IntelGenx Announces USPTO Has Granted Patent Protecting RIZAPORT™ Oral Film for Migraines
February 18, 2016 (Source) — IntelGenx Corp., (TSX VENTURE:IGX)(OTCQX:IGXT), today announced the USPTO (United States Patent and Trademark Office) has granted a patent protecting Rizaport™, an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines. This patent protects the composition of Rizaport™ and will be listed in the Orange Book upon approval of the product by the FDA.
The patent application, entitled “Instantly Wettable Oral Film Dosage Form Without Surfactant or Polyalcohol” covers rapidly disintegrating film oral dosage forms and is expected to be valid until 2034 once granted.
“Rizaport™ is the first patent allowed for an oral film for the treatment of migraine,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “We are committed to bringing Rizaport™ to market as soon as possible as we believe it will be a beneficial treatment for patients suffering from migraines. The patent allowance is one more systematic step towards strengthening our patent portfolio supporting IntelGenx’s proprietary VersaFilm™ technology. This will now further enable IntelGenx to accelerate our ongoing partnering efforts in the USA and abroad.”
Background on Rizaport™:
Rizaport™ was granted marketing authorization in November 2015 from the Federal Institute for Drugs and Medical Devices of Germany (BfArM). The worldwide migraine market is expected to exceed $2 billion in sales in 20161. Rizaport™ is the first oral thin film bioequivalent to Maxalt® Lingua. The Rizaport™ oral thin film has a pleasant taste and dissolves rapidly in the mouth, without the need for water. It is a therapeutic alternative for patients suffering from dysphagia (difficulty swallowing), and patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population(1). Rizatriptan is considered 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.
IntelGenx and its co-development partner, RedHill Biopharma Ltd. submitted a New Drug Application (NDA) to the FDA in 2013 seeking marketing approval of Rizaport™ in the U.S. In 2014, the companies received a Complete Response Letter (CRL) from the FDA which raised questions primarily related to CMC. It is noted that no deficiency was raised relating to the safety or bio-equivalence data of Rizaport™. IntelGenx and RedHill reported that they believe that FDA approval of the Rizaport™ NDA is subject to the satisfactory resolution of the remaining CMC questions. IntelGenx and RedHill continue their cooperative effort to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.
Get our daily investorintel update
Rizaport™ is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt®. Rizaport™ 5mg and 10mg was approved for marketing in Germany in October 2015, under the European Decentralized Procedure. A New Drug Application for Rizaport™ was also filed with the U.S. FDA in 2013 and a CRL was received in 2014. Rizatriptan is considered 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. The worldwide annual sales of triptans were estimated to have exceeded $870 million in 2014(2). Rizaport™ is based on IntelGenx’s proprietary “VersaFilm™” technology. It dissolves rapidly and releases its active ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract. The administration method of the Rizaport™ oral thin film, which does not require the patient to swallow a pill or consume water, along with its pleasant flavor, presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population.
IntelGenx is a leading drug delivery company focused on the development of innovative products based on its proprietary oral drug delivery technologies.
Established in 2003, the Montreal-based company, listed on the TSX-V and OTC-QX, develops innovative oral drug delivery solutions based on its proprietary platform technologies, VersaFilm™, VersaTab™ and AdVersa™.
IntelGenx has developed a broad and diverse product portfolio addressing unmet market needs and offering lifecycle management opportunities. Forfivo XL™, launched in 2012, is the first and only FDA approved once-daily bupropion HCl 450mg dose in a single tablet for the treatment of major depressive disorder.
IntelGenx highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, clinical monitoring, IP protection, analytical method development and regulatory services. IntelGenx 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 our clients. More information is available about the company at: www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx’ 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’ 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’ 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’ annual report on Form 10-K for the fiscal year ended December 31, 2014, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and 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.
(1) 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.
(2) EvaluatePharma 2013 WW annual sales report.
InvestorIntel is a trusted source of reliable information at the forefront of emerging markets that brings investment opportunities to discerning investors.