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Pharmaceuticals Announces License Agreement and Expanded
Acquires Two New Clinical-Stage Drug Candidates
APRIL 4 /PRNewswire-FirstCall/ - Manhattan Pharmaceuticals, Inc. (Amex:
announced that it has acquired exclusive, North American rights to develop
commercialize two novel product candidates from Thornton & Ross Limited -
the largest independent pharmaceutical manufacturer in the United Kingdom (UK).
The two acquired product candidates are Altoderm(TM) (topical cromolyn sodium)
for the treatment of atopic dermatitis and Altolyn(TM) (oral cromolyn sodium
tablet) for the treatment of mastocytosis. The company believes the acquisition
of these two product candidates is an important step in Manhattan
Pharmaceuticals corporate strategy as it allows the company to continue to
create a robust pipeline while building on the existing dermatology franchise.
sodium, also known as sodium cromoglycate, is a non-steroidal, anti-inflammatory
medicine that has been used worldwide for over 35 years to treat a number of
allergic conditions including asthma, allergic rhinitis (nasal allergies),
allergic conjunctivitis, and mastocytosis.
is a novel, proprietary formulation of topical cromolyn sodium and is designed
to enhance the absorption of cromolyn sodium in order to treat atopic
dermatitis, or "eczema". This product candidate is currently being tested in
Phase 3 clinical trial in the UK. In a previously completed randomized,
double-blind, placebo-controlled, parallel-group, Phase 3 clinical study the
compound was administered for 12 weeks to 144 child subjects with moderately
severe atopic dermatitis. In the study results, published in the British Journal
of Dermatology in February 2005, Altoderm(TM) demonstrated a statistically
significant reduction in symptoms. During the study, subjects were permitted
continue with their existing treatment, in most cases this consisted of
emollients and topical steroids. A positive secondary outcome of the study
reduction in the use of topical steroids for the Altoderm(TM)- treated subjects.
to the National Institutes of Health (NIH), more than 15 million people in
US have symptoms of atopic dermatitis, and US health insurance companies spend
more than $1 billion per year on the condition.
is a proprietary, site specific, tablet formulation of oral cromolyn sodium
the treatment of mastocytosis. This novel formulation is designed to provide
optimal availability by preferentially releasing the drug in the upper part
the small intestine, the purported site of action. Early clinical experience
the UK suggests promising activity in patients with various allergic disorders,
including inflammatory bowel conditions. Oral cromolyn sodium is the active
ingredient in Gastrocrom an oral liquid solution that is currently FDA approved
for the treatment of mastocytosis.
and Altolyn(TM) are innovative topical and oral formulations of cromolyn sodium,
a widely used molecule with a well established safety profile. We believe
Altoderm(TM) has the potential to provide an important treatment alternative
steroids and immunomodulators for patients with atopic dermatitis," stated
Abel, President and Chief Executive Officer. "Our new relationship with Thornton
& Ross Limited represents an ideal strategic opportunity for Manhattan
Pharmaceuticals. Thornton & Ross is an industry leader for prescription and
consumer products in the UK, with a pipeline of innovative healthcare products.
The addition of these two product candidates is an important step in our
corporate strategy as it allows us to grow our existing dermatology business,
while continuing to build a strong, diverse pipeline."
licensing transaction increases the Manhattan Pharmaceuticals pipeline to five
clinical stage product candidates.
to the NIH, more than 15 million people in the U.S. have symptoms of atopic
dermatitis with an estimated 20 percent of those being infants and young
children. Roughly 60 percent of these infants continue to have one or more
symptoms in adulthood. It affects both males and females and accounts for 10
20 percent of all visits to dermatologists.
dermatitis is a chronic (long-lasting) disease that affects the skin. It is
contagious; it cannot be passed from one person to another. In atopic
dermatitis, the skin becomes extremely itchy. Scratching leads to redness,
swelling, cracking, "weeping" clear fluid, and finally, crusting and scaling.
The cause of atopic dermatitis is not known, but the disease seems to result
from a combination of genetic (hereditary) and environmental factors. The most
common symptoms are dry, itchy skin and rashes on the face, inside the elbows
and behind the knees, and on the hands and feet.
topical corticosteroids are the primary anti-inflammatory treatment for atopic
dermatitis. They are extremely effective in controlling acute exacerbations,
are also used for long-term maintenance treatment when emollients alone do
provide adequate control. However, local side effects are common, in particular
skin thinning, telangiectasis, bruising, hypopigmentation, acne, striae and
secondary infection. There is, therefore, an understandable reluctance on the
part of patients, parents and physicians to use topical corticosteroids on
long-term basis. Recently, topical formulations of the immunosuppressive drugs
tacrolimus and pimecrolimus have been introduced as anti-inflammatory agents.
However, there is limited evidence of their long-term safety.
is a rare disorder that occurs in both children and adults. It is caused by
presence of too many mast cells in the body. Mast cells are found in skin,
linings of the stomach and intestine, and connective tissue (such as cartilage
and tendons). Mast cells play an important role in helping the immune systems
defend these tissues from disease. They release chemical "alarms" such as
histamine and cytokines to attract other key players of the immune defense
system to sites in the body where they might be needed. People with mastocytosis
experience abdominal discomfort, nausea and vomiting, ulcers, diarrhea, and
Manhattan Pharmaceuticals, Inc.
Pharmaceuticals, Inc., a development-stage pharmaceutical company, acquires
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 the treatment of
both common obesity and morbid obesity. To meet the needs of other major,
underserved medical markets Manhattan Pharmaceuticals is also developing PTH
(1-34), a peptide believed to be a regulator of epidermal cell growth, for
treatment of 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)
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