Chiron (NASDAQ:CHIR)
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Chiron Corporation (Nasdaq:CHIR) today announced that
the European Commission has granted marketing approval for CUBICIN(R)
(daptomycin), a first-in-class IV antibiotic. The marketing approval
was granted in the 25 member states of the European Union, Iceland,
Liechtenstein and Norway. Under the approval, CUBICIN is indicated for
the treatment of complicated skin and soft-tissue infections (cSSTI)
caused by Gram-positive bacteria. CUBICIN is expected to become
available in the United Kingdom and the Netherlands within the next
few weeks, followed by additional European countries, in accordance
with local legal regulations.
Gram-positive bacteria are a major cause of problematic infections
in many healthcare facilities and institutions. Of particular concern
are methicillin-resistant Staphylococcus aureus (MRSA),
glycopeptide-intermediate S. aureus (GISA) and glycopeptide-resistant
enterococci (VRE or GRE), particularly E. faecium, which are driving
the need for new antibacterial agents. The novel mechanism of action
of CUBICIN means that it is unaffected by the high-level
cross-resistance that occurs with many other antibiotic
classes.(1),(2) The use of CUBICIN is supported by clinical data from
two pivotal Phase 3 clinical trials conducted by Cubist that examined
the safety and efficacy of CUBICIN in the treatment of cSSTI. These
trials demonstrated that CUBICIN was as effective as standard therapy
in this indication.(3)
"The launch of CUBICIN in Europe provides an important new
alternative in the treatment of serious skin infections, which are
increasingly resistant to standard drug therapies," said Craig
Wheeler, president of Chiron BioPharmaceuticals. "Chiron's work to
make CUBICIN available in Europe is a reflection of our continuing
commitment to protecting people through innovative science."
Mike Bonney, President and CEO of Cubist, said, "European market
approval helps to validate the potential of CUBICIN, our
first-in-class lipopeptide antibiotic, worldwide. The news today is
also a reflection of our solid working relationship with Chiron."
Chiron licensed development and commercialization rights to
CUBICIN in the European Union from Cubist, which launched CUBICIN in
the United States in November 2003.
About CUBICIN(R) (Daptomycin Powder for Solution for Infusion)
CUBICIN is the first of a new class of antibiotics called cyclic
lipopeptides. Its mechanism of action, distinct from any other
antibiotic, involves binding to the cell membrane of Gram-positive
bacteria, causing depolarization and leading to inhibition of protein,
DNA and RNA synthesis. This results in bacterial cell death.
Two randomized, controlled clinical trials studied the efficacy
and safety of 4mg/kg once daily CUBICIN in complicated skin and
soft-tissue infections in adults compared to vancomycin or
semi-synthetic penicillins. In both of these studies, CUBICIN was
shown to be as effective as the comparator agents. CUBICIN has been
shown to be effective clinically in complicated skin and soft-tissue
infections caused by the following organisms: Staphylococcus aureus,
Streptococcus agalactiae, Streptococcus dysgalactiae subsp equisimilis
and Streptococcus pyogenes.
For subjects who received CUBICIN in clinical trials, the adverse
reactions most frequently reported were headache, nausea, vomiting,
diarrhea, muscle pain, fungal infections, rash, infusion site
reaction, increased Creatine phosphokinase (CPK) and abnormal liver
enzymes Alanine aminotransferase (ALT), Aspartate aminotransferase
(AST) and Alkaline phosphatase (ALP).
CUBICIN was approved for the treatment of complicated skin and
skin-structure infections by the U.S. Food and Drug Administration in
September 2003. CUBICIN is also approved for use in Israel and
Argentina.
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References
(1) Raja A et al. Nat Rev Drug Discov 2003; 2: 943-44.
(2) Silverman JA et al. Antimocrob Agents Chemother 2001; 45:
1799-1802.
(3) Arbeti RD et al. Clin Infect Dis 2004; 38: 1673-81.
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About Chiron
Chiron delivers innovative and valuable products to protect human
health by advancing pioneering science across the landscape of
biotechnology. The company works to deliver on the limitless promise
of science and make a positive difference in people's lives. For more
information about Chiron, please visit www.chiron.com.
Chiron Forward-Looking Statement
This news release contains forward-looking statements, including
statements regarding local European member state regulatory approval
of CUBICIN, expected timing for such approvals and sales and marketing
of CUBICIN, that involve risks and uncertainties and are subject to
change. Forward-looking statements often address our expected future
performance and often contain words such as "expects," "anticipates,"
"intends," "plans," "believes," "seeks" or "will." A discussion of the
company's operations and financial condition, including factors that
may affect its business and future prospects that could cause actual
results and developments to differ materially from those expressed or
implied by forward-looking statements, is contained in documents the
company has filed with the SEC, including the Form 10-K for the year
ended December 31, 2004, and the Form 10-Q for the quarter ended
September 30, 2005, and will be contained in all subsequent periodic
filings made with the SEC. These documents identify important factors
that could cause the company's actual performance to differ from
current expectations, including the outcome of clinical trials,
regulatory review and approvals, competition, manufacturing
capabilities, intellectual property protections and defenses, and
marketing effectiveness. In particular, there can be no assurance that
Chiron will receive approval to market or begin marketing CUBICIN in
any European member states in the first quarter of 2006 or achieve
market acceptance for CUBICIN.
Chiron does not undertake an obligation to update the
forward-looking information the company is giving today.
NOTE: Cubist and CUBICIN are registered trademarks of Cubist
Pharmaceuticals Inc.; HepeX-B is a trademark of XTL Biopharmaceuticals
Ltd.