RPRX
I know you're all sick of RPRX by now, but there's been a lot of news over the past week. Here's more.
No more posts from me on RPRX until Jan 4. I'll be attending the analyst's meeting in NYC.
HEADLINE: Positive trial just what the Repros doctor ordered
BYLINE: Mary Ann Azevedo
BODY:
A male erectile dysfunction drug developed by the company formerly known as
Zonagen Inc. never made it to market, but a pain-reducer made by the surviving
company seems to be doing well with the ladies.
Now known as Repros Therapeutics Inc., the company's shares got a boost
this week on the news that its endometriosis drug, Proellex, helped
significantly reduce pain in female patients compared to current available
treatment.
Repros' stock climbed by 11.8 percent on Dec. 18 after results of the
European Phase 2 clinical trial of Proellex were announced.
In that study, Repros found that women treated with 50 milligrams of Proellex
reported pain-free days 95 percent of the time during three months of treatment.
The findings were in comparison to 67.8 percent pain-free days reported by
patients on Lucrin, the current pharmaceutical standard of care for the
treatment of endometriosis, a condition that affects approximately 5.5 million
women in the U.S. and Canada.
Proellex, the company's lead compound, is a progesterone receptor modulator,
or PRM, that also is being studied in a Phase 2 clinical trial for the treatment
of uterine fibroids, a condition that affects some women of childbearing age and
results in a significant number of hysterectomies each year.
Androxal, Repros' other program in late clinical development, is designed to
restore normal testosterone production by the testes and is being tested in a
Phase 3 clinical trial for the treatment of testosterone deficiency in men.
In the 1990s, Repros, then known as Zonagen, caught international attention
as it worked to develop a treatment for erectile dysfunction, much like the
popular Viagra pill that beat it to market.
Once a Wall Street darling with its stock trading at more than $45 per share,
Zonagen later shifted its focus to other drugs after several problematic trials
of its Vasomax drug.
After enduring several rounds of job cuts and years of lackluster stock
performance, Repros seems to be headed for a rebound.
Shares of the company's stock closed up 11.8 percent to $6.90 on Dec. 18,
after having traded as high as $7 earlier in the day. The stock has traded
between $4.50 and $14.27 in the past 52 weeks.
While data on the uterine fibroid indication for Proellex was expected by the
end of this week, Repros announced on Dec. 20 interim results of a U.S. Phase 3
study of Androxal, its oral drug that restores normal testicular function. Early
results suggest that treatment with Androxal results in a statistically
significant increase in mean testosterone. Also, Repros says that Androxal is so
far proving to not be inferior to Androgel, a commercially available
testosterone replacement cream marketed for the treatment of low testosterone by
Solvay Pharmaceuticals.
Meanwhile, industry analysts believe the this week's trial results of
Proellex might very well be the beginning of a string of positive data released
by Repros.
"From the stock perspective, the data presented on Proellex was an important
de-risking event," says Vinny Jindal, an analyst in ThinkEquity Partners LLC's
San Francisco office. "This proves that Proellex is not just on parity, but also
superior to the current standard of care."
Matt Kaplan, an analyst with New York's Punk, Ziegel & Co., says the results
of Repros' other trials, which are bigger and later-stage, could potentially be
even more important than this one.
Meanwhile, despite this week's stock climb, Kaplan believes Repros' shares
are "significantly undervalued based on the value of the company and the status
and potential of its programs."
He describes this week's trial results as "very encouraging from an efficacy
point of view."
Repros President and CEO Joseph Podolski said he was actually surprised at
the robustness of the trial data.
"Typically, trials where pain is the end point can be very difficult,
considering that pain is very subjective," Podolski says. "But these results
were some of the strongest I've seen in my 37 years in the pharmaceutical
industry."
The next step, Kaplan says, is for Repros to file for an Investigative New
Drug, or IND, application in the United States on the same indication.
Podolski said in a prepared statement that the potential for Proellex is
huge.
"The endometriosis market is large and remains under-served," he said. "Few
drug therapies are viable for long-term use."Higher profile
Earlier this year, Repros, which employs six full-time employees, was the
subject of takeover speculation. (See "Zonagen turnaround positions firm as
likely acquisition target," March 17, 2006).
At that time, Efficacy Capital Ltd.'s Mark Lappe told BusinessWeek magazine
that "it's likely (that) the likes of Pfizer or Wyeth will buy Zonagen."
Efficacy Capital, which invests mostly in biotech firms, owned a 9.9 percent
stake in Zonagen as of December 2005.
Last spring, Podolski played down buyout talk in an interview with the
Houston Business Journal.
"I wouldn't say that's not the case, but I would say it's too early to happen
anytime soon," he said of the firm's potential to be acquired.
Nine months later, ThinkEquity Partners' Jindal believes the company indeed
has takeover potential.
"As Repros continues to consistently present high-quality data, their drugs
will become more and more attractive to larger pharmaceutical companies who are
willing to pay more for drugs that have a track record in the clinic," he says,
"particularly for a drug like Proellex, which could be used by millions of women
in the U.S. for the up to decades at a time."
But, Jindal warns, the U.S. Food and Drug Administration will want to be
assured that the drug doesn't cause any major side effects over time.
