Forest Laboratories and Blue Ash Therapeutics Enter Into Asset Purchase Agreement for Azimilide, a Novel Phase III Antiarrhythmic Agent
Public Company Information:
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX) today announced that its wholly-owned subsidiary Forest Laboratories Holdings Limited and Blue Ash Therapeutics, LLC have entered into an asset purchase agreement, pursuant to which Forest has acquired worldwide rights to azimilide, a novel antiarrhythmic agent originally developed by Procter & Gamble Pharmaceuticals.
Through the asset purchase agreement, Forest has been assigned a license agreement between Warner Chilcott Company, LLC and Blue Ash, providing for worldwide rights to azimilide, and will be responsible for all future development and commercialization activities and associated costs. Forest will provide to Blue Ash an undisclosed upfront payment and future milestone payments for the successful commercialization of azimilide. Forest will also make royalty payments to Warner Chilcott on net sales of azimilide under the assigned license agreement.
Howard Solomon, Chief Executive Officer, and President of Forest, said, "We are pleased to have acquired the worldwide rights to azimilide. Azimilide is a well studied drug which has been reviewed in the past by the FDA as an antiarrhythmic treatment for patients with a history of life-threatening ventricular arrhythmias and who have an implantable cardioverter defibrillator (ICD), a group for which there are currently no approved antiarrhythmics. We will conduct the final registration trial required for approval in the United States under a previously established FDA Special Protocol Assessment (SPA). Azimilide could be the first agent to be approved specifically for this patient population in the United States and would be prescribed, if approved, by many physicians who also prescribe our beta blocker Bystolic for the treatment of hypertension. We will also investigate the potential to obtain approval for azimilide in markets outside the United States to help expand our ex-US commercial presence in specialty markets.”
Azimilide is a class III antiarrhythmic agent. It was originally developed by Procter & Gamble and has been studied in over 5,300 patients to investigate its potential as an antiarrhythmic agent. Based on its mechanism of action and results of clinical trials, azimilide was determined to be best suited for use in patients with a history of life-threatening ventricular arrhythmias and who have an implantable cardioverter defibrillator (ICD). In 2006, the FDA, under its then operable review practices, issued an Approvable Letter requesting an additional clinical trial for azimilide. In 2009 Procter & Gamble sold its pharmaceutical business to Warner Chilcott including its rights to azimilide. Blue Ash subsequently obtained an exclusive worldwide license for azimilide from Warner Chilcott, and in 2010 Blue Ash received agreement from FDA for one additional Phase III study to support a regulatory submission for azimilide in the U.S. Agreement was reached with the FDA for the registration trial design under a Special Protocol Assessment. As a new chemical entity, azimilide will be eligible for five and ten years of data exclusivity in the United States and Europe, respectively, commencing on approval. While the composition of matter patent for azimilide will expire in 2012, other patent applications have been filed with respect to azimilide which may further extend its period of exclusivity.
About Blue Ash Therapeutics
Blue Ash Therapeutics is a privately held company based in Cincinnati, Ohio led by Greg Flexter, CEO, and Dr. Kevin Malloy, COO and former P&G Pharmaceuticals Scientist/Manager. Supported by an extended team of experts, including several former P&G physicians and scientists, Blue Ash acquired exclusive worldwide rights to azimilide and secured agreement with the FDA on the design and final steps for completing clinical development to enable marketing approval. Lead investors include Healthcare Value Capital, CincyTech Ventures and Queen City Angels. For further company information, visit http://www.blueashtx.com/index.html.
About Forest Laboratories
Forest Laboratories' (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory medicine. The Company's pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.