Bioenvision (NASDAQ:BIVN)
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Bioenvision, Inc. (NasdaqGM:BIVN) today announced it is
expanding into Japan and Southeast Asia for the clinical and
commercial development of Evoltra(R) (clofarabine) in this newly
licensed territory. Bioenvision licensed these previously ungranted
rights to manufacture, sell, market and distribute Evoltra in this
region from Southern Research Institute of Birmingham, Alabama, the
inventor of clofarabine.
Bioenvision had the exclusive, irrevocable option to develop,
market and distribute clofarabine in Japan and Southeast Asia; and
converted it into an exclusive license. In Southeast Asia, Bioenvision
successfully licensed these rights in the countries of Indonesia,
Malaysia, Taiwan, Hong Kong, Singapore, Vietnam, Cambodia, Thailand,
Laos, Philippines and South Korea.
"Now that clofarabine has been approved in the U.S. and Europe, it
is important for Bioenvision to establish a base of operations from
which to develop clofarabine in Japan, the second largest
pharmaceutical market in the world," said David P. Luci, Bioenvision's
Chief Financial Officer and General Counsel. "Bioenvision's strategy
is to develop clofarabine across therapeutic areas and across
geographic locations. Succeeding to the Japanese rights is a critical
step in this strategy."
"We are pleased with the commitment Bioenvision has made to bring
our latest innovative drug - clofarabine - to the largest patient
populations possible," said Tina S. Rogers, Ph.D., interim CEO and
vice president of the Drug Development Division at Southern Research.
"Bioenvision's management has been successful in its European
development strategy and we have every expectation they will do the
same with the Japanese regulatory authorities."
Japanese health officials recently announced their desire to
expedite the clinical development of clofarabine in Japan. The
Japanese Ministry of Health's Advisory Committee for the Usage of
Unapproved Drugs has noted that clofarabine is approved in the U.S.
and Europe but is not available in Japan. The Advisory Committee has
publicly stated its position that clofarabine needs to be brought to
immediate clinical development in Japan.
"We are pleased to know the medical experts in Japan recognize the
benefit of Evoltra(R) for critically ill children with leukemia," said
Dr. Christopher B. Wood, Chairman and Chief Executive Officer of
Bioenvision. "We will work closely with the Japanese authorities and
oncologists to ensure Evoltra(R) is made available for clinical
development in Japan as soon as possible."
About Evoltra(R) (clofarabine)
The European Marketing Authorization 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 (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(R). 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.