Want to get in the mood? Don’t read this blog post.
It involves what might be the least-sexy writing about sex ever published.
Don’t believe me? Try this: “Testosterone is a 19 carbon sex-steroid that is a male hormone circulating in human blood that affects male androgen dependent tissues, e.g., the prostate, scrotum, and apocrine glands.”
Is that enough to make you faint with desire?
It’s from a 214-page court ruling handed down this week in Indianapolis in a patent dispute over a testosterone treatment. The shortened version might be this: The route to sexual desire begins in the armpit. And here's how scientists figured that out.
The drug in question, Axiron, is marketed to men who have a deficiency or absence of testosterone. It is applied with an underarm applicator.
The issue took center stage in a nine-day trial this summer. And judging from the ruling, what is possibly the most sexy category of medicine on the market turned into a technical, very unsexy discussion on body parts.
A few days ago, U.S. District Judge Sarah Evans Barker handed down her ruling, which I wrote about in a news story. She found that the drug’s developer, Acrux of West Melbourne, Australia, and its licensing partner, Eli Lilly of Indianapolis, could not stop generic competitors from selling their own versions of the medicine.
The issue before the court: whether the generic competitors violated patents held by Acrux and the drug’s scientific inventors.
But just as interesting was the story of how the drug was developed. And when I say “interesting,” I mean how that story about sex treatments unfolded in a somber, wood-paneled federal courtroom.
I didn’t attend the trial, so I can only guess how it might have sounded in person. But I did read the court ruling several times, and it’s enough to make wrinkle your nose a few dozen times. Drug development is not always pretty.
The story begins in the 1980s, when a group of scientists were studying skin pigmentation and toying around with sunscreen. They discovered that sunscreen could help certain compounds penetrate the skin.
A few years later, using that knowledge, they discovered that sunscreen compounds in combination with testosterone helped absorb the medicine through the skin. They thought they were on to a better testosterone treatment—better than the gels and patches common at the time.
In the haunting words of Judge Barker: “The patches were associated with skin irritation, and the scrotal patch in particular was associated with elevated dihydrotestosterone levels.”
According to the court paperwork, in 2004, Acrux began clinical trials to assess the safety, effectiveness and feasibility of administering testosterone through what scientists call the “axilla.”
Axilla is the armpit, making the whole thing even sexier.
Why there? Because of all the parts of the body tested, the permeability of skins in the armpit “was the second greatest among the sites tested, with the scrotum having the highest permeability, which was 42 times more permeable than the forearm.”
Now you know.
Even so, there were scientific challenges galore—and this next part might show why scientists are not overpaid, no matter how much they make.
“There are both hairy and non-hairy portions of the axilla,” Judge Barker wrote. “The axilla is known to be sweaty and is often treated with antiperspirants and deodorants to offset odors.”
The Acrux team had a lot of testing to do before they could find the most effective dosage and method of application.
According to one witness who testified: “The most useful starting dose for most men is a 6% gel, 2.5 mL applied to the nonhairy area of the axilla.”
The court ruling continues for many pages about hairy armpits, wrinkles, creases and folds. Like I said, it’s a real bodice-ripper. But no one ever said science was all fun and games.
So, anyway, what’s the best way to apply the treatment? That’s another whole exciting chapter, on how the company developed an applicator. Here’s a short excerpt:
“Because the axilla is primarily a concave surface, the general wisdom at the time was to use an applicator with a complementary shape: a convex applicator to fit the concave surface.”
In plain English, Acrux eventually developed a drug and an underarm applicator to help guys with low testosterone. Lilly began selling it.
It was not exactly a blockbuster product, but rang up decent sales. In the second quarter of this year, Axiron had global sales of $29.3 million.
But along the away, a batch of generic competitors, including Actavis and Perrigo, began edging into the market. They came up with their own products.
Last summer, Acrux and Lilly sued the generic makers, accusing them of patent infringement. And the court had to decide issues of validity, enforceability and infringement of three patents owned by Acrux.
Each side brought expert witnesses to Indianapolis. The judge, who built a career deciding questions of free speech, immigration and voting rights, spent days listening to armpit testimony.
At one point, one of Lilly’s and Acrux’s witnesses, Dr. Alexander Slocum, an expert in the field of mechanical engineering and the design of medical devices, testified about how he tested the applicators made by the generic competitors.
“Dr. Slocum’s wet testing,” Judge Barker wrote, “consisted of his using the Actavis and Perrigo applicators to apply a homemade contrived liquid formulated by him from ingredients he found at his personal residence (consisting of a combination of cranberry juice and household rubbing alcohol in unknown amounts) to his own axilla, while standing in his bathroom shower.”
After nine days of testimony like this, Judge Barker had heard plenty to make a decision.
She ruled that a formulation patent originally granted for the drug was invalidated and therefore would not be infringed by the commercialization of generic versions.
She also found that the applicator patent is valid but was not infringed.
Her ruling contained plenty of pictures and charts of how the drug is used and applied, and even several screen grabs from Lilly’s “Application Video,” which is a “step by step instructions on how to properly apply Axiron.”
In the aftermath of the court decision, Acrux’s stock took a beating: down 37 percent in one day. The company said it was disappointed. Lilly said it would appeal.
If the appeals court takes the case, stay tuned for more exciting reading. It’s sure to be another page-turner.