Aytu BioScience May Lead the Way in Low T

Company has created a therapy that may change the game in the Low T space

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Feb 28, 2017
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For low testosterone patients, the practice of "never having to say you're sorry" isn't a phrase that typically goes over very well in certain situations. However, thanks to the ingenuity of modern science, men no longer need to lose their swagger from low testosterone issues with testosterone replacement therapy available from most any physician on the block.

While testosterone replacement therapy is widely available, don't assume for a minute that they are all created equal because, in several significant and distinctive ways, they are all quite different. Patients currently taking advantage of testosterone replacement therapy best be sure to read the fine print unless they want their female partners to replace JoJo the Bearded Lady in the now struggling Ringling Brothers Circus. Think it can't happen? Think again.

I took a look at six brands of low testosterone replacement options with treatment options produced by Eli Lilly (LLY, Financial), Aytu Bioscience (AYTU, Financial), AbbVie (ABBV, Financial), Endo International (ENDP, Financial) and Upsher-Smith. While this article is not intended to be a play-by-play commentary for any particular product, what did become apparent is that there is a company that clearly stands apart from its competitors, based not only on efficacy but especially in regard to safety, tolerability and ease of administration. In fact, there is only one in the six that is not currently being sued or being impugned by the Food and Drug Administration (FDA) to use a black box warning.

Spoiler Alert:Â For those who have trouble reading entire articles, Aytu Bioscience's Natesto is by far the best option available. For that reason, it deserves more air time.

Aytu Bioscience and Natesto

Aytu Bioscience has several products either in clinical trial or available commercially, but Natesto may be the product that contributes the greatest and most immediate impact to the company's revenue stream.

Natesto, Aytu Bioscience's testosterone replacement therapy (TRT), may be an early stage emerging giant, being the only nasally administered TRT available in the market. Not sure why that matters? Stay tuned.

Uniquely delivered through nasal passageways, Natesto is a widely patented low testosterone therapy that has significant patent protection along with several apparent advantages over leading products brought to market by AbbVie, Eli Lilly, Endo Pharmaceuticals and Upsher-Smith.

First, and I hate to keep beating this advantage over people's heads, but Natesto is nasally delivered. That means that with just two pumps (one in each nostril) from the bottle, two or three times daily, patients can regulate their testosterone levels in as little as 90 days. The dosing is meticulously graded with Natesto delivering the lowest topically applied FDA-approved dose of testosterone available.

Additionally, the FDA-approved Natesto has no black box warning, the only product the FDA has not required to use the bold informative that clearly defines a warning about the severe and unintended effects of secondary exposure to testosterone. To paraphrase, the black box warning states that virilization (development of male characteristics) has been reported in children who were secondarily exposed to testosterone (thanks, Dad). Second, the warning states that children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. And, third, health care providers should advise patients to strictly adhere to recommended instructions for use.

OK, so secondary exposure –Â through a counter top, unwashed hands, unwashed clothes, leftover gel on the shampoo bottle, or even from skin to skin contact from "when the moment is right"Â – just seems like too much to handle, especially when it really isn't all that necessary to use that particular product in the first place.

Let's say that as a patient, the guy simply takes whatever his doctor prescribes, regardless of the fact that his significant other female partner may grow a beard or develop pectorals larger than Schwarzenegger in his prime, he decides to stick with the topical gel. What then?

Well, without being informed of reliable TRT delivery options, that patient would be giving up on the most discreet method of testosterone delivery available, would maintain a high risk of secondary exposure and may continue to be subjected to painful subcutaneous or intramuscular injections. If that's the case, two questions arise. First, does the patient know he has an option? And, second, why continue with topical applications?

Physicians should be obligated to explain treatment options. Natesto, for instance, is equally efficacious to topical applications. In the pivotal clinical trial studying the safety and efficacy of Natesto, 91% of the patients in the test group achieved normal testosterone levels by day 90. Additionally, over 70% of the patients in the twice daily Natesto treatment group achieved normal testosterone levels at day 90 as well. Probably more important, Natesto caused statistically significant improvements in each of the five domains of erectile function with the majority of the effect on erectile dysfunction evident by day 30. In plain English, their ability for a more pronounced sexual performance increased significantly within a month.

Being marketed for "men on the go" primarily for ages 45 to 64, Natesto offers convenience, discretion and quick use ability when a TRT is important or necessary.

Upon successful market penetration, Natesto can grab a potentially large piece of the $2 billion market, and even a 5% share could deliver over $100 million per year in revenues to Aytu Bioscience.

Now, for those that have not asked for or are not currently using Natesto, let's see what the benefits of competing products offer. Or not.

AbbVie and AndroGel

From Drugwatch, Androgel by AbbVie is the blockbuster gel used to treat low testosterone, but it is linked to an increased risk of cardiovascular problems. Many men filed lawsuits against Abbott and AbbVie. (source: drugwatch)

AndroGel is a topically applied formula prescribed to men whose natural biological production fails to produce sufficient amounts of the male hormone testosterone. AndroGel was approved by the FDA in 2011 for use in men diagnosed with low T. With a huge marketing budget, Abbott Labs (ABT, Financial) began a laborious marketing effort to commercialize the drug, ultimately becoming successful in making the brand widely recognized by the medical profession. AndroGel is synthetic testosterone, mixed with a gel and alcohol that is prescribed to be applied to the skin daily. The treatment can be costly, ranging as high as $500 per month without certain insurance coverage.

