussion teleconference to be held
at 8:30am ET on Tuesday, July 10, 2007, is attached hereto as Exhibit
99.1
and
incorporated by reference herein.
Item
9.01. 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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Manhattan
Pharmaceuticals, Inc. press release dated July 9,
2007.
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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:
July 9, 2007
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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
Financial Officer
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EXHIBIT
INDEX
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Exhibit
No.
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Description
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99.1
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Manhattan
Pharmaceuticals, Inc. press release dated July 9,
2007.
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Exhibit
99.1
News
From:
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Contact:
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Douglas
Abel
President
& Chief Executive Officer
Manhattan
Pharmaceuticals, Inc.
212.582.3950
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Michelle
Carroll
Corporate
Communications
Manhattan
Pharmaceuticals, Inc.
212.582.3950
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Manhattan
Pharmaceuticals Announces Results of
Phase
2a Studies for Oral Oleoyl-estrone
| · |
Results
Fail to Demonstrate Meaningful Placebo Adjusted Weight Loss; Obesity
Program to be Discontinued
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| · |
Company
to Focus Efforts on Development of Its Pipeline of Four Clinical Stage
Products
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| · |
Company
Will Seek to Outlicense Propofol Lingual Spray
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| · |
Management
discussion call to be held tomorrow, Tuesday, July 10, 2007 at 8:30
AM
ET
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NEW
YORK, NY JULY 9, 2007
-
Manhattan Pharmaceuticals, Inc. (AMEX: MHA) today announced results of the
company’s two Phase 2a clinical trials of oral Oleoyl-estrone (OE). The results
of both randomized, double-blind, placebo-controlled studies, one in common
obesity and the other in morbid obesity, demonstrated no statistically or
clinically meaningful placebo adjusted weight loss for any of the treatment
arms
evaluated. Based on these results, Manhattan Pharmaceuticals will discontinue
its OE programs in both common obesity and morbid obesity.
Both
studies also showed dose-dependent increases in estrone and estradiol and
concomitant suppression of testosterone. In addition, thyroid hormone changes
were observed as well as changes in other hormones related to reproductive
function (i.e., FSH, LH, prolactin, sex hormone binding globulin). Despite
these
changes returning to baseline during off therapy periods they preclude
exploration of higher doses of OE.
“Unfortunately,
the study results were disappointing but definitive,” said Douglas Abel,
president and chief executive officer of Manhattan Pharmaceuticals. “With
all our development programs, Manhattan Pharmaceuticals is committed to the
practice of excellent science and the highest standard of clinical research
to
ensure both accurate outcomes and patient safety. Based on positive
preclinical data on OE, confirmatory results recently reported by Columbia
University, and the Phase 1 clinical profile, we had been encouraged regarding
the compound’s potential as an effective weight loss agent. However, due
to the findings from the two Phase 2a trials, we believe it is the correct
decision to discontinue our work with OE. These well designed Phase 2a
trials produced quality data that permits us to make a clear cut decision at
an
early stage of the program.”
Going
forward the company intends to continue with the
advancement of its four clinical stage product candidates, and the exploration
of other opportunities in the areas of dermatology/immunology and
endocrine/metabolic disorders. The four clinical-stage product candidates
include topical PTH (1-34) for psoriasis, as well as recently-acquired
Altoderm™
for
atopic dermatitis (eczema), Altolyn™
for
mastocytosis, and Hedrin™
for head
lice.
In
keeping with this strategic focus, Manhattan Pharmaceuticals also announced
today that it intends to pursue appropriate out-licensing opportunities for
Propofol Lingual Spray for pre-procedural sedation.
Management
Discussion Call and Webcast
Manhattan
Pharmaceuticals will hold a management discussion call and webcast to describe
the OE results in further detail, and to discuss the advancement of its four
clinical stage product candidates at 8:30 AM ET on Tuesday, July 10, 2007.
To
access the call, please dial 800.289.0468 (domestic) or 913.981.5517
(international) five minutes prior to the start time. A replay of the call
will
be available approximately 2 hours following the event and will last until
Friday, July 13, 2007 at 6:00 PM ET. To access a replay, please dial
888.203.1112 (domestic) or 719.457.0820 (international), and provide the pass
code 1451123. To access the live audio webcast please visit the “Investors &
Media” section of the company’s website located at www.manhattanpharma.com.
An
archived webcast will be available on the website approximately 2 hours after
the event and will be available in the archive until Friday, July 13, 2007
at
6:00 PM ET.
About
Manhattan Pharmaceuticals, Inc.
Manhattan
Pharmaceuticals, Inc., (Amex: MHA) is a clinical-stage pharmaceutical company
that acquires and develops novel, high-value drug candidates primarily in the
areas of dermatologic/immunologic and endocrine/metabolic disease disorders.
With a pipeline consisting of four clinical-stage product candidates, Manhattan
Pharmaceuticals is developing potential therapeutics for large, underserved
patient populations seeking superior treatments for conditions including
psoriasis, atopic dermatitis (eczema), mastocytosis, and head lice. Please
visit
our new corporate website at http://www.manhattanpharma.com
for more
information.
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 Pharmaceutical'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 "anticipates," "expects,"
"plans," "believes," "intends," “will,” and similar words or phrases. These
statements are based on Manhattan Pharmaceuticals’ 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' development efforts relating to its PTH (1-34), Altoderm™,
Altolyn™ or Hedrin™ product candidates, or any future product candidates, will
be successful, or that Manhattan Pharmaceuticals will be able to out-license
its
discontinued programs to other companies on terms acceptable to Manhattan
Pharmaceuticals, or at all. Other risks that may affect forward-looking
information contained in this press release include the possibility of being
unable to obtain regulatory approval of Manhattan Pharmaceuticals' product
candidates, the risk that the results of clinical trials may not support the
company’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-KSB for the year
ended December 31, 2006. Manhattan Pharmaceuticals assumes no obligation to
update these statements, whether as a result of new information, future events,
or otherwise, except as required by law.
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