EXHIBIT 99.1
CONTACTS:
Cubist Pharmaceuticals, Inc. Noonan/Russo Communications
Jennifer LaVin Emily Poe - media
Senior Director, Corporate Communications (212) 696-4455 ext. 221
(781) 860-8362 e.poe@noonanrusso.com
jennifer.lavin@cubist.com
CUBIST PHARMACEUTICALS ANNOUNCES RESULTS FROM FIRST PHASE III CIDECIN(R)
COMMUNITY-ACQUIRED PNEUMONIA TRIAL
ENDPOINT NOT ACHIEVED IN OVERALL INTERNATIONAL STUDY; EQUIVALENCE
ACHIEVED IN NORTH AMERICAN & WESTERN EUROPEAN STUDY POPULATIONS
CONFERENCE CALL & WEBCAST TODAY AT 5:00 PM ET
LEXINGTON, MA, JANUARY 16, 2002 -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST)
today announced preliminary results from the first of two pivotal, Phase III
trials investigating the safety and efficacy of its investigational antibiotic
Cidecin(R) (daptomycin for injection) in the treatment of community-acquired
pneumonia requiring hospitalization (the CAP1 Study). The Company indicated that
the primary endpoint of demonstrating non-inferiority to an active comparator
agent was not achieved in the overall international study. However, the endpoint
was achieved in the intent-to-treat and clinically evaluable cohorts
representing the North American and Western European populations.
The CAP1 study analyzed data from 714 patients. The study was an international,
randomized, prospective, double-blinded study and was conducted predominantly in
North America, Western and Eastern Europe and South Africa. The primary endpoint
in the study is to demonstrate non-inferiority in clinical efficacy (resolution
of signs and symptoms) to the comparator agent. CIDECIN, dosed at 4 mg/kg once
daily, was compared to Rocephin(R) (ceftriaxone sodium), the current standard of
care, dosed at 2 g once daily. Both drugs were administered intravenously.
The CIDECIN arm of the study in the clinically evaluable populations analyzed
demonstrated a clinical success rate of 79% and the ceftriaxone arm demonstrated
an 87% clinical success rate. While there are no apparent significant
differences in key demographic parameters in the overall study, a strong
geographic difference was observed. The cause of these differences continues to
be investigated. CIDECIN achieved higher success rates compared to ceftriaxone
(72 vs. 62%) in the North American intent-to-treat patient population. The
clinical success rate in the clinically evaluable populations in North America
and Western Europe was 85% for CIDECIN and 84% for ceftriaxone. These data
represent the first level of analysis of the CAP1 study and further details are
planned for presentation at an appropriate scientific meeting in the near
future.
Importantly, the adverse event profiles were similar between the CIDECIN and
ceftriaxone study arms and there were no study withdrawals due to creatine
phosphokinase (CPK) elevations in this study. These safety data are intended to
be included in the CIDECIN New Drug Application (NDA) to be filed with the U.S.
Food & Drug Administration (FDA).
Enrollment in the second pivotal, Phase III study examining the safety and
efficacy of CIDECIN in the treatment of community-acquired pneumonia requiring
hospitalization (the CAP2 study) has been suspended pending further review and
evaluation of the CAP data to consider a North American and Western
European-only trial for this indication. This potential strategy is based on the
successful clinical outcomes observed in CAP1 in these geographic areas.
Scott M. Rocklage, Ph.D., Chairman & CEO of Cubist commented: "The results in
the CAP1 study, while mixed, do not diminish the Cubist commitment to the
continued clinical development of CIDECIN. CIDECIN's performance in the CAP1
Study was encouraging from a medical perspective, however, it did not perform
well enough in certain geographies to achieve the required statistical endpoint
in the overall population. The successful clinical outcomes in CAP1 observed in
North America and Western Europe suggest that a reassessment of the geographic
focus of the second CAP trial may be appropriate." Dr. Rocklage concluded, "We
are currently evaluating the overall CIDECIN regulatory filing strategy and hope
to be able to provide better guidance on the timing and content of the filing
following our discussions with the FDA."
Cubist previously reported the successful completion of two pivotal Phase III
trials examining the safety and efficacy of CIDECIN in the treatment of
complicated skin and soft tissue infection (cSST). The Company originally
intended to file the U.S. NDA in the third quarter of this year for the
indications of cSST and CAP, along with data on treating resistant infections.
In view of the CAP1 data, Cubist is re-evaluating its options regarding the CAP
indication and the intended timing of its NDA filing. The Company may consider
filing the NDA this year based on the cSST and resistance data, may complete a
CAP program prior to filing, or may pursue alternative indications. Cubist will
work in close collaboration with the FDA over the next several months to
establish the registration strategy for CIDECIN going forward.
******************CONFERENCE CALL INFORMATION******************
WHEN: WEDNESDAY JANUARY 16, 2002 AT 5:00 PM ET
DOMESTIC & CANADA CALL-IN: (800) 446-4472
INTERNATIONAL CALL-IN: (416) 695-9753
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=CBST&script=2400&item_id=579637
REPLAY WILL BE AVAILABLE FOR 30 DAYS VIA THE INTERNET
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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(R) (daptomycin for injection) in
the EDGE(TM) (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 Lexington, MA and has operations in
Vancouver, BC, Canada and Slough, UK.
CUBIST SAFEHARBOR 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, THAT 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 THE COMPANY. THESE FACTORS
INCLUDE, BUT ARE NOT LIMITED TO: (I) THE COMPANY'S ABILITY TO SUCCESSFULLY
COMPLETE PRODUCT RESEARCH AND DEVELOPMENT, INCLUDING PRE-CLINICAL AND CLINICAL
STUDIES AND COMMERCIALIZATION; (II) THE COMPANY'S ABILITY TO OBTAIN REQUIRED
GOVERNMENTAL APPROVALS; (III) THE COMPANY'S ABILITY TO ATTRACT AND/OR MAINTAIN
MANUFACTURING, SALES, DISTRIBUTION AND MARKETING PARTNERS; AND (IV) THE
COMPANY'S ABILITY TO DEVELOP AND COMMERCIALIZE ITS PRODUCTS BEFORE ITS
COMPETITORS. ADDITIONAL FACTORS THAT WOULD CAUSE ACTUAL RESULTS TO DIFFER
MATERIALLY FROM THOSE PROJECTED OR SUGGESTED IN ANY FORWARD-LOOKING STATEMENTS
ARE CONTAINED IN THE COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE
COMMISSION, INCLUDING THOSE FACTORS DISCUSSED UNDER THE CAPTION "RISK FACTORS"
IN THE COMPANY'S RECENT SEC FILINGS.
Cidecin(R) (daptomycin for injection) is a registered trademark of Cubist
Pharmaceuticals, Inc. All otheR trademarks, servicemarks or trade names referred
to in this release are the property of their respective owners.
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Additional information can be found at the Company's web site at
www.cubist.com or at www.noonanrusso.com.