Cubist and Gilead End European Commercialization Agreement for Investigational Antibiotic CIDECIN; Cubist On Track for CIDECIN U.S. NDA Filing in Fourth Quarter 2002.Business Editors and Health/Medical Writers BIOWIRE2K LEXINGTON, Mass. & FOSTER CITY, Calif.--(BUSINESS WIRE)--Sept. 9, 2002 Conference Call & Webcast Today at 5:00 pm ET Cubist Pharmaceuticals, Inc. (Nasdaq: CBST CBST Center for Biophotonics Science and Technology CBST Congregation Beth Simcha Torah (NYC) CBST Complete Binary Search Tree ) 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 Cubist and continue to believe in the potential of CIDECIN to address an important unmet medical need for patients with serious bacterial infections," said John C. Martin, PhD, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 tenofovir disoproxil fumarate Viread Pharmacologic class: Nucleoside analog reverse transcriptase inhibitor Therapeutic class: Antiretroviral Pregnancy risk category B ) for HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. and preparations for the launch of Hepsera(TM) (adefovir dipivoxil adefovir dipivoxilHepsera Pharmacologic class: Nucleotide reverse transcriptase inhibitor Therapeutic class: Antiviral Pregnancy risk category C FDA Boxed Warning) for chronic hepatitis Chronic hepatitisLong lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B." Cubist continues on track to file the U.S. CIDECIN New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) 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 VRE vancomycin-resistant enterococcus. VRE Vancomycin-resistent enterococcus, see there ) infections, bacteremia bacteremia: see septicemia. bacteremia Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites. and complicated urinary tract infections urinary tract infection (UTI), n infection in one or more of the structures that make up the urinary system. Occurs more often in women and is most commonly caused by bacteria. . 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 in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. activity against virtually all clinically relevant Gram-positive organisms. As part of its ongoing package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific 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, Cubist will assume responsibility for managing the CIDECIN regulatory process in Europe," said Scott M. Rocklage, 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 ceftriaxone /cef·tri·ax·one/ (cef?tri-ak´son) a semisynthetic, ß–resistant, third-generation cephalosporin effective against a wide range of gram-positive and gram-negative bacteria, used as the sodium salt. (OCTX), a broad-spectrum cephalosporin cephalosporin (sĕf'əlōspôr`ĭn), any of a group of more than 20 antibiotics derived from species of fungi of the genus Cephalosporium and closely related chemically to penicillin. Cephalosporins, e.g. antibiotic, and CAB-175, a next generation cephalosporin antibiotic with demonstrated in vitro activity against methicillin-resistant Staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline, . 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 www.cubist.com or www.gilead.com.
CONFERENCE CALL INFORMATION
WHEN: Monday September 9, 2002 at 5:00 pm ET
DOMESTIC & CANADA CALL-IN: (800) 915-4836
INTERNATIONAL CALL-IN: (973) 317-5319
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
http://www.vcall.com/EventPage.asp?ID=82290
Replay will be available for 30 days via the Internet
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