South Brunswick pharmaceutical company Tris Pharma has inked a licensing agreement to commercialize Karbinal ER, the first time-release drug that treats allergic rhinitis in children aged 2 and older.
FSC Laboratories will market the drug, expected to hit pharmacies by the spring 2014 allergy season, and pay Tris Pharma up to $20 million in fixed and sales-related milestones plus a royalty on net sales.
Karbinal ER is the first sustained-release histamine receptor-blocking agent for the treatment of allergic rhinitis, commonly called hay fever. The liquid drug is taken orally in 4-milligram dosages once every 12 hours.
Manufactured by Tris through proprietary technology, Karbinal ER received approval by the U.S. Food and Drug Administration in March.
FSC President Peter Steelman said Karbinal ER is an attractive alternative for about 30 percent of allergy suffers who don't get adequate relief from second generation antihistamines or are dissatisfied with inconvenient dosing schedules of current drugs on the market.
Tris Pharma CEO Ketan Mehta said in a statement today: "This agreement demonstrates the continued success of our OralXR+ (sustained-release) technology and is representative of Tris' history of developing and manufacturing first-to-market liquid sustained release products that fill significant unmet patient needs."