November 26, 2014 5:17 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
Director of Finance and Controller
Vice President of Operations
Age: 57
President of Generic Pharmaceuticals Business
Age: 50
Chief Scientific Officer and Executive Vice President of R&D Including Regulatory Affairs
Age: 66
Compensation as of Fiscal Year 2014.

Tris Pharma, Inc. Key Developments

Tris Pharma, Inc. and Vernalis PLC Announces FDA Accepts Tuzistra(TM) XR NDA for Full Review

Vernalis plc and Tris Pharma, Inc. announced that the U.S. Food and Drug Administration has confirmed that the New Drug Application for Tuzistra(TM) XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015. Under the exclusive licensing agreement announced in February 2012, Tris is developing, on behalf of Vernalis, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. Tuzistra(TM) XR represents the first product within this pipeline to reach NDA stage. The financial terms of this licensing deal are not disclosed.

Vernalis plc and Tris Pharma, Inc. Announce New Drug Application

Vernalis plc and Tris Pharma, Inc. announced that a new drug application has been submitted to the U.S. Food and Drug Administration for Tuzistra XR (CCP-01), for the acute treatment of cough cold. The FDA has 60 days in which to confirm whether the NDA is accepted for full review, and on receipt of this confirmation a milestone payment to Tris is triggered. CCP-01 represents the first product within this pipeline to reach NDA stage.

Tris Pharma Announces Executive Appointments

Tris Pharma announced two key additions to its' executive team: Sally A. Berry, MD, PhD will join as chief medical officer and Norma Cappetti will join as vice president of regulatory affairs. Prior to joining Tris, most recently Berry was working with Pfizer, and prior to that was chief medical officer of NextWave Pharmaceuticals. Ms. Cappetti joins Tris with over 35 years of experience in the pharmaceutical industry including 25 years in managing and leading regulatory affairs. Ms. Cappetti has both international and domestic regulatory experience and her therapeutic areas of experience include but are not limited to CNS, Respiratory, Cardiovascular and Endocrinology.

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