Public Relations
Cubist Pharmaceuticals Announces Successful Human Proof-of-Principal Study Using Oral Formulations of Ceftriaxone
LEXINGTON, Mass., Jan 7, 2002 /PRNewswire via COMTEX/ -- Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced successful results from a human clinical research study examining the bioavailability of ceftriaxone in a variety of oral formulations.
In these studies, intended to determine whether certain formulations could make ceftriaxone bioavailable, cubist achieved its goal, demonstrating clinically relevant blood levels of ceftriaxone delivered intraduodenally, or directly to the small intestine, in human volunteers. These studies confirm earlier work performed in both non-human primates and rodents. Based on these studies, the Company intends to continue clinical research on oral ceftriaxone (OCTX) by developing and optimizing oral dosage formulations. Should this development be completed successfully along currently forecasted timelines, Cubist believes it could file an Investigational New Drug (IND) application with the U.S. Food & Drug Administration by the end of 2002 to begin formal clinical development.
"We are extremely encouraged by the achievement of the first ever meaningful blood levels of a formulation of ceftriaxone intended to be delivered orally," said Scott M. Rocklage, Ph.D., Chairman & CEO of Cubist. "With these results and based on ceftriaxone's long history of safety and efficacy in its injectable versions, we are looking forward to continuing our clinical research on OCTX throughout 2002."
Hoffman-La Roche's Rocephin(R) (ceftriaxone sodium) for Injection had sales of over $1 billion in 2000. Injectable ceftriaxone has been successfully and safely prescribed for over 15 years in both adults and children. The drug is a third-generation cephalosporin that has demonstrated a broad spectrum of bactericidal activity against Gram-positive and Gram-negative bacteria. These bacteria are responsible for the majority of community-based infections, which include upper and lower respiratory tract infections (including otitis media. sinusitis, bronchitis and community- acquired pneumonia) and urinary tract infections. These infections result in nearly 80 million treated patients annually in the United States.
To date, ceftriaxone has been primarily used to treat hospital in-patients due to the lack of an oral version of the drug. If successfully developed, Cubist believes that an oral formulation could expand the utility of ceftriaxone through community-based prescribing. In addition, the Company believes an oral formulation of ceftriaxone could also be used for the continuation of parenteral antibiotic therapy (step-down therapy). Step-down therapy provides multiple benefits, including convenience and cost savings of an oral therapy versus parenteral therapy, potential earlier hospital discharge and associated healthcare cost savings, and increased physician confidence in an optimal therapeutic outcome given that a discharged patient is receiving the same therapy taken intravenously in the hospital setting.
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(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. The Company is engaged in strategic partnerships with Novartis Pharma AG and Merck & Co for the discovery and development of novel antiinfectives and with Gilead Sciences for the commercialization of daptomycin in Europe. Cubist is headquartered in Lexington, 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 successful 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 of 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.
Jennifer Lavin
Senior Director, Corporate Communications
(781)860-8362
jennifer.lavin@cubist.com
Noonan/Russo Communications
Emily Poe - media
(212)696-4455 ext.221
e.poe@noonanrusso.com
Source
Cubist Pharmaceuticals, Inc.
Contact: Jenifer Lavin, Senior Director, Corporate Communications of Cubist Pharmaceuticals, Inc., +1-781-860-8362, jennifer.lavin@cubist.com; or Emily Poe - media of Noonan/Russo Communications, +1-212-696-4455 ext. 221, e.poe@noonanrusso.com
Company news on-call:
http://www.prnewswire.com/gh.cnoc.comp.119304.html
Photo:
http//www.newscom.com/cgi-bin/prnh/20000717/cubelogo
AP Archive:
http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840 (CBST)
http://www.prnewswire.com
Copyright (C) 2002 PR Newswire. All rights reserved.
News provided by COMTEX. User agreement applies.