01.08.2007 11:30:00
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CUBICIN Approved for S. aureus Bloodstream Infections in South Korea and Taiwan
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that CUBICIN® (daptomycin for injection) received approvals in July for S.
aureus bacteremia, including right-sided infective endocarditis
(SAB/RIE), in both South Korea and Taiwan. The recent approval in South
Korea includes both complicated skin and skin structure infections
(cSSSI) and SAB/RIE. CUBICIN was previously approved in Taiwan (in
November of 2006) for cSSSI caused by Gram positive bacteria. The
approvals were received by Kuhnil Pharmaceutical Corp. (CUBICIN
marketing partner for South Korea) and TTY BioPharm Company, Ltd.
(CUBICIN marketing partner for Taiwan.)
Mike Bonney, Cubist President and CEO commented: "I
congratulate the regulatory teams at Kuhnil and TTY, as well as the
clinical and regulatory teams at Cubist who work closely with our
CUBICIN international partners on regulatory filings and reviews. All
involved in the development of CUBICIN are proud of the role that this
important therapy will continue to play not only in the U.S. but across
the globe in the treatment of patients with serious infections,
particularly those caused by methicillin-resistant S. aureus
(MRSA).” About CUBICIN
CUBICIN is currently the only once-daily bactericidal antibiotic
approved in the U.S. 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 also
approved in the U.S. as therapy for S. aureus bloodstream
infections (bacteremia), including right-sided endocarditis, caused by
MRSA and MSSA. CUBICIN is not indicated for the treatment of
pneumonia. Most adverse events reported in clinical trials were mild to
moderate in intensity. The most common were anemia, constipation,
diarrhea, nausea, vomiting, 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. For full prescribing
information, visit www.cubicin.com.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on
the research, development and commercialization of pharmaceutical
products that address unmet medical needs in the acute care environment.
In the U.S., Cubist markets CUBICIN®
(daptomycin for injection), the first antibiotic in a new class of
antiinfectives called lipopeptides. The Cubist product pipeline includes
our lipopeptide program and our natural products screening program.
Cubist is headquartered in Lexington, MA. Additional information can be
found at Cubist’s web site at www.cubist.com.
Cubist Safe Harbor Statement Statements contained herein that are not historical fact may be
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934, and such statements are subject to a variety of risks and
uncertainties. There are a number of important factors that could
cause actual results to differ materially from those projected or
suggested in any forward-looking statements made by Cubist. These
factors include, but are not limited to: (i) the level of acceptance of
CUBICIN by physicians, patients, third-party payors and the medical
community; (ii) any changes in the current or anticipated market
demand or medical need for CUBICIN; (iii) any unexpected adverse
events related to CUBICIN, particularly as CUBICIN is used in the
treatment of a growing number of patients around the world; (iv)
competition in the markets in which we and our partners market CUBICIN,
including marketing approvals for new products that will be competitive
with CUBICIN; (v) whether the U.S. Food and Drug Administration, or FDA,
accepts proposed clinical trial protocols that may be achieved in a
timely manner for additional studies of CUBICIN or any other drug
candidate we seek to enter into clinical trials; (vi) whether we will
receive, and the potential timing of, regulatory approvals or clearances
to market CUBICIN in other countries; (vii) legislative and
policy changes in the United States and other jurisdictions where our
products are sold that may affect the ease of getting a new product or a
new indication approved; (viii) changes in government
reimbursement for our or our competitors’
products; (ix) whether or not third parties may seek to market generic
versions of our products by filing Abbreviated New Drug Applications, or
ANDAs, with the FDA, and the results of any litigation that we file to
defend and/or assert our patents against such generic companies; (x) our
ability to conduct successful clinical trials in a timely manner; (xi)
the effect that the results of ongoing or future clinical trials of
CUBICIN may have on its acceptance in the medical community; (xii) the
ability of our third party manufacturers, including our single source
provider of active pharmaceutical ingredient, or API, to manufacture
sufficient quantities of CUBICIN in accordance with Good Manufacturing
Practices and other requirements of the regulatory approvals for CUBICIN
and at an acceptable cost; (xiii) our dependence upon collaborations
with our partners and our partners’ ability to
execute on development, regulatory and sales expectations in their
territories; (xiv) our ability to finance our operations; (xv) the
effectiveness of our sales force and our sales force’s
ability to access targeted physicians; (xvi) potential costs resulting
from product liability or other third party claims; (xvii) our ability
to protect our proprietary technologies; (xviii) our ability to
integrate successfully the operations of any business that we may
acquire and the potential impact of any future acquisition on our
financial results; (xix) our ability to discover, acquire or in-license
drug candidates and develop and achieve commercial success for drug
candidates; and (xx) a variety of risks common to our industry,
including ongoing regulatory review, public and investment community
perception of the industry, legislative or regulatory changes, and our
ability to attract and retain talented employees. Additional factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking
statements are contained in Cubist’s recent
filings with the Securities and Exchange Commission, including those
factors discussed under the caption "Risk
Factors” in such filings.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals,
Inc.
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