Cubist Pharmaceuticals Presents Phase III Clinical Results on Cidecin(TM) at 11th ECCMID in Istanbul, Turkey

Trial Achieves Primary Efficacy Endpoint



LIVE WEBCAST OF INVESTOR PRESENTATION TODAY AT 12:20 PM EASTERN TIME



CONFERENCE CALL TODAY AT 4:30 PM EASTERN TIME



Apr 03, 2001, 01:00 ET from Cubist Pharmaceuticals, Inc.

    CAMBRIDGE, Mass., April 3 /PRNewswire/ -- Cubist Pharmaceuticals, Inc.
 (Nasdaq:   CBST) today presented data from its international clinical trial
 (Study 9901), examining the safety and efficacy of its investigational
 antibiotic Cidecin(TM) (daptomycin for injection) in the treatment of
 complicated skin and soft tissue infections caused by Gram-positive bacteria.
 Data were presented at the 11th European Congress of Clinical Microbiology and
 Infectious Diseases in Istanbul, Turkey.
     In summary, the data showed that Cidecin achieved the required endpoint of
 statistical equivalence to the comparator agents based on criteria set forth
 in the protocol previously reviewed by the U.S. Food & Drug Administration.
 The comparator agents used are currently considered optimal antibiotic
 standards of care for these types of infections.  The data revealed that in
 all study populations analyzed, the clinical success rates ranged from 81% to
 91% in the Cidecin arm, versus 81% to 92% in the comparator arm.  Clinically
 successful patients receiving Cidecin required fewer days of intravenous
 therapy than patients receiving the comparator agents.  In addition, the
 incidence of total adverse events was similar in both arms of the trial.
     Study 9901 was an international, multi-center, randomized, double blinded
 (evaluator blinded) study.  The study enrolled 562 patients, aged 18-85 years,
 with complicated skin and soft tissue infections caused by Gram-positive
 bacteria.  "Complicated" infections are those requiring hospitalization and
 parenteral (intravenous) antimicrobial therapy.  Infections included major
 abscesses, wound infections and infected skin ulcers.  Patients were scheduled
 to be treated for 7 to 14 days and randomized to Cidecin, 4 mg/kg once daily,
 or to comparator, where investigators had the choice of vancomycin, given
 twice daily, or a semi-synthetic penicillin (usually oxacillin) given four
 times daily.
 
     Patient outcomes were determined using the following criteria:
     -- Clinical Success:  evaluator-blinded assessment of clinical resolution
        or improvement with no further antibiotic therapy required
     -- Clinical Failure:  evaluator-blinded assessment of worsening or
        inadequately improving clinical condition during therapy, up to and
        including one week post-treatment
 
     Study populations were described as follows:
     -- Intent-to-Treat (ITT):  patients received at least one dose of study
        medication
     -- Modified Intent-to-Treat (MITT):  Gram-positive pathogen at baseline
        culture
     -- Clinically Evaluable (CE):  patients fulfilled all protocol criteria
        (inclusion/exclusion criteria, duration of therapy & evaluations)
     -- Microbiologically Evaluable (ME):  clinically evaluable with Gram-
        positive pathogen(s)
 
     Table 1 presents the Clinical Success Rates for Cidecin vs. Comparator in
 Study 9901
 
                    Cidecin                Comparator           95% Confidence
               Total       Success      Total       Success        Interval*
      ITT       269       219 (81%)      293       237 (81%)      -6.4, 6.5
      MITT      212       181 (85%)      256       214 (84%)      -7.6, 5.5
      CE        245       217 (89%)      262       235 (90%)      -4.3, 6.5
      ME        196       179 (91%)      231       212 (92%)      -4.9, 5.7
      * statistical equivalence defined as +/- 10%
 
 
     Table 2 presents the Duration of Therapy Data Analysis for Cidecin vs.
 Comparator in Study 9901
 
        Duration of IV Therapy in      Cidecin            Comparator
       Clinically Successful Patients
      Total Patients                     202                 213
      Duration of Therapy: 4 - 7 days    79%                 40%
      Duration of Therapy: > 7 days      21%                 60%
 
 
     Scott M. Rocklage, Ph.D., Chairman and Chief Executive Officer of Cubist,
 commented on the data release, "We are very pleased to have achieved the
 desired efficacy endpoint in our first pivotal Phase III trial with Cidecin.
 Preliminary analysis of the data reveals that clinically successful patients
 administered Cidecin required fewer days of intravenous antibiotic therapy
 than patients receiving the comparator agents.  If this trend is seen in our
 other clinical trials as well, treatment with Cidecin could potentially reduce
 healthcare costs, should the drug be approved by the FDA.  We are continuing
 to analyze the microbiologic data sets to determine Cidecin's effect on Gram-
 positive pathogens resistant to many currently available therapies."
     "Many in the field of infectious disease have been eagerly anticipating
 the results of this Cubist trial," said Robert C. Moellering, Jr., MD, of the
 Beth Israel Deaconess Medical Center and Harvard Medical School.  "With the
 increasing challenges facing the infectious disease community in the United
 States and throughout the world, we need more and better alternatives to treat
 serious and life-threatening bacterial infections.  The results of this trial,
 involving 562 patients, indicate that once-daily Cidecin was as effective as
 optimal antibiotic therapy in the treatment of patients with a range of
 serious skin and soft tissue infections.  Importantly, the incidence of
 adverse events with Cidecin was similar to the standard antibiotics used in
 the active control group in this trial.  These are very important and
 encouraging findings."
 
