Bioenvision and Mayne Pharma Announce Marketing and Distribution Agreement for Evoltra(R); Exporting Evoltra(R) Rights Commence
May 16 2006 - 7:00AM
Business Wire
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.
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