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Sanofi also helps structures and organizations develop their products commercially beyond national borders. If you are in the early stage of your international expansion or want to make the international expansion of your products certain, we can help. We have the expertise and know-how to market your products.
Sanofi and Regeneron: a successful long term partnership
Our partnership with Regeneron, a leading US biopharmaceutical company, is a perfect illustration of our long-term commitment to our partners. It has grown steadily over the years since its 2007 inception. Strong ties have been forged and there has been a fusion of cultures, leading to the delivery of new products in many therapeutic areas: cardiovascular, metabolism, neurology, anti-cancer, dermatology, immunology, infectology, ophthalmology, respiratory and technology.
The collaboration comprises a Discovery Research Agreement under which Regeneron and Sanofi identify targets and Regeneron then generates related antibodies and conducts pre-clinical development until the IND filing. The partnership also includes a License and Collaboration Agreement setting out the antibodies selected by Sanofi for joint development. Sanofi opts-in at IND stage the antibodies that will be developed further.
Amongst the key products co-developed since 2007, the following could have a tremendous positive impact on the lives of many patients:
Alirocumab, the PCSK9 mAb to lower LDL cholesterol
The control of cholesterol is one of the key defenses against risks of heart attack or cardiovascular disease, one of the leading causes of death in the world. Using Regeneron’s innovative Veloclmmune technology, Sanofi developed PCSK9, an antibody that can help people who are unable to control their cholesterol rate. PCSK9 is a fully human monoclonal antibody administered via subcutaneous injection. It can have a significant impact on the life of many patients. George D.Yancopoulos, M.D.,Ph.D., Regeneron’s Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories, explains : “We believe that the expertise of Regeneron, in the field of discovery and development of antibodies associated with Sanofi’s experience in clinical development and self-injection devices, will facilitate making available this new treatment as quickly as possible to patients who cannot reach their target LDL-C, ...”.
Sarilumab, the anti IL-6 mAb for Rheumatoid Athritis
Rheumatoid arthritis is a chronic systemic autoimmune disease affecting approximately 0.5% to 1% of the global adult population. It causes inflammation in the joints with resulting swelling and pain around the affected joints and loss of normal movement. Around one quarter of the patients affected by rheumatoid arthritis are treated with an anti-TNF and do not respond to the treatment. Sanofi and Regenron are working on the development of Sarilumab, a fully human monoclonal antibody. Administered via subcutaneous injection, it is directed against the alpha subunit of the IL-6 receptor complex (IL-6R∝), which contributes to the inflammatory mechanism of rheumatoid arthritis. It blocks the binding of IL-6 to its receptor, so interrupting the resultant cytokine-mediated inflammatory signaling cascade. Sarilumab has been developed using Regeneron VelocImmune® antibody technology. “The MOBILITY results provide evidence that IL-6R blockade with sarilumab represents a promising new anti-inflammatory investigational therapy for reducing RA disease symptoms. We are very pleased that the first of our novel VelocImmune® derived antibodies is poised to enter phase 3 development,” comments George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories.
Dupilumab, the anti IL-4 mAb for atopic dermatitis and severe asthma
Atopic dermatitis is a chronic inflammation of the skin that can causes intolerable itching. Its prevalence of atopic dermatitis is estimated to be between 1 and 3% of adults. Asthma is a chronic inflammatory disease of the airways. An estimated 235-300 million people have asthma worldwide, and an estimated 10 to 20% of these asthmatics are less than optimally monitored despite existing therapies.
There is currently no long-term well tolerated treatment for patients with moderate to severe dermatitis. It is necessary to address this unmet medical need by providing a systematic and effective treatment. Likewise, for patients with moderate to severe persistent asthma, there are few treatment options.
Dupilumab is a fully human monoclonal antibody developed in collaboration with Regeneron. It is administered via subcutaneous injection, targeting the alpha subunit of the interleukin 4 receptor (IL-4R∝) which contributes to mechanisms inducing atopic dermatitis and some types of asthma. “The proof of concept obtained both in asthma and atopic dermatitis showed that the drug Dupilumab could be effective in several other diseases with similar underlying pathological mechanism”, comments Gianluca Pirozzi, Head of Global project Dupilumab, Sanofi.