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): October 3, 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 Presents Pipeline Update
Manhattan
Pharmaceuticals, Inc. is giving an update on its product pipeline today at
4:30
PM through a presentation at the American Stock Exchange, 14th Floor
Boardroom, 86 Trinity Place, New York, New York 10006. The presentation will
be
simultaneously webcast, which can be accessed on the internet by using the
link
http://www.wsw.com/webcast/cc/mha4
Pipeline
Update
Topical
PTH (1-34) for Psoriasis -
A
corporate investigational new drug (IND) application for the improved
formulation of topical PTH (1-34) was accepted by the U.S. Food and Drug
Administration (FDA) in September 2007. Clinical trial material has been
manufactured and clinical sites have been identified and secured. Central
internal review board approval has been received. Pending local clinical site
review board approvals, the company intends to initiate a Phase 2a multi-center,
randomized, double-blind, vehicle-controlled, parallel group clinical trial
in
the fourth quarter of 2007.
The
study
will involve 54 subjects in a 1:1:1 randomization, two doses of topical PTH
(1-34) compared to vehicle for an eight week treatment period. The vehicle
is
the topical PTH (1-34) product without the active ingredient, PTH (1-34).
Altoderm™
for Atopic Dermatitis
-
Analysis of the preliminary data from the initial 12 week, blinded portion
of
this European Phase 3 randomized, double-blind, vehicle controlled clinical
trial being conducted by Thornton & Ross Limited has been completed. In this
study the vehicle was the Altoderm product without the active ingredient,
cromolyn sodium.
Data
indicate that Altoderm was safe and well tolerated. Altoderm treated subjects
experienced a 33.1% improvement in SCORAD from baseline. (See
below for an explanation of SCORAD.)
This
efficacy is consistent with findings from the first European Phase 3 study
of
Altoderm. While this improvement from baseline was dramatic in the Altoderm
treated subjects, the vehicle only treated subjects experienced a similar
improvement, and therefore, the study did not achieve statistical significance.
Preliminary results of the open label extension of this study show that the
subjects treated with the vehicle only in the blinded portion of the study
demonstrated further marked improvement in SCORAD when switched to Altoderm.
Manhattan Pharmaceuticals believes these outcomes were due to the vehicle being
very effective on its own, as evidenced by the 20% improvement in SCORAD
demonstrated in the prior Phase 3 study, and a much less rigorous study design
where subjects were unrestricted in their use of concomitant therapies such
as
topical steroids and immunomodulators.
A
meta-analysis of both studies shows Altoderm treated subjects experienced a
statistically significant improvement in pruritus, the itch associated with
atopic dermatitis, versus vehicle only treated subjects.
The
extensive data obtained from these studies will be submitted in support of
Altoderm to both European and US regulatory agencies.
Given
the
promising clinical data obtained from the prior European Phase 3 study, and
the
symptom improvements reported in the ongoing European Phase 3 study, both
Manhattan Pharmaceuticals and Thornton & Ross Limited believe there is
significant potential for Altoderm and will continue development of this product
candidate. Manhattan
Pharmaceuticals is requesting a pre-IND meeting with the FDA and is finalizing
a
pre-IND package in anticipation of that meeting. The company also expects
Altoderm clinical studies to be required in the U.S. with the first of these
studies commencing as early as the second quarter 2008.
Hedrin™
for Head Lice
- Hedrin
is currently marketed as a device in Western Europe and as a pharmaceutical
in
the UK. In Europe Hedrin has achieved significant sales (in excess of $40
million) and market share (greater than or equal to 40%) in certain countries.
Manhattan Pharmaceuticals is pursuing a Premarket Approval (PMA) application
development pathway for Hedrin as a medical device, and is currently preparing
to meet with the FDA’s Center for Devices and Radiological Health in the first
quarter of 2008. Pending the outcome of these regulatory discussions, the
company expects to initiate clinical activities in 2008. Manhattan
Pharmaceuticals expects to be required to complete at least one clinical trial
with this product candidate.
Altolyn™
for Mastocytosis
-
Manhattan Pharmaceuticals is working with Thornton and Ross Limited and the
current U.K. manufacturer of Altolyn to develop a GMP compliant manufacturing
process. Pending finalization of this process the company will request a pre-IND
meeting and prepare a pre-IND package. The company believes that Altolyn may be
a candidate for an accelerated 505(b)2 regulatory pathway or orphan drug
designation in the indication of mastocytosis. Early U.K. clinical experience
also suggests that Altolyn may have potential for patients with food allergy
and
gastrointestinal functional disorders, and the company intends to pursue these
as additional indications.
More
about SCORAD
SCORAD
is
an evaluation tool developed by the European Task Force on Atopic Dermatitis
to
objectively assess the severity of the condition, and is used extensively in
Europe and in the United Kingdom (UK).
Safe
Harbor Statement
The
statements made in this presentation that are not historical are
“forward-looking statements” within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of
1934,
as amended, including statements regarding the expectations, beliefs, intentions
or strategies regarding the future. We use words such as we “expect,”
“anticipate,” “believe,” and “intend” and similar expressions to identify
forward-looking statements. In particular, we make forward-looking statements
about future events and financial performance, including statements about the
following:
| Ø |
Our
product development efforts
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| Ø |
Anticipated
operating losses and capital
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Anticipated
regulatory filing dates and clinical trial initiation
dates
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| Ø |
Our
estimates regarding our capital requirements and our needs for additional
financing
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Our
estimates for future revenues and
profitability
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Our
selection and licensing of product
candidates
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Our
ability to attract partners and other collaborators with
acceptable development, regulatory, commercialization
expertise
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| Ø |
The
benefits to be derived from corporate collaborations, license agreements
and other collaborative efforts, including those relating to the
development and commercialization of our product
candidates
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| Ø |
Sources
of revenues and anticipated revenues, including contributions from
corporation collaborations, license agreements and other collaborative
efforts for the development and commercialization of our product
candidates, and the continued viability and duration of those agreements
and efforts
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A
number
of important factors could, individually or in the aggregate, cause actual
results to differ materially from those expressed or implied in any
forward-looking statements. Such factors include, but are not limited to, the
following: our lack of significant revenues and profitability; our need for
additional capital; the results of clinical trials of our product candidates;
our ability to successfully commercialize our technologies; our ability to
obtain various regulatory approvals; the illiquidity and volatility of our
common stock, and the other “Risk Factors” identified in our Annual Report on
Form 10-KSB for the fiscal year ended December 31, 2006.
Item
9.01. Financial Statements and Exhibits
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Exhibit
No.
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Description
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99.1
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Power
Point Slides dated October 3, 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: October
3, 2007 |
By: |
/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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Power
Point Slides dated October 3, 2007
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