HIGH POINT, N.C. & NEW YORK—TransTech Pharma Inc. and Forest Laboratories Inc. have entered into a license agreement for the development and commercialization of small molecule compounds discovered and developed by TransTech Pharma that are functionally liver-selective glucokinase activators (GKAs). In addition to representing a novel class of glucose-lowering agents for the treatment of diabetes, the deal also represents a potentially billion-dollar-plus deal.
The deal, which is between TransTech Pharma and Forest Laboratories Holdings Limited—a wholly owned subsidiary of Forest Laboratories Inc.—involves Forest providing to TransTech an upfront license payment of $50 million. Ultimately, though, TransTech 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 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 preclinical stages of development.
"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," says Dr. Adnan M. M. Mjalli, founder, chairman and CEO of TransTech Pharma. "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."
Mjalli also notes the his company and Forest Laboratories are encouraged by early data that suggests potential additional decreases in serum lipids that tend to be elevated among patients with diabetes.
"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," says Howard Solomon, chairman and CEO of Forest. "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."
Glucokinase is an enzyme localized in the pancreas and in the liver, acting as a glucose sensor and having 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.
According to Mjalli, 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.
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.
The deal, which is between TransTech Pharma and Forest Laboratories Holdings Limited—a wholly owned subsidiary of Forest Laboratories Inc.—involves Forest providing to TransTech an upfront license payment of $50 million. Ultimately, though, TransTech 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 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 preclinical stages of development.
"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," says Dr. Adnan M. M. Mjalli, founder, chairman and CEO of TransTech Pharma. "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."
Mjalli also notes the his company and Forest Laboratories are encouraged by early data that suggests potential additional decreases in serum lipids that tend to be elevated among patients with diabetes.
"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," says Howard Solomon, chairman and CEO of Forest. "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."
Glucokinase is an enzyme localized in the pancreas and in the liver, acting as a glucose sensor and having 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.
According to Mjalli, 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.
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.
