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April 27, 2015 7:13 AM ET

Biotechnology

Company Overview of TransTech Pharma, LLC.

Company Overview

TransTech Pharma, LLC., a clinical stage pharmaceutical company, engages in the discovery, development, and commercialization of human therapeutics. The company’s Translational Technology is a drug discovery platform that translates the functional modulation of human proteins into medicines. It has a pipeline of small-molecule clinical and pre-clinical drug candidates for the treatment of a range of human diseases, including central nervous system and metabolic disorders, diabetes, obesity, cardiovascular disease, inflammation, and oncology. The company’s products include TTP488, an orally bioavailable compound for the treatment of Alzheimer’s disease; TTP399, a functionally liver selective ...

4170 Mendenhall Oaks Parkway

High Point, NC 27265

United States

Founded in 1998

Phone:

336-841-0300

Fax:

336-841-0310

Key Executives for TransTech Pharma, LLC.

President, Chief Financial Officer and President of High Point Pharmaceuticals, LLC
Age: 57
Chief Scientific Officer and Senior Vice President
Senior Vice President of Chemistry
Senior Vice President of Clinical Development
Senior Vice President of Biometrics & Regulatory
Compensation as of Fiscal Year 2014.

TransTech Pharma, LLC. Key Developments

Calithera Biosciences, Inc. Gains Exclusive, Worldwide License to TransTech Pharma's Hexokinase II Inhibitor Program

Calithera Biosciences Inc. announced an exclusive global license agreement with TransTech Pharma, a clinical stage pharmaceutical company, granting Calithera exclusive world-wide rights to research, develop and commercialize TransTech's portfolio of hexokinase II inhibitors. Hexokinase II is the first and rate-limiting enzyme in the pathway that enables cancer cells to convert glucose to energy and building blocks that feed cancer cell growth. Under the terms of the agreement, Calithera will obtain exclusive, worldwide rights to TransTech's hexokinase II inhibitors for research, development and commercialization. TransTech will receive an upfront payment and will be eligible to receive future development and commercialization milestones as well as royalties on sales of approved products.

TransTech Pharma, LLC Announces Agreement with FDA on Special Protocol Assessment for TTP488 Phase 3 Trial in Patients with Mild Alzheimer's Disease

TransTech Pharma, LLC announced that it has reached an agreement with the U.S. Food and Drug Administration Division of Neurology Products, under the Special Protocol Assessment (SPA) process, on the design of a single Phase 3 trial of TTP488 for the treatment of patients with mild Alzheimer's disease. A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the Phase 3 trial design, planned execution and statistical analyses are acceptable to support regulatory approval. The Phase 3 trial will be a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of TTP488 for the treatment of patients with mild Alzheimer's disease. The trial will compare TTP488 5mg daily to placebo over the course of 18 months of treatment. Approximately 800 patients with mild Alzheimer's disease receiving standard of care (that is acetylcholinesterase inhibitors) will be enrolled. The primary efficacy analysis will be based on the changes in ADAS-cog (Alzheimer's Disease Assessment Scale -- cognitive subscale) and CDR-sb (Clinical Dementia Rating -- sum of boxes). TransTech Pharma anticipates beginning enrollment of patients before the end of 2014.

TransTech Pharma, LLC and High Point Pharmaceuticals, LLC Appoint Stephen L. Holcombe as President

TransTech Pharma, LLC (TransTech) announced that effective March 28, 2014, Stephen L. Holcombe, who previously served as the company's Senior Vice President and Chief Financial Officer, has been appointed to serve as the President of TransTech and its sister company High Point Pharmaceuticals, LLC (High Point). Mr. Holcombe will also continue his duties as Chief Financial Officer. Mr. Holcombe's appointment as the President of the companies follows the resignation by the founder Adnan M.M. Mjalli, Ph.D. from his role as President and Chief Executive Officer of TransTech and High Point effective March 28, 2014. Dr. Mjalli will continue to serve as a member of the Board of Directors of both companies as well as Chief Executive Officer of TransTech's affiliate, High Point Clinical Trials Center, LLC.

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