R&D Keys figures
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So as to respond more effectively and more rapidly to patient needs, sanofi -aventis is refocusing and streamlining its R&D strategy. This reorganization of the R&D portfolio is designed to channel resources to projects with the greatest potential for success in the current business environment. The Group invested 4.6 billion euros in R&D in 2008, The R&D structure at sanofi-aventis promotes a culture of sharing expertise and experience among multicultural team.
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R&D Portfolio in late stage – Pharmacy and Vaccines
The R&D portfolio comprises projects in different phases of clinical development, of which some in late stages (phase III) or submitted to health authorities for approval.
Among the various projects which recently entered Phase III, there are:
- the IMOJEV™ vaccine (Japanese encephalitis)
- the micro-injection influenza vaccine
- BSI-201, a PARP inhibitor developed by Bi-Par Sciences (a company recently acquired by sanofiaventis) entered Phase III in July 2009 to evaluate the product in association with chemotherapy in women with metastatic triple negative breast cancer.
In the first quarter of 2010, otamixaban (injectable, selective direct inhibitor of coagulation factor Xa) is due to enter Phase III. Results from Phase II study showed a clinically significant reduction in complications in the invasive management of acute coronary syndromes, with a similar safety profile to that of existing treatments.
Among the applications for approval, the application of Ciltyri® (eplivanserin), in the treatment of sleep disorders, was submitted to the FDA and the EMEA during the fourth quarter of 2008 and accepted for filing.
In July 2009, FDA approved Multaq® to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter. In September 2009, the CHMP (Committee for Medicinal Products for Human Use) issued a positive opinion recommending the granting of marketing authorization for Multaq® in the European Union. Multaq® has also been approved in Canada and Switzerland.
A submission for approval of Plavix® in the prevention of major vascular events in patients with atrial fibrillation who cannot take oral anticoagulant medication (based on the results of the ACTIVE-A study) was filed in Europe in October. A similar submission will be filed in the United States by end 2009.
Many products have been approved in particular Sculptra® which was approved by the FDA in a new indication (aesthetic dermatology) as well as ClikSTAR®, the new rechargeable insulin pen, approved in Europe and Canada. In September 2009, the monovalent AH1N1 pandemic influenza vaccine was licensed in the United States.
Among the others highlights there was, in October 2009, the FDA approval for the inclusion in the Lantus® labeling of favourable results from a 5-year study comparing the effect of Lantus® with that of NPH insulin on the progression of retinopathy in patients with type 2 diabetes. During the same period, Elitek® was approved by FDA for the management of hyperuricemia in adults suffering from leukemia, lymphoma or solid malignancies who are receiving anti-cancer treatments that carry a risk of inducing tumor lysis syndrome and hence hyperuricemia. This product was approved in Japan under the name Rasuritek®.
All projects in late phases of development
R&D Portfolio as of October 30, 2009
R&D Portfolio in early stage – Pharmacy and Vaccines
Each year, Clinical Development begins and carries out several hundred clinical trials for the Group's drugs and vaccines.
The R&D portfolio is also boosted by exclusive worldwide licenses and collaborations agreement with external societies. Thereby, an agreement was signed why a US biotechnology company Merrimack related to MM-121, currently in Phase I for solid malignancies and also with Wellstat Therapeutics for PN2034, a novel oral first-inclass insulin sensitizer for the treatment of type 2 diabetes. The compound is currently in Phase II clinical testing.
After the acquisition in October 2009 of the French biopharmaceutical company Fovea, specialized in ophthalmology, many news compounds entered the portfolio:
- FOV 1101, a fixed dose combination of prednisolone and cyclosporine in eye-drop form, currently in Phase II for the treatment of persistent allergic conjunctivitis;
- FOV 2302, a recombinant peptide plasma kallikrein inhibitor, in Phase I for the treatment by intravitreal injection of Retinal Vein Occlusion induced macular oedema;
- FOV 2304, a potent antagonist of bradykinin B1 receptors in eye-drop form, scheduled to enter Phase I by end 2009 for the treatment of diabetic macular oedema.
All projects in early phases of clinical development
R&D Portfolio as of October 30, 2009
New approaches and partnerships
Our R&D strategy is focusing on key technologies and diseases to better serve the needs of patients. Our internal R&D division is organized to maximize flexibility and innovation.
Biotechnology, genomics and proteomics are the pathways of future research, areas that sanofi-aventis has already begun to explore. The Group has entered into a number of collaboration agreements with both public and private research organizations and biotechnology companies. To strengthen Discovery Research, the Group has set up two types of alliances: technological partnerships (for access to new technologies) and product-based partnerships, which make it possible to explore new opportunities in the Group's spheres of excellence.
A Scientific Advisor contributes to the R&D decision making process related to the portfolio and strategy, particularly in the creation of partnerships.
