Exhibit 99.1
FOR IMMEDIATE RELEASE
GENOME THERAPEUTICS LICENSES NOVEL ANTIBIOTIC PRODUCT, RAMOPLANIN,
FROM BIOSEARCH ITALIA
--Phase III Clinical Trial Ongoing in U.S.--
WALTHAM, MASS., OCTOBER 9, 2001 - Genome Therapeutics (Nasdaq: GENE) has
acquired the exclusive license in the United States and Canada for the novel
antibiotic, Ramoplanin, from Biosearch Italia S.p.A. (Nuovo Mercato: BIO.MI).
Genome Therapeutics will immediately assume responsibility for the development
program for Ramoplanin, currently in a Phase III clinical trial in the United
States. Ramoplanin is a novel antibiotic under investigation for the prevention
of bloodstream infections caused by vancomycin-resistant enterococci (VRE). If
approved, Ramoplanin would be the first available antibiotic to prevent VRE
bloodstream infections.
"Ramoplanin represents an exciting, advanced stage clinical candidate for
prevention of potentially life-threatening VRE bloodstream infections," said
Steven M. Rauscher, Chief Executive Officer and President of Genome
Therapeutics. "This promising drug will enable Genome Therapeutics to capitalize
on its established expertise in infectious disease research and apply it to a
near-term commercial opportunity. In addition, the Ramoplanin product license
enables us to rapidly realize our goal of becoming a biopharmaceutical company
with our own pipeline of clinical candidates."
CLINICAL STATUS OF ORAL RAMOPLANIN
In a Phase II, multicenter, double-blind, placebo-controlled trial, oral
Ramoplanin was shown to be safe and well tolerated. In addition, after seven
days of treatment, 90% of patients who received Ramoplanin had no detectable VRE
in their gastrointestinal tract, while all of the placebo patients had
detectable VRE (p(is less than)0.01). Ramoplanin has been granted Fast Track
status by the FDA and is currently being tested in a Phase III clinical study.
The ongoing Phase III study is designed to demonstrate whether oral prophylaxis
with Ramoplanin reduces the incidence of VRE bloodstream infections in cancer
patients known to carry VRE bacteria in their intestines. More than 25 percent
of the planned 950 patients have been enrolled in the study at more than 40
clinical trial sites in the U.S. Genome Therapeutics expects to file a New Drug
Application in 2004.
TERMS OF THE AGREEMENT
Today's agreement provides Genome Therapeutics with exclusive rights to develop
and market oral Ramoplanin in the U.S. and Canada. Biosearch Italia will provide
the bulk material for the manufacture of the product, and will retain all other
rights to market Ramoplanin. Recently, Biosearch Italia reacquired rights in the
U.S. and Canada to Ramoplanin from California-based IntraBiotics and has since
been conducting the U.S. clinical trial.
Under the terms of the agreement, Genome Therapeutics will pay Biosearch an
initial consideration of $2 million. Thereafter, Genome Therapeutics will make
milestone payments up to an additional $8 million in a combination of cash and
notes convertible into Genome Therapeutics stock. In addition to purchasing bulk
material from Biosearch, Genome
Therapeutics will fund the completion of clinical trials and pay a royalty on
product sales. The combined total of bulk product sales and royalties is
expected to be 26% of Genome Therapeutics' net product sales.
Genome Therapeutics and Biosearch Italia have established a joint committee to
coordinate global efforts for the ongoing clinical development and future
commercialization of Ramoplanin.
"This is excellent news for Ramoplanin and Biosearch. We have always believed
that Ramoplanin is a promising and highly effective product, and the interest we
received in the North American rights has reinforced our optimism," said Dr.
Francesco Parenti, President and Chief Scientific Officer of Biosearch. "Genome
Therapeutics has a long history of innovation in infectious disease research and
understanding the genetic structures of the organisms that cause serious
infection. Its commitment, experience and financial resources will ensure that
Ramoplanin completes development as quickly as possible and achieves its full
potential."
"VRE poses a significant threat to immunocompromised patients, particularly
those undergoing chemotherapy, who are most at risk for developing bloodstream
infections from these bacteria," said Robert C. Moellering, M.D., chairman of
medicine at Beth Israel Deaconess Medical Center and member of the Data Safety
Monitoring Board that reviewed the Phase II clinical results for Ramoplanin. "As
treatment options are limited, a new agent that effectively prevents VRE
infections would make a valuable addition to our arsenal against these
potentially life-threatening pathogens."
