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Manhattan Pharmaceuticals Expands Licensing Agreement


Posted on 2007-04-04 09:31:00



Manhattan Pharmaceuticals, Inc.today announced that it has acquired exclusive, North American rights to develop and commercialize two novel product candidates from Thornton & Ross Limited, which is reportedly the largest independent pharmaceutical manufacturer in the United Kingdom.

The two acquired product candidates are Altoderm (topical cromolyn sodium) for the treatment of atopic dermatitis and Altolyn (oral cromolyn sodium tablet) for the treatment of mastocytosis. The company believes the acquisition of these two product candidates is an important step in the Manhattan Pharmaceuticals corporate strategy as it allows the company to continue to create a robust pipeline while building on the existing dermatology franchise.

Cromolyn 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.

Altoderm 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 a 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 demonstrated a statistically significant reduction in symptoms. During the study, subjects were permitted to continue with their existing treatment, in most cases this consisted of emollients and topical steroids. A positive secondary outcome of the study was a reduction in the use of topical steroids for the Altoderm-treated subjects.

According to the National Institutes of Health (NIH), more than 15 million people in the US have symptoms of atopic dermatitis, and US health insurance companies spend more than $1 billion per year on the condition.