Bioenvision (NASDAQ:BIVN)
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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.