Palatin Technologies, Inc. (NYSE MKT: PTN) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. The company’s lead product candidate, bremelanotide, is currently in pivotal phase III clinical trials for the treatment of female sexual dysfunction.
In early August, Palatin announced completion of reconnect studies related to its eight-month trial evaluating the efficacy and safety of subcutaneous bremelanotide as an on-demand treatment for premenopausal women with hypoactive sexual desire disorder (HSDD). The company is currently awaiting data verification, which it expects to be completed later this month, with topline data set to be announced “shortly thereafter,” according to Carl Spana, Ph.D., president and chief executive officer of Palatin.
The commercial potential for the drug candidate is substantial. According to a report published by the U.S. National Library of Medicine (http://nnw.fm/eN7Ie), female HSDD may occur in up to one-third of adult women in the U.S. Potential treatment options for the disorder, which is characterized by a deficiency or absence of sexual fantasies and desire for sexual activity, make up a sizable percentage of the larger sexual dysfunction treatment market, an industry that’s expected to eclipse $7.7 billion by 2019, according to London-based research firm Visiongain (http://nnw.fm/yUR5h).
Bremelanotide’s on-demand dosage requirements make it unique amongst an HSDD treatment market that’s caught plenty of headlines in recent months. In August 2015, the U.S. Food and Drug Administration approved Addyi (flibanserin) as the first available treatment for acquired, generalized HSDD in premenopausal women. Shortly after the FDA’s decision, Sprout Pharmaceuticals, maker of Addyi, was acquired by Valeant Pharmaceuticals (NYSE: VRX) for $1 billion. Valeant has since caught the ire of Sprout investors, who allege that Valeant “predatorily priced Addyi.” In a letter (http://nnw.fm/Mw2Zj) sent to Valeant in March, investors representing Sprout’s shareholders added, “As a result of this predatory pricing, insurance companies refused to cover the drug, which has led to the drug not being affordable for millions of women.”
Hailed as the ‘Female Viagra’ ahead of its launch (a not-so-subtle nod to Pfizer’s (NYSE: PFE) well-known erectile dysfunction medication), potentially predatory pricing may not be the only thing holding back the adoption of Addyi. The drug requires daily administration and, as a result, modifications to general lifestyle. This is in direct contrast to the convenient, on-demand treatment options targeting male sexual dysfunction, including Viagra and Eli Lilly’s (NYSE: LLY) Cialis, among others. If approved for commercialization, Palatin’s bremelanotide could directly address this inconsistency, becoming the first on-demand treatment option for female HSDD.
Last month, ahead of the upcoming release of topline data from its phase III clinical trial, Palatin successfully closed on an underwritten offering that added roughly $8.5 million in net proceeds to its cash reserves. With this financing in place, the company forecasts a clear runway to complete its phase III trials of bremelanotide for the treatment of HSDD in the coming weeks, moving one step closer to potential commercialization.
The company will provide additional insight into its current cash position next week during a scheduled teleconference and webcast to be held on September 20 before the open of the U.S. financial markets. Palatin will also conduct a conference call and live audio webcast hosted by its management team at 11:00 a.m. ET to discuss the company’s Q4 2016 operating results, as well as its ongoing development programs.
For more information, visit www.Palatin.com
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