NEW YORK--(BUSINESS WIRE)-- Forest Laboratories, Inc. (Forest) (NYSE: FRX) today announced that Forest Laboratories Holdings Limited, its wholly owned subsidiary, has entered into a definitive collaboration and distribution agreement for Bystolic® (nebivolol) and Savella® (milnacipran HCl) in Canada with Janssen Pharmaceutica, NV and Janssen Pharmaceutical respectively, on behalf of Janssen Inc., which will market the products in Canada.
Under the terms of the agreement, Janssen Pharmaceutica NV and Janssen Pharmaceutical will pay Forest an undisclosed signing fee, milestones and sales-related royalties in exchange for exclusive sublicenses to Janssen Inc. for the commercialization of Bystolic® and Savella® in Canada.
Janssen Inc. is headquartered in Toronto and markets a broad range of medications used in psychiatry, dementia, attention deficit hyperactivity disorder, psoriasis, pain management, women’s health, infectious disease, anemia, oncology, and virology. Janssen Inc. will assume responsibility for the Canadian regulatory approval and commercialization of Bystolic® and Savella® in Canada. Forest will have the opportunity to co-promote at any time after the first anniversary of regulatory approval for either product.
Over the next few years, Forest plans to establish a wholly owned Canadian affiliate that will exercise the co-promotion rights for Bystolic® and Savella® in Canada, and that will also take responsibility for the future regulatory filings and commercialization of its pipeline products in Canada. Current late-stage products for which Forest holds Canadian rights include Teflaro™ (ceftaroline), linaclotide, F-2695 and cariprazine.
Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories said, "We are pleased to have entered into this collaboration for the commercialization of Bystolic® and Savella® in Canada. This collaboration is a significant and valuable first step towards establishing a Forest presence in Canada. We look forward to the expansion of Forest Laboratories into Canada.”
Bystolic® (nebivolol) was approved by the U.S. Food and Drug Administration for the treatment of hypertension (chronic high blood pressure). Savella® was approved by the U.S. Food and Drug Administration for the management of fibromyalgia.
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 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 Report on Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.
Frank J. Murdolo Vice President - Investor Relations
KEYWORDS: United States North America Canada New York
INDUSTRY KEYWORDS: Health Hospitals Pharmaceutical Other Health