Early in January, IntelGenx (OTCQX:IGXT; TSXV:IGX) will regain exclusive worldwide rights to develop and commercialize its Rizaport oral thin-film treatment of acute migraines.
The move follows a decision by partner, RedHill Biopharma (NASDAQ, TASE:RDHL), to terminate its co-development and commercialization partnership with IntelGenx.
“We were expecting RedHill’s decision because in recent years RedHill has been increasingly focused on its gastrointestinal projects and it has started reallocating its resources accordingly,” Horst Zerbe, president and CEO of IntelGenx, says in an interview with BioTuesdays.
“Because of that revised product strategy, this decision did not come out of the blue,” he adds. “RedHill has considered Rizaport to be a non-core asset for some time.”
In a statement, RedHill said it expects to report top line data in 2018 from two Phase 3 gastrointestinal programs in Crohn’s disease and H. pylori infection. The company also has a plan in place to gradually reduce the average quarterly cash burn rate in 2018 to approximately $8.5-million.
IntelGenx is a leader in developing oral thin films that provide therapeutic advantages to patients. The product also can be taken without the need for water.
Rizaport is the first rizatriptan oral disintegrating film for the treatment of migraine to achieve marketing approval in Europe. It was formulated using VersaFilm, IntelGenx’s proprietary oral film technology. Compared to other triptan-based medications, rizatriptan demonstrates high efficacy and provides a quick onset of action to migraine sufferers.
As an oral soluble film and along with its pleasant flavor, Rizaport 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 difficulty swallowing, especially children and the elderly.
Rizaport previously demonstrated bioequivalence in a successful pivotal clinical trial, compared with the reference-listed drug, Maxalt-MLT, which is sold by Merck & Co.
Dana Matzen, VP of business and corporate development for IntelGenx, says investors should not be concerned that RedHill is exiting the Rizaport partnership. “Rizaport is a fully developed product with no remaining development work outstanding. Going forward there is only upside for us as we don’t need to share any future payments from licensing fees and royalties.”
In addition, she points out that while IntelGenx is grateful for RedHill’s support during the past few years, “we should be able to move quickly to engage with potential marketing partners for Rizaport. We are now definitely in the driver’s seat.”
Dr. Zerbe says RedHill will swiftly transfer all rights and obligations under the existing licensing agreements to IntelGenx, including the NDA submission that is currently pending at the FDA. As a result, IntelGenx will continue its dialogue with existing and prospective new commercial partners for Rizaport in the U.S., Europe and other territories after acceptance of the NDA for review, he adds.
Earlier this month, the FDA informed RedHill and IntelGenx that it would require additional information before it will start the review clock for the NDA. Dr. Zerbe says the FDA’s questions relate to chemistry, manufacturing and controls, which represent the technical information related to the filing.
He explains that most of the requested information had already been sent to FDA but apparently not been considered. The FDA did not raise any questions about Rizaport’s safety or efficacy data, and does not require additional clinical testing.
"We are disappointed by the delay, but remain committed to working with the FDA to achieve our goal of bringing this product to the U.S. market," he adds. "We hope to meet the agency as soon as practicable to clarify its request for additional information. Although, for the most part, we believe the seemingly missing information has previously been provided.”
In 2016, commercialization agreements for Rizaport were signed with Grupo JUSTE for Spain and Pharmatronic for South Korea. Dr. Matzen says IntelGenx is working with Grupo, now Exeltis, to obtain marketing authorization in Spain and “we are preparing for the launch with them.”
In addition, she says the NDA dossier, when it is accepted for review by the FDA, also will be filed for regulatory approval in South Korea.