In June 2015, German pharma firm Bayer Healthcare signed an agreement with Acura Pharmaceuticals to jointly develop an undisclosed methamphetamine resistant pseudoephedrine containing product using Acura’s abuse deterrent platform.
But in a filing sent to the SEC yesterday, Palatine, Illinois-headquartered Acura said it received a letter from Bayer on June 28 exercising its right to end the agreement prior to the completion of any development obligations.
Acura said it believes the termination “is as a result of Bayer’s de-prioritization of development of the methamphetamine resistant pseudoephedrine-containing product (the “Product”) contemplated in the Agreement.”
Bayer had not responded to a request for further information from in-Pharmatechnologist at the time of going to press.
As chemists, law enforcers and fans of the TV show Breaking Bad know, pseudoephedrine in prescription and over-the-counter medicines can be converted into the illicit drug methamphetamine.
The Impede technology consists of a polymer matrix that forms a thick gel when hydrated, preventing such abuse. Acura’s Nexafed (pseudoephedrine HCI) range of marketed nasal and sinus decongestion tablets are based on the platform.
“Under the Bayer Agreement, and at Bayer’s expense, the Company completed formulation of a 12-hour pseudoephedrine-containing combination product using Acura’s IMPEDE 1.0 Technology that has completed initial clinical testing,” Acura said in its filing. “The Company believes this formulation is suitable for final development for a 505(b)(2) NDA submission to the US Food and Drug Administration.”
Acura could continue the programme through a deal struck in March 2017 with Mainpointe Pharmaceutical giving the emerging US OTC pharmaceutical company the option to take Bayer’s place upon payment of $500,000 to Acura, along with royalty of 7.5% on product sales.
Mainpointe has not exercised such option as yet.