Forest Laboratories, Inc. and TransTech Pharma, Inc. Enter Into License Agreement for the Development and Commercialization of Glucokinase Activators; Deal Valued at Up to $1.105 Billion
Through the license agreement, Forest will provide to TransTech Pharma an upfront license payment of $50 million. TransTech Pharma could receive up to $1.105 billion in upfront and milestone payments for the successful development and commercialization of the GKA compounds. Forest will also pay TransTech Pharma royalties on worldwide product sales and will be responsible for development and commercialization costs. TransTech Pharma retains the rights to the Middle East and North Africa, while Forest receives exclusive rights to the rest of the worldwide market. The portfolio licensed by Forest consists of a lead compound, TTP399, which has completed Phase I studies and other compounds in Phase I and pre-clinical stages of development.
Adnan M. M. Mjalli, Ph.D., Founder, Chairman and Chief Executive Officer of TransTech Pharma, said, “We are excited to be partnering our GKA program with Forest. We selected Forest because of its highly dedicated team and leadership that bring a wealth of experience and resources to our compounds. Forest is driven by entrepreneurial spirit, innovation and dedication. We believe this novel class of compounds has the potential to be a major therapeutic advance in the treatment of diabetes. Our GKAs are specifically selected to improve glycemic control without exerting pressure on the pancreas to produce insulin. We are encouraged by early data suggesting potential additional decreases in serum lipids which tend to be elevated in diabetic patients.”
Howard Solomon, Chairman and Chief Executive Officer of Forest, said, “We are pleased to partner with TransTech Pharma for this novel and exciting program. Diabetes is a serious disease with a substantial need for new treatments. We are impressed with TransTech’s experience in selecting liver targeted GKAs that have the potential to contribute to diabetic control without increasing the risk of hypoglycemia. The program may offer a unique and compelling new therapeutic option for the millions of patients who suffer from diabetes and we look forward to advancing it through development.”
About Glucokinase and TransTech Pharma GKA Compounds
Glucokinase is an enzyme localized in the pancreas and in the liver. It acts as a glucose sensor and has an important role in the regulation of blood glucose levels. In the pancreas, glucokinase controls insulin secretion, whereas, in the liver, glucokinase is a major regulator of glucose metabolism, increasing glucose utilization under hyperglycemic conditions. TransTech Pharma has identified a series of liver selective GKA compounds and has advanced three compounds to Phase I trials with one compound ready to start Phase II trials. Multiple observations suggest that a reduction in hepatic glucose utilization might contribute to the hyperglycemia observed in humans with Type II diabetes. Thus, the pharmacological enhancement of glucokinase activity may lower blood glucose in diabetic patients. Moreover, by activating glucokinase selectively in the liver but not in the pancreas, it may increase glucose utilization and lower blood glucose levels without inducing excessive insulin secretion thus reducing the risk of hypoglycemia. Data from early clinical experiments with TransTech Pharma GKA compounds indicate that the licensed GKAs appear to be well tolerated with no evidence of hypoglycemia. Furthermore, testing to date shows that oral administration of the compounds reduced fasting blood glucose levels. TransTech Pharma’s compounds are covered by composition of matter patents and applications which, in the case of the lead compound TTP399, extend to 2025 with additional patent term extension available.
About TransTech Pharma
TransTech Pharma is a privately held clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. The Company’s high-throughput drug discovery platform, Translational Technology®, translates the functional modulation of human proteins into safe and effective medicines. TransTech Pharma has a pipeline of small molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases, including central nervous system disorders, Type I and Type II diabetes, obesity, cardiovascular and cancer. For further company information, visit http://www.ttpharma.com.
About Forest Laboratories
Forest Laboratories, Inc. (NYSE: FRX - News) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Contact:
TransTech Pharma, Inc. Stephen L. Holcombe, 336-841-0300 ext 150 Senior Vice President and Chief Financial Officer sholcombe@ttpharma.com or Forest Laboratories, Inc. Frank J. Murdolo, +1-212-224-6714 Vice President - Investor Relations Frank.Murdolo@frx.com