Repros Announces Acceptance of Dossier for Enclomiphene for Secondary Hypogonadism by European Authorities
October 05 2016 - 10:35AM
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has
received confirmation of acceptance of its September 12, 2016
filing for enclomiphene in the treatment of secondary hypogonadism
in Europe.
- Analogous to acceptance of an NDA by U.S. Food and Drug
Administration
- Responses expected by end of January 2017
The MAA was submitted to the European Medicines Agency (EMA) by
Renable Pharma Limited, the UK subsidiary of Repros.
As has been described in previous communications, the typical
time from submission to authorization of a medicinal product
through the EMA’s centralized procedure is 13-16 months and
culminates in one authorization being obtained which is valid in
all European Union and European Economic Area countries, i.e. 31 in
total. The centralized procedure allows for a pan-EU review
of the data, led by the Rapporteur’s and Co-Rapporteur’s assessment
teams, and is governed by set timelines; therefore the review time
is well defined. In this context, the Company expects to receive
all questions relating to the application by the end of January
2017.
Dr. Michael Wyllie, Independent Director of Repros, commented:
“The acceptance of the dossier by the EMA represents a key
milestone toward the commercialization of enclomiphene and signals
the acceptability and adequacy of the data for formal review. At a
defined time point, ‘day 120’, toward the end of January, we expect
to get an initial reaction from the examiners.”
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.
Forward-Looking Statements
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 the timing and nature of the results
of clinical studies and the impact of such results. 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 risks that
the EMA may not ultimately grant the marketing authorization, on
the expected timeline or at all, the risk that the marketing
authorization, if granted, may have significant limitations on use,
that even if the marketing authorization is ultimately granted, the
Company may not be able to successfully commercialize the product
candidate, risks relating to the Company’s ability to protect its
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 http://www.reprosrx.com.
CONTACT:
Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com
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