Bioenvision Provides Evoltra(R) (clofarabine) Regulatory Update
August 16 2007 - 8:00AM
Business Wire
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.
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