Manhattan Pharmaceuticals Provides Update on Clinical Pipeline
July 10 2007 - 7:00AM
PR Newswire (US)
- Preliminary Phase 3 European clinical results for Altoderm(TM)
expected 3Q07 NEW YORK, July 10 /PRNewswire-FirstCall/ -- Manhattan
Pharmaceuticals, Inc. (AMEX:MHA) today provided an update regarding
the company's pipeline. As announced yesterday, 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 product candidates include topical PTH (1-34) for psoriasis,
as well as Altoderm(TM) for atopic dermatitis (eczema), Altolyn(TM)
for mastocytosis, and Hedrin(TM) for head lice. Topical PTH (1-34)
-- Manhattan Pharmaceuticals is developing topical PTH (1-34) for
the treatment of psoriasis. Approximately 4.5 million Americans
suffer from psoriasis creating a potential U.S. market of
approximately $400 million for topical therapies. The company is
currently conducting preclinical studies on its improved topical
formulation for PTH (1-34) and intends to submit a corporate
investigational new drug application (IND) in the third quarter of
2007. Pending the outcome of that IND submission, the company
intends to initiate a randomized, double-blind, placebo-controlled
Phase 2a clinical trial in 2H07. In addition, the company has filed
new patent applications in the U.S. with respect to the product.
Altoderm(TM)-- In April 2007, Manhattan Pharmaceuticals acquired
the North American rights to develop and commercialize Altoderm for
the treatment of atopic dermatitis, or "eczema." Eczema represents
a major potential market opportunity. According to the National
Institutes of Health, 15 million Americans suffering from the
condition, and insurance companies spending more than $1 billion
annually for treatment. Altoderm is presently being studied in an
ongoing Phase 3 clinical trial being conducted in Europe by
Thornton & Ross Limited. Preliminary data from this European
study are expected in 3Q07. Altoderm previously completed a
randomized, double-blind, placebo-controlled, parallel-group, Phase
3 clinical study in the United Kingdom (UK). The results of that
study were published in the British Journal of Dermatology in
February 2005. These studies have been conducted according to UK
regulatory requirements and are expected to be submitted to the UK
authorities in pursuit of marketing authorization. Manhattan
Pharmaceuticals is presently preparing to meet with the United
States Food and Drug Administration (FDA) to determine the
regulatory pathway for Altoderm in the U.S. The company expects
this meeting to take place in 2H07. Altolyn(TM)-- In April 2007,
Manhattan Pharmaceuticals acquired the North American rights to
develop and commercialize Altolyn for the treatment of
mastocytosis. The company believes that Altolyn may be a candidate
for an accelerated 505(b)2 regulatory pathway or orphan drug
designation in this indication. Early UK clinical experience also
suggests that Altolyn may have potential for patients with food
allergy and gastrointestinal functional disorders. The company is
presently preparing to meet with the FDA to discuss these
possibilities and any additional regulatory considerations for
Altolyn in the U.S. The company expects this meeting to take place
in 2H07. Hedrin(TM)-- In June 2007, Manhattan Pharmaceuticals
acquired the North American rights to develop and commercialize
Hedrin, a non-insecticide product candidate for the treatment of
head lice. According to the American Academy of Pediatrics, an
estimated 6 to 12 million Americans are infested with head lice
each year. Hedrin is currently marketed in Europe and in the UK,
and according to market research firm Information Resources, Inc.,
has recently achieved significant market share (greater than or
equal to 40%) in certain European countries. Manhattan
Pharmaceuticals is presently preparing to meet with the FDA to
determine the regulatory pathway for Hedrin in the U.S. The company
expects this meeting to take place in 2H07. In addition to these
programs, Manhattan Pharmaceuticals will continue to explore other
opportunities in the areas of endocrine and metabolic disorders. On
July 9, 2007, Manhattan Pharmaceuticals announced the company has
discontinued development of oral Oleoyl-estrone for the treatment
of common obesity and morbid obesity due to the compound's failure
to demonstrate statistical and clinically meaningful weight loss in
recently completed Phase 2a clinical trials. The company also
reported that it intends to pursue appropriate outlicensing
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
http://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(TM), Altolyn(TM) or
Hedrin(TM) 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. Contact
information Douglas Abel President & Chief Executive Officer
212.582.3950 phone DATASOURCE: Manhattan Pharmaceuticals, Inc.
CONTACT: Douglas Abel, President & Chief Executive Officer of
Manhattan Pharmaceuticals, Inc., +1-212-582-3950 Web site:
http://www.manhattanpharma.com/
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