ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR) Files An 8-K Termination of a Material Definitive AgreementItem 1.02. Termination of a Material Definitive Agreement.
On June 28, 2017, we received written notice from Bayer Healthcare LLC (“Bayer”) terminating our License and Development Agreement with Bayer dated as of June 5, 2015 (the “Agreement”). Bayer exercised its convenience termination right prior to the completion of our development obligations under the Agreement, which we believe is as a result of Bayer’s de-prioritization of development of the methamphetamine resistant pseudoephedrine-containing product (the “Product”) contemplated in the Agreement.
As previously reported, the Agreement provided, among other things, for (i) the grant by us to Bayer of an exclusive worldwide license to our Impede® technology for use in the Product, and (ii) that we would jointly develop the Product with Bayer utilizing our Impede® technology for the U.S. market. Under the Agreement we received reimbursement of our development expenses, and were entitled to receive success-based development and regulatory milestones payments, and low mid-single digit royalties on net sales of the Product.
As a result of the termination, Mainpointe Pharmaceutical, LLC (“Mainpointe”) has the option to license our Impede technology with respect to the Product in the United States and Canada upon payment to us of $500,000 (together with a royalty of 7.5% on Product net sales) in accordance with our License, Commercialization and Option Agreement with MainPointe dated as of March 16, 2017. To date Mainpointe has not exercised such option.
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. The Company believes this formulation is suitable for final development for a 505(b)(2) NDA submission to the US Food and Drug Administration.
About ACURA PHARMACEUTICALS, INC. (NASDAQ:ACUR)
Acura Pharmaceuticals, Inc. is a pharmaceutical company. The Company is engaged in the research, development and commercialization of technologies and products intended to address medication abuse and misuse. The Company has discovered and developed three platform technologies, which can be used to develop multiple products. The Company’s Oxaydo Tablets (oxycodone HCl, CII), which utilizes the Aversion Technology, is an approved and immediate-release (IR) oxycodone product in the United States. The Company’s Impede technology products include Nexafed and Nexafed Sinus Pressure + Pain. Its third deterrent technology is Limitx, which is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested. The Company’s Aversion and Limitx technologies are intended to address methods associated with opioid and its Impede technology is directed at the extraction and conversion of pseudoephedrine into methamphetamine.
