LEXINGTON, Mass. (Business Wire) -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced the appointment of David S. Mantus, Ph.D., to the position of Vice President, Regulatory Affairs, effective May 9, 2005. Dr. Mantus' responsibilities at Cubist include strategic and executional oversight for all U.S. and international regulatory matters, including filings and interaction with regulatory authorities. Dr. Mantus will also serve on Cubist's Executive Team.
Immediately prior to joining Cubist, Dr. Mantus served as V.P. Regulatory Affairs for Sention, Inc. and previously was Director, Regulatory Affairs for Shire Biologics, Inc. Dr. Mantus is an Adjunct Professor, Drug Regulatory Affairs, at the Massachusetts College of Pharmacy and is co-editor of FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, published in 2004. He has also co-authored numerous publications and presentations in peer-reviewed journals and at international research and regulatory conferences. Dr. Mantus received both his M.S. and PH. D. degrees in Chemistry from Cornell University and was a post-doctoral fellow in Biomedical Engineering at the University of Washington, Seattle.
Mike Bonney, President and CEO of Cubist said, "We are pleased to have Dave here to lead our regulatory affairs team. Dave's regulatory expertise and his strategic thinking make him an important addition to our Executive Team." Bonney added, "We also thank Dan Cushing, Ph.D., Managing Partner, Scientific Commercialization LLC, who has done a great job overseeing our regulatory affairs team while we conducted the search that brought Dave to us." Cubist expects to announce top line results of the CUBICIN Phase 3 Infective endocarditis/bacteremia trial in mid-2005. If the trial is successful, the company expects to file an sNDA for an expanded label for CUBICIN late this year.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of antiinfective products that meet unmet medical needs. In the U.S., Cubist markets Cubicin(R) (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides. CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. with activity against both methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MSSA and MRSA) in complicated skin and skin structure infections. Cubist's pipeline includes HepeX-B(TM), a monoclonal antibody biologic currently in the second of two Phase 2 trials to determine its potential for the prevention of infection by the Hepatitis B virus (HBV) in liver transplant patients, and research efforts focused on novel members of the lipopeptide class of molecules and on natural products discovery. Cubist is headquartered in Lexington, MA.
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, and such statements 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 Cubist. These factors include, but are not limited to: (i) the level of acceptance of CUBICIN by physicians, patients, third-party payors, and the medical community generally; (ii) Cubist's ability to continue to develop, secure additional regulatory approvals for, and successfully market, CUBICIN; (iii) Cubist's expectations regarding our ability to continue to manufacture sufficient quantities of CUBICIN in accordance with current Good Manufacturing Practices; (iv) commercialization of products that are competitive with CUBICIN; (v) Cubist's ability to discover or in-license drug candidates; (vi) Cubist's ability to successfully develop drug candidates in its pipeline, including HepeX-B; (vii) Cubist's ability to successfully commercialize any product or technology developed by Cubist; (viii) Cubist's ability to establish and maintain successful manufacturing, sales and marketing, distribution, and development collaborations; (ix) legislative or regulatory changes adversely affecting Cubist or the biopharmaceutical industry; (x) Cubist's expectations regarding the future market demand and medical need for CUBICIN; (xi) Cubist's ability to protect its intellectual property and proprietary technologies; and (xii) Cubist's ability to finance its operations . Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings.
Cubist and Cubicin are registered trademarks of Cubist Pharmaceuticals, Inc.; HepeX-B is a trademark of XTL Biopharmaceuticals Ltd.
Additional information can be found at Cubist's web site at www.cubist.com
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Eileen.mcintyre@cubist.com
or
Fleishman-Hillard, Inc.
Christine Regan, 617-692-0522
reganc@fleishman.com
