AURIGA MEDICAL™'S YTTRIUM-90 CHLORIDE STERILE SOLUTION AVAILABLE FOR CLINICAL TRIALSBurlington, MA, USA, June 2003 - Auriga Medical™, the new name for the medical therapy business of QSA, a business owned by UK-based AEA Technology plc, has been granted a license by the Bezirksregierung Braunschweig, a regional regulatory authority in Germany, to manufacture and distribute Yttrium-90 Chloride sterile solution for pharmaceutical and drug-substance suppliers. This license allows Auriga Medical™'s sterile Yttrium-90 Chloride to be produced, according to current good manufacturing practices (cGMPs), at the AEA Technology QSA GmbH site in Braunschweig, Germany. This product can then be used in clinical trials as a component of radioimmunotherapy agents in the treatment of cancer. The new, state-of-the-art plant enables Auriga Medical™ to distribute sterile Yttrium-90 chloride worldwide. This plant will also ensure that Auriga Medical™'s distribution center in Burlington, Massachusetts has a permanent stock of Yttrium-90 which will enable prompt fulfillment of customer requests within the US. The AEA Technology QSA site in Braunschweig has many years of experience in the distribution of radioactive products worldwide and the proprietary production process used in the Auriga Medical™ plant draws on over 15 years of experience in producing this isotope for clinical use. This expertise has produced an automated plant with the capacity to produce up to 200 vials per day which can meet the current worldwide demand for this important cancer treatment product. Meeting every customer's need is key to the Auriga Medical™ offering and with this in mind the plant has been designed to provide maximum flexibility. Auriga Medical™ is able to produce Yttrium-90 chloride in the exact configuration required for a particular radioimmunotherapy cancer agent. This allows Auriga Medical™ to meet the needs of radioimmunotherapy partners within the pharmaceutical industry as well as direct customers such as nuclear medicine physicians, radiation therapy specialists or radiopharmacists. Radioimmunotherapy is a systemic, tumor targeted-radiation therapy which delivers radiation to cancer cells thus avoiding damage to the surrounding tissue. Radioimmunotherapy using monoclonal antibodies (MAbs) or other biological agents linked to radioactive isotopes or radionuclides such as, Yttrium-90, is a new approach for treating cancer. In the U.S., Yttrium-90 is classified as a drug substance which means it can be used by radioimmunotherapy partners in clinical trials. It is the responsibility of the partner to seek a clinical indication once the trials are completed. Yttrium-90 is currently approved for use with a biologic drug and is expected to be submitted for use with other drugs in the near future. In Europe, Auriga Medical™ intends to submit an MAA application to the EMEA this year so it can be used in combination with approved radioimmunotherapy products. Commenting on the license, Patrick Donahue, Director of Medical Therapies at Auriga Medical™, said, "A key part of Auriga Medical™'s strategy is to form strategic alliances with radioimmunotherapy developers within the pharmaceutical industry. This new manufacturing plant provides Auriga Medical™ with the capacity, flexibility and logistical infrastructure on which to form those alliances and supply sterile products to partners looking to embark on clinical trials." - Ends - Notes to editors: Auriga™ Medical AEA Technology QSA is an international market leader in the production of high-quality radioactive products for medical, industrial, environmental and research applications. Auriga™ Medical provides a custom design, development and manufacturing service to develop radioactive products for partners involved in therapy development and also assists in delivering these products to patients. The company currently produces sealed Sr-90 Brachytherapy sources for Novoste Corporation's 3.5F BetaCath™ system, the market leader in intravascular brachytherapy where the beta radiation is used for the treatment of in-stent restenosis. The new manufacturing facility draws on AEA Technology QSA's many years of experience in design, development, packaging and worldwide distribution of radioactive products used in a variety of applications. Through its related Isotrak™ family of calibration sources, AEA Technology QSA sets the standard for calibration and measurement of beta-emitting radioisotopes used in many of the new targeted radiotherapy products. For further information, or an interview with the Pat Donahue, Director of Medical Therapies, at Auriga Medical™, contact:
Andrew Knill or Paul Jarman at Harvard Health
Tel: +44 1932 350006
Fax: +44 1932 353336
Email: aknill@harvardhealth.co.uk Pjarman@harvardhealth.co.uk < back
|