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1st EMEA application filed for product using innovative intradermal microinjection system BD Soluvia

Franklin Lakes, NJ, USA (February 13, 2008) -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group, has submitted the first application in Europe to deliver a vaccine using BD Soluvia, the innovative microinjection system developed by BD (Becton, Dickinson and Company). The submission for the first influenza vaccine using BD Soluvia has been accepted for review by the European Medicines Agency (EMEA).

Sanofi Pasteur conducted clinical trials on more than 7000 subjects to evaluate safety and the ability to generate an immune response of the novel intradermal (ID) influenza vaccine. Compared with intramuscular (IM) injection, ID delivery was shown to be especially effective in enhancing the immune response in the elderly1,2. Independently, BD conducted clinical trials involving more than 700 subjects and 3500 injections with BD Soluvia, and demonstrated that the system was safe and easy to use.3. Clinical testing showed that the BD microneedle is barely perceptible when it enters the skin and ensures the administration of the injected solution to the dermal layer irrespective of the subject s gender, age, ethnicity and body mass.4

BD Soluvia is a prefillable microinjection system that is integrated with a tiny BD microneedle. It has been proven to offer a simple, reliable method of delivery. While most vaccines are injected into the muscle, the BD microneedle allows the vaccine to be accurately delivered intradermally -- within the dermal layer of the skin. The dermal layer contains a dense network of lymphatic vessels feeding local lymph nodes, resulting in rapid and efficient access of the vaccine into the immune system. It also contains a high concentration of potent immune cells that play a key role to initiate the immune response following vaccination.

BD is committed to developing innovative solutions to advance drug delivery with pharmaceutical companies, and to meet the needs of healthcare professionals, said Philippe Laurent, Vice President, Medical Affairs, BD Medical V Pharmaceutical Systems. The BD Soluvia microinjection system is a breakthrough technology that is intuitive to use and allows accurate and consistent delivery of substances such as the flu vaccine into the dermal layer. We believe it has the potential to help address some of the important health challenges facing the world today, and embodies BD s purpose of helping all people live healthy lives.

We are delighted to have reached this landmark in development with our partner, sanofi pasteur, said Alex Conroy, President, BD Medical - Pharmaceutical Systems. In practical terms, the BD Soluvia microinjection system has the potential to increase patients acceptance of injections and enhance immunization practices. BD is deeply committed to continuing the development of BD Soluvia for the intradermal route of administration for use with infectious disease and emerging cancer vaccines.

Contact: Alyssa Zeff
Ruder Finn Public Relations

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