Tris Pharma, Inc. and FSC Laboratories, Inc. today announced the signing of a definitive licensing agreement for the commercialization of Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4 mg/5 ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.  Karbinal ER is expected to be available in pharmacies across the U.S. in time for the 2014 spring allergy season.
“Karbinal ER offers an attractive treatment option for the approximately 30 percent of allergy sufferers who don’t get adequate relief from second generation antihistamines or are dissatisfied with the inconvenient dosing schedules of currently available antihistamines,” said Peter Steelman, President of FSC Laboratories.
“We’re excited to be partnered with Tris to make this pleasant-tasting extended-release liquid formulation of carbinoxamine, a mildly-sedating antihistamine with years of proven safety and efficacy, available for patients as young as two years old.” “This agreement demonstrates the continued success of our OralXR+ technology and is representative of Tris’ history of developing and manufacturing first-to-market liquid sustained-release products that fill significant unmet patient needs,” added Ketan Mehta, President and CEO of Tris Pharma.
Under the terms of the exclusive agreement, Tris will manufacture Karbinal ER using its proprietary OralXR+ technology and FSC will market the drug.  FSC will pay Tris up to $20 million in fixed and sales-related milestones, as well as a significant double-digit royalty on net sales.