July 25, 2017 10:13 AM ET

Pharmaceuticals

Company Overview of Tris Pharma, Inc.

Company Overview

Tris Pharma, Inc., a specialty pharmaceutical company, researches, develops, manufactures, and markets over-the-counter, Rx branded, and specialty generic products in the United States. The company develops extended release formulations for products intended for children, seniors, and adults who have difficulty swallowing pills and require multi-dose treatment. It also offers OralXR+, a particulate-based technology in which millions of small particles deliver the drug over time; Nobuse, an abuse resistant proprietary technology; and specialty generic products in immediate and extended release versions. In addition, it offers Lipisol for lipophilic/insoluble drugs (log P 1 to 5) as liquid-fil...

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
Vice President of Operations & Technical Services
President of Generic Pharmaceuticals Business
Age: 53
Chief Medical Officer
Senior Vice President of Corporate Development - Pediatric Business
Age: 54
Compensation as of Fiscal Year 2017.

Tris Pharma, Inc. Key Developments

Tris Pharma, Inc. Announces Executive Changes

Tris Pharma, Inc. (Tris) announced that it has appointed Paul Rogers as its new Chief Commercial Officer to lead Tris' brand business. Paul has worked for both large and small pharma companies, and brings more than 25 years of industry experience – first in clinical research and then in commercial roles. He has led commercialization of well-known, successful brands such as Nexium, Crestor, Vyvanse and most recently Linzess. Sharon Clarke, who until recently served as Chief Commercial Officer, will transition to a newly created position of Senior Vice President, Corporate Development of Pediatric Business. In this role, Sharon will focus on enhancing Tris' pediatric portfolio and pipeline.

Tris Pharma, Inc. Announces Results from Laboratory Classroom Study of DYANAVEL XR in Children with ADHD Featured

Tris Pharma, Inc. announced that results from a laboratory classroom study of DYANAVEL XR (amphetamine) extended-release oral suspension, CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six years and older, were presented at the 2017 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting held in Washington, D.C. The study concluded that DYANAVEL XRwas effective in reducing symptoms of ADHD from one to 13 hours after dosing in children aged six to 12 years, with a safety profile similar to other extended-release amphetamines. Key findings include: DYANAVEL XR met its primary endpoint of change from pre-dose in the SKAMP-Combined score at 4 hours post-dosing (P<0.0001). DYANAVEL XR also met key secondary endpoints by demonstrating an onset of clinical effect at one hour that persisted through 13 hours post-dosing compared to placebo. DYANAVEL XR was well tolerated in this study, with a safety profile similar to other extended release amphetamines. DYANAVEL XR received approval from the U.S. Food and Drug Administration (FDA) in October 2015. Based on clinical trial experience with DYANAVEL XR, side effects appear to be similar to other once-daily ADHD medicines with the same active ingredient. The most common (=2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%). As is the case with other stimulant medications because of its potential for abuse, DYANAVEL XR is classified as a controlled substance (CII).

Vernalis plc and Tris Pharma, Inc. Announce FDA Acceptance of CCP-08 NDA for Full Review

Vernalis plc and Tris Pharma, Inc. (Tris) are announced that the U.S. Food and Drug Administration (FDA) has accepted the CCP-08 New Drug Application (NDA) 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 4 August 2017. Under the exclusive licensing and collaboration agreement announced in February 2012, Tris is developing up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments for the US market. CCP-08 is the third product from this pipeline to be accepted for full NDA review. The first product, Tuzistra XR, was approved by the FDA in April 2015 and was launched by Vernalis in September 2015 by a dedicated sales force. The second product, CCP-07, was accepted for full review by FDA in September 2016 and has a PDUFA date of 20 April 2017.

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