Pipeline

Hedrin

Topical GEL for the treatment of psoriasis

Since 2005, Manhattan Pharmaceuticals has been developing a topical formulation of parathyroid hormone (1-34) ("Topical PTH (1-34)") for the prescription treatment of mild to moderate psoriasis.  In July 2008, we announced Phase 2a study results where PTH (1-34) failed to demonstrate a statistically significant or clinically meaningful improvement in psoriasis versus a vehicle (placebo).  In this study, the vehicle (placebo) was a topical gel ("GEL") that had been developed by Manhattan Pharmaceuticals and was identical to the Topical PTH (1-34) product minus the active ingredient, PTH (1-34).  Both the active and vehicle (placebo) arms of the study showed similar improvements in study subjects’ psoriasis plaques.  In summary, the study results indicated that PTH (1-34) was not effective for the treatment of psoriasis since it did not achieve superiority or a statistical separation in efficacy over the GEL.  The GEL placebo may be effective enough to market as an OTC product.  Due to these study results, the Company has decided to discontinue development of PTH (1-34) as a prescription topical pharmaceutical candidate, and instead, we are exploring the possibility of developing the GEL as an OTC product for mild psoriasis.

The GEL vehicle (placebo) used in the above-mentioned study is the Company’s proprietary topical GEL.  The topical GEL showed evidence of psoriasis improving properties.  In this Phase 2a study, when it was utilized as the vehicle (placebo), 15% of study subjects achieved a clear or almost clear state at the end of week two.  At the end of week four, 20% of subjects treated with the GEL had achieved a clear or almost clear state, and at the end of week eight, 25% of subjects treated with the GEL had achieved a clear or almost clear state.  The Company owns worldwide rights to this topical GEL and is exploring the possibility of developing it as an OTC product for mild psoriasis.

According to the National Psoriasis Foundation approximately 125 million people worldwide, including approximately 6 million Americans, suffers from psoriasis.  Of these, approximately 65% (4.4 million) have mild psoriasis and maybe likely to be treated with an OTC product.  According to Datamonitor, only an estimated 55% of psoriasis sufferers have been formally diagnosed by a physician, so the OTC market could potentially be much larger.