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Genome Therapeutics Expands Ramoplanin Clinical Program with Initiation of Infection Control Study.

Business Editors/Health/Medical Writers

WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 5, 2003

Pilot study will examine impact of Ramoplanin in reducing pathogen

transmission in the hospital

The clinical development program for Genome Therapeutics' (Nasdaq: GENE) product candidate, Ramoplanin, has been expanded to investigate the role of the novel antibiotic in controlling the spread of important antibiotic-resistant pathogens in the hospital setting. Erika D'Agata, M.D., M.P.H., an Assistant Professor of Medicine at Harvard Medical School and a physician at Beth Israel Deaconess Medical Center in Boston, is the principal investigator. The study is designed to determine whether oral Ramoplanin can reduce the transmission of VRE by decreasing skin contamination through gastrointestinal (GI) decolonization. This trial will form the basis of additional clinical investigations of Ramoplanin as a pharmacological intervention for controlling pathogen transmission and preventing nosocomial infections.

Ramoplanin is currently being studied for two other indications: a Phase III clinical trial for the prevention of bloodstream infections caused by VRE and a Phase II study for the treatment of Clostridium difficile-associated diarrhea.

"The threat posed by serious, antibiotic-resistant, nosocomial bacteria, such as VRE, continues to increase despite aggressive hospital and nursing home infection control programs," stated Dr. D'Agata. "Because previous studies have demonstrated that skin contamination is greatest in patients with the highest densities of VRE in the GI tract, and because Ramoplanin has been shown to suppress VRE below the level of detection in previous clinical studies, GI decolonization with Ramoplanin could prove to be a critical part of a hospital's infection control program."

The study will enroll up to 50 patients, all of whom will be colonized with VRE. The first patients enrolled will not receive the study drug, but will be observed as controls. The second group of patients will receive oral Ramoplanin, 400mg twice daily for seven days. Skin cultures and stool samples will be collected from all participants to measure the absence or presence of VRE. In addition, the study will examine environmental samples taken from colonized patients' rooms to evaluate the presence of VRE on inanimate surfaces in the hospital. The primary endpoint of the study is the frequency of VRE skin contamination in the Ramoplanin versus the control group after seven days of treatment or observation. Normal hospital infection control procedures will be maintained throughout the study.

"Previous studies, both preclinical and clinical, have shown Ramoplanin's ability to exert its bactericidal activity in the GI tract," stated Steven M. Rauscher, Chairman and CEO of Genome Therapeutics. "We believe that expanding Ramoplanin's clinical development program by exploring the antibiotic's use as part of an institution's infection control program may offer clinicians a novel approach to reducing VRE contamination and transmission in conjunction with current infection control measures."

About Nosocomial (Hospital-Based) Infections

Hospital-acquired infections are caused by a variety of highly antibiotic-resistant pathogens and are often serious and difficult to treat. Antibiotic-resistant nosocomial pathogens are transmitted from patient to patient by the hands of healthcare workers and by inanimate objects that come into contact with the skin of infected patients, such as stethoscopes, food trays and bed linens. The Centers for Disease Control has estimated that nearly two million people a year in the U.S. develop nosocomial infections, and nearly 90,000 of those people die. Several antibiotic-resistant, Gram-positive bacteria have emerged as major threats to healthcare institutions, including methicillin-resistant Staphylococcus aureus (MRSA), VRE and most recently, vancomycin-resistant Staphylococcus aureus (VRSA). The rise in hospital costs for treating VRE bloodstream infections alone is nearly $80,000 per case. Current infection control programs call for pathogen surveillance, diligent hand washing and patient contact isolation in order to slow the spread of these bacteria. However, many studies have demonstrated that despite these measures, the rate of infections caused by serious, antibiotic-resistant bacteria continues to rise.

About Ramoplanin

Ramoplanin is an investigational new drug in clinical development by Genome Therapeutics for the prevention, treatment and control of serious hospital-based infections. Genome Therapeutics acquired development and commercialization rights to Ramoplanin for North America from Vicuron Pharmaceuticals. Ramoplanin, a novel glycolipodepsipeptide, has potent in vitro bactericidal activity targeted against Gram-positive bacteria, including many antibiotic-resistant strains such as VRE, MRSA and VRSA. It is also bactericidal in vitro against Clostridium difficile. Because it is not absorbed systemically from the GI tract following oral dosing and exerts its bactericidal activity in the GI tract, Ramoplanin represents a potential new concept for managing certain pathogens commonly found in the hospital. In a Phase II study, Ramoplanin was shown to be highly effective at decolonizing patients carrying VRE in their GI tracts. Ramoplanin, which has Fast Track status from the FDA, is currently being studied for two indications: a Phase III clinical trial for the prevention of VRE bloodstream infections and a Phase II study for treating Clostridium difficile-associated diarrhea.

About Genome Therapeutics

Genome Therapeutics is a biopharmaceutical company focused on the discovery and development of pharmaceutical products for specialty markets. The Company's lead product candidate, Ramoplanin, is in development for the prevention, treatment and control of serious hospital-based infections. Ramoplanin is currently in a Phase III clinical trial for the prevention of bloodstream infections caused by vancomycin-resistant enterococci (VRE), and in a Phase II clinical trial for the treatment of Clostridium difficile-associated diarrhea (CDAD). Genome Therapeutics' biopharmaceutical portfolio also includes seven major product discovery and development alliances with pharmaceutical companies including Amgen, AstraZeneca, bioMerieux, Schering-Plough and Wyeth.

This news release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. Forward-looking statements typically are identified by use of terms such as "may," "will," "should," "plan," "expect," "intend," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. We do not plan to update these forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of risks affecting our business. These risk factors include risks related to our lead product candidate, Ramoplanin, such as (i) our inability to obtain regulatory approval to commercialize Ramoplanin due to negative, inconclusive or insufficient clinical data and (ii) delays in the progress of our clinical trials for Ramoplanin, and increased cost, due to the pace of enrollment of patients in the trials or fluctuations in the infection rate of enrolled patients. We are also subject to risks related to our inability or the inability of our alliance partners to (i) successfully develop products based on our genomics information, (ii) obtain the necessary regulatory approval for such products, (iii) effectively commercialize any products developed before our competitors are able to commercialize competing products or (iv) obtain and enforce intellectual property rights. In addition, we are subject to the risk factors set forth in Exhibit 99.1 to the Company's Annual Report on Form 10-K for the year ended December 31, 2002 and those set forth in other filings that we may make with the Securities and Exchange Commission from time to time.
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Date:Aug 5, 2003
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