IntelGenx To Regain Rights for RIZAPORT After RedHill Ends Partnership

IntelGenx (TSXV:IGX; OTCQX:IGXT) announced it received notice that RedHill Biopharma (NASDAQ:RDHL) intends to end their agreement for the co-development and commercialization of RIZAPORT.
As quoted in the press release:

The termination notice follows receipt of a communication by the U.S. Food and Drug Administration (“FDA”) indicating that, based on an initial review of the 505(b)(2) New Drug Application (“NDA”) resubmission for RIZAPORT® 10 mg, the Agency will require additional information before the NDA resubmission is deemed complete and permitted a full review.
RIZAPORT® is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines. RIZAPORT® offers an innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water, and neutral flavor.
Following a first RIZAPORT® NDA submission to the FDA in March 2013, IntelGenx and RedHill received a Complete Response Letter (“CRL”) from the Agency. The questions raised by the FDA, which triggered the current resubmission, primarily related to third party chemistry, manufacturing and controls, and the packaging and labeling of the product. The FDA raised no questions or deficiencies relating to RIZAPORT®’s safety and bio-equivalence data and did not require additional clinical trials.

Click here to read the full press release.

Source: www.marketwired.com