Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for US Patent Application Serial Number 14/313,258 (the ‘258 application). The allowed claims are for methods of treating female sexual dysfunction using the formulation and dose used in Palatin’s ongoing phase 3 clinical trials and commercialization upon FDA approval.
Carl Spana, Ph.D., president and CEO of Palatin, commented, “The allowed patent is significant because it applies specifically to methods of treatment of female sexual dysfunction consistent with our projected approved product. Securing strong patent protection is a key component of our development programme.”
Once issued, the patent is expected to expire no earlier than November 2033, and will further enhance Palatin’s key bremelanotide patent family, which includes US Patent Nos. 6,579,968 and 6,794,489, which expire in June 2020 before patent term extensions. Each of these patents contain composition and method of use claims covering bremelanotide.
Top-line results of the phase 3 trials are on target for release in the third quarter of calendar 2016. Assuming the phase 3 trials are successful, Palatin will file a New Drug Application in the first half of calendar 2017.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The Notice of Allowance for the ‘258 application has been posted on the USPTO public PAIR website.
Palatin is developing bremelanotide as a subcutaneous, on-demand treatment of female sexual dysfunction (FSD) in premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD). 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 as-needed (not chronic), centrally-mediated medication, unlike flibanserin (ADDYI) or certain other FSD treatments in development that require daily administration. Studies have shown that bremelanotide starts working within 30 to 60 minutes of administration and remains effective for approximately eight hours, providing women with control and flexibility in their treatment as well as a quick response.
Female sexual dysfunction covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. We plan to seek approval of bremelanotide for the largest category of FSD, hypoactive sexual desire disorder (HSDD). HSDD is a medical condition marked by a lack of sexual thoughts and desire for sexual activity, which causes a woman distress or puts a strain on the relationship with her partner, and cannot be accounted for by another medical, physical or psychiatric condition, or as a result of other medication. It is estimated that one in 10 women may have the signs of HSDD at some point in their life, and as such HSDD represents a major opportunity to address a tremendous medical need.