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): April 28, 2006
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
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(Commission
File Number)
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(IRS
Employer
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incorporation)
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Identification
No.)
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810
Seventh Avenue, 4th
Floor
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10019
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(Address
of principal executive offices)
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(Zip
Code)
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(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:
[
] Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
[
] Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
[
] Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[
] Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item
8.01. Other
Events.
On
April
28, 2006, Manhattan Pharmaceuticals, Inc. issued a press release announcing
the
status of the development of its product candidates Oleoyl-estrone and
PTH(1-34). The press release is attached to this Current Report as Exhibit
99.1
and incorporated herein by reference.
Item
9.01. Financial Statements and Exhibits
(d)
Exhibits. The following exhibit is filed herewith.
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Exhibit
No.
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Description
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99.1
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Press
release dated April 28, 2006.
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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:
May 1, 2006
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By:
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/s/
Nicholas J.
Rossettos
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Nicholas
J. Rossettos
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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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Press
release dated April 28,
2006.
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EXHIBIT
99.1
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Press
Release
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Source:
Manhattan Pharmaceuticals, Inc.
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Manhattan
Pharmaceuticals Reports Update on Clinical Development
Programs
NEW
YORK,
April 28, 2006 (PRIMEZONE) -- Manhattan Pharmaceuticals, Inc. (AMEX:MHA
-
News)
announced the following update regarding the development status of oral
Oleoyl-estrone for obesity and topical PTH (1-34) for psoriasis.
The
Phase
IIa protocol for Oleoyl-estrone in the treatment of obesity has received local
ethics committee approval and has been submitted to SwissMedic, the Swiss
medical regulatory authority, for review. The Company plans to initiate this
trial immediately upon receiving final regulatory approval.
Dosing
of
topical PTH (1-34) in the Investigator IND-conducted Phase IIa study has been
delayed due to issues identified with the current formulation and the difficulty
of conducting a psoriasis study in the summer. Ideally, psoriasis trials are
conducted in the fall and winter due to the natural improvement of the disease
during the summer months.
Manhattan
Pharmaceuticals is working with formulation experts to assist in addressing
the
issues and anticipates a one- to two-quarter formulation effort. The Company
believes these formulation activities may lead to additional intellectual
property surrounding the product.
Manhattan
is committed to moving forward with topical PTH (1-34) in light of the highly
statistically significant clinical results demonstrated in the Investigator
IND
conducted Phase I/II study published in the British Journal of Dermatology
(2003). In this study, over 60 percent of patients experienced complete clearing
of treated psoriasis lesions and 85 percent experienced at least partial
clearing.
About
Manhattan Pharmaceuticals, Inc.
Manhattan
Pharmaceuticals, Inc. (AMEX:MHA
-
News),
a
development stage pharmaceutical company, acquires and develops proprietary
prescription drugs for large, underserved patient populations. In view of the
worldwide obesity epidemic, the company is developing OE, an orally administered
novel therapeutic for weight loss. To meet the needs of other major, underserved
medical markets while lowering development risks, Manhattan Pharmaceuticals
is
also developing PTH (1-34), a peptide believed to be a regulator of epidermal
cell growth, for psoriasis and Propofol Lingual Spray, a convenient, proprietary
lingual spray formulation of propofol, the world's best-selling general
anesthetic, as a sedative-hypnotic for use during diagnostic and therapeutic
procedures. http://www.manhattanpharma.com
Note
Regarding Forward-Looking Statements
This
news
release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements are valid only as
of
today, and we disclaim any obligation to update this information. These
statements are subject to known and unknown risks and uncertainties that may
cause actual future experience and results to differ materially from the
statements made. These statements are based on our current beliefs and
expectations as to such future outcomes. Drug discovery and development involve
a high degree of risk. Factors that might cause such a material difference
include, among others, uncertainties related to the ability to attract and
retain partners for our technologies, the identification of lead compounds,
the
successful preclinical development thereof, the completion of clinical trials,
the FDA review process and other governmental regulation, our pharmaceutical
collaborator's ability to successfully develop and commercialize drug
candidates, issues relating to drug formulation and manufacturing, competition
from other pharmaceutical companies, product pricing and third party
reimbursement, and other factors described in our filings with the Securities
and Exchange Commission.
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Contact:
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Manhattan
Pharmaceuticals, Inc.
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Nicholas
J. Rossettos, CPA, Chief Financial Officer
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(212)
582-3950
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Redington,
Inc.
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Thomas
Redington
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(203)
222-7399
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(212)
926-1733
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