Palatin Technologies (PTN) Stock: Creating A Soulmate For Viagra

Palatin Technologies, Inc. (NYSEMKT: PTN)

The provocative television commercials for Viagra may soon be getting a companion with the late stage success of Palatin Technologies’ bremelanotide, an experimental drug intended to boost the libido of pre-menopausal women that are distressed by a lack of sexual desire. Subsequent to the late breaking news after hours on Tuesday, the stock is trading 54% higher (6:12) from the regular session close.

Will PTN’s Bremelanotide Cause A ’60s Rewind?

Perhaps a ’60s flashback is wishful thinking, especially for those of us that grew up in that wonderful decade. However, even though many of us had to grow up and grab a slice of mid-life reality, the info released by PTN on Tuesday is genuinely a great piece of news that will likely be met by a receptive and lucrative market.

The loss of sexual desire is a serious matter, and the complications that come with that loss include low self-esteem, relationship problems, divorce, low self-image and a lesser quality of life. What those with a strong libido may take for granted is a debilitating hardship for others. And, it is PTN’s hope that what Viagra did for men bremelanotide will do for women.

Positive And Statistically Significant Phase III Results

[pms-restrict subscription_plans=”11543,11544″]

Palatin has been working intensely on its experimental drug, bremelanotide. The drug is intended to boost the libido in women, addressing a condition called hypoactive sexual desire disorder (HSDD).

PTN has completed its late stage, phase III trial and has produced statistically significant results. The study compiled data from over 1200 women, all of whom were diagnosed with HSDD. The study was placebo-controlled and was recorded by using results from patient groups being measured in 24-week intervals.

According to one of the study’s principal investigators, the phase III trial of bremelanotide delivered a significant reduction in distress. Additionally, bremelanotide was safe and well tolerated, with mild nausea being the most prevalent side effect. Significantly, no new safety issues were identified or associated with the treatment or the drug during the pivotal phase III trial.

Although there are some drugs on the market that are intended to treat distress and conditions related to HSDD, the comparisons differ widely, to the benefit of PTN’s bremelanotide.

Did PTN Invent The Female Viagra?

Valeant Pharmaceuticals is marketing a product named Addyi, a drug that was approved, in part, due to the immense pressure applied to the FDA by patient advocacy groups. PTN may face some initial competition from Addyi. However, PTN’s bremelanotide has demonstrated superior efficacy and a substantially better safety profile.

Addyi, though, has not fared well in the market. The drug was approved back in August, but the efficacy was never truly demonstrated to provide measurable benefit. User’s of Addyi have reported significant and dangerous side effects, inclusive of fainting and extremely low blood pressure. In fact, the side effects were so prevalent that the FDA required a warning label to be applied to the outside of the package citing the effects listed above. Additionally, consumers were advised not to consume alcohol when taking Addyi. To add further insult, several panelists have argued that the drug provided more of a placebo effect rather than measurable efficacy, causing some dissent on the FDA panel.

To put it all together, fainting, extremely low blood pressure, AND no wine? Addyi is ripe to be replaced.

Say Hello To Her Little Friend

It’s about time that women were afforded a drug to address HSDD, and PTN is on the verge of delivering the goods.

Bremelanotide met its primary endpoints in the phase III trial, and although PTN only provided investors with a small taste of the data, it is apparent that future data will be positive.

Palatin’s bremelanotide is relatively similar to that of the male enhancement drug, Viagra. Unlike some sexual enhancement drugs that require a daily dose, bremelanotide is similar to Viagra in that the drug is taken on an as-needed basis in anticipation of sexual activity.

The potential drawback at this point might be that bremelanotide is not a pill. It is a drug that is administered subcutaneously via an autoinjector. But, if a women decides she is not in the mood, it won’t be because of the autoinjector.

Autoinjector’s are not deal breakers. They are typically spring-loaded syringes that offer a quick and relatively painless injection of a medication. They are approved by the FDA and allow a person to self medicate, providing a quick injection and alleviating some of the hesitation and apprehension of self injection. The advances in auto-injection have progressed well since 2014, when they were initially approved for personal use, and the level of discomfort is minimal.

Once in the body, bremelanotide, a peptide analog, begins to work by mimicking the naturally occurring hormone in the body that elicits sexual desire.

How Close Is PTN From Bringing Bremelanotide To Market?

The good news for investors and for PTN is that the company is expected to file with regulators to seek U.S. approval for the drug in the second half of 2017. Although it might sound like an eternity to some investors, it is likely that the stock will be bid up sooner rather than later.

Because investors did not get an entire set of data today, investors should continue to seek additional information pertaining to the phase III trial. But, based on the investigators comments and the size of the study, the results provided do offer some key insight and act as a precursor to the potential strength of the additional pending data.

With Addyi being the closest competitive product, bremelanotide is in a strong position to seize upon the weaknesses of Addyi as well as to capitalize on a market that is supported by influential patient advocacy groups. With no severe side effects and the efficacy data well supported in the 1200-patient study, PTN should face very little resistance on their path to approval.

PTN is a “Soulstring Select” and has been added to my speculative favorite list. With most of the heavy lifting behind them, PTN could soon be benefiting from their results and address an anxious and substantial market. Overcoming the autoinjector may be the highest hurdle, but, for most women, the ultimate benefit will surely outweigh the microsecond of an inconvenient stick.

[/pms-restrict]

This Article Is Available To Premium Members Only!

You must be subscribed to “CNA Finance Premium”, please log in here, or sign up here!
[adrotate group=”4″]
[adrotate group=”6″]

[Image Courtesy of Wikimedia]

Add Comment