Repros Therapeutics Inc (NASDAQ:RPRX)
Repros Therapeutics Inc (NASDAQ:RPRX) has announced a meeting with the U.S Food and Drug Administration to discuss the progress in the development of Proellex® (telapristone acetate) – a treatment for uterine fibroids. Just before the meeting, the company was issued a notice that the meeting would be a Guidance of type C meeting and not an End of phase 2 of type B meeting as earlier expected.
During the meeting the FDA said that Proellex® will remain on a partial clinical hold as consultations between the agency and liver experts continue. Additionally, the agency agreed to take in the additional information provided by the company. Repros will also be submitting a proposed clinical protocol and additional information in a month’s time. The company will be making all information public after receiving more guidance from the FDA.
Repros President and Chief Executive Officer Larry Dillaha, M.D said they are pleased with the guidance, adding that although they are still on a partial clinical hold, the company will continue working on the plan by submitting phase 2 protocols to the FDA for review.
Repros Therapeutics also announced a new patent – U.S. Patent number 9,616,074 or the ‘074 patent which confirms the company’s intellectual property in relation to telapristone acetate which markets under the brand name Proellex®. The patent is expected to expire in 2027. The patent details the use of Progesterone Receptor Modulators (SPRM), especially the use of Telapristone Acetate (Proellex®) also referred to as the Ulipristal Acetate which has an Off Drug Interval (ODI) and is used in the treatment of hyperproliferative uterine conditions using estrogen. These include endometriosis and uterine fibroids. According to the terms of the patent, Off Drug Interval refers to a daily administration of the SPRM over a specified period of time and then followed by enough ODI to allow the patient to menstruate. This is followed by another period of SPRM administration.
I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.
About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.