Repros Therapeutics Inc. RPRX received encouraging news with the European Medicines Agency saying that the company’s enclomiphene citrate (previously known as Androxal) capsules can be submitted for a centralized marketing authorization application (MAA) as a new active substance (NAS).
With the NAS designation in place, Repros is eligible to submit a supplementary protection certificate for the extension of the exclusivity period of the product. We note that last December, the company had expressed its intention to submit a regulatory application in the EU in the first quarter of 2016.
The EU update comes shortly after Repros announced that the FDA has accepted its new drug application for enclomiphene citrate for review. The company is looking to get the candidate approved for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.
Meanwhile, Repros has made significant progress with its pipeline. Apart from enclomiphene citrate, the company has Proellex in its pipeline. Proellex is being developed for indications like uterine fibroids and endometriosis. In Dec 2014, the company initiated a couple of phase IIb efficacy studies on Proellex (both oral and vaginal administration) for the treatment of uterine fibroids in women who experience heavy vaginal bleeding due to these benign tumors. The company is also conducting a phase II study on Proellex (low-dose oral administration) for the treatment of endometriosis.
With no approved product in Repros’ portfolio at the moment and enclomiphene citrate being the company’s lead pipeline candidate, we expect investor focus to remain on its approval status.
Currently prescribed treatments for hypogonadism include AbbVie’s ABBV AndroGel.
Repros currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Acorda Therapeutics, Inc. ACOR and Horizon Pharma plc HZNP. Both hold a Zacks Rank #1 (Strong Buy).
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