Repros Amends Proellex License

THE WOODLANDS, Texas -- Repros Therapeutics (NasdaqGM:RPRX) 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.

In August 2009 Repros 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 new agreed amendment allows Repros 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 FDA that would support of the safety of lower doses that could be tested in short duration trials.

If the hold on the active ingredient of Proellex cannot be lifted, the Repros 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 NIH license allows for Repros to sub-license the technology pending NIH approval.

Repros also announced that Dr. Paul Lammers has resigned as President to become the CEO of Mirna Therapeutics, a private biotechnology company. In an unrelated move Repros 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.

Source: Repros Therapeutics