Media

MONMOUTH JUNCTION, N.J. & CHARLOTTE, N.C., September 4, 2013 — 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. 

About Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension

Karbinal™ ER Extended-release Oral Suspension is an H1 receptor antagonist indicated for the symptomatic treatment of:

• Seasonal and perennial allergic rhinitis
• Vasomotor rhinitis
• Allergic conjunctivitis due to inhalant allergens and foods
• Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
• Dermatographism
• As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
• Amelioration of the severity of allergic reactions to blood or plasma

About FSC Laboratories:

FSC Laboratories, Inc. (including its wholly-owned subsidiary, FSC Pediatrics, Inc.), based in Charlotte, NC, is a specialty pharmaceutical and medical device company founded in 2004, solely dedicated to providing innovative solutions to unmet medical needs for pediatric patients across the communities they serve. FSC Pediatrics provides products that meet pediatric-primary care and specialist needs in the following therapeutic categories: Infection, Central Nervous System (CNS), Allergy, and Asthma. More information is available at http://www.fscpediatrics.com

About Tris Pharma:

Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, U.S.A. For more information, please visit https://www.trispharma.com