ABOUT RAMOPLANIN
Ramoplanin is a novel glycolipodepsipeptide antibiotic produced by fermentation
of ACTINOPLANES species, with activity against gram-positive aerobic and
anaerobic microorganisms. In preclinical studies Ramoplanin has been shown to be
bactericidal for most gram-positive species, including methicillin-resistant
staphylococci and VRE. Ramoplanin inhibits the bacterial cell wall peptidogly
can biosynthesis with a mechanism different from that of vancomycin, teicoplanin
or other cell wall-synthesis inhibitors. No evidence of cross-resistance between
Ramoplanin and other glycopeptide antibiotics has been observed.
BACKGROUND ON VRE INFECTIONS
Enterococci are a family of bacteria that are part of the normal flora of the
gastrointestinal tract. However, the widespread use of antibiotics such as
vancomycin and third generation cephalosporins has increased the prevalence of
resistant strains of enterococci, posing a significant threat to patients. In
1999, more than 25% of intensive care unit enterococci infection were vancomycin
resistant, a 47% increase from 1994. VRE infections are associated with longer
hospital and intensive care unit stays, higher mortality and greater health care
costs. Current options for treating VRE bloodstream infection are limited and
not always effective. In addition, there are no products approved for prevention
of VRE infection. Certain patient populations are at greater risk of VRE
infection, including patients undergoing treatment with chemotherapy,
radiotherapy or immunosuppressive drugs. Studies have reported that VRE
infections occur in 14% of patients in the adult oncology unit, 19% of pediatric
patients with malignancies and 17% of patients with leukemia who are colonized
with VRE.
Biosearch Italia S.p.A. (Nuovo Mercato: BIO.MI) is a leading Italian
biotechnology company focused on the discovery, development, production and
eventually marketing of new antibiotics for the treatment of infectious diseases
caused by multi-resistant micro-organisms (bacteria and
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fungi). Biosearch's discovery strategy is based on the high-throughput screening
of its large and diversified library of microbial extracts, which is
continuously expanding.
Genome Therapeutics (www.genomecorp.com) is focused on the commercialization of
genomics-based pharmaceutical and diagnostic products. The Company operates two
lines of business: genomics services and biopharmaceutical. The Genomics
Services business focuses on services that enable other organizations to achieve
their drug discovery objectives and includes custom contract sequencing and the
PathoGenome(TM) Database. The Biopharmaceutical business focuses on the
development of novel therapeutics and diagnostics to solve major medical needs
and includes six alliances with pharmaceutical companies including
Schering-Plough, AstraZeneca, Wyeth-Ayerst and bioMerieux.
ADDITIONAL FINANCIAL DISCLOSURE: Genome Therapeutics' management team noted that
development expenditures associated with the acquisition of Ramoplanin are
expected to be approximately $15-20 million through the end of 2002.
STATEMENTS IN THIS PRESS RELEASE THAT ARE NOT STRICTLY HISTORICAL, INCLUDING
STATEMENTS REGARDING FUTURE REVENUES AND EXPENSES, ARE "FORWARD LOOKING"
STATEMENTS AS DEFINED IN THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. A
NUMBER OF IMPORTANT FACTORS COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM
THOSE PROJECTED OR SUGGESTED IN THE FORWARD LOOKING STATEMENT, INCLUDING, BUT
NOT LIMITED TO, THE ABILITY OF THE COMPANY AND ITS ALLIANCE PARTNERS TO (I)
SUCCESSFULLY DEVELOP PRODUCTS BASED ON THE COMPANY'S GENOMIC INFORMATION, (II)
OBTAIN THE NECESSARY GOVERNMENTAL APPROVALS, (III) EFFECTIVELY COMMERCIALIZE ANY
PRODUCTS DEVELOPED BEFORE ITS COMPETITORS AND (IV) OBTAIN AND ENFORCE
INTELLECTUAL PROPERTY RIGHTS, AS WELL AS THE RISK FACTORS DESCRIBED IN EXHIBIT
99 OF THE COMPANY'S ANNUAL REPORT ON FORM 10-K FOR THE FISCAL YEAR ENDED AUGUST
31, 2000 AND FROM TIME TO TIME IN THE COMPANY'S OTHER REPORTS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
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