Manhattan Pharmaceuticals Inc. (NASDAQ:MHA)
Industry: Healthcare

Listed 7 Consecutive Market Days. On List as of 05/11/2006 Through 05/22/2006

Manhattan Pharmaceuticals, Inc., incorporated in May 1993, is engaged in the business of developing and commercializing biomedical and pharmaceutical technologies. The Company focuses on acquiring rights to these technologies by licensing or otherwise acquiring an ownership interest, funding their research and development and eventually bringing the technologies to market. As of December 31, 2005, Manhattan Pharmaceuticals did not have any drugs or other products available for sale, but it was researching and developing three biomedical technologies: oleoyl-estrone, an orally administered hormone that has been shown to cause significant weight loss in preclinical animal studies regardless of dietary modifications; PTH (1-34), a topical treatment for psoriasis, and lingual spray propofol, a lingual spray technology to deliver propofol for pre-procedural sedation prior to diagnostic, therapeutic or endoscopic procedures. Although it is primarily focused on developing these technologies, the Company continues to seek to acquire rights to other biomedical and pharmaceutical technologies, by licensing or acquiring an ownership interest, funding their research and development and bringing the technologies to market. Oleoyl-estrone Manhattan Pharmaceuticals acquired the rights to develop and commercialize oleoyl-estrone, a hormone modified by an attachment to a fatty acid, pursuant to a February 2002 license agreement with Oleoylestrone Development, SL., a Spanish corporation. The Company considers Oleoyl-estrone as a potential out-licensing candidate. In January 2005, the United States Food and Drug Administration (FDA) accepted the Company's filed investigational new drug application (IND) for the human clinical testing of Oleoyl-estrone. Manhattan Pharmaceuticals completed Phase Ia and Phase Ib clinical trials in May 2005 and July 2005, and released data on both trials in October 2005. Both trials were completed in Basel, Switzerland, after obtaining formal approval from the Swiss medical authority, Swissmedic, however, only the Phase Ia trial was conducted pursuant to the IND accepted by the FDA. The objective of both dose escalation studies was to determine the safety and tolerability of defined doses of orally administered Oleoyl-estrone in obese adult volunteers, as well as the pharmacokinetic profile (the manner in which the drug is absorbed, distributed, metabolized and excreted by the body) of Oleoyl-estrone in both men and women. PTH (1-34) Manhattan Pharmaceuticals acquired the rights to PTH (1-34) in connection with the acquisition of Tarpan Therapeutics, Inc. (Tarpan) in April 2005. Tarpan acquired a license to develop and commercialize this drug compound pursuant to an April 2004 agreement with IGI, Inc. In August 2003, researchers reported positive results from the United States Phase I and II clinical trial evaluating the safety and efficacy of PTH (1-34) as a topical treatment for psoriasis. This double-blind, controlled trial in 15 patients compared PTH (1-34) formulated in the Novasome Technology versus the Novasome vehicle alone. Following eight weeks of treatment, the topical application of PTH (1-34) resulted in complete clearing of the treated lesion in 60% of patients and partial clearing in 85% of patients. Additionally, there was a statistically significant improvement in the global severity score. Ten patients continued receiving PTH (1-34) in an open-label extension study, in which the Psoriasis Area and Severity Index (PASI) was measured; PASI improvement across all 10 patients achieved statistically significant improvement compared to baseline. This study showed PTH (1-34) to be well tolerated and efficacious for the treatment of plaque psoriasis with no patients experiencing any clinically significant adverse events. A follow on physician IND Phase IIa trial involving PTH (1-34) was initiated, in December 2005, under the auspices of Boston University. Patient recruitment is ongoing and dosing has not yet begun. Lingual Spray Propofol On April 4, 2003, Manhattan Pharmaceutica

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