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 (BestGrowthStock) – 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)

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