PLANTATION, Fla., Jan. 24 /PRNewswire-FirstCall/ -- The following is
Part I of a letter from Charles A. Rice, President and CEO of Viragen, Inc.
(Amex: VRA; VRA.U; VRA.WS) and Viragen International, Inc. (OTC Bulletin
Board: VGNI). In addition to these comments, stockholders and potential
investors are referred to: the Company's SEC filings, including Form 10-K
and Form 10-Q (Annual and Quarterly Reports); press releases; website; and
other publicly disseminated information, which is available free of charge
upon request by contacting the Company. Part II of Mr. Rice's letter will
be issued tomorrow.
Dear valued Stockholder,
While no one is satisfied with the current valuation of our Company,
the key for our success is to achieve the refocused objectives we have
identified for the next twelve months. These include:
- accomplishing our regulatory strategy in Europe for Multiferon(R);
licensing Multiferon(R) for marketing in the European Union (EU) to
generate revenues;
- developing the final pre-clinical supporting data for our anti-cancer
candidates, so that we are prepared to meet with U.S. and EU regulatory
authorities to agree on designs for human clinical trials;
- selecting an initial therapeutic protein candidate for OVA(TM)-expressed
production to proceed along a regulatory pathway;
- debuting VG106, a new product candidate, with supporting in-vitro and
in-vivo anti-cancer data; and
- securing appropriate funding through financings, grants and/or strategic
initiatives.
In this, Part I of my letter, I will provide updates on our
Multiferon(R) activities, to be followed by Part II, which will detail our
anti-cancer candidates and the OVA(TM) System -- our avian transgenics
program.
Multiferon(R)
In order to capitalize on the Multiferon(R) European market
opportunity, it was imperative that it first be approved in Sweden, a
member of the European Union, for the first-line adjuvant treatment of
malignant melanoma, which it was in February 2006. This approval was no
small achievement, as long-term clinical data needed to be resurrected,
patients located for further follow-up, and statistics recomputed, managed
and formatted into a complex application that presented a compelling
argument to regulatory authorities. We did indeed accomplish these goals,
and I applaud our team in Sweden at ViraNative for their relentless work
and excellent results, advancing our objective to position Multiferon(R) as
the most prescribed human alpha interferon in the world.
While the alpha interferon market is quite competitive, the limitations
of recombinant alpha interferon products are widely recognized and
improvements are desirable. Multiferon(R) offers significant improvements
in some settings, such as malignant melanoma, and we are committed to
promoting its adoption by clinicians around the world.
As part of this campaign, our Swedish team has forged a presence at the
major international melanoma conferences throughout the year, helping us to
bring the clinical data to the forefront of prescribing physicians around
the world. This effort will continue as part of our ongoing sales and
marketing efforts, as message repetition is highly important to achieving
our goals.
When Multiferon(R) was approved for the first-line melanoma indication
in February 2006, it was approved in an ampoule presentation. However,
since late 2004, we have progressed plans to convert from glass ampoules to
a new pre-filled syringe (PFS), which you can now view on the home page of
our website. This change facilitates compliance for patients and makes
administration of Multiferon(R) much more convenient and error-free. After
collecting the required stability data over the product's expected two-year
shelf life, we submitted this PFS application to the Swedish authorities in
December 2006 for their review. We expect this review to be completed in
the second quarter of 2007.
Once the new PFS presentation is approved in Sweden, we are prepared to
proceed with an EU regulatory process, 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. Provided the
Swedish approval and the MRP application go well, the MRP decision could be
expected as early as the second half of this year.
We know our stockholders are extremely anxious to know where we stand
in relation to licensing exclusive marketing rights to a European marketer.
It is critical that the product is expertly marketed by a specialty sales
force to the appropriate audience in each country, and our selection will
be vital to our ultimate sales success. While the licensing process has
been lengthy, evolving and complex, completing these negotiations to result
in a final agreement is among our highest priorities. Additionally, we have
built new relationships with key opinion leaders in the EU and put together
a team of melanoma advisors, comprised of some of the more prominent
clinical thought leaders within and outside the EU. Such relationships are
anticipated to support our licensee's marketing efforts.
At the current time, we are reviewing multiple proposals for licensure
of Multiferon(R) for the EU. Our intent will be to enter into the best
arrangement possible to result in realization of significant sales of
Multiferon(R) at the earliest possible date. The EU represents our first
"major market" opportunity for Multiferon(R).
We are proceeding with plans to conduct a post-marketing clinical trial
in high-risk malignant melanoma. This trial is scheduled to begin this
year, assuming we secure the necessary funding to support it. The trial is
planned to include approximately 800 patients internationally, with centers
in at least 16 different countries participating. The physician
investigators that will administer therapy in this trial are among the more
influential thought- leaders and experts in the field of melanoma in their
respective countries.
While we have rightfully prioritized Europe, we have not ignored the
promise of other countries contributing to the growth of Multiferon(R).
However, some of our existing smaller active markets have been
disappointing. As a result, we have notified certain distributors that
near-term performance measures must be reached in order to retain their
rights to market Multiferon(R). With regards to such changes, we have
agreed with our South Korean licensee, Kuhnil Pharmaceuticals, to terminate
their exclusive license to Multiferon(R). We will continue to seek regional
licensure for Multiferon(R), including for this valuable country.
Beyond Europe, there are other countries where we aim to launch
Multiferon(R). Just last month, we reported a new agreement with Orphan
Australia, granting exclusive marketing rights in Australia and New
Zealand, which report the highest melanoma incidence rates in the world. We
continue to field indications of interest from other parts of the world as
well.
Working with independent researchers in Sweden, the United Kingdom and
the U.S., we have expanded our research work on Multiferon(R). We plan to
report progress on these studies in the coming months, which will lead us
toward the next indication(s) and future clinical trials with
Multiferon(R).
Part II of Mr. Rice's Letter will be issued tomorrow.
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 letter 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.
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SOURCE Viragen, Inc.
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http://www.viragen.com
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CONTACT:
Douglas Calder, Director of Communications of
Viragen, Inc., +1-954-233-8746, or fax, +1-954-233-1414, or
dcalder@viragen.com
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