Attached files
| file | filename |
|---|---|
| 8-K - REPROS THERAPEUTICS INC. | v164475_8k.htm |
| EX-10.2 - REPROS THERAPEUTICS INC. | v164475_ex10-2.htm |
| EX-99.2 - REPROS THERAPEUTICS INC. | v164475_ex99-2.htm |
| EX-10.1 - REPROS THERAPEUTICS INC. | v164475_ex10-1.htm |
|
Contact:
|
Joseph
S. Podolski
|
Chief Executive Officer
(281) 719-3447
Repros
Therapeutics Announces Amendment of NIH Proellex®
License
THE
WOODLANDS, Texas, October 28, 2009 – Repros Therapeutics (NasdaqGM:RPRX) today
announced that the Company has entered into an amendment with the National
Institutes of Health (NIH) to its existing exclusive license for Proellex® that
revises the existing milestones and dates for performance to provide additional
time to lift the current clinical hold on Proellex or select a second generation
molecule for further development from the family of anti-progestational agents
covered by the license.
Previously
the Company announced in early August 2009 that it had voluntarily suspended
dosing of all patients in its Proellex clinical trials. The FDA subsequently
notified Repros that the Proellex program was placed on full clinical hold due
to the observation of increased liver enzymes in a number of patients treated
with Proellex.
The
clinical hold on Proellex affected a variety of benchmark milestones used by the
NIH to enforce its license. The Company believes the new agreed amendment
between Repros and the NIH allows Repros sufficient time to determine whether it
is possible to lift the clinical hold on Proellex. The Company is addressing the
deficiencies noted by the FDA and hopes to submit pharmacokinetic data as soon
as possible to the Agency that would be supportive of the safety of lower doses
that could be tested in short duration trials that would be suggestive of
clinical efficacy. However, there can be no assurances that the FDA will view
such data as sufficient for lifting the current full clinical hold.
If the
hold on the active ingredient of Proellex cannot be lifted, the Company can
satisfy the diligence portion of the NIH license by selecting a second molecule
from the family of anti-progestational agents covered by the license and, after
sufficient pre-clinical work, submit a pre-clinical package for opening an
Investigational New Drug Application to the FDA to commence human clinical
testing of this new agent. The Company believes the time allowed in the
amendment for this determination and resultant activity is
reasonable.
The NIH
license allows for Repros to sub-license the technology pending NIH
approval.
The
Company also reported that Dr. Paul Lammers has resigned his position as
President to become the CEO of Mirna Therapeutics, a private biotechnology
company. In an unrelated move the Company has further reduced its headcount by
eliminating the full time position of Sr. VP of Regulatory and Clinical Affairs
held by Dr. Andre van As. Dr. Jean Fourcroy, member of the Company’s Board of
Directors, and former Medical Officer at the FDA’s Division of Reproductive and
Urological Products, the Division where both of the Company’s drug development
programs are being evaluated, has agreed to serve as the Company’s Chief Medical
Officer on an as needed basis.
About
Repros Therapeutics Inc.
Repros
Therapeutics focuses on the development of oral small molecule drugs for major
unmet medical needs that treat male and female reproductive
disorders.
Any
statements that are not historical facts contained in this release are
forward-looking statements that involve risks and uncertainties, including
Repros' ability to raise needed additional capital in the immediate future in
order for it to continue its operations on acceptable terms or at all, to settle
or otherwise resolve its outstanding liabilities resulting from the Proellex
clinical trials recently put on clinical hold, to successfully defend
itself against the recently-filed class action complaints, to continue to
maintain its listing on any Nasdaq trading market, whether a clear clinical path
for Androxal® can be
realized, the eventual outcome of the recent discussions and correspondence with
the FDA regarding the Proellex clinical trials currently on clinical hold
and whether clinical trials of Proellex may be resumed, whether any
safe and effective dose for Proellex can be determined, whether the NIH license
for Proellex can be maintained, and such other risks which 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.