Cranbury-based Palatin Technologies, Inc. (AMEX: PTN) announced it and Bristol, Tenn.-based King Pharmaceuticals Inc. (NYSE: KG) have agreed to end their collaborative development and marketing agreement on sexual-disfunction drug bremelanotide. The decision follows recent responses from representatives of the U.S. Food and Drug Administration (FDA), which raised serious concerns about the acceptable benefit/risk ratio to support the progression of bremelanotide into Phase 3 studies for erectile dysfunction as a first-line therapy in the general population, according to Palatin. The termination of the collaborative development and marketing agreement is effective December 6, 2007.
Palatin said it is in the process of reviewing the responses and comments made by the FDA and plans to engage the FDA in further discussions in order to determine next steps related to the further development of bremelanotide for the treatment of erectile dysfunction.
Separately, Palatin announced results for its fourth quarter and fiscal year. Palatin reported a net loss of $6.1 million, or $0.07 per share, for the quarter ended June 30, 2007, compared to a net loss of $7.9 million, or $0.11 per share, for the same period in 2006. Total revenues in the quarter ended June 30, 2007 were $2.6 million, compared to $5 million for the same period in 2006. The decrease in the net loss for the quarter ended June 30, 2007 versus the quarter ended June 30, 2006 was primarily attributable to decreased research and development spending on bremelanotide, Palatin said.
For the years ended June 30, 2007 and 2006, total revenues were $14.4 million and $19.7 million, respectively. Palatin’s net loss for the year ended June 30, 2007 was $27.8 million, or $0.36 per share, compared to a net loss of $29 million, or $0.48 per share, for the year ended June 30, 2006.
