Forest Laboratories, Inc.(Forest) 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 Pharmaceutical, NV and Janssen Pharmaceutical respectively, on behalf of Janssen Inc., which will market the products in Canada.
Under the terms of the agreement, Janssen Pharmaceutical 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, anaemia, oncology, and virology. They 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 US Food and Drug Administration (FDA) for the treatment of hypertension (chronic high blood pressure). Savella was approved by the US FDA for the management of fibromyalgia.
Forest Laboratories long standing 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.