Firm will work on regulatory filing for hypertension drug Bystolic and fibromyalgia drug Savella.
Forest Laboratories has granted Janssen, headquartered in Toronto, commercialization rights for Bystolic® and Savella® in Canada. In the U.S. Bystolic is approved for hypertension and Savella for fibromyalgia, but neither drug is sanctioned in Canada.
Janssen will assume responsibility for Canadian regulatory approval. Forest will receive a signing fee, milestones, and royalties and has 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 on establishing a wholly owned Canadian affiliate that will exercise the co-promotion rights for Bystolic and Savella in Canada. It will also take responsibility for future regulatory filings and commercialization of Forest’s pipeline products in Canada.
Current late-stage products for which Forest holds Canadian rights include Teflaro™, linaclotide, F-2695, and cariprazine. Teflaro received FDA clearance on October 29 to treat adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections including methicillin-resistant Staphylococcus aureus. Given as an injection, Teflaro is an antibacterial agent in a class of drugs known as cephalosporins, which act by interfering with the bacterial cell wall.
Linaclotide is in Phase III development for chronic constipation and constipation-predominant irritable bowel syndrome. The firm reported positive results from two Phase III trials in May and expects an NDA filing next year. Linaclotide is a chloride channel activator that boosts intestinal fluid secretion. F-2695 is being investigated as a therapy for major depressive disorder and cariprazine for schizophrenia and bipolar mania. Forest anticipates filing NDAs for both in 2012.
Janssen markets a range of medications used in psychiatry, dementia, attention deficit hyperactivity disorder, psoriasis, pain management, women’s health, infectious disease, anemia, oncology, and virology.