<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
-------------
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
MARCH 5, 2000
CUBIST PHARMACEUTICALS, INC
(Exact Name of Registrant as Specified in Charter)
DELAWARE 0-21379 22-3192085
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
24 EMILY STREET, CAMBRIDGE, MASSACHUSETTS 02139
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (617) 576-1999
<PAGE>
-2-
ITEM 5. OTHER EVENTS.
On March 5, 2000, the Registrant presented efficacy and safety data
from its ongoing dose-ranging Phase II clinical studies of its lead drug
candidate, daptomycin, at the Center for Disease Control's 4th Decennial
Conference on Nosocomial and Healthcare-Associated Infections. The results of
the Phase II clinical trials are described in the Registrant's press release
dated March 6, 2000, a copy of which is filed as Exhibit 99(A) to this Report.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(C) EXHIBITS.
Exhibit 99(A) Press Release dated March 6, 2000.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CUBIST PHARMACEUTICALS, INC.
By: /s/ Thomas A. Shea
-----------------------------
Thomas A. Shea
Vice President of Finance and
Administration, Treasurer and
Chief Financial Officer
Dated: March 7, 2000
<PAGE>
-3-
EXHIBIT 99(A)
CONTACTS:
CUBIST PHARMACEUTICALS, INC. NOONAN/RUSSO COMMUNICATIONS
THOMAS A. SHEA CHRISTOPHER MORRISON (MEDIA)
VICE PRESIDENT AND CFO (212) 696-4455 X230
[email protected] [email protected]
CUBIST PHARMACEUTICALS PRESENTS PHASE II DAPTOMYCIN DATA AT THE 4TH
DECENNIAL INTERNATIONAL CONFERENCE ON NOSOCOMIAL AND HEALTHCARE-
ASSOCIATED INFECTIONS
Daptomycin, a Novel Antibiotic, Shows Promise in the Treatment of
Bacteremia and Serious Gram-Positive Infections
CAMBRIDGE, MASS., MARCH 6, 2000 -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST)
yesterday presented positive efficacy and safety data from its ongoing
dose-ranging phase II studies of daptomycin, a new class of bactericidal
antibiotic being developed to treat serious and life-threatening Gram-positive
infections. The dose-ranging phase II open-label clinical studies were presented
at the Center For Disease Control's (CDC) 4th Decennial Conference on Nosocomial
and Healthcare-Associated Infections held in Atlanta. The objective of these
Phase II trials was to investigate dose selection based on clinical efficacy and
safety. The combined Phase II clinical trial data showed that daptomycin,
administered once-a-day at 4 mg/kg, has a 91% clinical success rate. In
addition, daptomycin administered once-a-day at 4 mg/kg demonstrated a 86%
clinical success rate in a subset of patients infected with a
vancomycin-resistant pathogen or who were intolerant or refractory to
vancomycin.
"We are very pleased with the continued clinical success of
daptomycin, particularly since we've presented our findings at this important
CDC conference," said Francis P. Tally, MD, executive vice president of
scientific affairs at Cubist. "This data suggests that a once-a-day regimen of
daptomycin is safe and effective against serious and life-threatening
infections, as well as antibiotic resistant populations."
The daptomycin data discussed were from two ongoing multi-center
open-label phase II studies. The first study is focused on patients diagnosed
with bacteremia, a serious bloodstream infection. The second study is focused on
patients who have failed or are unable to tolerate other therapies for the
treatment of serious Gram-positive infections, including bacteremia, complicated
skin and skin structure, complicated urinary tract infection, intra-abdominal
infection and pneumonia. The combined data consisted of 63 evaluable patients in
total, 56 patients were initiated on one of three doses of daptomycin (4 mg/kg
once-a-day, 6 mg/kg once-a-day, or 3 mg/kg twice-a-day) and seven patients were
placed on standard doses of an optimal comparator regimen, either vancomycin,
oxacillin or nafcillin.
<PAGE>
-4-
The data in Table 1, which are based on a modified intent-to-treat
analysis, shows that daptomycin provided an overall clinical success rate of 91%
(4 mg/kg once-a-day), 63% (6 mg/kg once-a-day) and 45% (3 mg/kg twice-a-day) of
patients, compared with 71% in the comparator arm. Once-a-day dosing of
daptomycin (4 mg/kg or 6 mg/kg) in bacteremic patients was clinically successful
in 80% and 65% of patients, respectively. The data in Table 2 show that
daptomycin had a microbiologic eradication rate of 91% (4 mg/kg once-a-day), 67%
(6 mg/kg once-a-day), and 55% (3 mg/kg twice-a-day) of patients, compared with
71% in the comparator arm. The data in Table 3 show that in patients that are
resistant, refractory or contraindicated for vancomycin, daptomycin had a
clinical success rate of 86% at 4 mg/kg once-a-day.
