Bioenvision (NASDAQ:BIVN)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Bioenvision Charts. Click Here for more Bioenvision Charts.](/p.php?pid=staticchart&s=N%5EBIVN&p=8&t=15)
Bioenvision, Inc (NASDAQ: BIVN) and Mayne Pharma
Limited (ASX- MYP) today jointly announced that they have entered into
a Marketing and Distribution Agreement for the innovative new cancer
product, Evoltra(R) (clofarabine).
Under the agreement, Bioenvision granted Mayne Pharma exclusive
rights to market Evoltra(R) (clofarabine) for certain haematological
malignancies in Australia and New Zealand. Bioenvision will receive
milestone payments and a percentage of Mayne's net sales revenue.
Mayne Pharma is responsible for securing regulatory approval and
government reimbursement in Australia and New Zealand.
Michael Kotsanis, President of the Asia Pacific region for Mayne
Pharma said: "Evoltra(R) is an exciting addition to our growing
branded oncology portfolio. We are very pleased to enter into a
partnership with Bioenvision to bring an important new oncology
product into the Australian and New Zealand market. We look forward to
filing the regulatory dossier with the Australian and New Zealand
agencies in the second half of 2006."
Clofarabine has been approved in the United States for the
treatment of acute lymphoblastic leukaemia in paediatric patients who
have relapsed or are refractory to other chemotherapies. In Europe,
the CHMP have adopted a positive opinion for the use of Evoltra(R)
(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(R) for the treatment of
other haematological malignancies including for use as first line
therapy of adult acute myeloid leukaemia (AML).
Dr. John Seymour MBBS FRACP, Chairman of the Australasian
Leukaemia and Lymphoma Clinical Trials Group said: "The clinical data
presented at recent international conferences on the use of Evoltra(R)
in elderly patients with AML appear very promising, with encouraging
efficacy and good tolerability. Effective new agents for use in the
first line setting for these patients would be of great interest to
Australian haematologists, as this is an area of clear un-met need."
Note: Dr. Seymour has acted as a consultant for Mayne Pharma.
Dr. Christopher B. Wood, Chairman and Chief Executive Officer of
Bioenvision added "we are delighted to be working with Mayne Pharma
given its marketing and distribution capabilities in these territories
and to get this very active cancer agent into the Australian and New
Zealand markets. This is the first step of the build out of the
Evoltra(R) franchise beyond Europe and the U.S. and demonstrates our
overarching strategy to expand the geographical reach of this exciting
cancer agent."
About Evoltra(R) (clofarabine):
The CHMP have adopted a positive opinion for the use of Evoltra(R)
(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(R) 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(R) .
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(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 for
clofarabine (outside Japan and Southeast Asia) and an exclusive,
irrevocable option to develop and market clofarabine for all human
applications in Japan and Southeast Asia. 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 Mayne Pharma:
Mayne Pharma Limited focuses on the development, manufacture, sale
and distribution of medicines used by oncologists. The company is
listed on the Australian Stock Exchange under the code "MYP".
Mayne Pharma's product portfolio has been built on world class
process development capabilities in the two families of drugs that are
commonly used in the treatment of cancer today: taxanes and platinum
derivatives. The company has also expanded from its origins in generic
chemotherapy medicines to related therapeutic drugs used by
oncologists in the treatment of cancer such as antibiotics and pain
management. On the back of this expertise, Mayne Pharma has expanded
from Australia so that it now distributes its products in more than 65
countries around the world. It has established strong commercial
footholds especially in Europe and Asia Pacific.
Mayne Pharma has increased its sales revenues significantly in the
last three years on the back of acquisitions and internal growth.
Pro-forma sales in its 2005 financial year were AU$687 million up
approximately 35% on the prior year.
In November 2005, Mayne Pharma was demerged from Mayne Group
Limited so the business could focus on its core competencies and have
increased flexibility to implement appropriate strategies and a
capital structure that would help facilitate its continued success.
For more information on Mayne Pharma please visit our website at
www.maynepharma.com/global/
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) (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 or Mayne Pharma's
business, structure or projections; the development of competing
products; uncertainties related to Bioenvision's and Mayne Pharma's
dependence on third parties and partners; and those risks described in
Bioenvision's filings with the SEC, and Mayne Pharma's filings with
the ASX. Bioenvision and Mayne Pharma independently disclaim any
obligation to update these forward-looking statements.