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news.Palatin Technologies and Gedeon Richter (Richter) mutually and amicably agreed to terminate the license and collaboration agreement for bremelanotide for the treatment of female sexual dysfunction (FSD).
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All rights and licenses granted to Richter have terminated and reverted back to Palatin. There are no payment or reimbursement obligations as a result of the license agreement termination.
Palatin entered into the license agreement with Richter in August 2014 to co-develop and commercialize bremelanotide for FSD in the European Union, other European countries and additional selected countries.
Palatin received €7.5m ($9.8m) in total upfront payments from Richter, and a milestone payment of €2.5m ($3.1m) upon the initiation of its Phase 3 clinical trial program in the United States.
Palatin now has the global rights to bremelanotide for FSD, providing the Company and its business development efforts with additional options and flexibility. Palatin is actively engaged in licensing and collaboration discussions with multiple companies for both global and regional commercial rights to bremelanotide.
Bremelanotide development overview for the treatment of FSD:
– Palatin initiated Protocols 301 and 302 of its Phase 3 reconnect study in the United States and Canada for the treatment of FSD in December 2014 and January 2015, respectively. Further information on the trial protocols can be found at clinicaltrials.gov.
– The two Phase 3 studies are progressing as planned and meeting target objectives.
– Enrollment is greater than 50% to date and is expected to be completed in the fourth quarter of calendar year 2015.
– Top-line data is expected to be available in the third quarter of calendar year 2016.
– The clinical trials are designed to randomize approximately 1,100 women (~550 per trial) to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder as an on-demand, as-needed treatment.
About Bremelanotide for Female Sexual Dysfunction
Palatin is developing bremelanotide subcutaneous for the treatment of FSD in premenopausal women diagnosed with FSD. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). Bremelanotide is an on-demand, as-needed treatment and has the potential to transform the treatment of patients with FSD.
About Female Sexual Dysfunction
Female Sexual Dysfunction covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. We will seek approval of bremelanotide for the largest category of FSD, hypoactive sexual desire disorder. To establish a diagnosis of FSD, one or more of the disorders making up FSD must be associated with personal distress, as determined by the affected women.(i) A study of more than 30,000 U.S. women in 2008 reported an age-adjusted point prevalence of sexual difficulties causing personal distress in 12 percent of respondents.