VRA Receives $2M Licensing Fee and Multi-Million Dollar Funding Commitment
for Melanoma Trial
PLANTATION, Fla., April 18 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA; VRA.U; VRA.WS) and its majority-owned subsidiary, Viragen
International, Inc. (OTC Bulletin Board: VGNI), today announced that a
licensing agreement has been completed with Swedish Orphan International
AB, granting exclusive marketing rights to Multiferon(R) (multi-subtype,
human alpha interferon) for the European Union (excluding previously
licensed member states).
Under terms of the agreement, Viragen received approximately $2 million
(1.5 million euro) as an up-front license fee and will serve as the sole
manufacturer of the product. Swedish Orphan International will pay Viragen
for Multiferon(R) at an agreed upon sales price, and, in addition, Viragen
will receive double-digit royalties from Swedish Orphan International on
their net sales.
Swedish Orphan International will also control and fund a significant
portion of the costs for a planned European post-marketing clinical study.
The melanoma post-marketing trial will further evaluate the use of
Multiferon(R) for the first-line adjuvant treatment of high-risk malignant
melanoma (Stages IIb-III).
Multiferon(R), which is manufactured by Viragen International's
ViraNative AB subsidiary in Sweden, is currently approved for malignant
melanoma and other diseases in Sweden, and the parties will collaborate on
registration throughout the European Union with new regulatory approvals
expected by early 2008.
Headquartered in Stockholm with a focus on specialty drugs targeting
patients with rare, life-threatening diseases, Swedish Orphan
International, "The Pioneer Orphan Drug Company", distributes more than 40
drug products throughout Europe in partnerships with more than 30
companies.
President and CEO, Bo Jesper Hansen, welcomed the addition of
Multiferon(R) to Swedish Orphan International's product portfolio, "Surgery
remains the predominant treatment for malignant melanoma in Europe,
however, the risk of relapse remains high for the patients with this severe
malignant disease. In Multiferon(R), we are extremely excited about
offering a safe, cost-effective, human interferon that can significantly
reduce the risk of relapse and extend overall survival, thus giving promise
for an increased life expectancy and quality of life for patients with
malignant melanoma. Based on our extensive relationships with hospitals,
physicians, patient advocacy groups and government agencies, we are
committed to making this a priority product in our portfolio, as it holds
high potential to emerge as a preferred therapy for patients with malignant
melanoma and other severe diseases."
"By licensing Multiferon(R) to one of the fastest growing companies in
Europe and with their highly specialized marketing coverage in the orphan
indications space, we believe we have the optimal collaborator in place to
significantly increase our sales throughout Europe within the next few
years," stated Viragen's President and CEO, Charles A. Rice.
Viragen is preparing to proceed with an EU regulatory process for
Multiferon(R), through a registration pathway called the Mutual Recognition
Procedure (MRP). This procedure allows a single registration dossier to be
filed for approval among a targeted group of EU countries via one
application and review process.
Mr. Rice added, "For a specialty product such as Multiferon(R), it is
of vital importance that we work with an accomplished team for which our
drug represents a source of dramatic growth, for them as well as for us. We
are confident that Swedish Orphan International will appropriately
'champion' the product, and provide a level of commitment and investment to
rapidly advance its uptake throughout Europe."
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 Swedish Orphan International AB:
Swedish Orphan International, which was established in 1988 in Sweden,
has developed into a worldwide pioneer in the field of orphan drugs. Today
Swedish Orphan International supplies orphan drugs to around 50 countries,
including in Europe as well as the USA, Japan, Australia and Canada. The
company's business objective is to develop and make available drugs for the
treatment of rare disease patients for which no satisfactory treatment is
available. Swedish Orphan International is, since 2004, owned by a
consortium comprising Investor Growth Capital ("IGC"), the largest
investment company in Scandinavia (http://www.investorgrowthcapital.com), Skandia
Investment, a Swedish private equity fund managed by Priveq Investment
(http://www.priveqinvestment.se) and Swedish Orphan International's Management.
For more information, please visit: http://www.Swedishorphan.com
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
Viragen, Inc. Corporate Contact:
Douglas Calder, Director of Communications
Phone: (954) 233-8746; Fax: (954) 233-1414
E-mail: dcalder@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.; Viragen International, Inc.
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Related links:
http://www.viragen.com
http://www.Multiferon.com http://www.Swedishorphan.com
Photo Notes: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,
dcalder@viragen.com
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