Boehringer Ingelheim receives positive opinion for FLEXcombo® in the European Union

Ingelheim, Germany, 25 May 2010 - The Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to approve FLEXcombo®, the combined use of the veterinary medicinal products Ingelvac CircoFLEX® and Ingelvac MycoFLEX®, in the European Union. The simultaneous administration of both vaccines represents an innovation in of pig health management. From now on, the two most prominent and costly diseases, Porcine Circovirus Disease (PCVD) and Enzootic Pneumonia, can be prevented with a single injection instead of up to four injections. Today an average of more than 70% of European pigs receive vaccines for these two diseases.

The CVMP is responsible for the assessment of any modifications to the existing marketing authorisation. Assessments conducted by the CVMP are based on purely scientific criteria and determine whether products meet the necessary quality, safety and efficacy requirements.

The combined use of Ingelvac CircoFLEX® and Ingelvac MycoFLEX® is already registered in North America (e.g. USA and Canada), Asia (e.g. Philippines and South Korea) and in Oceania (New Zealand). It is globally the first and only product of its kind. With this combination of vaccines, pigs can be protected against PCVD and Enzootic Pneumonia in an easy and effective manner. In addition, vaccination schedules can be targeted to specific epidemiological disease situations. This can enhance and improve animal welfare as well as overall animal husbandry (e.g. by decreasing vaccination stress and animal handling by half).

About Ingelvac CircoFLEX®
Ingelvac CircoFLEX® is registered for use as a single vaccination for pigs around weaning against the clinical signs associated with porcine circovirus type 2 (PCV2) including mortality, weight loss and lesions in lymphoid tissues. It is based on ImpranFLEX®, a unique adjuvant platform. Ingelvac CircoFLEX® is the global market leading PCV2 vaccine.

About Ingelvac MycoFLEX®
Ingelvac MycoFLEX® is a vaccine for the active immunisation of pigs aged three weeks and more to reduce lung lesions following infection with Mycoplasma hyopneumoniae. It is based on ImpranFLEX®, a unique adjuvant platform. Ingelvac MycoFLEX® was first launched in the US in 2008 where it became the leading Mycoplasma vaccine within a few months.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 15 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.