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July 04, 2015 1:48 AM ET

Pharmaceuticals

Company Overview of Tris Pharma, Inc.

Company Overview

Tris Pharma, Inc., a specialty pharmaceutical company, engages in research, development, and manufacture of over-the-counter, Rx branded products, and specialty generic products in the United States. The company develops extended release formulations for products intended for children, elderly, and adults having difficulty swallowing pills and requiring multi-dose treatment. Its products pipeline includes products for various disease indications, such as cough and cold, pain management, and neurological disorders. The company also offers specialty generic products in immediate and extended release versions. Tris Pharma, Inc. offers its products in various dosage forms, such as package powder...

2033 Route 130

Brunswick Business Park

Suite D

Monmouth Junction, NJ 08852

United States

Founded in 2000

Phone:

732-940-2800

Fax:

732-940-2855

Key Executives for Tris Pharma, Inc.

Founder, Chief Executive Officer and President
Director of Finance and Controller
Vice President of Operations
Age: 58
President of Generic Pharmaceuticals Business
Age: 51
Chief Scientific Officer and Executive Vice President of R&D Including Regulatory Affairs
Age: 67
Compensation as of Fiscal Year 2015.

Tris Pharma, Inc. Key Developments

Tris Pharma, Inc. Enters into License, Supply, and Distribution Agreement with Pfizer Consumer Healthcare

Tris Pharma, Inc. announced that it has entered into a license, supply, and distribution agreement with Pfizer Consumer Healthcare. Under the terms of the agreement, Pfizer Consumer Healthcare will commercialize Tris' extended release dextromethorphan cough syrup under the Robitussin Brand. In exchange for providing Pfizer Consumer Healthcare U.S. branded rights to its protected intellectual property for an extended release dextromethorphan formulation, Tris will receive an upfront payment, milestone payments and sales-based royalties. Tris will be responsible for manufacturing and regulatory activities while Pfizer Consumer Healthcare will manage sales, marketing, and distribution.

Tris Pharma, Inc. Manufactures 3 Registration Batches of CCP-07

Vernalis plc announced that its partner, Tris Pharma, has successfully manufactured 3 registration batches of CCP-07 and material from these batches is now up on stability. CCP-07 is the second programme in Vernalis' cough cold pipeline from its exclusive licensing agreement with Tris Pharma. The first product, Tuzistra XR was approved by the FDA on 30 April 2015. The CCP-07 NDA submission will include 12 months of stability data and so Tris now anticipates the filing with the FDA to occur during 2016. Further news flow will follow the completion of the pivotal single-dose and multi-dose bioavailability studies anticipated to take place between now and NDA filing. Tris is developing, on behalf of Vernalis, up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments. The financial terms of this licensing deal are not disclosed.

Tris Pharma, Inc. Announces the FDA Acceptance of NDA for Dyanavel™ XR

Tris Pharma, Inc. announced that U.S. Food and Drug Administration has accepted for review its New Drug Application for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for mid-October, 2015. Dyanavel XR was developed using Tris' innovative technology, LiquiXR®, which has already produced several breakthrough products. The NDA submission was based on a multicenter, phase III efficacy study conducted in over 100 patients, which demonstrated a positive outcome by meeting all its primary end points.

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