Healthcare Industry News: Cytogen
News Release - February 12, 2008
Cubist Pharmaceuticals Names Steven C. Gilman, Ph.D., as Senior Vice President, Discovery and Non-Clinical Development and Chief Scientific OfficerLEXINGTON, Mass.--(HSMN NewsFeed)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST ) today announced that Dr. Steven Gilman has joined Cubist as Senior Vice President, Discovery and Non-clinical Development and Chief Scientific Officer, a newly created position. Dr. Gilman will be a member of the company’s Executive Team. In this new position, Dr. Gilman will oversee all areas of drug discovery for Cubist. These areas had reported to Michael Bonney, President and CEO of Cubist.
Dr. Gilman has more than 25 years of drug research and development experience. Most recently, he was Chairman of the Board and Chief Executive Officer of ActivBiotics, Inc. While at ActivBiotics, Dr. Gilman led the transition of the organization from early research/academic stage to focus on advanced product development/commercialization. Dr. Gilman’s positions prior to his most recent role at ActivBiotics included President, Chief Executive Officer of ActivBiotics and Vice President and General Manager, Inflammation Franchise, Millenium Pharmaceuticals, Inc. Earlier in his career, Dr. Gilman was responsible for pharmaceutical research units at Pfizer, Sterling Winthrop, Cytogen Corporation and Wyeth Laboratories in areas including chronic inflammatory diseases, transplant rejection, autoimmune diseases and bacterial infections. Dr. Gilman has a Ph.D. in Microbiology from Pennsylvania State University and did post doctoral work in the Department of Immunopathology at Scripps Clinic and Research Foundation in La Jolla, CA.
Cubist recently has announced that it expects to file two Investigative New Drug Applications (INDs) in 2008. Compounds advancing towards IND include potential new therapies for the treatment of infections caused by the Hepatitis C virus (HCV) and for Clostridium difficile-associated diarrhea (CDAD). The company also is progressing lead compounds in preclinical development for the treatment of infections caused by Gram-negative bacteria. As Senior Vice President, Discovery and Non-clinical Development, Dr. Gilman will oversee these and other existing internal discovery programs. Dr. Gilman also will pursue innovative approaches to identify new molecules with medical and commercial potential in the acute care arena, including but not limited to Cubist’s current focus on antinfectives.
Cubist developed and commercializes CUBICIN® (daptomycin for injection) which, since its launch in 2003, continues to track as the most successful IV antibiotic in U.S. history in dollar terms.
CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant and methicillin susceptible strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is also approved in the U.S. as therapy for bloodstream infections (bacteremia), including right-sided endocarditis, caused by S. aureus. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN® (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections.) Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist’s web site at www.cubist.com.
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; (ii) any changes in the current or anticipated market demand or medical need for CUBICIN; (iii) any unexpected adverse events related to CUBICIN, particularly as CUBICIN is used in the treatment of a growing number of patients around the world; (iv) competition in the markets in which we and our partners market CUBICIN, including marketing approvals for new products that will be competitive with CUBICIN; (v) whether the U.S. Food and Drug Administration, or FDA, accepts proposed clinical trial protocols that may be achieved in a timely manner for additional studies of CUBICIN or any other drug candidate we seek to enter into clinical trials; (vi) whether we will receive, and the potential timing of, regulatory approvals or clearances to market CUBICIN in countries where it is not yet approved; (vii) legislative and policy changes in the United States and other jurisdictions where our products are sold that may affect the ease of getting a new product or a new indication approved; (viii) changes in government reimbursement for our or our competitors’ products; (ix) whether or not third parties may seek to market generic versions of our products by filing Abbreviated New Drug Applications, or ANDAs, with the FDA, and the results of any litigation that we file to defend and/or assert our patents against such generic companies; (x) our ability to conduct successful clinical trials in a timely manner; (xi) the effect that the results of ongoing or future clinical trials of CUBICIN may have on its acceptance in the medical community; (xii) the ability of our third party manufacturers, including our single source provider of active pharmaceutical ingredient, or API, to manufacture sufficient quantities of CUBICIN in accordance with Good Manufacturing Practices and other requirements of the regulatory approvals for CUBICIN and at an acceptable cost; (xiii) our dependence upon collaborations with our partners and our partners’ ability to execute on development, regulatory and sales expectations in their territories; (xiv) our ability to finance our operations; (xv) the effectiveness of our sales force and our sales force’s ability to access targeted physicians; (xvi) potential costs resulting from product liability or other third party claims; (xvii) our ability to protect our proprietary technologies; (xviii) our ability to integrate successfully the operations of Illumigen Biosciences, Inc., which we recently acquired, or any other business that we may acquire and the potential impact of the acquisition of Illumigen or any other future acquisition on our financial results; (xix) our ability to discover, acquire or in-license drug candidates and develop and achieve commercial success for drug candidates; and (xx) a variety of risks common to our industry, including ongoing regulatory review, public and investment community perception of the industry, legislative or regulatory changes, and our ability to attract and retain talented employees.
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.
Source: Cubist Pharmaceuticals
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