SAINT LAURENT, QUEBEC–(Marketwired – Dec 5, 2017) – IntelGenx Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”) currently announced it has perceived notice that RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill”) intends to cancel a agreement with a Company for a co-development and commercialization of RIZAPORT®. The stop notice follows receipt of a communication by a U.S. Food and Drug Administration (“FDA”) indicating that, formed on an initial examination of a 505(b)(2) New Drug Application (“NDA”) resubmission for RIZAPORT® 10 mg, a Agency will need additional information before a NDA resubmission is deemed finish and accessible a full review.
RIZAPORT® is a exclusive verbal thin-film plan of rizatriptan for a diagnosis of strident migraines. RIZAPORT® offers an innovative and potentially fitting healing choice for many migraine patients, essentially patients who humour from dysphagia or migraine-related nausea, due to a accessible dosing, rudimentary intake due to a miss of need for water, and neutral flavor.
Following a initial RIZAPORT® NDA acquiescence to a FDA in Mar 2013, IntelGenx and RedHill perceived a Complete Response Letter (“CRL”) from a Agency. The questions lifted by a FDA, that triggered a stream resubmission, essentially associated to third celebration chemistry, prolongation and controls, and a wrapping and labeling of a product. The FDA lifted no questions or deficiencies relating to RIZAPORT®’s reserve and bio-equivalence information and did not need additional clinical trials.
“We are unhappy by a delay, though sojourn committed to operative with a FDA to grasp a idea of bringing this product to a U.S. market,” commented Dr. Horst G. Zerbe, President and CEO of IntelGenx. “To that end, we are plan to accommodate with a Agency as shortly as practicable to explain a additional information request.”
Dr. Zerbe continued, “We are beholden for RedHill’s support over a past few years and trust that a information generated by this partnership countenance a intensity for RIZAPORT® as a new healing choice for a advantage of patients pang from migraines. IntelGenx will continue a discourse with impending new blurb partners for RIZAPORT® in a U.S., Europe and other territories, and we do not design this change to materially impact those discussions. We also intend on entirely honoring a existent chartering agreements with Grupo JUSTE S.A.Q.F and Pharmatronic Co. to commercialize RIZAPORT® in Spain and South Korea, respectively.”
About RIZAPORT® (RHB-103):
RIZAPORT® is a exclusive verbal skinny film plan of rizatriptan benzoate, a 5-HT1 receptor agonist and a active drug in Merck Co.’s Maxalt®. RIZAPORT® 5 mg and 10 mg were authorized for selling in Germany in Oct 2015 and in Luxembourg in Apr 2017 underneath a European Decentralized Procedure. A New Drug Application for RIZAPORT® was resubmitted to a U.S. FDA in Oct 2017.
Rizatriptan is deliberate to be one of a many effective verbal triptans, a category of molecules that constricts blood vessels in a mind to soothe flourishing and other migraine symptoms. RIZAPORT® is formed on IntelGenx’s exclusive VersaFilm™ technology. It dissolves fast and releases a active part in a mouth, streamer to fit fullness of a drug by a gastrointestinal tract. The administration process of a RIZAPORT® verbal soluble film, that does not need a studious to swallow a tablet or devour water, along with a neutral flavor, presents a potentially appealing healing choice for migraine patients, privately for patients who humour from migraine-related nausea, estimated to be approximately 80% of a sum migraine studious race and patients pang from dysphagia (difficulty swallowing)1.
Reference:
1Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and weight of headache-related nausea: formula from a American Migraine Prevalence and Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.
About IntelGenx:
Established in 2003, IntelGenx is a streamer verbal drug smoothness association essentially focused on a growth and prolongation of innovative curative films formed on a exclusive VersaFilm™ record platform.
IntelGenx’ rarely learned group provides extensive pharmaceuticals services to curative partners, including RD, methodical process development, clinical monitoring, IP and regulatory services. IntelGenx’ state-of-the-art prolongation facility, determined for a VersaFilm™ record platform, supports lab-scale to commander and commercial-scale production, charity full use capabilities to a clients. More information about a association can be found during www.intelgenx.com.
Forward-Looking Statements:
This request might enclose forward-looking information about IntelGenx’ handling formula and business prospects that engage estimable risks and uncertainties. Statements that are not quite chronological are forward-looking statements within a definition of Section 21E of a Securities Exchange Act of 1934, as amended, and Section 27A of a Securities Act of 1933, as amended. These statements include, though are not singular to, statements about IntelGenx’ plans, objectives, expectations, strategies, intentions or other characterizations of destiny events or resources and are generally identified by a difference “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and identical expressions. All forward-looking statements are specifically competent in their entirety by this cautionary statement. Because these forward-looking statements are theme to a series of risks and uncertainties, IntelGenx’ tangible formula could differ materially from those voiced or pragmatic by these forward-looking statements. Factors that could means or minister to such differences include, though are not singular to, those discussed underneath a streamer “Risk Factors” in IntelGenx’ annual news on Form 10-K, filed with a United States Securities and Exchange Commission and accessible during www.sec.gov, and also filed with Canadian bonds regulatory authorities and www.sedar.com. IntelGenx assumes no requirement to refurbish any such forward-looking statements.
Neither TSX Venture Exchange nor a Regulation Services Provider (as that tenure is tangible in a policies of a TSX Venture Exchange), nor a OTCQX accepts shortcoming for a endowment or correctness of this release.
Source: IntelGenx Technologies Corp.
