Biacore and Boehringer Ingelheim develop SPR system for improved drug manufacturing quality control

BIACORE AND BOEHRINGER INGELHEIM DEVELOP SPR SYSTEM FOR IMPROVED DRUG MANUFACTURING QUALITY CONTROL New, Fully Audited System Provides Greater Assay Reliability and Reproducibility Faster to Replace Conventional Technology Uppsala, Sweden, June 5, 2001. Biacore International AB (Biacore) (SSE: BCOR; Nasdaq: BCOR) today announced that it has successfully completed a supplier audit to become an approved supplier of analytical equipment to Boehringer Ingelheim Pharma KG for biopharmaceutical drug development, in-process controls and routine quality control procedures. Boehringer Ingelheim Pharma KG is the German operating unit of the Boehringer Ingelheim group of companies based at Ingelheim, Germany. The two companies entered into a technology collaboration at the end of 1999 to co-develop a specific system for use in biopharmaceutical manufacturing procedures which would improve quality of data and increase time and resource efficiencies. The success of this collaboration marks yet another milestone in Biacore's commitment to provide novel analytical and quality management systems to help the pharmaceutical industry increase the flow of high-quality drug leads reaching the market. The new systems, which are now fully installed and operational at one of Boehringer Ingelheim's biopharmaceutical manufacturing facilities in Biberach, Germany, will be used as dedicated instrumentation for measuring protein concentration in in-process control and quality control procedures. Biacore's SPR technology offers an unparalleled level of quality biological information in real time biomolecular interaction analysis. Two Biacore systems were evaluated over a six month period, providing high quality data with no incident of equipment failure. Already the improved data reproducibility and sample throughput generated has seen Biacore's technology replace the conventional and time consuming ELISA based assay technology previously used for routine analysis at the facility. Biacore has supported Boehringer Ingelheim with Installation Qualification (IQ), Operational Qualification (OQ) and Software Design Validation Certificate to facilitate their internal validation processes. The Wizard software used in the Biacore system has been developed using a defined Software Development Lifecycle and subjected to fully documented testing, designed for compliance with Good Automated Manufacturing Practice both in the EU and USA. "Boehringer Ingelheim has implemented Biacore´s biosensor technology into its in-process and quality control procedures already in the early 90´s. The collaboration with Biacore in developing a validated software has supported the quality control concept for our innovative biopharmaceutical manufacturing at Boehringer Ingelheim. Biacore's technology increases time and resource efficiencies," said Dr Hans- Jürgen Leuchs, Member of the Board of Managing Directors responsible for Operations and Animal Health, "The collaboration has been extremely productive and we now have a very reliable system." "We are very pleased at the successful outcome of this collaboration with Boehringer Ingelheim," commented Dr Ulf Jönsson, President of Biacore. "Supported by Boehringer Ingelheim, we have achieved yet another key milestone demonstrating our commitment to produce quality systems which add real value to biopharmaceutical drug discovery and development right from the exploratory research stages of proteomics through to the strict regulatory environment of drug manufacture." Biacore plans to launch the new SPR technology for biopharmaceutical QC towards the end of 2001. [Reuters: BCOR.N] - Ends - This press release contains certain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, which, by their nature, involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Notes to editors: Biacore is a global market leader in Surface Plasmon Resonance (SPR) based technology with its own sales operations in the U.S., across Europe, in Japan, Australia and New Zealand. The technology is protected by a strong patent portfolio. Target groups consist primarily of medical and life science research laboratories and pharmaceutical and biotechnology companies all over the world. Biacore focuses on drug discovery as the prime area for future growth. The company currently has six systems on the market with its BIACORE®3000 system offering specific application in drug discovery processes upstream of high-throughput screening (HTS). A new high-performance system is currently under late- stage development and will focus on applications downstream of HTS. Based in Uppsala, Sweden, the company is listed on Stockholmsbörsen and Nasdaq in the U.S. In 2000 the company has sales of SEK 438.8 million and an operating income of SEK 78.0 million. Further information on Biacore can be found on the web: www.biacore.com Address and phone: Biacore International AB Rapsgatan 7, SE-754 50 Uppsala, SWEDEN Phone: +46 (0)18-675700 Fax: +46 (0)18-150111 info@biacore.com The Boehringer Ingelheim group of companies, headquartered in Ingelheim, Germany, is one of the 20 leading pharmaceutical corporations in the world. In 2000, it posted revenues of more than EUR 6 billion. Boehringer Ingelheim, which has some 140 affiliated companies worldwide, focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95% of sales, is comprised of prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers . Research and development, production, and distribution facilities are located around the globe. In 2000, Boehringer Ingelheim spent almost EUR 1.0 billion on R&D, equivalent to 16% of net sales. For more information on Boehringer Ingelheim, please see the international Internet website www.boehringer-ingelheim.com Address and phone: Kerstin Felix Boehringer Ingelheim GmbH CD Public Relations/ R&D Communications 55216 Ingelheim, GERMANY Phone: + 49 - 6132 - 779040 Fax: + 49 - 6132 - 776601 e-mail: felixk@ing.boehringer-ingelheim.com ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.bit.se/bitonline/2001/06/05/20010605BIT00600/bit0001.doc http://www.bit.se/bitonline/2001/06/05/20010605BIT00600/bit0001.pdf