Palatin Technologies, a biopharmaceutical company, and Gedeon Richter, a major pharmaceutical company in Central Eastern Europe, have entered into a collaboration and licence agreement to co-develop and commercialise bremelanotide for female sexual dysfunction (FSD) indications in the European Union, other European countries and additional selected countries. Richter is a European-based specialty pharmaceutical company with a strong focus in female health and annual sales of more than €1.2 billion ($1.6 billion).
Under the terms of the agreement, Palatin will receive total upfront payments of €7.5 million ($9.9 million). Palatin and Richter will each contribute to the European co-development activities (primarily one phase 3 clinical trial in Europe) for obtaining regulatory approval in Europe. Palatin anticipates that its part of the European co-development activities will be cash neutral through the European regulatory filing stage. All sales, marketing, and commercial activities and associated costs in the licensed territory will be the sole responsibility of Richter.
Palatin will additionally receive €2.5 million ($3.3 million) upon initiation of its phase 3 clinical trial programme in the United States. Palatin is also eligible to receive €20 million ($26.4 million) regulatory related milestones. Palatin has the potential to receive up to €60 million ($79.2 million) potential sales related milestones and low double-digit royalties on net sales in the licensed territory.
"We are extremely pleased to have Richter as our European partner for bremelanotide. They are a leader in the development and marketing of female healthcare products. Their female healthcare franchise had over $500 million in sales in 2013 and they have a strong and growing presence in Europe and other regions," stated Carl Spana, Ph.D., president and chief executive officer, of Palatin. "This collaboration is aligned with Palatin's global strategy to bring bremelanotide to the market for the millions of women who have female sexual dysfunction and are seeking a safe and effective treatment." Dr. Spana further stated that, "In addition, we are focussed on starting the bremelanotide phase 3 clinical trials in the US in the fourth quarter of 2014 and on furthering discussions for partnerships for the US and other territories."
Erik Bogsch, chief executive officer of Richter, commented, "We are pleased to partner with Palatin and assist in the advancement of the bremelanotide programme for the treatment of female sexual dysfunction. Female Healthcare is an important area of our strategy and is growing nicely. We are committed to development activities to treat conditions in women that have a severe impact on the patient's quality of life. Bremelanotide complements our active strategy to bring innovative and first-in-class compounds to market and we look forward to advancing bremelanotide to address the large, unmet medical needs of women with 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).
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. 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 per cent of respondents.
There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand treatment and has the potential to transform the treatment of patients with FSD.
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.