Repros Meets With FDA to Discuss Data Requirements for Androxal(R) in the
Treatment of Secondary Hypogonadism
*NDA submission remains anticipated by year end 2014
*No additional long-term safety assessments currently planned before NDA
submission and review
THE WOODLANDS, Texas, Feb. 6, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics
Inc.^® (Nasdaq:RPRX) today announced the outcome of its previously announced
meeting with the FDA regarding the Androxal^® Phase 3 data requirements for an
NDA in the treatment of secondary hypogonadism. Repros expects to maintain its
timeline for submitting an NDA prior to the end of 2014. This submission will
include studies ZA-304 and ZA-305 which were initiated in January 2014.
Following the meeting, the Company understands that the safety of Androxal
will stand on its own merits during NDA review and no additional safety
assessments are currently planned prior to NDA submission. The FDA requested
additional background information regarding the endpoints that the Company
will use to confirm maintenance of fertility by semen assessments in studies
ZA-304 and ZA-305. The Company plans to provide this information promptly to
the FDA and while doing so to continue enrollment of ZA-304 and ZA-305 without
Conference Call Details:
Time: Thursday, February 6, 2014 – 9:30 AM Eastern
Participant Dial-In Number (Domestic): 877-407-8629; International:
It is recommended that participants call in approximately 15 minutes prior to
the start time of the conference call.
Replay Call Details:
Conference ID #: 13575904
Teleconference replay will be available approximately 60 minutes after the
conclusion of the teleconference and will remain available for 7 days.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of small molecule drugs for
major unmet medical needs that treat male and female reproductive disorders.
Any statements made by the Company that are not historical facts contained in
this release are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and are subject to various risks,
uncertainties and other factors that could cause the Company's actual results,
performance or achievements to differ materially from those expressed or
implied by such forward-looking statements. These statements often include
words such as "may," "will," "expect," "anticipate," "continue," "estimate,"
"project," "intend," "believe," "plan," "seek," "could," "can," "should" or
similar expressions. These statements are based on assumptions that the
Company has made in light of the Company's experience in the industry, as well
as the Company's perceptions of historical trends, current conditions,
expected future developments and other factors the Company believes are
appropriate in these circumstances. Forward-looking statements include, but
are not limited to, those relating to planned clinical studies and the timing
and nature of the results thereof, the impact of the studies on the Androxal
label, the lack of need for additional long-term safety assessments and the
timing of the Company's expected filing of an NDA for Androxal. Such
statements are based on current expectations that involve a number of known
and unknown risks, uncertainties and other factors that may cause actual
events to be materially different from those expressed or implied by such
forward-looking statements, including the ability to have success in the
clinical development of the Company's technologies, the reliability of interim
results to predict final study outcomes, the ability to protect the Company's
intellectual property rights and such other risks as are identified in the
Company's most recent Annual Report on Form 10-K and in any subsequent
quarterly reports on Form 10-Q. These documents are available on request from
Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
For more information, please visit the Company's website at
CONTACT: Investor Relations:
The Trout Group
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