New Anti-Fungal Drug
February 25, 2004 09:04 AM EST
Indevus Initiates Phase I Clinical Trial of Aminocandin for Systemic
Fungal Infections
LEXINGTON, Mass.--(BUSINESS WIRE)--Feb. 25, 2004--Indevus
Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced the initiation
of a Phase I clinical trial with aminocandin, a member of a new class
of anti-fungal compounds under development for the treatment of a
broad spectrum of systemic, invasive infections. This trial will test
the safety and tolerability of escalating single doses of aminocandin
administered intravenously in healthy volunteers. Results of the
trial are expected in the second half of 2004.
"This trial will build upon an extensive pre-clinical dossier on
aminocandin compiled by Aventis SA, from whom Indevus licensed
exclusive worldwide rights to this compound in 2003," said Glenn L.
Cooper, M.D., chairman, president and chief executive officer of
Indevus. "Findings will determine the safety of intravenously
administered aminocandin in humans. In vitro and animal studies with
aminocandin have demonstrated activity against a broad range of fungi
and the ability to protect against systemic fungal infections in an
immune-compromised host. We also believe aminocandin has the
potential to be administered orally, and we have initiated
feasibility studies related to the development of an oral
formulation."
Echinocandins are the first new class of anti-fungal agents to be
developed and introduced in more than 40 years. They are designed to
be fungicidal, that is, to destroy fungi, rather than simply to
inhibit their growth, and to have broad-spectrum activity against the
fungi that cause serious systemic infections.
According to reports from Datamonitor, Inc., an industry market
research firm, the worldwide market for anti-fungal agents is
currently valued in excess of $4 billion, of which approximately $2.5
billion relates to systemic, invasive fungal infections, and is
projected to grow to $6.5 billion by 2008, of which approximately one-
half is predicted to represent systemic infections.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the
development and commercialization of a diversified portfolio of
pharmaceutical product candidates, including multiple compounds in
development: trospium for overactive bladder, pagoclone for panic and
generalized anxiety disorders, citicoline for ischemic stroke, IP 751
for pain and inflammatory disorders, PRO 2000 for the prevention of
infection by HIV and other sexually transmitted pathogens and
aminocandin for systemic fungal infections.
Except for the descriptions of historical facts contained herein,
this press release contains forward-looking statements that involve
risks and uncertainties that could cause the Company's actual results
and financial condition to differ materially from those anticipated
by the forward-looking statements. These risks and uncertainties are
set forth in the Company's filings under the Securities Act of 1933
and the Securities Exchange Act of 1934 under "Risk Factors" and
elsewhere, and include, but are not limited to: dependence on the
success of trospium; the early stage of products under development;
uncertainties relating to clinical trials, regulatory approval and
commercialization of our products, particularly trospium; risks
associated with contractual agreements; dependence on third parties
for manufacturing and marketing; competition; need for additional
funds and corporate partners, including for the commercialization of
trospium and for the development of pagoclone; failure to acquire and
develop additional product candidates; history of operating losses
and expectation of future losses; product liability and insurance
uncertainties; risks relating to the Redux-related litigation;
limited patent and proprietary rights; dependence on market
exclusivity; valuation of our Common Stock; risks related to
repayment of debts; risks related to increased leverage; and other
risks.
|
