ORGANON AND CYPRESS BIOSCIENCE COLLABORATE
Organon, the human pharmaceutical business of Akzo Nobel, and Cypress Bioscience have joined forces to attempt to develop and commercialize the first novel pharmacological treatment for Obstructive Sleep Apnea (OSA).
A common breathing disorder which affects 15 to 20 million people in the U.S. and another 10 to 20 million in Europe, OSA -- a condition which is not currently treatable with an approved drug -- is characterized by brief interruptions in breathing during sleep, typically caused by a collapse of the upper airway.
Under the terms of the agreement, the two companies will combine their expertise in an effort to develop a safe and effective treatment for OSA.
The collaborative program (currently in Phase IIa) will involve an enantiomer of mirtazapine, ORG 4419, and combinations of mirtazapine with another approved drug to potentially augment efficacy and improve tolerability, with Organon and Cypress jointly selecting the best development candidate based upon various proof of concept trials performed independently by both companies. The companies will also share costs and final responsibility for clinical development activities.
Initially, development costs will be shared equally between Cypress and Organon. In the U.S., Canada and Mexico (NAFTA), the companies will co-commercialize successful candidates. Cypress will have the right to set up its own sales force responsible for 25 percent of the total detailing and promotional efforts in the NAFTA countries. Organon will be solely responsible for commercialization in the rest of the world and will pay Cypress a royalty on net sales.
Organon will also have principal responsibility for the manufacturing and commercialization of pharmaceutical products resulting from the collaboration, while Cypress will take the operational lead regarding clinical development activities.
Mirtazapine has been independently evaluated as a potential OSA treatment in a small preliminary investigator sponsored pilot trial performed at the University of Illinois. In the University of Illinois trial, two doses of mirtazapine were compared to placebo in a ten patient, double-blind, placebo controlled, cross-over study. The total duration of the trial was three weeks, and the effects of each intervention were assessed via sleep polysomnography at the end of seven days. In summary, it was found that mirtazapine was able to reduce the number of abnormal respiratory events over the course of the night by roughly fifty percent.