R&D Keys figures
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The mission of Sanofi-aventis Research and Development is to address patients' real needs – those that are either poorly covered or completely ignored - and provide them with appropriate therapeutic solutions. To fully achieve this objective, the Group launched a transformation program in 2009 to make R&D an innovation driver operating in a new environment that would stimulate creativity, openness and higher performance.
Innovation stands at the heart of Research activities, operating through acquisitions, partnerships and close scientific collaboration with academia and biotechnology research institutions.
In 2009, sanofi-aventis devoted €4,583 million to R&D. Eighteen R&D partnerships or licensing agreements were signed and two acquisitions were made. Sixty percent of the company’s portfolio consists of biological products and vaccines, and 55% of compounds from external research
Advanced stage R&D portfolio - Pharmaceuticals and Vaccines
The R&D portfolio contains projects in various stages of clinical development, some of them fairly advanced (stage III) or in the process of seeking marketing authorization from health authorities.
After streamlining (Eplivanserin submission has been withdrawn as the benefit/risk ratio did not reach the expectations), the R&D portfolio in Feb, 2010 comprises 49 projects in clinical development, 17 of them either in Phase III (including seven Vaccine projects) or pending requests for authorization from health authorities.
Products submitted for approval include:
- The vaccine IMOJEV® (Japanese Encephalitis) in Asia-Pacific.
- Plavix® in the prevention of major vascular events in patients with atrial fibrillation who cannot take oral anticoagulant medication
- Humenza™ the adjuvanted A(H1N1) monovalent influenza vaccine in the European Union (which received a positive opinion from the CHMP on 19/02/2010).
- Pediacel®, the 5-in-1 combination of pediatric vaccines in the European Union*.
Several other projects have benefited from the FDA "fast track" procedure to make a rolling submission using updated product data.
- Cabazitaxel a tubulin inhibitor, in the second-line treatment of prostate cancer.
- BSI-201, a PARP-1 inhibitor, in the treatment of triple negative metastatic breast cancer.
Otamixaban, (an injectable selective direct inhibitor of activated coagulation factor Xa) is now in Phase III for the treatment of patients with moderate to high risk patients with UA/NSTEMI with planned early invasive strategy.
Approvals received in 2009
Multaq® was approved in the United States, the European Union, Switzerland, Canada, Brazil and Mexico. Sculptra® has been approved by the FDA for a new cosmetic dermatology indication, while ClikSTAR®, the new rechargeable pen for Lantus® insulin, has been approved in Europe and Canada. The non-adjuvanted monovalent H1N1 pandemic flu vaccine has been approved in the United States and Panenza™ in the rest of the world. Fluzone® High Dose was licensed by the FDA and is available for people aged over 65.
Among other 2009 highlights, the FDA gave approval for the wording on the labeling of Lantus® insulin concerning the favorable results of a 5-year study comparing the effect of Lantus® to that of NPH insulin on the progression of retinopathy in patients with type 2 diabetes. Elitek® (rasburicase) has been approved by the FDA for the treatment of hyperuricemia in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. The product was also approved in Japan in October under the name of Rasuritek®.
All projects in late phases of development
R&D Portfolio as of February 10, 2010
Early stage R&D portfolio - Pharmaceuticals and Vaccines
Each year, clinical development launches and carries out hundreds of clinical trials for the Group’s drugs and vaccines so as to support the most promising projects at an early stage.
On February 10 2010, the Phase I and II portfolio included 32 projects (11 of them for Vaccines), some of which derive from exclusive global agreements for licenses and collaboration with external companies.
For example, an agreement was signed with the American biotechnology company Merrimack for the MM-121, currently in Phase 1 in solid tumors as well as with Wellstat Therapeutics for PN2034, an innovative new oral insulin sensitivity agent for the treatment of type 2 diabetes. The compound is currently in clinical development Phase II. At the same time, collaboration with Regeneron Pharmaceutical Inc. has been broadened and extended in time to enable the research, development and marketing of monoclonal antibodies. Sanofi Pasteur has also signed an exclusive licensing agreement with World Syntiron for the development and marketing of a prophylactic vaccine against staphylococcal infections.
Promising candidates now in Phase I include:
- The monoclonal anti-PCSK9 (SAR236553), evaluated for the treatment of hypercholesterolemia, due to our partnership with Regeneron.
- The monoclonal anti-IL4 (SAR231893) for the treatment of asthma and atopic dermatitis also due to our partnership with Regeneron.
- The SAR161271, a promising long-acting form of insulin for diabetes.
- A candidate vaccine (multiprotein formulation) against streptococcus pneumonia, a vaccine (antibody fragments) against Pseudomonas aeruginosa and a rotavirus vaccine developed by Shantha.
All projects in early phases of clinical development
R&D Portfolio as of February 10, 2010