Daptomycin also had a favorable safety profile similar to the
comparator agents. Specifically, laboratory and clinical measures of adverse
events, such as musculoskeletal, vascular or gastrointestinal, were comparable
to standard treatment. Therefore, daptomycin appears to be safe and
well-tolerated, with no trends in drug-related local or systemic adverse events.
"These preliminary data on daptomycin correlate well with what we
have observed in patients treated with daptomycin at our medical center," said
David Snydman, MD, Professor of Medicine at Tufts University Medical Center and
Chief of Infectious Disease at the New England Medical Center. "Daptomycin would
be an important addition to our antibiotic arsenal with the potential to
significantly aid in the treatment of patients infected with Gram-positive
bacteria."
Based on these phase II data, Cubist will continue the clinical
investigation of once-a-day daptomycin in patients with serious infections,
including bacteremia. During 2000, Cubist plans to expand clinical studies into
other serious and life-threatening infections including complicated urinary
tract infections and endocarditis.
Daptomycin, a novel lipopeptide being developed by Cubist, has
demonstrated potent bactericidal activity in vitro against Gram-positive
bacteria including methicillin resistant staphylococci (MRSA), vancomycin
resistant enterococci (VRE) and glycopeptide intermediate susceptible
staphylococci (GISA). In the first quarter of 1999, Cubist commenced one US and
one worldwide phase III clinical trial investigating once-a-day daptomycin (4
mg/kg once-a-day) in complicated skin and soft tissue infections.
Cubist Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on the research, development and commercialization of novel
antimicrobial drugs to combat serious life threatening bacterial and fungal
infections. Cubist is evaluating the efficacy and safety of daptomycin in the
EDGE(TM) (Evaluation of Daptomycin in Gram-positive Entities) clinical trial
program. Cubist is engaged in strategic partnerships with Novartis Pharma AG,
Merck & Co., Inc. and Bristol-Myers Squibb for the discovery and development of
novel antiinfective products, and has formed biotechnology alliances with
ArQule, Inc. and Neurogen Corporation.
<PAGE>
-5-
CUBIST SAFEHARBOR STATEMENT
STATEMENTS CONTAINED HEREIN THAT ARE NOT HISTORICAL FACTS 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
IS 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 S-3 REGISTRATION STATEMENT, DATED FEBRUARY 8, 2000.
Table 1: Daptomycin Clinical Success Rates*
Modified Intent-to-Treat Population
BAC and RRC Combined
<TABLE>
<CAPTION>
Site of Infection 4 mg/kg q24h 6 mg/kg q24h 3 mg/kg q12h Comparator**
n (%) n (%) n (%) n (%)
<S> <C> <C> <C> <C>
Bacteremia 8/10 (80) 11/17 (65) 5/11 (45) 5/7 (71)
All Others 11/11 (100) 4/7 (57) N/A N/A
Total 19/21 (91) 15/24 (63) 5/11 (45) 5/7 (71)
</TABLE>
* Clinical Success Rates = Cure + Improvement
** BAC Only
Table 2: Daptomycin Microbiological Eradication Rates
Modified Intent-to-Treat Population
BAC and RRC Combined
<TABLE>
<CAPTION>
Site of Infection 4 mg/kg q24h 6 mg/kg q24h 3 mg/kg q12h Comparator*
n (%) n (%) n (%) n (%)
<S> <C> <C> <C> <C>
Bacteremia 8/10 (80) 11/17 (65) 6/11 (55) 5/7 (71)
All Others 11/11 (100) 5/7 (71) N/A N/A
Total 19/21 (91) 16/24 (67) 6/11 (55) 5/7 (71)
</TABLE>
* BAC Only
Table 3: Daptomycin Clinical Success Rates*
RRC Protocol**
<PAGE>
-6-
<TABLE>
<CAPTION>
Site of Infection 4 mg/kg q24h 6 mg/kg q24h 3 mg/kg q12h
n (%) n (%) n (%)
<S> <C> <C> <C>
All Infections 12/14 (86) 8/15 (53) 0/3 (0)
</TABLE>
* Clinical Success Rates = Cure + Improvement
** RRC = Resistant, Refractory, Contraindicated
For additional information, visit the Company's Internet web site at
HTTP://WWW.CUBIST.COM or HTTP://WWW.NOONANRUSSO.COM.
