Bioenvision (NASDAQ:BIVN)
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Bioenvision, Inc. (Nasdaq:BIVN) today announced an update on the status
of its Marketing Authorization Application to the European Medicines
Evaluation Agency (EMeA) to include a new indication for Evoltra®
(clofarabine) for the treatment of acute myeloid leukaemia (AML) in
elderly patients who have one or more of the following: adverse
cytogenetics, secondary AML, ? 70 years old
or significant co-morbidities and are therefore not considered suitable
for intensive chemotherapy. Evoltra is currently approved in Europe 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.
In May 2007, Bioenvision received a Request for Supplemental Information
from the EMeA’s Committee for Medicinal
Products for Human Use. In order to allow Bioenvision to fully respond
to this request, the EMeA has agreed to accept the Company’s
responses by November 16, 2007. This extension of time to respond will
enable Bioenvision to prepare more comprehensive responses to the
Request for Supplementary Information, including interim data from the
ongoing, multi centre AML 16 study. The Company anticipates that in
December, 2007 the EMeA will provide an Assessment Report, and in
January 2008 the EMeA will provide either an Opinion on whether or not
to grant the request of marketing authorization of the drug for this new
indication, or a second request for Supplementary Information.
It should be noted that the foregoing may be subject to change and the
Assessment Report and/or Opinion may require Bioenvision to provide
further data and/or to attend an oral explanation. The Opinion of the
EMeA is also required to be adopted by the European Commission as a
pre-condition to the grant of marketing authorization of Evoltra for
this new indication. In addition, in relation to the Company’s
variation application to include a new indication (elderly AML), the
EMeA has requested that data from the ongoing AML 16 trial be provided.
The AML 16 trial, sponsored by the National Cancer Research Institute
(UK), randomizes clofarabine against the standard of care (low-dose
cytarabine) for the treatment of elderly patients with adult AML who are
not considered suitable for intensive chemotherapy. The Company believes
it will be able to make data from this trial available to the EMeA by
November 2007, to satisfy this request. There can be no assurances,
however, that this data will be made available to the Company for its
application. The AML 16 trial will not be fully enrolled at the time of
submission of the Company's response to the EMeA and there can be no
assurances that interim data will be satisfactory, or that the data
itself will be supportive of the Company's application. Further, if the
EMeA does not accept this data, the Company may have to run an
additional randomized study.
About Evoltra® (clofarabine)
Evoltra® is currently approved in Europe 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 has conducted a
phase I clinical study of Evoltra® for the
treatment of psoriasis and is planning further worldwide development of
Evoltra® in autoimmune diseases.
Evoltra® (clofarabine) is a next generation
purine nucleoside analog. Bioenvision holds an exclusive worldwide
license (excluding U.S. and Canada) for the cancer applications of
clofarabine and an exclusive worldwide license for all non-cancer
indications. 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®. 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 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®,
Modrenal® (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
Suvus® which is currently in clinical
development for refractory chronic hepatitis C infection. For more
information on Bioenvision please visit our website at www.bioenvision.com.
Forward-looking Statements
Certain statements contained in this press release are
"forward-looking" statements, including express or implied statements
regarding Bioenvision obtaining regulatory approval of its products and
Bioenvision’s ability to deliver the
additional data requested by the EMeA. Because these statements are
subject to 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
whether the merger of Wichita Bio Corporation with and into Bioenvision
will be approved by the stockholders of Bioenvision; risks associated
with the uncertainty as to whether such merger will in fact occur, risks
associated with disruptions from the proposed merger transaction which
may harm relationships with customers, employees, suppliers and
partners; risks associated with the outcome of litigation and regulatory
proceedings to which we are currently a party and may become a party in
the future; 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 assumes no
obligation to update any forward-looking statements as a result of new
information or future events or developments, except as required by law
and the statements contained in this press release are current as of the
date of this release only.