Wednesday, September 18, 2013

Servier in licensing pact with SIMM for the development in China of lucitanib

Servier has signed an agreement with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, (SIMM)  for the development in China of lucitanib, a promising targeted anti-tumor drug with antiangiogenic effects. The drug has demonstrated impressive efficacy in PhI/PhII trials in metastatic breast cancer patients

In heavily pre-treated breast cancer patients, lucitanib (E-3810) demonstrated an objective responses in 7 out of 10 women with evaluable breast cancer presenting alteration of FGFR pathway. Lucitanib is a kinase inhibitor which targets fibroblast growth factor receptor 1-2 (FGFR1-2), and vascular endothelial growth factor receptor-1-3 (VEGFR-1-3). This unique activity profile confers on lucitanib specific antitumor activity in FGFR1-2 dependent tumors and a strong antiangiogenic effect. Results presented at the European Society for Medical Oncology 2012 Congress on the breast cancer cohort of a Phase-I study put lucitanib firmly on the list of the most promising breakthroughs in oncology.

In September last year, Servier acquired the worldwide rights for lucitanib except for the People’s Republic of China, Japan and the United States from Ethical Oncology Science (EOS). Servier had paid Euro 45 million to EOS as upfront payment. EOS would also receive undisclosed milestone payments.
Today was announced that Servier will extend its rights to China in sealing a collaboration and license agreement with SIMM and other stake holders in China, notably ADVENCHEN and SFFT.
The aim of the present agreement between SIMM and Servier is to provide evidence of the clinical benefits of lucitanib in specific Chinese indications through national clinical studies involving Haihe Pharmaceuticals, a local pharmaceutical company created by SIMM.
In addition, SIMM will conduct specific research in biomarkers and support Servier regarding the participation of China in international clinical studies. Under the terms of this agreement, SIMM and Servier will be co-owners of the marketing authorizations for the People’s Republic of China.
Dr Jean-Philippe Seta, CEO at Servier World declared, “Lucitanib has a high therapeutic potential for cancer, and we are proud to work now with SIMM to bring such an innovation to Chinese patients. The pattern of our coming collaboration is unique since it will embrace global and national study programs, clinical development and biomarker research.”
Pr GENG Meiyu, Deputy Director of SIMM, declared: “With its tyrosine kinases inhibition profile, lucitanib is a good candidate for targeted therapy and personalized medicine, it is therefore of importance to include biomarker development programs in our collaboration with Servier.”
Dr Emmanuel Canet, President Research & Development at Servier recalled that SIMM and Servier have collaborated for 15-years in academic research and drug discovery, and added: “We are glad to see this collaboration now extended to clinical development and biomarker research. Important Chinese studies will soon contribute to the overall understanding of lucitanib therapeutic potential and will help us positioning it in the anti-cancer armamentarium.”
Pr DING Jian , Academician of the Chinese Academy of Engineering and Director of SIMM and one of the inventors of lucitanib in China, concluded that the clinical studies of lucitanib in China would follow the most advanced clinical protocols and that the success of lucitanib in China would bring great benefits to the Chinese patients. Pr DING added “this project is the first clinical candidate through SIMM-Servier long-term collaboration and we expect to deliver more and more fruitful results in our on-going collaboration projects.”
About tyrosine kinase receptor
In humans there are 23 proteins in the fibroblast growth factors family. There are 4 receptors for these FGF: FGFR 1/2/3/4 (FGFR, R standing for receptor).
Tumor cells express receptors for FGF in various cancers: FGFR1 is expressed in 10 to 20% of cases of breast cancers; and in 5 to 10% for NSCLC.
These receptors display tyrosine kinase enzymatic activity; so a kinase inhibitor like lucitanib is a good candidate for a targeted anti-tumor approach in patients with tumor cells that express FGF receptors.
About SIMM
Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences (CAS) evolved from the Institute of Materia Medica of Peking Academy of Sciences founded in 1932.
Through several generations of effort, SIMM has become one of the leading interdisciplinary research centers in China. It is recognized worldwide for its outstanding achievements in both basic and applied research fields.
Its current location is in the Zhang Jiang Hi-Tech Park, Pudong New District.
SIMM’s mission is to provide comprehensive solutions in drug discovery and development. By combining basic and applied research efforts and through cross-fertilization between chemistry and biology, scientists at SIMM carry out studies toward the elucidation of the structural basis of bioactive substances, discovery of new targets or mechanisms of action, comprehensive pre-clinical evaluation of drug candidates, and promotion of commercialization, thereby playing an indispensable role in building China’s drug innovation capabilities.
The major research fields of SIMM include drugs against diseases seriously endangering the health of Chinese people, like tumors, cardiovascular diseases, neurological diseases, metabolic diseases, autoimmune diseases, as well as infectious diseases. Another task of SIMM is to strengthen research and development of Traditional Chinese Medicine (TCM). 
SIMM ranks at the top in China for its drug discovery and development activities. More than 70 drugs have been developed since its establishment. Of these, 10 have been listed in the Chinese Pharmacopoeia.
Supported by the Ministry of Science and Technology of China, CAS and Shanghai Municipality, a number of drug candidates are currently under pre-clinical evaluation.

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