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Boehringer Ingelheim receives FDA approval for new biopharmaceutical production plant in record time

Pressmeddelande   •   Jul 08, 2004 11:19 CEST

Ingelheim/Germany, 8 July 2004 - Boehringer Ingelheim has received official approval for its new biopharmaceutical active ingredients production plant following an inspection of the plant at the Biberach (Riss) site by the US regulatory agency, the FDA (Food and Drug Administration). The approval opens up the USA, the world’s largest pharmaceutical market, to biopharmaceuticals manufactured at the Biberach site. It comes only about 45 months after the first turf for this complex project was dug.

No major shortcomings or criticisms were identified during the very in-depth FDA inspection held in Biberach 17 - 28 May. The so-called "Pre-Approval Inspection" focused on approval of the new building for production of Enbrel®1, for the US market, which is a treatment for rheumatoid arthritis.

The FDA already had approved Boehringer Ingelheim`s first biotech plant as a multi-product site in 1996. In such an inspection it is closely examined whether the company is able to manufacture the product applying the state-of-the-art technology and cGMP2 rules recognised in the USA. It is also investigated whether data generated in the development and analytical laboratories support the statements made about the product in the registration documentation submitted.

Dr Hans-Jürgen Leuchs, Head of Corporate Board Divisions Operations and Animal Health at Boehringer Ingelheim, emphasised that "the excellent outcome of this internationally important inspection is a major milestone in the utilisation of the new plant for our customers, who are primarily located in the USA".

The positive outcome of the inspection was also acknowledged by Dr Wolfram Carius, Vice-President Biopharmaceuticals: "All those involved can be proud of the result, which greatly strengthens Boehringer Ingelheim’s position in this field. It allows us to meet all the production obligations made to our business partners". Four hundred new jobs were created in connection with the new biotech plant.

The FDA’s approval of the new building in connection with production of Enbrel® for the American market affirms Boehringer Ingelheim’s position as a world-class player in a business area which last year saw sales increase by 26% to EUR 280 million and which gives cause for further hope. At present there are worldwide more than 300 new biological entities at different stages of development and undergoing clinical trials. The successful outcome of the inspection also allows Boehringer Ingelheim to confirm its position as a recognised provider of services to third parties, not least since the new plant comprehensively covers the entire process chain, from genetic engineering through fermentation and formulation to registration and distribution. With obvious pleasure Dr Leuchs remarked that “this potential was recognised by strong collaboration partners. They know that Boehringer Ingelheim will devote all its capacities to making their biotechnology products a success too.”

However, the approval of the new production plant also provides Boehringer Ingelheim with an excellent starting position for producing new biological active ingredients of its own. The fruit of collaboration between the research and development and biopharmacy units, these new active ingredients are being purposefully pushed ahead by cross-divisional projects. Dr Leuchs emphasised that "this is and will remain the focus of our efforts to secure the company’s strong position using its own resources".

Involving investments of over EUR 250 million, the new production building for biopharmaceutical active ingredients in Biberach and the resultant doubling of production capacities there, it was one of the most complex and important projects in the company’s history. As early as in the the first half of the Eighties Boehringer Ingelheim already viewed Biotech as a technology of the future and further established the company as one of the leaders in biotechnological development and production.

Photograph of plant available upon request or below.

Related links:
Photo of the new biopharmaceutical plant

Contact:
Boehringer Ingelheim GmbH
Corporate Division Communications
Judith von Gordon
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 35 82
Fax: +49/6132/77 66 01
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