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EMERYVILLE, Calif. & LEXINGTON, Mass. -- Chiron Corporation and Cubist Pharmaceuticals, Inc. today announced that Chiron has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) under the European Union's Centralized Procedure for approval to market CUBICIN(R) (daptomycin for injection). The indication in the submission is for complicated skin and soft-tissue infections (cSSTI) where the presence of susceptible gram-positive bacteria is confirmed or suspected. The filing includes safety data from two pivotal Phase 3 clinical trials conducted by Cubist that examined the safety and efficacy of CUBICIN in the treatment of cSSSI.
"This filing is a crucial step toward our goal of launching CUBICIN in the European Union," said Craig Wheeler, president, Chiron BioPharmaceuticals. "Approval to market CUBICIN would expand our portfolio of anti-infective products and allow us to leverage our existing sales and marketing force in the European Union (EU) to bring a potentially important new product to patients."
Michael W. Bonney, president and CEO of Cubist, added, "This filing is an important milestone in Cubist's partnership with Chiron. The two companies have worked closely and effectively to make this happen on schedule. We look forward to supporting Chiron through the European Review cycle and, if approved, in their launch of CUBICIN in the second largest marketplace for this drug, the EU."
As a result of the filing, the EMEA Committee for Medicinal Products for Human Use (CHMP) will evaluate the application to determine whether to approve the marketing of CUBICIN in all 25 member states of the EU. In October 2003, Cubist and Chiron completed a license agreement for the development and commercialization of CUBICIN in Western and Eastern Europe, Australia, New Zealand, India and certain Central American, South American and Middle Eastern countries. Under the terms of the agreement, Chiron is responsible for regulatory filings in those territories.
About CUBICIN(R) (Daptomycin for Injection)
CUBICIN is currently the only once-daily bactericidal antibiotic approved in the United States indicated for the treatment of complicated skin and skin-structure infections caused by susceptible strains of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild or moderate in intensity, and the most common were constipation, nausea, injection site reactions and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN.
Source: Cubist Pharmaceuticals, Inc.