With a burgeoning pipeline of pharmaceutical oral films, IntelGenx’s (OTCQX:IGXT; TSXV:IGX) business development strategy is focused on partnering its product pipeline along with actively meeting with potential partners to explore manufacturing opportunities, and continuing to build its product pipeline jointly with R&D.
“We are a global leader in oral thin films and our mission is to use our technology to develop products that can be taken without water and can improve the safety and performance of existing drugs,” Dana Matzen, VP of business and corporate development, says in an interview with BioTuesdays.
“We develop rapidly disintegrating oral films products that provide tangible benefits for patients, such as improved efficacy due to better bioavailability, quicker onset of action and reduced side effects,” she adds. “We then engage with partners to finalize development and bring the product to market.”
As many as 40% of American adults have experienced difficulty swallowing traditional tablets and capsules, she points out, making the company’s VersaFilm and AdVersa products an ideal solution, especially for pediatric and geriatric patients.
IntelGenx also focuses on the repurposing of existing drugs for new indications and developing opportunities for life cycle extensions of brand products leveraging its VersaFilm technology platform for oral thin films. The company also has products based on the AdVersa technology for controlled-release tablets for oral absorption over an extended period of time that are available for licensing outside the U.S.
Dr. Matzen says the company also offers partners a full service of growth opportunities, including R&D formulation and feasibility studies; patent protected intellectual property for the VersaFilm technology, regulatory and quality dossiers in the U.S. and Europe to ensure GMP compliance and a smooth transition to regulatory approval and commercial manufacturing; and state-of-the-art, high capacity manufacturing.
Addressing an unmet medical need, with strong safety and efficacy data, is critically important for payers to consider reimbursement, she adds.
Prior to founding IntelGenx in 2003, Horst Zerbe, chairman, president and CEO, was a co-developer of Listerine thin filmstrips as a novel breath freshener.
Today, some of IntelGenx’s partners are U.S.-based Par Pharmaceutical, Endo Pharmaceuticals of Ireland and the U.S., RedHill Biopharma of Israel and Chemo Group of Spain, which has an exclusive worldwide license to commercialize two generic tablets and a U.S. license for two other generic oral films.
“This is not an easy and fast approach, but we are a lean organization that lets us develop strong relationships with our partners,” Dr. Matzen contends. “This is how we differentiate ourselves from bigger companies.”
IntelGenx’s most advanced VersaFilm product is Rizaport for migraines, which is partnered with RedHill Biopharma and received European marketing approval in November 2015. RedHill is funding the development program and the companies, which anticipate FDA approval within the next 12 months, share net revenues. Distribution deals have been signed for several European and Asian countries.
Rizaport, which contains rizatriptan, is bioequivalent to Merck’s Maxalt-MLT and negotiations with U.S. commercialization partners are ongoing, Dr. Matzen points out. “Rizaport can be attractive for migraine patients because it does not need to be taken with water and has the potential to avoid gastrointestinal side effects,” she adds.
The FDA is expected to conduct a pre-approval inspection in the second half this year of IntelGenx’s 17,000-square-foot manufacturing plant in Montreal. A GMP certificate is part of the FDA approval process for new products.
IntelGenx has three other oral films available for partnering: Tadalafil, for erectile dysfunction (ED); Loxapine, for agitation in schizophrenia and bipolar 1 disorder; and Montelukast, for brain degenerative diseases, such as early-stage dementia.
IntelGenx previously confirmed the bioequivalence of Tadalafil to Eli Lilly’s Cialis, which had sales of $1.5-billion in 2016 but faces generic competition in 2020. IntelGenx has an exclusive license for oral films from Lilly for its dosing patent, which would allow Tadalafil to enter the ED market in the U.S. free from patent litigation from Lilly.
Dr. Matzen explains that Tadalafil, which offers a discrete dosing alternative, could enter the market in 2018, with up to three years of market exclusivity before Cialis is hit with generic competition.
In addition, IntelGenx is currently optimizing the oral film formulation of Loxapine, which has been shown to offer greater absorption, faster onset of action and no pulmonary complications, compared with a tablet and an inhalation device that must be taken under supervision of a physician. “We believe our oral film will have a significant benefit for patients,” she adds.
Dr. Matzen says IntelGenx also is looking for a commercial partner to share the development risk of its Montelukast oral film, which has generated strong early-stage data and is based on an active pharmaceutical ingredient approved for a completely different indication.
“Our data indicates that Montelukast oral film crosses the blood-brain-barrier and reaches its target while the existing tablet, on which it is based, does not,” she contends, adding that the company is now preparing the protocol for a proof-of-concept study.