New Biacore® 3000 GxP Package Launched

Pressmeddelande   •   Apr 01, 2003 00:00 CEST

Uppsala, Sweden, 1st April 2003. Biacore International AB (Biacore) (SSE: BCOR; Nasdaq: BCOR) today announced the launch of its Biacore®3000 GxP Package, which will strengthen the system’s use in pre-clinical and clinical applications. The new product was developed to facilitate compliance with worldwide regulatory expectations and will complement Biacore®C, launched in 2001 for rapid concentration analysis in drug development, manufacturing quality control and in-process control applications.

The combined Biacore®3000 GxP Package enables rapid and high quality kinetic analysis of both well characterized biopharmaceuticals and small molecule therapeutics in the pre-clinical and clinical areas of drug development. The system was developed for use in regulated applications such as immunogenicity studies, biomolecular characterization and stability studies, ligand binding assays for potency and kinetics-based QC to expedite product release. The addition of the GxP package enables both legacy and new Biacore 3000 systems to meet current USFDA 21 CFR Part 11 Regulations for electronic records.

"Drug companies are increasingly faced with the pressure of bringing new products to market faster while meeting ever stricter regulatory requirements. Biacore is committed to providing technology that addresses their needs through systems that not only deliver rapid, high quality data, but that also meets the requirements for security and traceability of that data," commented Julian Abery, Vice President and Head of the Pharmaceutical and Biotechnology Business Unit. "Our Biacore®3000 GxP Package was developed in response to our pharmaceutical and biotechnology customer’s requirements to complement our existing offering in this area."

With its comprehensive validation support services, Biacore also supports its customers through the entire systems validation process, including equipment qualification and training carried out by GMP-trained personnel upon system installation.

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Cautionary Statement
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.

About Biacore
Biacore is a global market leader in Surface Plasmon Resonance (SPR) technology based systems with its own sales operations in the U.S., across Europe, Japan, Australia and New Zealand. A strong patent portfolio protects Biacore’s SPR technology, which gives unique real-time insights into biomolecular interactions. Target groups for the Company’s products consist primarily of medical and life science research laboratories and pharmaceutical and biotechnology companies around the world. Biacore is focusing on drug discovery and development as its prime areas for future growth. The Company currently has eight systems on the market, the most important of which are: Biacore®S51 for applications downstream of high-throughput screening (HTS) including rapid characterization of HTS hits and comprehensive pre-clinical evaluation of lead compounds, Biacore®3000, which offers flexibility in key life science research and drug discovery applications upstream of HTS, and its recently introduced cell-based system for pharmacological profiling, Procel™. Biacore®C is specifically designed for compliant concentration analysis of biopharmaceuticals in GLP/GMP applications. A new SPR array chip system, which will provide higher information content, is expected to reach the market in 2004.

Based in Uppsala, Sweden, the Company is listed on Stockholmsbörsen and Nasdaq in the U.S. In 2002 the Company had sales of SEK 614.2 million and an operating income of SEK 140.6 million.

Further information on Biacore can be found on the web:

For further information, please contact:
Julian Abery, Biacore International SA
Vice President, Head of
Pharmaceutical & Biotechnology Unit
+44 (0)1386 853 949
+44 (0) 7808 900732 (mobile)

Scientific/Trade Press Enquiries:
Michelle Lerner, HCC De Facto Group
+44 (0) 207 496 3354