Bioenvision's Clofarabine Receives a Positive Opinion from the European Medicines Agency; Bioenvision Prepares for Marketing La
February 23 2006 - 11:08AM
Business Wire
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.
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