Bioenvision (NASDAQ:BIVN)
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Bioenvision (Nasdaq: BIVN) today announced that the
European Medicines Agency has adopted a positive opinion on the
marketing authorization application for Evoltra(TM) (clofarabine).
Evoltra(TM) is indicated for the treatment of acute lymphoblastic
leukemia (ALL) in pediatric patients who have relapsed or are
refractory to at least two prior regimens.
Originally the Agency's scientific committee, the Committee for
Medicinal Products for Human Use (CHMP), was expected to formally
adopt an opinion at their meeting of March 20-23, 2006. However,
Bioenvision is pleased to receive this positive opinion a month
earlier than anticipated. The CHMP positive opinion must now be
converted into a Marketing Authorization by the European Commission, a
process that is expected to take 3 months, at which time Bioenvision
will launch Evoltra(TM) throughout Europe. Evoltra(TM) has already
been granted orphan drug designation, providing marketing exclusivity
for 10 years in Europe following this Marketing Authorization.
"Evoltra(TM) is the first new drug for children with multiple
relapsed or refractory leukemia to receive a positive opinion in
Europe in more than a decade. It offers a genuine hope of response and
disease free survival for this patient group," said Hugh Griffith,
Bioenvision's Chief Operating Officer. Mr. Griffith continued: "The
achievement of this significant milestone enables Bioenvision to
further build out its commercial infrastructure to ensure the
successful launch of Evoltra(TM) throughout Europe."
"Pediatric hematologists will be very interested by the CHMP
positive opinion on the favorable benefit to risk profile of
Evoltra(TM) in this vulnerable patient group," said Professor Andre
Baruchel, Head of Pediatric Haematology Department, Hopital
Saint-Louis, Paris, France. Professor Baruchel added: "achieving a 20%
to 30% overall response rate, which can be durable, in children and
adolescents with ALL who have relapsed or are refractory, is very
promising."
"The introduction of Evoltra(TM) into the European market is the
cornerstone of Bioenvision's commercial strategic plan," commented Dr.
Christopher Wood, Chairman and CEO of Bioenvision. Dr. Wood added,
"this positive opinion provides a solid foundation for building the
Evoltra(TM) franchise throughout Europe and the rest of the world."
Bioenvision has already begun preparation for the marketing of
Evoltra(TM) in Europe with the appointment of general managers in
certain of the major European markets. Bioenvision will expand its
existing sales and marketing team across Europe in preparation for the
launch of Evoltra(TM). Once formally approved via the Centralized
Procedure, Evoltra(TM) can be marketed throughout all 25 member states
of the European Union which has a population of approximately 450
million.
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.