NEW YORK, March 6, 2008 (PRIME NEWSWIRE) -- Manhattan Pharmaceuticals, Inc. (AMEX:MHA) today announced that it has concluded successful pre-IND (Investigational New Drug) meetings with the U.S. Food and Drug Administration (FDA) and may file IND applications for both Altoderm(tm) and Altolyn(tm). The company intends to develop Altoderm (topical cromolyn sodium) to treat pruritus (itching) associated with atopic dermatitis, and Altolyn (oral tablet cromolyn sodium) to treat mastocytosis.
The pre-IND meetings were held to obtain the FDA's concurrence regarding the requirements for IND applications, and to clarify development pathways and regulatory status of both products in the U.S.
Based on a review of the submitted package for Altoderm, including data from the two previously reported Phase 3 clinical studies (conducted in Europe by Thornton & Ross Ltd.), the FDA determined that following completion of certain nonclinical studies and the acceptance of an IND, Phase 2 clinical studies may be initiated in the U.S. The FDA also concurs that the proposed indication of pruritus associated with dermatologic conditions including atopic dermatitis can be pursued.
Based on a review of the submitted package for Altolyn, the FDA concurred that the 505(b)(2) NDA would be an acceptable approach provided a clinical bridge is established between Altolyn and Gastrocrom(r), the oral liquid formulation of cromolyn sodium currently approved in the U.S. to treat mastocytosis. The FDA also affirmed that a single, Phase 3 study demonstrating the efficacy of Altolyn over placebo may be sufficient to support a product approval in the U.S. In addition, the FDA also concurs that no additional nonclinical studies will be required to support an IND application. Manhattan Pharmaceuticals expects to file an IND with a Phase 3 protocol following completion of the required IND enabling tablet development and manufacturing work.
"We are pleased to have confirmed the regulatory and development paths for Altoderm and Altolyn with the FDA," stated Douglas Abel, president and Chief Executive Officer of Manhattan Pharmaceuticals. "The successful completion of these meetings is an important milestone for the company because it provides important clarity for our clinical programs here in the U.S."
About 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug and Cosmetic Act permits the FDA to approve a New Drug Application (NDA) in part on the basis of published literature or on a previous finding of safety or effectiveness of a drug. The process allows the sponsor to use the existing information in the public domain to support their approval. A 505(b)(2) application can apply to new chemical entities or to changes to previously approved drugs. Examples of 505(b)(2) applications include changes to formulation, dosage forms, or routes of administration. This procedure potentially allows for a more rapid approval timeline compared to new chemical/molecular entities based in part by referencing this information.
About Altoderm
Altoderm is a topical formulation of cromolyn sodium, a non-steroidal, anti-allergic medication which is categorized as a mast cell stabilizer. Cromolyn sodium has been shown to block allergic reactions by inhibiting the release of inflammatory mediators, including histamine and leukotrienes. It has been used worldwide for over 35 years to treat a number of allergic conditions including asthma, allergic rhinitis, allergic conjunctivitis, and mastocytosis.
About Altolyn
Altolyn is a novel tablet formulation of cromolyn sodium that has been formulated using site specific drug delivery technology. This unique formulation targets release of the drug in the upper region of the small intestine. Since cromolyn sodium is a mast cell stabilizer, treatment with Altolyn may control the symptoms of mastocytosis, as well as other mast cell associated disorders (e.g., food allergies and symptoms of irritable bowel syndrome).
About Manhattan Pharmaceuticals, Inc.
Manhattan Pharmaceuticals, Inc. is a pharmaceutical company that acquires and develops novel, high-value drug candidates primarily for the treatment of dermatologic and immune 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 pediculitis (head lice), psoriasis, pruritus associated with atopic dermatitis (eczema), and mastocytosis. (http://www.manhattanpharma.com)
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 Pharmaceuticals, Inc.'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, Inc.'s 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, Inc.'s 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, Inc. or at all. Other risks that may affect forward-looking information contained in this press release include the company's extremely limited capital resources, the possibility of being unable to obtain regulatory approval of Manhattan Pharmaceuticals, Inc.'s product candidates, or obtain the treatment we are seeking for Hedrin, 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, the company's lack of experience in developing and commercializing pharmaceutical products, and that trading in the company's stock may be adversely impacted by the company's voluntary delisting of its common stock from the American Stock Exchange. 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, Inc. assumes no obligation to update these statements, whether as a result of new information, future events, or otherwise, except as required by law.