Lilly and Transition Therapeutics Announce Licensing and Collaboration Agreement

Lilly to Acquire Exclusive Rights to Gastrin/GLP-1 Based Therapies Program for Diabetes. 

Eli Lilly and Co., is soon to loose it’s top selling drugs to generics and management has decided to go back to it’s roots and invest hundreds of millions of dollars into its diabetes business,  its oldest franchise, in an effort to find better treatments for what is becoming a worldwide epidemic of the debilitating disease.

In the past 18 months, Lilly has launched five new injection pens, including one with computerized memory, to try to boost sales of its insulins. It has given more than $30 million in grants to hospitals and foundations for diabetes research and programs. It has expanded its marketing outreach program targeting people at high risk for the disease.

Meanwhile, it is replenishing its diabetes pipeline with a batch of licensing deals. Last fall, Lilly bought the rights to a molecule being tested by a Maryland biotechnology company for treatment of Type 1 diabetes. On Thursday, Lilly said it has bought the rights to develop the therapies being developed by Transition Therapeutics a Toronto biotech company specializing in diabetes research. And it is pushing ahead with testing of its own compounds for treatment of Type 2 diabetes.

Eli Lilly and Company and Transition Therapeutics Inc. announced that the two companies have again entered into a licensing and collaboration agreement granting Lilly exclusive worldwide rights to develop and commercialize 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.

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 commercialized. 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.

"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 program 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 hemoglobinA1C, 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.
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DID YOU KNOW:
J&J diabetes training institute makes debut: Johnson & Johnson opened its first diabetes institute in the United States, a training facility outside San Francisco the company hopes will improve care of the disease. The institute, located on the campus of J&J’s Lifescan subsidiary in Milpitas, Calif., will offer intensive, two-day training sessions for doctors, nurses and educators. The courses are being offered twice a week, 52 weeks a year, according to Kenneth Moritsugu, a former acting Surgeon General and chairman of the Johnson & Johnson Diabetes Institute. The New Brunswick health-care conglomerate has already opened a diabetes institute in Tokyo, and has plans for others in France and China. All of the centers will have courses tailored to local conditions, Moritsugu said. Participants will learn about new technology, discuss reimbursement issues and explore challenges patients face. Trainees, for example, will wear an insulin pump for 24 hours to experience the advantages and limitations of the equipment firsthand.  J&J hopes to train 2,500 people in the United States each year. Since plans for the four institutes were announced last October, the company has heard from 4,000 health-care professionals around the nation who were interested in the courses.

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