Dr. Horst Zerbe reports

INTELGENX AND REDHILL BIOPHARMA SUBMIT EUROPEAN MARKETING AUTHORIZATION APPLICATION FOR MIGRAINE DRUG RIZAPORT(R)

IntelGenx Corp., together with RedHill Biopharma Ltd., an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, has submitted a marketing authorization application to the German Federal Institute for Drugs and Medical Devices seeking European marketing approval of the oral thin-film formulation of rizatriptan for acute migraines, under the brand name Rizaport. The brand name Rizaport was also conditionally approved by the United States Food and Drug Administration as part of the new drug application review process in the U.S., subject to a complete response letter received from the FDA in February, 2014, and currently under discussions with the FDA.

The MAA was submitted under the European mutual recognition procedure, with Germany as the reference member state. The submission is supported by several studies, including a recently completed comparative bioavailability study that successfully established the bioequivalence between Rizaport and the European reference drug, Maxalt lingua, and follows a positive scientific advice meeting with the BfArM. Rizaport oral thin film does not require the patient to swallow a pill or consume water and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated to be approximately 80 per cent of the total migraine patient population (1).

IntelGenx and RedHill previously conducted a successful bioavailability study that demonstrated the required FDA criteria for therapeutic bioequivalence between the Rizaport soluble oral thin film and the U.S. reference drug, Maxalt-MLT. Following the successful bioequivalence study, IntelGenx and RedHill announced in March, 2013, the submission to the FDA and acceptance for review of an NDA seeking marketing approval of the product in the U.S., also under the brand name Rizaport. Following a CRL received from the FDA in February, 2014, which raised questions primarily related to chemistry, manufacturing and controls, 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, as well as securing a compliant source of the raw material. Accordingly, the companies continue 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.

"We are very pleased with the submission of a European marketing application for Rizaport, which follows our submission of a U.S. new drug application, currently under discussions with the FDA," said Dr. Elkan Gamzu, PhD, RedHill's Rizaport product manager. "This regulatory submission in Europe brings us closer to offering a new and potentially advantageous therapeutic alternative for patients suffering from migraines, including those who suffer from migraines with nausea and vomiting. We believe that Rizaport oral thin film's rapid dissolution, pleasant flavouring and ease of use from the ability to administer without water potentially improves compliance and adherence and we look forward to making the product available to patients in Europe."

"From a commercial perspective, obtaining marketing authorization in Europe would expand the commercialization of Rizaport into the second largest market of Maxalt," said Dr. Horst Zerbe, president and chief executive officer of IntelGenx. "Pursuing development activities in Europe demonstrates our commitment to bring Rizaport to migraine patients across the world and maximize the value of this asset."

About Rizaport

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. Marketing applications for Rizaport have been filed both in the U.S. (NDA filed in March, 2013) and in Europe (MAA filed in October, 2014). Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1-billion in 2013 (2).

Rizaport is based on IntelGenx's proprietary VersaFilm technology. Rizaport dissolves rapidly and releases its active ingredient in the mouth, leading to an efficient absorption of the drug through the gastrointestinal tract. The administration method of the Rizaport oral thin film does not require the patient to swallow a pill or consume water and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated to be approximately 80 per cent of the total migraine patient population (3).

(1) Lipton, R.B.; Buse, D.C.; Saiers, J.; Fanning, K.M.; Serrano, D.; Reed, M.L. 2013. Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention study, headache. January, 2013. 53 (1): 93 to 103.

(2) EvaluatePharma, 2013, worldwide annual sales by pharmacological class, 5-HT1B (serotonin) and 5HT1D (serotonin) agonist.

(3) Lipton, R.B.; Buse, D.C.; Saiers, J.; Fanning, K.M.; Serrano, D.; Reed, M.L. 2013. Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention study, headache. January, 2013. 53 (1): 93 to 103.

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