Repros Announces Proellex® Development Program Will Remain on Partial Clinical Hold by the FDA
July 17 2017 - 5:30AM
Repros Therapeutics Inc.®, (Nasdaq:RPRX) dedicated to treating male
and female reproductive disorders, today announced that it received
preliminary feedback from the FDA on the Company’s clinical
development program for Proellex®, its oral delivery mechanism for
telapristone acetate. The Proellex® program will remain on
partial clinical hold, and based upon the FDA’s review of all the
existing liver function safety data, the FDA has indicated that the
Company will be required to compile a large pre-approval safety
data base to support future development.
Larry Dillaha, MD, Chief Executive Officer of
Repros, said, “We are appreciative of the preliminary feedback
received from the FDA and expect further clarification from the FDA
in the coming weeks on our Proellex® development program. Our
discussions with the FDA, and their guidance that a large safety
data base will be required to continue the development of
Proellex®, indicate that a much larger clinical trial, with
associated time and cost requirements, would be necessary.”
In light of the FDA guidance, the Company is
assessing increasing its focus on its uterine fibroid and
endometriosis development program utilizing a vaginal drug delivery
program for telapristone acetate, a selective progesterone
modulator (SPRM). Dr. Dillaha commented, “We are encouraged
by our clinical studies with our vaginal drug delivery program,
which may provide the potential opportunity to differentiate our
treatment from other orally-dosed compounds in development or on
the market to treat uterine fibroids. Clinical work done to
date suggests that vaginal delivery of telapristone acetate has the
potential to yield good efficacy with significantly lower systemic
blood levels. Furthermore, we intend to leverage drug
delivery technology that could offer dosing less frequently than
once per day.”
Additionally, Repros has received notice that on
August 2, 2017 it will be granted a European patent relating to the
use of SPRMs, in particular Telapristone Acetate (Proellex®) or
Ulipristal Acetate, with an Off Drug Interval (ODI) for the
treatment of estrogen-dependent hyperproliferative uterine
conditions, such as uterine fibroids and endometriosis. The
European patent is related to the Company’s recently granted U.S.
Patent number 9,616,074, announced by the Company in April 2017.
Finally, as previously announced, the Company
submitted to the European Medicines Agency (EMA) a marketing
authorization application (MAA) for enclomiphene in the treatment
of secondary hypogonadism in Europe in September of 2016. As
part of the ongoing review process, the Company expects to file
responses to the EMA in the third quarter of 2017.
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
relating to the Company’s pipeline and plans for growth; ongoing
and future clinical studies and the timing and results thereof; the
Company’s plans to communicate with and submit further information
to the FDA; possible submission of one or more NDAs; the commercial
potential of vaginally delivered telapristone acetate; the fact
that the EMA may not ultimately grant the marketing authorization,
on the expected timeline or at all; the fact that the marketing
authorization, if granted, may have significant limitations on use
and that even if the marketing authorization is ultimately granted,
the Company may not be able to successfully commercialize the
product candidate; 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:
Joe Schepers
jschepers@reprosrx.com
770-558-5517
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