It will soon be 50 years since the publication of Dr. David Reuben’s Everything You Always Wanted to Know about Sex: But Were Afraid to Ask had its profoundly liberalizing effect on our attitudes toward sex. The best seller helped bring the discussion on sexual behavior out of the bedroom and into other, more public forums. Its timing was opportune. In 1969, when it made its first appearance, America was already in the throes of a ‘sexual revolution’.
Reuben’s opus aligned with the emerging anti-Puritanical thinking that sexual desire was not something to be ashamed of. However, despite raising awareness that the desire for sexual satisfaction is acceptable, his manual was, unfortunately, silent on the pathologies that may plague sexual activity. Now it’s left to biopharmaceutical companies like Palatin Technologies, Inc. (NYSE MKT: PTN) to advance the ‘sexual revolution’.
Palatin Technologies has been doing just that for 20 years, ever since it started its biopharmaceutical operations in 1996. The company is focused on developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Its lead product is Bremelanotide, which it is developing for the treatment of female sexual dysfunction (FSD). Bremelanotide is currently undergoing phase III clinical trials for a type of FSD known as hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The essential feature of female HSDD is a deficiency or absence of sexual fantasies and desire for sexual activity resulting in marked distress and/or interpersonal difficulty.
The prevalence of HSDD is extensive. A publication in Sexual Medicine Reviews (http://nnw.fm/d3QB2) states that ‘HSDD is present in 8.9% of women ages 18 to 44, 12.3% ages 45 to 64, and 7.4% over 65.’ Other estimates (http://nnw.fm/FcE8i) put its occurrence at up to ‘one-third of adult women in the U.S.’ And a groundbreaking paper of 2011 on female HSDD (http://nnw.fm/bc2JB) claimed ‘lack of sexual desire or interest in sexual activity affects up to 43% of the adult American female population’ going on to say that ‘hypoactive sexual desire disorder (HSDD) is considered the most prevalent sexual disorder in women, and one of the most challenging to overcome.’
If even the most modest appraisals of HSDD’s extent are considered, it is apparent that the condition is an unmet medical need that presents a multi-billion dollar market opportunity. The last Census Bureau (2010) figures indicate that there are some 60 million pre-menopausal women in the U.S. Consequently, the potential market for Bremelanotide could be at least six million and may be as high as 24 million. Palatin estimates a market size of eight million with anticipated sales of $1.3 billion by 2020.
Palatin has already completed enrolling patients in two North American phase III pivotal trials for Bremelanotide. All patient visits in these phase III pivotal trials have been completed and top-line results are expected late in the third quarter of 2016. The company expects to file a New Drug Application (NDA) for Bremelanotide in the first half of 2017.
Palatin has other promising drugs in its pipeline. PL-3994 is a candidate for improving treatment outcomes in heart failure. Two phase I studies have already been completed for PL-3994 and a phase II trial is at the point of starting. For treatment of a variety of inflammatory diseases, the company is working on a melanocortin receptor-1 (MC1r) peptide drug. MC1r may have application in the treatment of inflammatory bowel disease, nephritis (inflammation of the kidneys), rheumatoid arthritis, and certain ocular and dermatologic indications. In addition, a melanocortin receptor-4 (MC4r) peptide candidate has had clinical proof-of-principle established. Proof-of-principle studies are an early stage of clinical drug development when a compound has shown potential in animal models and early safety testing.
For more information, visit www.Palatin.com
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