THE WOODLANDS, Texas (
) -- This morning's
conference call was boring. There was no discussion of
gay Cuban sex, no admission of fabricated clinical data
. The closest we got to fun was Repros CEO Joe Podolski explaining men who took the experimental testosterone-raising drug Androxal were reporting "lower rates of abstinence" and therefore had low sperm counts. (Lots of ejaculations, understand?)
Repros reported results from a second pivotal study of Androxal on Tuesday which read very much like what the company said
last March about the first study
: Androxal, a pill, normalized testosterone levels in men with lower-than-normal testosterone and did not cause a statistically lower sperm count than placebo.
A lot of Androxal data wasn't reported Tuesday, just like it was omitted last March. Instead, Repros' Podolksi offered assurances about Androxal's efficacy and safety, even while remaining non-committal about presenting complete results from the two clinical trials at a medical meeting.
The company intends to file Androxal for approval with the FDA in the middle of next year.
Repros shares rose 21% to 25.62 Tuesday, so like last March, investors are brushing off the real risk FDA rejects Androxal.
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.
In the second phase III study disclosed Tuesday, Repros said 81% of Androxal-treated men reached normal testosterone range, which exceeded the 75% threshold requirement under the Special Protocol Agreement reached with the FDA. [Seventy-nine percent of men on Androxal reported normal testosterone in the first phase III study.]
What was the rate of testosterone normalization for men treated with placebo in the phase III study? Repros did not disclose.