     Table 3 presents Creatinine Phosphokinase (CPK) Measurement (IU/L) in
 Patients in Study 9901
 
                                          Cidecin            Comparator
      Baseline CPK (mean +/- SEM*)       173 +/- 25          159 +/- 16
      On-Therapy CPK (mean +/- SEM)      145 +/- 15          136 +/- 12
      *SEM = standard error of mean;
       upper limit of normal = 200
 
     Francis P. Tally, MD, Executive Vice President, Scientific Affairs at
 Cubist said, "In this first pivotal clinical trial of Cidecin, CPK levels and
 muscle-related adverse event profiles were similar for both Cidecin and the
 comparator agents.  In addition, no patients required discontinuation of
 therapy due to CPK elevations in the study."
 
       ***************THOMAS WEISEL PARTNERS PRESENTATION***************
 
                  WHEN:  Tuesday, April 3, 2001 at 12:20 pm ET
 
       PRESENTATION WILL BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
 
       http://www.veracast.com/twp_healthcare_2001/webcasts/76204197.cfm
 
                      Replay will be available for 30 days
 
 
        ******************CONFERENCE CALL INFORMATION******************
 
                  WHEN:  Tuesday, April 3, 2001 at 4:30 pm ET
                   DOMESTIC & CANADA CALL-IN:    800-233-2795
                     INTERNATIONAL CALL-IN:    785-832-1523
 
         CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
 
                  http://www.videonewswire.com/CUBIST/040301/
 
                      Replay will be available for 30 days
 
     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(TM) (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, Schering-Plough and Merck & Co for the
 discovery and development of novel antiinfectives and with Gilead Sciences for
 the commercialization of Cidecin in Europe.  Cubist is headquartered in
 Cambridge, 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 Annual Report on Form 10-K filed on April 2, 2001.
     Additional information can be found at the Company's web site at
 www.cubist.com or at www.noonanrusso.com.
 
      Contacts:
 
      Cubist Pharmaceuticals, Inc.                 Noonan/Russo Communications
      Jennifer LaVin                               Renee Connolly - media
      Senior Director, Corporate Communications    (212) 696-4455 ext. 227
      (617) 576-4258                               renee@noonanrusso.com
      jlavin@cubist.com
 
 

SOURCE Cubist Pharmaceuticals, Inc.
    CAMBRIDGE, Mass., April 3 /PRNewswire/ -- Cubist Pharmaceuticals, Inc.
 (Nasdaq:   CBST) today presented data from its international clinical trial
 (Study 9901), examining the safety and efficacy of its investigational
 antibiotic Cidecin(TM) (daptomycin for injection) in the treatment of
 complicated skin and soft tissue infections caused by Gram-positive bacteria.
 Data were presented at the 11th European Congress of Clinical Microbiology and
 Infectious Diseases in Istanbul, Turkey.
     In summary, the data showed that Cidecin achieved the required endpoint of
 statistical equivalence to the comparator agents based on criteria set forth
 in the protocol previously reviewed by the U.S. Food & Drug Administration.
 The comparator agents used are currently considered optimal antibiotic
 standards of care for these types of infections.  The data revealed that in
 all study populations analyzed, the clinical success rates ranged from 81% to
 91% in the Cidecin arm, versus 81% to 92% in the comparator arm.  Clinically
 successful patients receiving Cidecin required fewer days of intravenous
 therapy than patients receiving the comparator agents.  In addition, the
 incidence of total adverse events was similar in both arms of the trial.
     Study 9901 was an international, multi-center, randomized, double blinded
 (evaluator blinded) study.  The study enrolled 562 patients, aged 18-85 years,
 with complicated skin and soft tissue infections caused by Gram-positive
 bacteria.  "Complicated" infections are those requiring hospitalization and
 parenteral (intravenous) antimicrobial therapy.  Infections included major
 abscesses, wound infections and infected skin ulcers.  Patients were scheduled
 to be treated for 7 to 14 days and randomized to Cidecin, 4 mg/kg once daily,
 or to comparator, where investigators had the choice of vancomycin, given
 twice daily, or a semi-synthetic penicillin (usually oxacillin) given four
 times daily.
 
