January 27, 2010 / 7:26 PM / 9 years ago

UPDATE 3-Repros gets FDA advice on testosterone drug, shrs soar

* FDA asks to propose a label to define patient population

* Shares up as much as 77 percent (Adds analyst comments, updates share to close)

BANGALORE, Jan 27 (Reuters) - Repros Therapeutics Inc RPRX.O said the U.S. health regulators asked the company to propose a label that better defines the population of individuals who will benefit from the use its male-infertility drug Androxal, sending its shares soaring.

The company had previously tried to pursue a hypogonadism label for the drug but was unable to reach an agreement with the U.S. Food and Drug Administration in 2007 regarding a clinical path for the drug.

Repros said the FDA also requested the company to conduct a literature review of the incidence of infertility associated with the use of exogenous testosterone.

If the submitted data is approved, no additional meeting regarding the label may be required, the company said.

“The development and regulatory pathways remain undefined. The company will need to deal with the two issues raised by the FDA first before a development pathway can be discussed,” said Wedbush PacGrow LifeSciences analyst Kimberly Lee.

Lee, who has an “underperform” rating on the stock, said the stock reaction was overdone.

The company said it can clearly define the intended patient population and provide the FDA with existing scientific citations that support the notion that administration of exogenous testosterone impairs male fertility.

In October last year, Repros said an exploratory study showed that Androxal restored normal sperm count while increasing testosterone levels.

Androxal is being developed for the treatment of secondary hypogonadism, or a defect of the gonads that results in the underproduction of testosterone.

Shares of the company went up as much as 77 percent, but pared some gains to close up 33 percent at 92 cents Wednesday on Nasdaq. (Reporting by Krishnakali Sengupta and Jennifer Robin Raj in Bangalore; Editing by Anne Pallivathuckal)

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