Novartis granted exclusive rights for development and commercialization of a novel insulin sensitizer from Dr. Reddy's
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Novartis Pharma AG and Dr. Reddy's laboratories Ltd announced today that they have entered a licensing agreement for a novel anti-diabetes agent. Under terms of the agreement Dr. Reddy's will grant Novartis worldwide exclusive rights to development and commercialization of their insulin sensitizer DRF 4158 in type 2 diabetes, in return for up to 55 million US dollars in upfront and milestone payments for specific clinical and regulatory endpoints, as well as royalties. Dr. Reddy's will have co-promotion rights for DRF 4158 in India. The agreement is subject to regulatory clearance in the United States.
Type 2 or non-insulin dependent diabetes affects about 120 - 140 million people world-wide and is a serious disease with increasing numbers of people being afflicted in both first and developing world countries. Dr. Reddy's compound, DRF 4158, belongs to a new class of anti-diabetic drugs called insulin sensitizers, and is a second-generation dual acting peroxisome proliferator activated receptor (PPAR) alpha and gamma agonist for the potential treatment of Type 2 diabetes, diabetic dyslipidemia, hypertension and obesity. DRF 4158 is currently in preclinical evaluation, prior to its entry into clinical trails in humans.
"The licensing agreement with Dr. Reddy's gives Novartis an excellent opportunity to work with one of India's premier pharmaceutical research groups. DRF 4158 is an important addition to our preclinical pipeline in the metabolic diseases area, and contributes an insulin sensitizing compound to further strengthen our portfolio of drugs for diabetes," said Dr Joerg Reinhardt, Head of Development, Novartis Pharma AG.
Commenting on the agreement, Dr K. Anji Reddy, Chairman of Dr. Reddy's said, "This is a very significant event in the evolution of Dr. Reddy's as a research-based pharmaceutical company. We are indeed thrilled to be partnering with Novartis, a company I personally admire."
This release contains certain forward looking statements that can be identified by the use of forward-looking terminology such as "novel", "new", "potential" and "predicted". There are no guarantees that the aforementioned agreement will result in a new anti-diabetes drug or any subsequent commercialization of any product in any market. Any such commercialization can be affected by, among other things, uncertainties relating to product research and development, clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other intellectual property protection and competition in general. Any of these and other factors can cause the actual results to differ materially from the expected or predicted results.
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