     Patient outcomes were determined using the following criteria:
     -- Clinical Success:  evaluator-blinded assessment of clinical resolution
        or improvement with no further antibiotic therapy required
     -- Clinical Failure:  evaluator-blinded assessment of worsening or
        inadequately improving clinical condition during therapy, up to and
        including one week post-treatment
 
     Study populations were described as follows:
     -- Intent-to-Treat (ITT):  patients received at least one dose of study
        medication
     -- Modified Intent-to-Treat (MITT):  Gram-positive pathogen at baseline
        culture
     -- Clinically Evaluable (CE):  patients fulfilled all protocol criteria
        (inclusion/exclusion criteria, duration of therapy & evaluations)
     -- Microbiologically Evaluable (ME):  clinically evaluable with Gram-
        positive pathogen(s)
 
     Table 1 presents the Clinical Success Rates for Cidecin vs. Comparator in
 Study 9901
 
                    Cidecin                Comparator           95% Confidence
               Total       Success      Total       Success        Interval*
      ITT       269       219 (81%)      293       237 (81%)      -6.4, 6.5
      MITT      212       181 (85%)      256       214 (84%)      -7.6, 5.5
      CE        245       217 (89%)      262       235 (90%)      -4.3, 6.5
      ME        196       179 (91%)      231       212 (92%)      -4.9, 5.7
      * statistical equivalence defined as +/- 10%
 
 
     Table 2 presents the Duration of Therapy Data Analysis for Cidecin vs.
 Comparator in Study 9901
 
        Duration of IV Therapy in      Cidecin            Comparator
       Clinically Successful Patients
      Total Patients                     202                 213
      Duration of Therapy: 4 - 7 days    79%                 40%
      Duration of Therapy: > 7 days      21%                 60%
 
 
     Scott M. Rocklage, Ph.D., Chairman and Chief Executive Officer of Cubist,
 commented on the data release, "We are very pleased to have achieved the
 desired efficacy endpoint in our first pivotal Phase III trial with Cidecin.
 Preliminary analysis of the data reveals that clinically successful patients
 administered Cidecin required fewer days of intravenous antibiotic therapy
 than patients receiving the comparator agents.  If this trend is seen in our
 other clinical trials as well, treatment with Cidecin could potentially reduce
 healthcare costs, should the drug be approved by the FDA.  We are continuing
 to analyze the microbiologic data sets to determine Cidecin's effect on Gram-
 positive pathogens resistant to many currently available therapies."
     "Many in the field of infectious disease have been eagerly anticipating
 the results of this Cubist trial," said Robert C. Moellering, Jr., MD, of the
 Beth Israel Deaconess Medical Center and Harvard Medical School.  "With the
 increasing challenges facing the infectious disease community in the United
 States and throughout the world, we need more and better alternatives to treat
 serious and life-threatening bacterial infections.  The results of this trial,
 involving 562 patients, indicate that once-daily Cidecin was as effective as
 optimal antibiotic therapy in the treatment of patients with a range of
 serious skin and soft tissue infections.  Importantly, the incidence of
 adverse events with Cidecin was similar to the standard antibiotics used in
 the active control group in this trial.  These are very important and
 encouraging findings."
 
     Table 3 presents Creatinine Phosphokinase (CPK) Measurement (IU/L) in
 Patients in Study 9901
 
                                          Cidecin            Comparator
      Baseline CPK (mean +/- SEM*)       173 +/- 25          159 +/- 16
      On-Therapy CPK (mean +/- SEM)      145 +/- 15          136 +/- 12
      *SEM = standard error of mean;
       upper limit of normal = 200
 
     Francis P. Tally, MD, Executive Vice President, Scientific Affairs at
 Cubist said, "In this first pivotal clinical trial of Cidecin, CPK levels and
 muscle-related adverse event profiles were similar for both Cidecin and the
 comparator agents.  In addition, no patients required discontinuation of
 therapy due to CPK elevations in the study."
 
       ***************THOMAS WEISEL PARTNERS PRESENTATION***************
 
                  WHEN:  Tuesday, April 3, 2001 at 12:20 pm ET
 
       PRESENTATION WILL BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
 
       http://www.veracast.com/twp_healthcare_2001/webcasts/76204197.cfm
 
                      Replay will be available for 30 days
 
 
        ******************CONFERENCE CALL INFORMATION******************
 
                  WHEN:  Tuesday, April 3, 2001 at 4:30 pm ET
                   DOMESTIC & CANADA CALL-IN:    800-233-2795
                     INTERNATIONAL CALL-IN:    785-832-1523
 
         CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
 
                  http://www.videonewswire.com/CUBIST/040301/
 
                      Replay will be available for 30 days
 
     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(TM) (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, Schering-Plough and Merck & Co for the
 discovery and development of novel antiinfectives and with Gilead Sciences for
 the commercialization of Cidecin in Europe.  Cubist is headquartered in
 Cambridge, 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 Annual Report on Form 10-K filed on April 2, 2001.
     Additional information can be found at the Company's web site at
 www.cubist.com or at www.noonanrusso.com.
 
      Contacts:
 
      Cubist Pharmaceuticals, Inc.                 Noonan/Russo Communications
      Jennifer LaVin                               Renee Connolly - media
      Senior Director, Corporate Communications    (212) 696-4455 ext. 227
      (617) 576-4258                               renee@noonanrusso.com
      jlavin@cubist.com
 
 SOURCE  Cubist Pharmaceuticals, Inc.

RELATED LINKS

http://www.cubist.com