Bioenvision to Formally Launch Evoltra(R) Throughout Europe; Bioenvision To Showcase Leukemia Drug At International Pediatric On
September 14 2006 - 6:06PM
Business Wire
Bioenvision, Inc. (NasdaqGM: BIVN) today announced the Company will
be formally launching Evoltra(R) throughout Europe at the 38th
Congress of the International Society of Pediatric Oncology (SIOP)
in Geneva, Switzerland from September 17th-21st. "This conference
is the perfect platform for Bioenvision to share data on our new,
innovative cancer drug Evoltra(R) (clofarabine) with hundreds of
oncologists, pediatricians, hematologists, surgeons and nurses who
treat pediatric patients all over the globe," said Dr. Christopher
B. Wood, Chairman and Chief Executive Officer of Bioenvision. The
annual scientific conference of SIOP is the major international
meeting for all healthcare professionals who treat children with
cancer. 1700 specialists are expected to attend. Interim results
from the Bioenvision European pediatric acute lymphoblastic
leukemia study have been selected for oral presentation in the
plenary scientific session on Tuesday, September 19th 2006. Dr
Pamela Kearns, one of the Chief Investigators for this important
study, will be making the presentation. Three additional abstracts
have also been selected for poster presentations and focus on the
most recent data from the pivotal study conducted in the US which
led to both US and EU marketing approval. Bioenvision is also
sponsoring a dedicated satellite symposium entitled "New treatment
options in pediatric acute leukemias" which will include
presentations relating to Evoltra from Professor Rob Pieters, Dr
Sima Jeha, Professor Vaskar Saha and Professor Andre Baruchel. "The
38th Congress of SIOP is the most appropriate forum for our formal
launch of Evoltra(R) throughout Europe. It provides an excellent
stage to further communicate the benefits associated with Evoltra
to the world's leading paediatric haematologists and oncologists,"
said Hugh S. Griffith, Chief Operating Officer of Bioenvision.
Evoltra(R) received marketing approval from the European Commission
this summer for the treatment of relapsed and refractory acute
lymphoblastic leukemia in children. About Evoltra(R) (clofarabine)
The European Marketing Authorisation for Evoltra(R) (clofarabine)
is for "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." Clofarabine is in clinical
development for the treatment of other hematological cancers and
solid tumors. Bioenvision is also conducting late-stage preclinical
development of Evoltra(R) for the treatment of psoriasis and is
planning further worldwide development of Evoltra(R) in autoimmune
diseases. Evoltra(R) (clofarabine) is a next generation purine
nucleoside analog. Bioenvision holds an exclusive worldwide license
for clofarabine (outside Japan and Southeast Asia) and an
exclusive, irrevocable option to develop, market and distribute
clofarabine for all human applications in Japan and Southeast Asia.
Bioenvision granted an exclusive sublicense to Genzyme Corporation
to develop and commercialize clofarabine for certain cancer
indications in the U.S. and Canada, which Genzyme markets under the
name of Clolar(R). Bioenvision holds an exclusive license in the
U.S. 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 acquisition, 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(R), 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 and
Suvus(R), an antimicrobial agent currently in clinical development
for refractory chronic hepatitis C infection. 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.
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