Full Press Release Details
Pharmaceuticals Acquires Hedrin
the Treatment of Head Lice
JUNE 27 -- Manhattan Pharmaceuticals, Inc. (Amex: MHA - News) today announced
that it has acquired exclusive, North American rights to develop and
commercialize Hedrin , a novel, non-insecticide product candidate for the
treatment of head lice. Hedrin is currently marketed in Europe and in the United
Kingdom (UK), and according to market research firm Information Resources,
has recently achieved significant market share (greater than or equal to 40%)
certain European countries. The product candidate is the third to be licensed
Manhattan Pharmaceuticals from Thornton & Ross Limited -- the largest
independent OTC pharmaceutical manufacturer in the UK. ADVERTISEMENT Hedrin
non-insecticide combination of silicones (dimeticone and cyclomethicone) that
acts as a pediculicidal (lice killing) agent by disrupting the osmotic balance
within the insect. Most currently available lice treatments contain chemical
insecticide. Because Hedrin kills lice physically rather than by acting on
central nervous system the insects cannot build up resistance to the treatment.
Both silicones in Hedrin are used extensively in cosmetics and
Phase 3, randomized, controlled equivalence, clinical study conducted in Europe,
Hedrin was administered to 253 adult and child subjects with head louse
infestation. The study results, published in the British Medical Journal in
2005, demonstrated Hedrin's equivalence when compared to the insecticide
treatment, phenothrin, the most widely-used pediculicide in the UK. In addition,
according to the same study, the Hedrin-treated subjects experienced
significantly less irritation (2%) than those treated with phenothrin (9%).
more recent randomized, controlled parallel group superiority clinical study
(currently awaiting publication) has demonstrated that Hedrin is superior to
malathion liquid in the treatment of head louse infestation. In addition to
killing lice, further analysis from both of the above clinical trials shows
Hedrin is effective in killing louse eggs.
is rapidly gaining market acceptance in Europe and in the UK, where it has
achieved 40% market share, and we believe it has the potential to provide an
important treatment alternative here in North America," stated Doug Abel,
president and chief executive officer. "The acquisition of exclusive North
American rights to Hedrin is another important step in Manhattan
Pharmaceuticals' corporate strategy to create a robust, dual focused pipeline
the areas of dermatology/immunology and endocrinology/metabolism."
to the American Academy of Pediatrics an estimated 6-12 million Americans are
infested with head lice each year, with pre-school and elementary age children,
3-11, and their families affected most often.
studies have indicated that insecticide resistance may be increasing and
therefore contributing to treatment failure. Accordingly, Manhattan
Pharmaceuticals believes that there is significant potential for a convenient,
non-insecticide treatment alternative.
licensing transaction increases the Manhattan Pharmaceuticals pipeline to six
clinical stage product candidates.
Manhattan Pharmaceuticals, Inc.
Pharmaceuticals, Inc., (Amex: MHA - News) is a clinical-stage pharmaceutical
company developing novel, high-value drug candidates primarily in the areas
endocrine/metabolic disease and dermatologic/immunologic disorders. With a
pipeline consisting of six clinical-stage product candidates, Manhattan
Pharmaceuticals is developing potential therapeutics for large, underserved
patient populations seeking superior treatments for conditions including common
obesity, morbid obesity, psoriasis, and atopic dermatitis (eczema).
Thornton & Ross Limited
in Huddersfield, Thornton & Ross (T&R) is a privately-owned company
which has grown to become a significant player within the UK healthcare market
with brands which span the Rx, OTC and consumer sectors. Its leading brands
include COVONIA (cough cold and flu range), HEDRIN (Headlice treatment), CARE
(range of everyday medicines), ALGESAL and TRANSVASIN (topical analgesics),
SETLERS and GASTROCOTE (heartburn and indigestion remedies). T&R's leading
household brand is ZOFLORA a range of floral disinfectants.
manufactures the majority of its products, specializing in pharmaceutical
liquids and creams. The company employs 350 people and has a turnover
approaching 40 million pounds Sterling. (www.thorntonross.com)
Pharmaceuticals, Inc.
Regarding Forward-Looking Statements
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
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," and similar words or phrases. These statements
are based on current expectations, forecasts and assumptions that are subject
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 any of Manhattan's development efforts relating to Hedrin or any of its
other product candidates will be successful. 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's product
candidates, including Hedrin , the risk that the results of clinical trials may
not support Manhattan's claims, the risk that a non-insecticide alternative
treatment may not achieve market acceptance in North America, Manhattan's
reliance on third-party researchers to develop its product candidates, and
lack of experience in developing and commercializing pharmaceutical products.
Additional risks are described in the company's filings with the Securities
Exchange Commission, including its Annual Report on Form 10-KSB for the year
ended December 31, 2006. Manhattan assumes no obligation to update these
statements, except as required by law.