Agreement with "Orphan Australia" targets skin cancer
Terms include up-front license fee and milestone payments
PLANTATION, Fla., Dec. 28 /PRNewswire-FirstCall/ -- 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.
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Related links:
http://www.viragen.com
http://www.Multiferon.com http://www.orphan.com.au
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20061228/CLTH041
http://www.newscom.com/cgi-bin/prnh/20010426/HSTH018LOGO-b
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Douglas Calder, Director of Communications of
Viragen, Inc., +1-954-233-8746, Fax, +1-954-233-1414, or
dcalder@viragen.com
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