Bioenvision Limited (NasdaqGM: BIVN) today announced the Scottish
Medicines Consortium (SMC) released positive advice on the use of
Evoltra(R) (clofarabine) within NHS Scotland.
The release of this positive advice ensures funding is now
available for Evoltra, which is a new treatment option for children
with acute lymphoblastic leukaemia (ALL) who have relapsed or are
refractory to the standard treatment options.
"The prognosis for children with relapsed/refractory ALL is very
poor, and the availability of Evoltra is great news for patients and
their families," said Hugh Griffith, Chief Operating Officer of
Edinburgh based Bioenvision. "We believe that Evoltra offers genuine
hope and a real chance for prolonged survival in children who have
exhausted all standard therapies and are very pleased that the SMC has
issued this positive advice and that the funding for Evoltra will now
be in place."
"Treatment for children with leukaemia in Scotland has improved
dramatically over the last three decades. However, for children with
resistant disease the prognosis remains poor and any new drug or
treatment that offers hope for this group of patients and their
families is welcomed," commented Dr Brenda Gibson, Consultant
Haematologist, Royal Hospital for Sick Children, Yorkhill, Glasgow,
Scotland, UK.
About Evoltra(R) (clofarabine)
The European Marketing Authorization for Evoltra(R) (clofarabine)
is for "the treatment of acute lymphoblastic leukaemia (ALL) in
paediatric 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 <=21 years old at initial
diagnosis."
Clofarabine is in clinical development for the treatment of other
haematological cancers and solid tumors. Bioenvision has conducted
nonclinical studies 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.
