Cambridge, MA, and Capua, Italy, June 15, 2001 -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) and DSM Fine Chemicals, a subsidiary of DSM, today jointly announced the opening of a new manufacturing facility on the DSM fermentation site in Capua, Italy. The facility, located just north of Naples, is dedicated to the commercial production of bulk daptomycin drug substance.
"The completion of this state-of-the art facility," said Scott M. Rocklage, Ph.D., Chairman and CEO of Cubist, "represents a truly international team effort. We believe this successful construction process is attributable to the combination of skills from both companies, drawing from experiences in the U.S., Holland, Italy, the UK and Canada. There was also strong management support from both companies to complete this key strategic facility within an aggressive timeline."
Cubist and DSM Fine Chemicals, entered into a services agreement in June 2000, whereby DSM agreed to provide supervisory and advisory services to Cubist relating to the construction and equipping of the manufacturing facility at DSM Capua. Cubist has also entered into a manufacturing and supply agreement with DSM, pursuant to which Cubist has agreed to purchase minimum annual quantities of bulk drug substance, provided the FDA determines the manufacturing facility to be compliant with Good Manufacturing Practices standards. Efforts are currently ongoing to prepare the facility for international regulatory filings and to ensure maximum production efficiency.
Henk Numan, Business Group Director of DSM Fine Chemicals, commented: "We are very pleased with the results of the construction phase and close working relationship between Cubist and DSM. Our employees have worked diligently over the past year, successfully meeting all timelines. This cooperation with Cubist is an example of our strategy to be a full service provider for the pharmaceutical industry.The permanent, full-time DSM staff in Capua is currently optimizing the manufacturing process at the facility, which has multi-metric ton capacity. We are looking forward to completing the registration of the facility and providing Cubist commercial-grade daptomycin."
Cubist
Cubist is evaluating the safety and efficacy of daptomycin (branded Cidecin™ in its intravenous formulation) in the EDGE™ (Evaluation of Daptomycin in Gram-positive Entities) clinical trial program. Cidecin is the first in a new class of investigational antibiotics and has demonstrated the unique ability in vitro to rapidly kill virtually all Gram-positive bacteria, including those that have become resistant to current therapies. Cubist recently announced the successful completion of the first of two pivotal Phase III trials examining the safety and efficacy of Cidecin in the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria. Multiple Phase III trials are also underway for Cidecin in the treatment of community-acquired pneumonia and complicated urinary tract infection.
Cubist Pharmaceuticals Inc. is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections. Cubist is evaluating the safety and efficacy of Cidecin™ (daptomycin for injection) in the EDGE™ (Evaluation of Daptomycin against Gram-positive Entities) clinical trial program and has broadened its pipeline to include multiple pre-clinical drug candidates. The Company is engaged in strategic partnerships with Novartis Pharma AG and Merck & Co for the discovery and development of novel antiinfectives and with Gilead Sciences for the commercialization of daptomycin in Europe. Cubist is headquartered in Cambridge, MA and has operations in Vancouver, BC, Canada and Slough, UK.
