Infertility is a rising problem and one in eight American couples may have difficulty conceiving. Traditionally, infertility is primarily related to woman. The fact, however is that male factor is equally responsible for infertility.
Focused on the development of oral small molecule drugs for major unmet medical needs in male and female reproductive health is Repros Therapeutics Inc. (RPRX).
For readers who are new to Repros, here's a brief overview of the company and the upcoming events to watch out for...
Repros has two oral drug candidates in its pipeline - Androxal for male reproductive health and Proellex for female reproductive health.
Androxal is under development for the treatment of low testosterone due to secondary hypogonadism. It is estimated that 13 million men in the U.S. experience low levels of testosterone. Secondary hypogonadism is one of the primary causes of male infertility.
The leading approved therapy for low testosterone is AndroGel, a testosterone replacement cream, marketed by Abbott Laboratories. Some of the other approved testosterone replacement therapies are Testim, a topical gel, currently marketed by Auxilium Pharmaceuticals and AndroDerm, a transdermal patch, marketed by Watson Pharmaceuticals.
According to IMS Health, the marketed treatments for low testosterone in the U.S. logged sales of over $1.6 billion in 2011.
Androxal has an edge over the approved testosterone replacement therapies since this oral drug candidate not only treats the cause of secondary hypogonadism, which is inadequate pituitary hormones, but also restores normal testicular function, according to Repros. Even though, the currently marketed testosterone treatments can restore serum testosterone levels, they do not restore testicular function.
In a phase II study, which compared Androxal with FDA-approved AndroGel in men with secondary hypogonadism, Repros' Androxal had a superior ability to improve testosterone levels than AndroGel and the improvement was found to be statistically significant.
In another phase II study, which compared Androxal with Testim, Androxal not only raised testosterone level equivalent to Testim, but a statistically significant and clinically relevant improvement in testosterone production was observed with the drug candidate. In addition, Androxal maintained sperm counts while Testim reduced counts in a significant number of men, well below the normal range.
Repros is scheduled to meet with the FDA during the first half of May, 2012 to discuss the design of pivotal phase III efficacy studies for Androxal.
Proellex, the oral drug candidate targeting women's health, is under development for the treatment of uterine fibroids and endometriosis.
Endometriosis is a condition in which the tissue that forms the lining of the uterus grows in places in the body other than the uterus, like ovaries, fallopian tubes, bladder or rectum. It is estimated that over 170 million women worldwide and more than 7 million women in the U.S. suffer from endometriosis.
Uterine fibroids are benign tumors that are formed in the uterus, and these tumors occur in up to 50% of all women. Uterine fibroids are associated with abnormal uterine bleeding, pelvic pain and pressure on the bladder and rectum. It is estimated that about 25 million women in the U.S. suffer from uterine fibroids.
Endometriosis and Fibroids can cause infertility and complicate pregnancy.
In phase II studies, Proellex at a dose of 12.5 mg and 25 mg demonstrated statistically significant results for endometriosis and uterine fibroids. However, in phase III efficacy and larger phase III safety studies in diverse populations, a small number of subjects exhibited serious adverse effects associated with elevated liver enzymes. As a result, the clinical trials were stopped and Proellex was placed on full clinical hold by the FDA in August 2009.
The following year - in July 2010, the FDA upgraded the full clinical hold to a partial hold, allowing the company to conduct a single study with Proellex in low dose ranges of 1, 3, 6, 9 and 12 mg. The phase II low-dose oral Proellex trial was completed earlier this year and all doses were found to be well tolerated. Over the evaluated dose range in the study, there was no evidence of liver enzyme elevations at any daily dose tested.
On completion of the final clinical study report, the company plans to request a Type B meeting, which in this case is, "end of Phase 2/pre-Phase 3 meeting", with the FDA. The company is optimistic that the meeting with the FDA can be scheduled this quarter. (2Q, 2012). If things pan out the way as expected, Repros intends to commence a phase II/III oral administration study of Proellex for endometriosis in the third quarter of 2012.
Besides oral administration, the company is also exploring the vaginal delivery of Proellex as an alternative administrative route.
A phase I/II vaginal administration study of Proellex for uterine fibroids was commenced in the first quarter of this year. Depending on the outcome of this study, the company intends to begin a phase III vaginal administration study for uterine fibroids in the fourth quarter (4Q, 2012).
A quick look at the company's balance sheet...
Being a development-stage company, Repros has had significant operating losses since inception in 1987. As of December 31, 2011, the company had accumulated losses of roughly $191.7 million.
The annual loss in 2011 was $12.5 million or $1.04 per share wider than $4.8 million or $0.59 per share in 2010, hurt by expenses associated with Androxal clinical development program. Total revenues and other income in 2011 decreased to $2,000 from $421,000 in 2010.
On February 1, 2012, the company raised about $10.3 million in a registered direct offering, selling its shares at a price of $4.50 each. The company has about $12.7 million in cash, which may be sufficient to conduct all its planned studies into the second quarter of 2013.
Repros went public in 1993. Over the past 1 year, the stock has traded as low as $3.34 and as high as $6.74. RPRX lost 1.39% on Tuesday to close the day's trading at $4.27.
by RTT Staff Writer
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