THE WOODLANDS, Texas (
) -- Yes,
CEO Joe Podolski really did get on a conference call Thursday morning to say that his experimental testosterone drug Androxal helped gay Cubans have more sex.
The gay Cubans entered the clinical trial with low testosterone. But after taking Androxal, their testosterone levels rose, leading to lots of sex, Podolski explained. The gay Cuban men had so much sex, in fact, that it caused their sperm counts to fall. Don't blame Androxal for lower sperm counts, Podolski said, blame gay Cubans having so much sex that their ammunition ran low.
At another point during the conference call, Podolski disclosed that a nurse at one of the Androxal clinical trial sites fabricated baseline sperm counts for patients. When Repros discovered the data fraud, the company changed the numbers and everything turned out fine.
Really? Um... Okay.
Repros shares are up 73% to $15.86 Thursday, so either investors truly believe Androxal works or Podolski is the greatest salesman in bio-pharma history. Maybe it's a bit of both. Either way, bulls and bear will continue to debate the future of Androxal but surely will agree Thursday's conference call was bizarre.
Androxal is a variant of the female reproductive hormone Clomid which Repros is developing as a treatment for men with low testosterone. Right now, men with "low T" are prescribed various testosterone-laden gels and creams --
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Axiron. The worldwide testosterone market is $2 billion annually and growing but these rub-on treatments are messy, carry the risk of transference and cause sperm counts to fall. (A big negative for men who still want to father kids.) As a pill, Androxal is designed to be much more convenient, can't be transferred to kids or women, and most importantly, doesn't lower sperm count.
Repros' phase III study enrolled 113 men with low testosterone and randomized them to receive Androxal or a placebo. The study had two primary endpoints: 1) 75% of the men in the Androxal arm were required to have 24-hour average testosterone level in the normal range after 12 weeks; and 2) Androxal had to demonstrate statistical non-inferiority compared to placebo for the percentage of men with a sperm count falling 50% from baseline to 12 weeks into the trial.