Repros to drop
testosterone drug in U.S. if key study fails
Send a link to a friend
[April 15, 2016]
By Amrutha Penumudi
(Reuters) - Repros Therapeutics Inc will
abandon efforts to seek approval for its testosterone drug in the United
States if an ongoing study fails, and shift focus to its uterine
fibroids drug that showed promise in a mid-stage trial.
|
Repros said on Tuesday its uterine fibroids drug Proellex stopped
severe menstrual bleeding in 52 percent of women enrolled in the
trial, pushing the company's shares up 175 percent the next day.
The shares continued their climb on Thursday, hitting their highest
in five and a half months.
The results offered some hope to the tiny drug developer, whose
testosterone drug Androxal was rejected by the U.S. Food and Drug
Administration in December, sending its shares into a spiral over
the next few months.
Repros is conducting an additional study in response to the FDA's
request for more data on Androxal, a drug that aims to treat
secondary hypogonadism, a condition that leads to low testosterone
levels in men, in combination with diet and exercise.

"We'll know before the beginning of June whether there's a benefit;
if not I'm not going to pursue it and we're going to focus all our
efforts on Proellex," Chief Executive Joseph Podolski told Reuters.
"That said, I am willing to bet that Androxal is going to show
results," he said.
Repros applied for U.S. marketing approval for Androxal in February
2015, based on data from four studies, two of which compared the
drug to a leading FDA-approved treatment.
The FDA rejected the application, saying the design of the studies
was not adequate to demonstrate clinical benefit.
The health regulator tightened its rules on the use of testosterone
drugs last year, saying they should be reserved for patients with
specific conditions, such as genetic disorders or tumors that impair
the function of the testicles.
[to top of second column] |

There is still hope for Androxal in Europe, where regulators had a
more positive outlook on it.
With Androxal's future in doubt, the focus has shifted to Proellex,
which has shown encouraging results in uterine fibroids and
endometriosis, a disease in which tissue that normally grows inside
the uterus grows outside it.
The standards of care for uterine fibroids and endometriosis consist
of surgery or short-term treatment with hormonal drugs, which cause
loss in bone density. They are not recommended for use for more than
six months.
Laidlaw & Co analyst Yale Jen said the potential sales for the two
indications combined could exceed $1 billion.
(Reporting by Amrutha Penumudi in Bengaluru; Editing by Sayantani
Ghosh and Don Sebastian)
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.

 |