Not long after a morning earnings call on March 27 in which Intelgenx Corp. CEO Horst Zerbe said his team was still awaiting word from the FDA on its resubmitted 505(b)(2) application for its acute migraine candidate, Rizaport Versafilm, that news arrived in the form of a complete response letter (CRL), its third following earlier CRLs in February 2014 and April 2019. Company shares, which trade on both the TSX Venture Exchange and OTCQX market plunged after a midmorning trading halt requested by the company, with the U.S.-listed shares (OTCQX:IGXT) falling 57.7% to 13 cents per share by the market's close.

According to the Saint Laurent, Quebec-based company, the FDA said it can't approve the new drug application for Rizaport in its present form and requested additional information, though specifics were not disclosed. It did not request a new bioequivalence study, perhaps satisfied to accept previous bioequivalence data on the drug generated in 2012.

"Obviously, we are surprised and disappointed," said Zerbe. "We are committed to addressing the concerns raised by the FDA in the CRL. To that end, we will request a meeting with the agency as soon as reasonably possible to discuss the scope of the CRL comments to obtain clarification and determine next steps." The company did not return a request for further information on Friday.

Rizaport is an oral thin-film formulation of the 5-HT1 receptor agonist rizatriptan, the active drug in Maxalt-MLT orally disintegrating tablets, a migraine product marketed by Merck & Co. Inc. It was co-developed with Tel Aviv, Israel-based Redhill Biopharma Ltd., which also helped commercialize it until terminating its agreement with Intelgenx at the end of 2017.

The medicine employs Intelgenx’s Versafilm technology, which consists of a thin polymeric film comprising components that are approved by the FDA for use in food, pharmaceutical and cosmetic products and are commonly used by breath-freshening strips. In the context of migraine, Zerbe said his team thinks Rizaport could be an attractive therapeutic alternative for the 80% of patients that experience migraine-related nausea and difficulty swallowing.

Despite the medicine's troubles in the U.S., following a positive opinion for its MAA under the European decentralized procedure in 2015, it has since gained market approvals for the treatment of acute migraines in Germany, Luxembourg and Spain.

In January, the company entered a binding term sheet with Vilnius, Lithuania-based Orivas for the commercialization of Rizaport in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or the Republic of Ukraine, as well as any of the Scandinavian countries.

In addition to Rizaport, Intelgenx is also working to advance several other thin film candidates. Together with Aquestive Therapeutics Inc. (formerly Monosol Rx), it's developing a thin film tadalafil product for the treatment of erectile dysfunction for which it expects FDA feedback and approval before the end of the second quarter.

Intelgenx is also developing a cannabis-infused Versafilm product that has been finalized with its co-development partner, Tilray Inc. Manufacturing scale-up for that product began in October and has been completed. The company is now in contact with Health Canada's cannabis licensing group, which is reviewing its application for a microprocessing license, which it expects to receive sometime in April. Success would enable the companies to begin commercial production, with product sales expected to begin in the third quarter.

In its most recent earnings report, published March 26, Intelgenx said it had full-year 2019 revenue of $742,000 vs. $1.8 million in 2018. It also posted a net loss of $10.3 million for 2019.

As at Dec. 31, 2019, the company's cash and short-term investments totaled $1.9 million, which did not include gross proceeds of CA$8.2 million (US$5.8 million) it raised in a February equity offering.

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