Palatin Technologies, Inc. is a biopharmaceutical company. The Company is engaged in developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Its programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. The Company's primary product in clinical development is bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD), which is a type of female sexual dysfunction (FSD) defined as low desire with associated distress. Its other drug development programs include Melanocortin receptor-4 (MC4r), PL-3994 and Melanocortin receptor-1 (MC1r). MC4r is a compound used for treatment of obesity and diabetes. PL-3994 is a subcutaneously injected guanylate-cyclase type A (GC-A) receptor agonist. MC1r agonist peptides are used for treatment of inflammatory and dermatologic disease indications.
There are three main reasons why I believe PTN is good buy right now.
Palatin’s Rekynda is categorically better than its competitor, Valeant’s Addy.
As it turns out, VRX’s “female Viagra” has far from been the saving grace for the female community of patients afflicted with sexual disorder, considering its black box warning for risks of severe hypotension and syncope for those who combine Addyi with alcohol. Considering Addyi is a chronic medication, meant to be taken daily to be effective, this would put the women Addyi targets between the ages of 18 and 44, women who likely enjoy indulging in even the occasional bottle of red wine, at risk. Meanwhile, as PTN’s drug passes through clinical tests and hurdles, we already know alcohol interaction will not stand in the way of the drug’s success. Last year, Rekynda’s Phase 1 trial revealed it was generally well-tolerated without serious adverse events from alcohol use interaction. Palatin CEO and President Dr. Carl Spana at the time cheered, noting that the positive results of the alcohol interaction study should more importantly act as a pivotal check mark for the FDA who requires alcohol interaction studies before clearing a drug for approval.
Massive Market Potential Waiting in the WingsThough Rekynda is still in trials, once the libido drug makes its launch into the world, it will be cracking a market worth billions and billions of dollars across the globe. Especially taking under account the drug’s competitive edge over the only other horse in the race, Addyi with all of pitfalls, Palatin could capture the largely untouched kingdom of market potential.
It is estimated that roughly 40% of women suffer from female sexual dysfunction, i.e. hypoactive sexual desire disorder. Yet, barely any of this percentage have sought out medical attention, likely due to the vastly limited options available. When you have an option like Addyi, which can poorly impact blood pressure and interacts harmfully with alcohol, women might be left feeling the one solution out there is not worth the price they have to pay. Yet, with a better prospect like PTN’s Rekynda, women could start flocking to their pharmacies in the near future. If Palatin can issue an even more attractive price than its rival, once Rekynda is unleashed to the market, it could rake in multi-billion dollar gains, which would subsequently send shares shooting through the roof.
Almost at the FDA Approval Finish Line with Sturdy Cash FlowPalatin’s answer to women with low sexual desire also appears to be on a clinical track towards garnering a green light from the FDA. Particularly on back of the biotech firm impressing investors back in November with the libido drug achieving both co-primary endpoints in its Phase 3 study in the indication of hypoactive sexual desire disorder, regulatory approval could be well under way. It is anticipated that PTN could file for an NDA for Rekynda by the first quarter of 2018, with open label extension study results to be completed by the middle of this year.
Especially following the biotech firm’s most recent quarterly print, which beat consensus expectations by just a hair, and an update from the management team indicating confidence in capital through at least the middle of next year, the firm appears to be in solid shape. After PTN’s licensing agreement established with AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG), where in exchange for AMAG gaining exclusive domestic rights to market Rekynda, PTN in turn added an upfront payment of $60 million, $25 million in R&D reimbursement, up to $80 million in regulatory milestones, and up to $300 million in sales milestones coupled with 10% royalty revenues, PTN’s scope of cash will cover the path from pipeline to FDA approval.
Keep your eyes peeled to Palatin. There is strategic buying opportunity in these shares, and it could be wise to invest sooner rather than later when Rekynda hits a home run with clinical and commercial success.