Repros Therapeutics and NIH confirmed that certain cancers related to the reproductive system are within the scope of the licensing arrangement covering the firm’s lead product, Proellex. Under an amendment to their agreement, the company’s deadline to submit the first NDA has been pushed back by two years to June 30, 2011.
Repros says that it remains committed to its target date for an initial NDA submission in the second half of 2010.
Additionally, the company obtained more time to submit a second NDA and to file for approval in Europe and Japan in multiple indications. The revised partnership also adds milestones relating to initiation of Phase III trials in Europe and Japan in a second indication. Failure to meet these benchmarks could result in modification or termination of the agreement.
Repros is obligated to pay NIH an amendment issue royalty in the amount of $100,000. Also according to the amendment, the firm is required to obtain financing, up-front licensing consideration, or any combination thereof for a total of $6 million by September 30.
Proellex is a selective blocker of the progesterone receptor. Repros is developing the candidate for the treatment of symptoms associated with uterine fibroids as well as endometriosis and as a short-course, presurgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids.