Wednesday May 31, 2:00 am Eastern Time
Company Press Release
SOURCE: Cubist Pharmaceuticals, Inc.
Positive Data on Cubist's Cidecin(TM) (Daptomycin
for Injection) Presented to 10th European Congress of Microbiology and
Infectious Disease
Cubist to Accelerate Cidecin Phase III Pneumonia Trial
CAMBRIDGE, Mass., May 31 /PRNewswire/ -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST - news) today announced that
positive data on Cidecin(TM) (daptomycin for injection), including expanded data from the Company's Phase II bacteremia
trial, are being presented in three separate sessions at the 10th European Congress of Microbiology and Infectious Diseases
(ECCMID) in Stockholm, Sweden. Cubist also announced that it expects to commence a Phase III pneumonia trial by the end
of 2000.
The first presentation, by Francis P. Tally, MD, Executive Vice President of Scientific Affairs at Cubist, is entitled
``Daptomycin (Cidecin(TM)) Treatment for Serious Gram-positive Infections Including Endocarditis'' and details expanded
safety and efficacy data from Cubist's two ongoing, dose-ranging, Phase II studies of daptomycin. Daptomycin is the first in a
new class of bactericidal antibiotics that Cubist is developing to treat serious and life-threatening Gram-positive infections.
These multi-center, open-label, Phase II studies focus on patients diagnosed with bacteremia, a serious bloodstream infection,
and patients who are refractory, resistant or contraindicated (RRC) to other therapies, including vancomycin.
The combined data include 101 enrolled patients and are summarized in Table 1. At a dose of 4 mg/kg in a once-daily regimen,
daptomycin had an overall clinical success rate of 92% in the modified intent-to-treat population and 100% on the clinically
evaluable patients. In terms of microbiologic eradication, daptomycin demonstrated a 75% success rate in the modified
intent-to-treat population and a 93% success rate in microbiologically evaluable patients. Notably, the data show that in the
RRC study, daptomycin demonstrated a clinical success rate of 86%. The RRC study includes patients suffering from a variety
of serious infections, including intra-abdominal infection, pneumonia, complicated skin and soft tissue infection (cSST) and
complicated urinary tract infection (cUTI).
Cubist recently announced that it has filed with the FDA to expand the protocol for the RRC study to include patients suffering
from endocarditis, an infection of the heart with a high rate of mortality, and the Company today announced plans to begin a
Phase III daptomycin trial in pneumonia by the end of 2000. Daptomycin is currently in multiple Phase III trials for the
treatment of cSST infections. A pivotal trial to examine the drug's efficacy in treating cUTI is expected to begin shortly.
The second presentation, by Debra D. Poutsiaka, MD, Assistant Professor in the Infectious Diseases Department at the New
England Medical Center, is entitled ``Successful Treatment of Leuconostoc Species Bacteremia in Recipients of Bone Marrow
Transplantation (BMT) by Daptomycin (D).'' Leuconostoc species are rare, Gram-positive pathogens that can infect
immunocompromised hosts and cause bacteremia. They are also vancomycin resistant. In Dr. Poutsiaka's study, daptomycin
was used to treat two BMT patients involved in the Phase II RRC study that had developed Leuconostoc bacteremia. In both
cases, daptomycin was delivered safely and cured these severely immunocompromised patients of their infections.
The third presentation, entitled ``In Vitro Activity of Daptomycin (Cidecin(TM)) Against Contemporary Gram-positive Clinical
Bacterial Isolates From 11 North American Medical Centers (NAMC)'', is being presented by Steven D. Brown, Ph.D.,
Associate Director of The Clinical Microbiology Institute in Oregon. This study compares the effectiveness of daptomycin
against 2,803 Gram-positive bacterial isolates from multiple medical centers. Daptomycin proved to be more effective and
consistently more potent than vancomycin in the treatment of the isolates. The data also confirm that daptomycin is active in
vitro against a variety of vancomycin-susceptible and vancomycin-resistant strains of enterococci as well as all species of
staphylococci and streptococci, including penicillin-susceptible, penicillin- intermediate and penicillin-resistant streptococcus
pneumoniae.
``We are extremely pleased with the amount of positive data we are seeing from all our studies in the Cidecin clinical program,''
said Scott M. Rocklage, Ph.D., Chairman, President and Chief Executive Officer of Cubist. ``These positive data, combined
with other recent studies, not only add to our comprehensive daptomycin safety package, but have also encouraged us to
increase the breadth of therapeutic indications we are exploring for Cidecin with the FDA.''
Cubist Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the research, development and
commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections. Cubist is
evaluating the efficacy and safety of Cidecin(TM) (daptomycin for injection) in the EDGE(TM) (Evaluation of Daptomycin in
Gram-positive Entities) clinical trial program. Cubist is engaged in multiple strategic partnerships including Novartis Pharma AG
and Merck & Co. for the discovery and development of novel antiinfective products.
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, 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/A (file No. 000-21379) filed on April 3, 2000.
Table 1: Daptomycin Phase II Clinical Summary
4 mg/kg IV Once-A-Day
Bacteremia and RRC Combined
Bacteremia Others Total
Site of Infection n (%) n (%) n (%)
Clinical Success Rate
Modified Intent-to-Treat* 12/14 (86) 10/10 (100) 22/24 (92)
Clinically Evaluable** 10/10 (100) 5/5 (100) 15/15 (100)
Microbiologic Eradication
Modified Intent-to-Treat* 10/14 (71) 8/10 (80) 18/24 (75)
Microbiologically Evaluable*** 10/10 (100) 3/4 (75) 13/14 (93)
* Modified Intent-to-Treat: All patients with documented
Gram-positive infections who receive greater than or equal to
1 dose of study medication
** Clinically Evaluable Population: Patients with documented
Gram-positive infection who complete study evaluations that
receive greater than or equal to 4 days study treatment and who
satisfy protocol eligibility and evaluation criteria
*** Microbiologically Evaluable Population: Patients with appropriate
bacteriologic cultures obtained in accordance with protocol
sampling schemes (e.g. within 48 hours of initiating study
therapy) and appropriate post-therapy evaluation
For additional information, visit the Company's Internet website at cubist.com or noonanrusso.com.
SOURCE: Cubist Pharmaceuticals, Inc. |
