Bioenvision (NASDAQ:BIVN)
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From Jul 2019 to Jul 2024
Bioenvision (NASDAQ: BIVN) today announced that the
Company will host a conference call with the financial community to
discuss the CHMP positive opinion of clofarabine on February 24th at 8
a.m. EST.
To participate in the live call by telephone, please dial
877-825-5811 from the U.S. and Canada or 973-582-2767 from outside the
U.S. A telephone replay of the call will be available beginning at 10
a.m. EST February 24th until 11:59 p.m. EST March 5th by dialing
877-519-4471 or 973-341-3080 and entering reservation number 7086938.
Those interested in listening to the conference call live via the
Internet may do so by visiting www.investorcalendar.com where a link
to Bioenvision's conference call can be found. To listen to the live
call, please go to the web site 15 minutes prior to its start to
register, download, and install the necessary audio software. A replay
will be available on the web site for 14 days.
About Evoltra(TM) (clofarabine)
The CHMP have adopted a positive opinion for the use of
Evoltra(TM) (clofarabine) in "the treatment of acute lymphoblastic
leukemia (ALL) in pediatric patients who have relapsed or are
refractory to at least two prior regimens and where there is no other
treatment option anticipated to result in a durable response. Safety
and efficacy have been assessed in studies of patients less than or
equal to 21 years old at initial diagnosis."
Bioenvision is also developing Evoltra(TM) for the treatment of
adult acute myeloid leukemia (AML) as first-line therapy. The Company
has completed enrollment of its Phase II clinical trial for the
treatment of adult AML in elderly patients unfit for intensive
chemotherapy and expects to file a Marketing Authorization Application
in mid-2006 for the Company's first label-extension for Evoltra(TM).
In addition, clofarabine is in clinical development for the
treatment of myelodysplastic syndrome (MDS), chronic lymphocytic
leukemia (CLL), chronic myeloid leukemia (CML), non-Hodgkin's lymphoma
(NHL), multiple myeloma (MM), solid tumors and as a preconditioning
regimen for transplantation. Bioenvision is also conducting late-stage
preclinical development of Evoltra(TM) for the treatment of psoriasis
and is planning further worldwide development of Evoltra(TM) in
autoimmune diseases.
Evoltra(TM) (clofarabine) is a next generation purine nucleoside
analog. Bioenvision holds an exclusive worldwide license for
clofarabine. Bioenvision granted an exclusive sublicense to Genzyme to
co-develop clofarabine for cancer indications in the US and Canada.
Genzyme is commercializing clofarabine for cancer indications in the
US and Canada under the brand name Clolar(R). Bioenvision holds an
exclusive license in the US and Canada for all non-cancer indications.
Bioenvision originally obtained clofarabine development and
commercialization rights under patents held by Southern Research
Institute.
Clofarabine has been granted orphan drug designation for the
treatment of both ALL and AML in the U.S. and Europe. In Europe, the
designation provides marketing exclusivity for 10 years following
Marketing Authorization.
About Bioenvision
Bioenvision's primary focus is the development, distribution and
marketing of compounds and technologies for the treatment of cancer.
Bioenvision has a broad pipeline of products for the treatment of
cancer, including: Evoltra(TM) (in co-development with Genzyme
Corporation), Modrenal(R) (for which Bioenvision has obtained
regulatory approval for marketing in the United Kingdom for the
treatment of post-menopausal breast cancer following relapse to
initial hormone therapy), and other products. Bioenvision is also
developing anti-infective technologies, including the OLIGON(R)
technology, an advanced biomaterial that has been incorporated into
various FDA approved medical devices. For more information on
Bioenvision please visit our Web site at www.bioenvision.com.
Certain statements contained herein are "forward-looking"
statements (as such term is defined in the Private Securities
Litigation Reform Act of 1995). Because these statements include risks
and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Specifically,
factors that could cause actual results to differ materially from
those expressed or implied by such forward-looking statements include,
but are not limited to: risks associated with preclinical and clinical
developments in the biopharmaceutical industry in general and in
Bioenvision's compounds under development in particular; the potential
failure of Bioenvision's compounds under development to prove safe and
effective for treatment of disease; uncertainties inherent in the
early stage of Bioenvision's compounds under development; failure to
successfully implement or complete clinical trials; failure to receive
marketing clearance from regulatory agencies for our compounds under
development; acquisitions, divestitures, mergers, licenses or
strategic initiatives that change Bioenvision's business, structure or
projections; the development of competing products; uncertainties
related to Bioenvision's dependence on third parties and partners; and
those risks described in Bioenvision's filings with the SEC.
Bioenvision disclaims any obligation to update these forward-looking
statements.