Miami, Florida, December 12, 2018 – Gensco® Pharma, a leading specialty pharmaceutical manufacturer specializing in development and commercialization of prescription transdermal products, today announced the execution of a definitive licensing, development and supply agreement (the “Agreement”) with IntelGenx Corp (TSX-V: IGX) (OTCQX: IGXT) (“IntelGenx”), a leading oral drug delivery company, for the exclusive commercialization of RIZAFILM® (U.S. market name for RIZAPORT®) in the United States.
Upon the anticipated RIZAFILM® approval by the US Food and Drug Administration (“FDA”), the product will become the first oral thin film on the market for the treatment of migraines and will also be the first commercialized film product developed and manufactured at IntelGenx’s state-of-the-art facilities.
“We believe this exciting partnership with Gensco® Pharma offers a tremendous opportunity to commercialize RIZAFILM® in the world’s largest migraine market1,” said Dr. Horst Zerbe, CEO of IntelGenx. “We are pleased to work with Gensco® Pharma and its seasoned team of industry veterans with proven track records of launching and commercializing important therapies using innovative drug delivery systems.”
“The Gensco® Pharma team is eager to launch RIZAFILM® as a new therapeutic option for the benefit of patients suffering from migraines. This innovative therapy aligns with Gensco® Pharma’s mission to provide patients with unique delivery systems to effectively and safely manage their pain. We look forward to partnering with the IntelGenx team and executing a highly successful RIZAFILM® commercial launch,” commented Carlos Alfaras, President and CEO of Gensco® Pharma.
Under the Agreement, Gensco® Pharma has been granted the exclusive right to commercialize the IntelGenx RIZAPORT® product in the United States. In return, IntelGenx is entitled to receive royalty payments based on net profits of RIZAFILM® (U.S. market name for RIZAPORT®). IntelGenx is also eligible to receive milestone payments upon FDA approval and product launch. The agreement also gives Gensco® Pharma exclusivity to develop the market, sell, distribute and fully commercialize products as an IntelGenx partner for the People’s Republic of China.
About RIZAFILM® (U.S. market name for RIZAPORT®):
RIZAFILM® is a patent protected proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt®.
Rizatriptan is considered to be one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms. RIZAFILM® is based on IntelGenx’s proprietary VersaFilm™ technology. It dissolves rapidly and releases its active ingredient in the mouth. The administration method of the RIZAFILM® oral soluble film, which does not require the patient to swallow a pill or consume water, along with its neutral flavor, presents a potentially attractive therapeutic alternative for migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population and patients suffering from dysphagia (difficulty swallowing)2.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 1, 2019, for completion of the review of the resubmitted New Drug Application for RIZAFILM®.
2 Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.
About Gensco® Pharma:
Gensco® Pharma is a specialty pharmaceutical manufacturer specializing in development and commercialization of prescription transdermal products. Gensco® Pharma ’s capabilities allow for the quick launch of products into significant niche markets.
Resources are focused on innovative research, the development of superior quality medications and unique delivery systems. Gensco® Pharma is an evidence-based solutions company that is progressively developing products utilizing new technologies that deliver outcomes to reduce the effects caused by disease or pathology. More information about Gensco® Pharma can be found at https://genscopharma.com.
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about IntelGenx can be found at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx’s operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’s plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp. and Gensco Pharma
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Randi Aileen Press
Executive Director, Marketing