Palatin Technologies and King Pharmaceuticals End
CRANBURY, N.J., Sept. 10, 2007 -- Palatin Technologies, Inc. today announced it has reacquired full rights to bremelanotide, a first in class melanocortin agonist drug candidate for the treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD) from King Pharmaceuticals Inc. .
The companies mutually agreed to end their collaborative development and marketing agreement on bremelanotide, with King exercising its right to terminate. Under the termination, Palatin has all rights to bremelanotide, without any obligation for future payments to King. King has no financial obligation for future payments to Palatin, other than for previously incurred costs not yet reimbursed and approved expense reimbursements related to the wind-down of the collaboration. 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 ED as a first-line therapy in the general population.
The termination of the collaborative development and marketing agreement is effective December 6, 2007. King retains the previously issued Palatin unregistered common stock and warrants.
Palatin 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 ED.
"Regarding the FSD program with bremelanotide, we have completed an exploratory at-home Phase 2 clinical trial in pre- and postmenopausal women and are in the final stages of compiling the data. We anticipate releasing the results later this month," stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin.
Palatin will also continue to focus its efforts on the Company's pipeline of preclinical therapeutics, including its compounds for obesity partnered with AstraZeneca and a lead clinical candidate for the treatment of congestive heart failure.