Eli Lilly and Company and Transition Therapeutics Inc. said that the two companies have entered into a licensing and collaboration agreement granting Lilly exclusive worldwide rights to develop and commercialise Transition's gastrin based therapies, including the lead compound TT-223, which is currently in early phase II testing.
Gastrin based therapies are an emerging class of potential disease-modifying therapies for patients with diabetes, and have been shown to provide sustained improvement in glycemic control in preclinical models and early clinical studies. Sustained improvement in glycemic control is a key goal for patients with diabetes in order to alleviate the symptoms of hyperglycaemia and to prevent diabetic complications, thereby improving their overall quality of life.
Under the terms of the agreement, Transition will receive a $7 million upfront payment, and may also receive up to $130 million in potential development and sales milestones, as well as royalties on sales of gastrin based therapies if any product is successfully commercialised. Transition and Lilly will both participate in the currently planned phase II clinical trial with lead compound TT-223 in type 2 diabetes. Thereafter, Lilly will be responsible for further development activities and the commercialization of all gastrin based therapeutic products worldwide. Other terms of the deal were not disclosed.
"This agreement represents an exciting new direction for Lilly's diabetes care research," said David Moller, M.D., Lilly, vice president of endocrine and cardiovascular research and clinical investigation. "We plan to leverage Transition's experience in gastrin based therapies with our own internal expertise, including Lilly's strong biotechnology discovery platform, to continue our mission to develop innovative, beneficial and cost-effective treatments for patients with diabetes."
The gastrin based therapies programme is focused on the development of gastrin analogues, alone or in combination with approved or experimental diabetes agents as potential disease modifying therapies for diabetes patients. Preclinical data in diabetes animal models demonstrate the efficacy of gastrin analogues alone, or in combination with GLP-1 analogues or epidermal growth factor analogues. In humans, Transition's recent phase IIa clinical trial data showed that 4-weeks of E1-I.N.T. therapy (combination of gastrin analogue, TT-223, and an epidermal growth factor analogue) in type 2 diabetes patients resulted in sustained reductions in blood glucose control parameters, including haemoglobinA1C, for 6 months post-treatment. These data suggest that gastrin based therapies might have an important role in beta cell differentiation and function, capable of providing sustained glucose control in type 2 diabetes.
"We are very pleased to enter into this strategic collaboration with Lilly, a recognized leader in diabetes care. Lilly has industry-leading clinical and commercial development capabilities in diabetes that are ideally suited to maximize the potential of the multiple gastrin based therapy opportunities," said Dr. Tony Cruz, chairman and chief executive officer, Transition.