Endo International plc’s subsidiary Endo Ventures Limited has entered into definitive agreements with Bioprojet SCR to register, commercialize, and distribute pitolisant on an exclusive basis in Canada. Paladin Labs Inc, an operating company of Endo, will be commercializing pitolisant in Canada.
Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons. The drug is approved in the European Union (EU) for the treatment of narcolepsy in adult patients with or without cataplexy and is distributed under the tradename WAKIX but is not approved in Canada (or in the United States).
Pitolisant increases the release of the brain chemical histamine to increase a patient’s wakefulness and alertness. The novel drug was developed after decades of research by Bioprojet co-founders Jeanne-Marie Lecomte and Jean-Charles Schwartz.
In accordance with the terms of the agreements, Paladin will be responsible for the registration distribution, sales, marketing, medical affairs, pricing, and reimbursement activities in connection with pitolisant while Bioprojet will be responsible for supplying the drug to Paladin.
“Bioprojet is proud to partner with Endo and its affiliate, Paladin, which has more than a 20 year successful track record of commercializing innovative, much-needed specialty products in Canada. We believe this partnership will be expertly led by Paladin, bringing relief to patients suffering from this debilitating disease,” Schwartz says in a release.
Rahul Garella, senior vice president, International Pharmaceuticals of Endo, says, “We are very pleased to work with Bioprojet to bring a new treatment option for Canadian narcolepsy patients. This product complements Paladin’s promoted specialty products portfolio and provides us with an additional pillar upon which to grow our portfolio of innovative treatments.”