PLANTATION, Fla., Dec. 289/PRNewswire-AsiaNet/ –
Agreement with "Orphan Australia" targets skin cancer
Terms include up-front license fee and milestone payments
Viragen, Inc. (Amex: VRA; VRA.U; VRA.WS) and its majority-owned subsidiary,
Viragen International, Inc. (OTC Bulletin Board: VGNI), today announced
completion of a licensing agreement that grants exclusive rights to Orphan
Australia to market, sell and distribute Multiferon(R) (multi-subtype, human
alpha interferon) in Australia and New Zealand. Orphan Australia will
initially focus its marketing efforts for Multiferon(R) to target the treatment
of high-risk malignant melanoma, as Australia and New Zealand report the
highest melanoma incidence rates in the world.
(Photo: http://www.newscom.com/cgi-bin/prnh/20061228/CLTH041)
While complete financial terms were not disclosed, the agreement provides
Viragen with an up-front license fee, and additional milestone payments to be
paid upon receipt of reimbursement authorization for Multiferon(R) in
Australia and possibly other countries to be added later. Viragen estimates
the agreement to be valued at approximately $10 - 15 million (USD) per year
for Viragen, pending regulatory approval and reimbursement authorization, and
based on revenue forecasts for peak year sales.
"The likelihood of being diagnosed with melanoma in Australia is four fold
higher than in the U.S. or Europe, so this is a very important market
opportunity, and we look forward to working closely with Orphan Australia to
position Multiferon(R) as a therapy option that will be preferred by
physicians and patients," stated Viragen’s President and CEO, Charles A.
Rice.
According to Alastair Young, Managing Director of Orphan Australia, demand
for a promising new melanoma treatment is high. "The current standard-of-care
for high-risk malignant melanoma is surgical treatment and no effective
adjuvant treatment currently exists, which leaves this patient category wide
open for new, effective products. We are extremely excited regarding our
ability to market Multiferon(R) as an emerging, leading adjuvant treatment for
this indication with excellent prospects to significantly improve patients’
survival rates, and we believe there could be ample opportunities for this
important product in other oncology indications as well. Orphan Australia is
pleased to be able to bring this platform product to our territories."
Mr. Rice added, "With Orphan Australia’s specialized expertise in
targeting such niche cancer indications, we believe this company is an ideal
licensee to launch Multiferon(R) in Australia. Within this agreement, we have
included the potential to expand this relationship into other countries
throughout the Pacific/Asia region."
Orphan Australia will be responsible for obtaining regulatory approvals
and will determine the most appropriate manner to enter other regional
countries as well. It is expected that the regulatory process in Australia
will take approximately 12 - 18 months. Clinicians who demand Multiferon(R)
for their patients prior to regulatory approval will be able to obtain it on a
"Named-Patient" basis according to the local mechanisms for such supply.
About Malignant Melanoma:
As reported on The Skin Cancer Foundation’s website, melanoma is the most
serious form of skin cancer. However, if it is recognized and treated early,
it is nearly 100 percent curable. But if it is not, the cancer can advance
and spread to other parts of the body, where it becomes hard to treat and can
be fatal. While it is not the most common of the skin cancers, it causes the
most deaths.
According to The Cancer Council Victoria, Australia has the highest rate
of melanoma in the world. As with the common skin cancers, the majority of
melanoma can be attributed to sun exposure in fair skinned populations.
About Multiferon(R):
Alpha interferon is produced by the human immune system and helps improve
the body’s natural resistance to disease.
Multiferon(R) differs from single-subtype recombinant alpha interferon
drug products in that it contains a unique mixture of multiple subtypes of
human interferon (a1, a2, a8, a10, a14, a21). It is believed that each
subtype, some of which are glycosylated, employs a specific biological
activity, but more importantly, the subtypes act synergistically to elicit an
overall effect.
In February 2006, Multiferon(R) was approved in Sweden for the first-line
adjuvant treatment of high-risk malignant melanoma. Viragen is proceeding
with a regulatory strategy targeting approvals throughout the broader European
Union.
For more on prescription information, please visit:
http://www.Multiferon.com
About Orphan Australia:
Orphan Australia is a privately owned pharmaceutical company based in
Melbourne, providing niche products to Australia, New Zealand and selected
South East Asian countries. Orphan Australia specializes in the development,
marketing and distribution of products typically used by specialists to treat
serious and/or life threatening disorders.
Additional information about Orphan Australia is available on the
company’s website at: http://www.orphan.com.au
About Viragen, Inc.:
With international operations in the U.S., Scotland and Sweden, we are a
bio-pharmaceutical company engaged in the research, development, manufacture
and commercialization of therapeutic proteins for the treatment of cancers and
viral diseases. Our product and product candidate portfolio includes:
Multiferon(R) (multi-subtype, human alpha interferon) which is uniquely
positioned in valuable niche indications, such as high-risk malignant
melanoma, other niche cancer indications and selected infectious diseases;
VG101, a humanized monoclonal antibody that binds selectively to an antigen
over-expressed on Stage IV malignant melanoma tumors; and VG102, a highly
novel humanized monoclonal antibody that binds selectively to an antigen that
is over-expressed on nearly all solid tumors. We are also pioneering the
development of the OVA(TM) System (Avian Transgenics), with the renowned
Roslin Institute, the creators of "Dolly the Sheep", as a revolutionary
manufacturing platform for the large-scale, efficient and economical
production of human therapeutic proteins and antibodies, by expressing these
products in the egg whites of transgenic hens.
For more information, please visit: http://www.Viragen.com
The foregoing press announcement contains forward-looking statements that
can be identified by such terminology such as "believes," "expects,"
"potential," "plans," "suggests," "may," "should," "could," "intends," or
similar expressions. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause the actual results to be
materially different from any future results, performance or achievements
expressed or implied by such statements. In particular, management’s
expectations regarding future research, development and/or commercial results
could be affected by, among other things, uncertainties relating to clinical
trials and product development; availability of future financing; unexpected
regulatory delays or government regulation generally; the success of third-
party marketing efforts; our ability to retain third-party distributors; our
ability to obtain or maintain patent and other proprietary intellectual
property protection; and competition in general. Forward-looking statements
speak only as to the date they are made. The Company does not undertake to
update forward-looking statements to reflect circumstances or events that
occur after the date the forward-looking statements are made.
SOURCE Viragen, Inc.
CONTACT: Douglas Calder, Director of Communications of Viragen, Inc.,
+1-954-233-8746
Fax, +1-954-233-1414
or dcalder@viragen.com
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20061228/CLTH041
http://www.newscom.com/cgi-bin/prnh/20010426/HSTH018LOGO-b
Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
Web site: http://www.viragen.com
http://www.Multiferon.com
http://www.orphan.com.au
(VRA VGNI)
December 29, 2006
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