EXHIBIT 99.1
CUBIST PHARMACEUTICALS CONTACTS: GILEAD SCIENCES
Xxxxxxxx XxXxx Xxxxx Xxxxxxx
000-000-0000 000-000-0000
xxxxxxxx.xxxxx@xxxxxx.xxx
Xxxxxx Xxxxx/Presence
Xxxxx Xxx (media)
000-000-0000
x.xxx@xxx-xxxx.xxx
CUBIST AND GILEAD END EUROPEAN COMMERCIALIZATION AGREEMENT FOR
INVESTIGATIONAL ANTIBIOTIC CIDECIN(R)
CUBIST ON TRACK FOR CIDECIN U.S. NDA FILING IN FOURTH QUARTER 2002
CONFERENCE CALL & WEBCAST TODAY AT 5:00 PM ET
LEXINGTON, MA AND FOSTER CITY, CA, SEPTEMBER 9, 2002 - Cubist Pharmaceuticals,
Inc. (Nasdaq: CBST) and Gilead Sciences (Nasdaq: GILD) today jointly announced
the termination of their licensing agreement for the commercialization of
Cidecin(R) (daptomycin for injection) and an oral formulation of daptomycin. The
agreement, executed in January 2001, granted Gilead exclusive commercialization
rights to the products in 16 European countries following regulatory approval.
Under the terms of the discontinuation, Gilead will not owe any future payments
to Cubist, and Cubist reacquires all European rights to both products. The end
of the European collaboration does not affect Cubist's U.S. regulatory or
commercialization strategy.
"We have greatly valued our partnership with Xxxxxx and continue to believe in
the potential of CIDECIN to address an important unmet medical need for patients
with serious bacterial infections," said Xxxx X. Xxxxxx, PhD, President and CEO
of Gilead Sciences. "Given the potential for a more focused CIDECIN label in
Europe, we have chosen to direct our resources toward our other key products,
including the continued multinational roll-out of Viread(R) (tenofovir
disoproxil fumarate) for HIV and preparations for the launch of Hepsera(TM)
(adefovir dipivoxil) for chronic hepatitis B."
Cubist continues on track to file the U.S. CIDECIN New Drug Application (NDA)
during the fourth quarter of 2002 for the indication of complicated skin and
soft tissue infections, based on data from two pivotal Phase III trials that met
their required statistical endpoints. Also included in the NDA package will be
Phase II supportive data from studies that include patients treated with CIDECIN
for vancomycin-resistant Enterococcal (VRE) infections, bacteremia and
complicated urinary tract infections. Phase I data will be included from a
multitude of studies examining drug-drug interactions, renal and hepatic
impairment, and special populations, including obese and geriatric subjects. The
NDA package will also contain a comprehensive microbiology section detailing
CIDECIN's IN VITRO activity against virtually all clinically relevant
Gram-positive organisms. As part of its ongoing package insert development
strategy, Cubist is currently conducting Phase III pivotal trials in infective
endocarditis/bacteremia and VRE
infections. Cubist recently announced the enrollment of the first patients in
the infective endocarditis/bacteremia study.
"In addition to continuing to manage the U.S. NDA filing, Xxxxxx will assume
responsibility for managing the CIDECIN regulatory process in Europe," said
Xxxxx X. Xxxxxxxx, PhD, Chairman and CEO of Cubist. "We expect to achieve
important efficiencies with coordinated regulatory and clinical processes in
place in Europe. While we evaluate our future options for European
commercialization of CIDECIN, we plan on seeking marketing approval as rapidly
as possible, following discussions with appropriate European regulatory
authorities."
About Cubist
Cubist Pharmaceuticals, Inc. is focused on becoming a global leader in the
research, development and commercialization of novel pharmaceuticals to combat
serious and life-threatening 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,
including an oral version of ceftriaxone (OCTX), a broad-spectrum cephalosporin
antibiotic, and CAB-175, a next generation cephalosporin antibiotic with
demonstrated IN VITRO activity against methicillin-resistant Staphylococcus
aureus. The company is engaged in a strategic partnership with Novartis Pharma
AG for the discovery and development of novel antiinfectives. Cubist is
headquartered in Lexington, MA and has operations in Vancouver, BC, Canada and
Slough, UK.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and
commercializes therapeutics to advance the care of patients suffering from
life-threatening diseases worldwide. The company has five marketed products and
focuses its research and clinical programs on anti-infectives, including
antivirals, antifungals and antibacterials. Headquartered in Foster City, CA,
Gilead has operations in the United States, Europe and Australia.
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 are subject to a variety
of risks and uncertainties. Factors that would cause actual results to differ
materially from those projected or suggested in any forward-looking statements
are contained in Cubist's filings with the Securities and Exchange Commission,
including those factors discussed under the caption "Risk Factors" for the year
ended December 31, 2001.
###
CIDECIN IS A REGISTERED TRADEMARK AND EDGE IS A TRADEMARK OF CUBIST
PHARMACEUTICALS, INC.
VIREAD IS A REGISTERED TRADEMARK AND HEPSERA IS A TRADEMARK OF
GILEAD SCIENCES, INC.
For additional information, visit either of the companies' web sites at
xxx.xxxxxx.xxx or xxx.xxxxxx.xxx.
******************CONFERENCE CALL INFORMATION******************
WHEN: MONDAY SEPTEMBER 9, 2002 AT 5:00 PM ET
DOMESTIC & CANADA CALL-IN: (000) 000-0000
INTERNATIONAL CALL-IN: (000) 000-0000
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
xxxx://xxx.xxxxx.xxx/XxxxxXxxx.xxx?XXx00000
REPLAY WILL BE AVAILABLE FOR 30 DAYS VIA THE INTERNET
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