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Teijin and Chugai enter an agreement to co-develop Ipsen's anti-diabetic medicine in Japan |
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24 Aug 2007 |
Teijin Pharma Limited and Chugai Pharmaceutical Co., Ltd. announced today that they have concluded a collaboration agreement to develop an anti-diabetic drug
TOKYO, Japan | August 23, 2007 | Teijin Pharma Limited ("Teijin"; headquarters: Chiyoda-ku, Tokyo; President: Shigeo Ohyagi) and Chugai Pharmaceutical Co., Ltd. ("Chugai"; headquarters: Chuo-ku, Tokyo; President and CEO: Osamu Nagayama) announced today that they have concluded a collaboration agreement to develop an anti-diabetic drug ITM-077 (Ipsen development code: BIM 51077, Roche and Chugai development code: R1583) in Japan originated by Ipsen (stock code Euronext: IPN), an innovation driven international specialty pharmaceutical group ("Ipsen"; headquarters: Paris, France; Chairman and CEO: Jean-Luc Belingard).
Teijin has been granted by Ipsen rights to co-exclusively develop, sell, market and promote ITM-077 in Japan with Ipsen's global partner under an agreement executed in July 2003 between Teijin and Ipsen. Until now, Teijin has been conducting the development of ITM-077 by itself and now expects, through collaboration with Chugai, to speed up the development, aiming at getting early regulatory approval.
F. Hoffmann-La Roche Ltd, the strategic alliance partner of Chugai, ("Roche"; headquarters: Basel, Switzerland; Chairman and CEO: Franz B. Humer) and Ipsen entered into an agreement for ITM-077 in October 2003, under which Roche obtained an option right to develop and sell ITM-077 worldwide exclusively except for co-exclusive rights in Japan and France. Roche exercised its option in July 2006, and licensed its rights in Japan to Chugai in an agreement executed in December 2006. Chugai is now committed to smoothly start the development of ITM-077 (R1583) in Japan, by closely working with Teijin.
About ITM-077
ITM-077 is a long acting analogue of the peptide hormone, GLP-1 (Glucagon like Peptide 1) which increases the level of insulin in response to elevated glucose levels, thus reducing the risk of hypoglycemia. A formulation based on Ipsen's proprietary technology will allow ITM-077 to maintain a longer duration of action and to be administered subcutaneously weekly or biweekly, while the currently available anti-diabetic drugs have to be administered daily. We therefore expect that ITM-077 will be an innovative therapy for patients with type-2 diabetes if the efficacy and safety are proven through the clinical development.
Outline of the agreement
(1) Teijin and Chugai will jointly develop ITM-077, by sharing the information and data, and the development cost.
(2) Teijin and Chugai will independently market and promote it under different trademarks after approval.
Development plan
ITM-077 is now in Phase I in Japan and Roche is conducting Phase II outside Japan. Teijin and Chugai are now working together to establish a co-development plan for ITM-077.
About diabetes
(1) Blood glucose concentrations of healthy people are controlled and kept within a certain appropriate range. However, those of patients with diabetes rise beyond the normal level due to poor control of blood glucose levels resulted from (i) destruction of insulin producing cells (type-1), or (ii) impaired insulin secretion and/or reduced insulin sensitivity in target tissues (type-2).
(2) Insulin is an important hormone responsible for controlling blood glucose level. When there is an increase in blood glucose, insulin is secreted from pancreas. Then it acts to increase intake of glucose from blood stream to the liver, muscle and adipose tissue (fat), and the blood glucose level immediately returns to normal. In recent years it has been understood that type-2 diabetes patients tend to have reduced GLP-1 secretion.
Market Needs
(1) The number of patients with diabetes has been on the rise worldwide. In Japan, it is estimated that approximately 16,200,000 people are either (i) strongly suspected as diabetes (6.1%=<hemoglobin A1c or being treated for diabetes) or (ii) not denied to have possibility as diabetes (5.6%=<hemoglobin A1c<6.1% and not being treated for diabetes) according to a survey report conducted by MHLW in 2002.
(2) In the early stages of type-2 diabetes, the blood glucose levels can be controlled with diet and exercise. As the disease progresses patients are treated first with oral anti diabetic drugs and then further insulin therapy may be used. Since excessive secretion or injection of insulin have potential risks of hypoglycaemia, there is a need for a drug like ITM-077 which can control insulin secretion in response to elevated blood glucose level and maintain its efficacy for prolonged duration.
SOURCE: Chugai Pharmaceutical Co., Ltd. |
