Forest Laboratories & TransTech Pharma Enter Into License Agreement for the Development & Commercialization of Glucokinase Ac...
June 08 2010 - 8:00AM
Business Wire
TransTech Pharma, Inc and Forest Laboratories, Inc. (NYSE: FRX),
today announced that TransTech Pharma and Forest Laboratories
Holdings Limited, a wholly owned subsidiary of Forest Laboratories,
Inc. have entered into a license agreement for the development and
commercialization of small molecule compounds discovered and
developed by TransTech Pharma. These compounds are functionally
liver-selective Glucokinase Activators (GKAs), which represent a
novel class of glucose-lowering agents for the treatment of
diabetes.
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.
TransTech Pharma, Inc. Stephen L. Holcombe Senior Vice President
and Chief Financial Officer 336-841-0300 ext 150
sholcombe@ttpharma.com
About Forest Laboratories
Forest Laboratories, Inc. (NYSE: FRX) 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.
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