3 Questions for Roaring Repros

Written by Dr. Michael White, Published on October 4th, 2012
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One number really jumps out when you examine the recent history of Repros Therapeutics (Nasdaq: RPRX) .: 264%. That's how much shares of the biotech have surged over the past six months. When a stock beats the S&P 500 by nearly sixty-fold, it's doing pretty well.

^INX data by YCharts

But that's history. How will Repros perform moving forward? The answer to that question depends on the answers to these three questions.

1. Will Androxal achieve success?This question really consists of two parts. The first part relates to how well the phase 3 study for Androxal will go.

The drug targets the treatment of low testosterone because of secondary hypogonadism. Repros completed a phase 2b study of Androxal in December 2011. The study found that the drug raised testosterone levels in men and was well tolerated in general. No warning flags have been raised thus far, so Repros expects success in the phase 3 trial.

The second part of the question relates to how successful Androxal will be in the marketplace. Several rivals have already entered the fray. Abbott Labs (NYSE: ABT) makes AndroGel. Auxilium Pharmaceutical (Nasdaq: AUXL) sells Testim. Bio-T-Gel is another new product entering the market. BioSante Pharmaceuticals (Nasdaq: BPAX) received FDA clearance in February and is sold by Teva Pharmaceuticals (NYSE: TEVA) .

There's a good reason for such interest. An estimated 13 million men in the U.S. alone suffer from low testosterone levels. Sales of products for the treatment of the condition top $1 billion annually. The challenge for Repros is in positioning Androxal to grab its share of that market, assuming the drug gains approval from the Food and Drug Administration.

2. What is the prognosis for Proellex?The other drug potentially bolstering Repros' outlook is Proellex. The drug, intended for treating endometriosis and uterine fibroids, encountered a bumpy path earlier but appears to be moving forward now.

The FDA placed a full clinical hold on Proellex in 2009 after patients in a study experienced increased liver enzymes. However, in 2011, Repros was allowed to conduct another study using low dosages of the drug. This study found no increases in liver enzymes. Based on these results, the FDA agreed to move Proellex to a partial clinical hold.

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3 Questions for Roaring Repros

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