Users are told to wash their hands thoroughly after use with soap and water. Wet naps won't do so hopefully they don't get frisky at the park. Oh, yeah, AndroGel is flammable so be sure to tell patients to avoid flames, smoking or open fires like the ones used at a backyard barbecue.

Perhaps that is why the FDA not only placed the dreaded black box warning on AndroGel, but lawyers jumped into the action with many lawsuits now facing both Abbott and AbbVie. Aside from the increased cardiovascular risk, reports of prostate cancer, larger red blood cells, reduced sperm count, edema, gynecomastia (enlarged breasts) and sleep apnea have been reported. Other than that, it's pretty good.

If I was a user, 'nuff said. I quit. Truly, I am not out to cause mischief. It's just that my eyes have been opened to some truly dangerous products and to an FDA that is keeping men in imminent danger.

Axiron by Eli Lilly

Axiron is seeing its share of problems, alongside AndroGel in a number of lawsuits. Like AndroGel, plaintiffs are alleging that the makers of Axiron withheld risks associated with the product. Like AndroGel, Axiron is intended to be a testosterone replacement therapy. Unfortunately for users, Axiron has been reported to have caused some of the same debilitating issues as AndroGel, inclusive of heart attack, strokes and death. As part of the investigation, the FDA has warned that users of the drug can increase the risk for dangerous blood clots.

The Axiron solution is applied topically to the skin, but, based on the side effects, can I please just move on to the next? I wouldn't put this stuff on my balding female dog, and she needs more hair badly.

Fortesta and Testim by Endo and GlaxoSmithKline

If you know a person using either of these two products for low-T, please have him ask the doctor why. Just when I thought I was going to find a natural competitor to Natesto, more bad news populated the screen. Both Fortesta and Testim have the dreaded black box warning, and both are facing numerous lawsuits that claim that Endo failed to adequately disclose the potential risks, and they further allege that Endo did not adequately test the safety of the products while consciously covering up risks.

This therapy is topically applied to the skin and provides hormone replacement to men who lack the ability to produce enough testosterone on their own. There are now over 3,800 cases pending against certain TRT products, inclusive of Axiron, AndroGel, Fortesta, Testim and Vogelxo.

While the Fortesta and Testim product may very well provide some benefit, the downside is that a patient may die. Time to move on.

Two names still absent from both the black box warnings and the lawsuits: Natesto and Aytu Bioscience.

Vogelxo by Upsher-Smith

This was the last hope to find a product to place in a side by side comparison to any of the five above. My goal was to offer options, but instead, I may have provided a road map of how to avoid potentially fatal side effects when searching for a testosterone replacement therapy.

Vogelxo is intended to be a therapy used to treat men with hypogonadism, the condition in which a man does not produce adequate amounts of testosterone, usually due to illness or disease. Unfortunately, Vogelxo makes it to the Black Box List along side the others. Vogelxo provides continuous transdermal delivery of testosterone for up to 24 hours and should be applied to clean, dry skin of the shoulders or upper arm.

According to its makers, safety and efficacy in men with "age-related hypogonadism" have not been established. Really?

To be fair to Vogelxo, the side effects reported amount to what appear to be far less than the others noted in this article. The fact that they admit to have not yet completed a thorough analysis puts them on my "no no" list. Until they can clear up the matter of safety and efficacy, there is a better option.

Final conclusion

What was an expected compare-and-contrast study turned into a "stay away " study. Of the six low testosterone treatments featured in this article, the only one that should be realistically prescribed to any patient is Natesto. Shame on the FDA for allowing products that have long and well articulated instances of severe and unintended side effects continue to be marketed to patients who don't know the proper questions to ask, or are merely too excited to get any course of treatment that they won't even read the fine print.

Aytu Bioscience has no civil cases pending and is not required to have the FDA Black Box Warning assigned on their box or label. Even if a potential user was to neglect the fact that Natesto is easy and convenient to use, the product risks that are not currently associated with Natesto make a clear case to make the switch. While Natesto has been reported to sometimes cause either a headache or runny nose, it certainly beats the known effects from other product options.

If the Natesto option is available, and you, as a patient require a TRT, ask your doctor about Natesto. The risk of not doing so is far greater than getting a product that might perform the job but possibly kill you at the same time.

Want a low-T option? Easy pick: Natesto. It's made by Aytu Bioscience.

Disclosure:Â I am long Aytu Bioscience and may purchase additional shares within the next 72 hours.

This article reflects my own opinions and unique articulation. This article is not intended to offer investing advice, guarantee 100% accurate predictions or to be interpreted as providing a personal recommendation. What I can guarantee, though, is accurate research, thoughtful analysis and an enthusiasm about any stock that I cover.

While I seek to uncover emerging companies that I feel have true value and potential, it's important that investors assign an appropriate time horizon to each of their investments, understanding that emerging companies need time to mature.

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