five and a half years later, let's update.......
Message 404068
100 million shares out, $0.95/share, and this today......
Tuesday March 12, 7:02 am Eastern Time
Press Release
SOURCE: Viragen, Inc.
Viragen Reports to Stockholders
PLANTATION, Fla., March 12 /PRNewswire-FirstCall/ -- VIRAGEN, INC. (Amex: VRA - news) reported on its business at the Company's Annual Meeting of Stockholders held February 27th at the American Stock Exchange in New York City. Shareholders were updated on Viragen's Avian Transgenic Project, Oncology Projects and Natural Interferon Program.
Avian Transgenic Project
Updating Viragen's collaboration with Roslin Institute, Scotland, it was announced that Roslin's Dr. Helen Sang, has produced a chimeric transgenic hen containing the gene for the R24 antibody for the treatment of melanoma, a potentially lethal skin cancer. This is a milestone achievement. The chimeric transgenic hen is currently being bred in order to establish a transgenic flock whose eggs will contain the targeted drug. Also, Dr. Sang's team continues to progress developing novel methods for avian nuclear transfer technology.
Viragen's Oncology Projects
-- Viragen's Director Emeritus of Research, Professor William Stimson,
presented updated information on Viragen's novel anti-cancer technology
collaborations:
-- Memorial Sloan-Kettering Cancer Center - Viragen has successfully
humanized an antibody which has a very high specificity for melanoma
and has undergone important functional analysis. Pre-clinical
development progress is on schedule.
-- National Institutes of Health - Addressing a broad range of cancers
including cervical, breast and lung cancers, pre-clinical development
is continuing. Many cancers protect themselves by over-expressing a
protein called "Notch-1". Successful in vitro studies have
demonstrated that antibodies produced to "Notch-1" can employ a death
signal which induces the cancer cells to commit suicide.
-- Cancer Research Campaign - The purpose of this project is to
commercialize a cancer vaccine which targets breast, ovarian,
colorectal and certain bone cancers. Successful in vitro studies
indicate that the cancer vaccine is capable of stimulating the body's
immune system to identify and destroy these cancers which over-express
a protein known as "CD55". Pre-clinical development continues to
progress.
Viragen's Natural Interferon Project
Viragen's Chief Medical Director, Dr. Orjan Strannegard, announced that Viragen is scheduled to present the results of a controlled Phase II/III clinical study conducted in Germany for the adjuvant treatment of malignant melanoma with Viragen's natural interferon. The data will be presented at the Fourth International Conference on the Adjuvant Therapy of Malignant Melanoma to be held in London, England on March 15-16.
Dr. Strannegard also described the results of some small pilot studies which utilized Viragen's natural alpha interferon for the treatment of hepatitis C. The results support the use of natural interferon as a second- line therapy for those patients that fail or cannot tolerate recombinant regimens. According to estimates, over 200 million people around the world are infected with hepatitis C.
Formal Election of Directors
In formal election proceedings, Mr. Charles Simons and Mr. Robert Salisbury were re-elected as Directors. The firm of Ernst & Young was re- appointed Viragen's independent auditors.
Stockholder's Questions
Stockholders participated in a Question & Answer session. The following questions and answers have been edited for the purpose of brevity.
Q: Why aren't Viragen's achievements reflected in the price of the stock?
A: The investing environment is dramatically different than in years past with revenues being a major determining factor. Viragen expects to realize revenues this year, probably the most critical milestone for any emerging biotech. We should recognize a minimum of $5 million in sales of our natural interferon to our distribution partner in Taiwan for an underwritten Phase III hepatitis C clinical trial. Additional sales are expected from existing or new international agreements. In total, we forecast about $5-$7 million this year. We also expect additional regulatory approvals as well as existing approvals to be broadened in terms of medical indications. Serious recognition by the investment community is anticipated as these revenues are generated.
Q: Which international markets are most important to Viragen?
A: It is estimated that four million people suffer from hepatitis C in the United States. To gain U.S. approval would take many years of clinical trials at a very significant cost. In contrast, it is estimated that Southeast Asia has over 100 million people afflicted with hepatitis C. Therefore, we have focused on significant markets which can be penetrated quickly. Upon regulatory approval in Taiwan, we will commence to service a quarter billion dollar contract to provide product over a period of five years.
Q: Viragen is positioning its natural interferon as a ``second-line therapy'' for those patients who fail or do not respond to recombinant therapies. Why not compete head-to-head and seek ``first-line approvals''?
A: Viragen does indeed intend to seek first-line approvals for natural interferon, but do not discount the importance of our second-line approvals. It is generally accepted that only 50% of patients are successfully treated by the recombinant versions of interferon. That leaves 50% of the market in need of a safe and effective alternative. The global interferon market is approaching $3 billion per year.
Q: What is the difference between Omniferon(TM), Alfanative® and Multiferon(TM)?
A: All three products are highly purified, leukocyte-derived, human natural alpha interferons. They are virtually identical. We combined the best elements of both organization's expertise and manufacturing processes and Multiferon is the result.
Q: What are Viragen's current and planned manufacturing strategies to produce enough Multiferon to meet demand?
A: Our facility in Umea, Sweden is capable of meeting our short-term demand. Additionally, our planned plant in Ersboda, Sweden is designed to be capable of servicing our Taiwan as well as other distribution agreements and product for clinical trials. We have several options to quickly ramp-up our production capabilities: (1) We can continue to independently build-out new facilities; (2) Or we may finance new plants by entering into collaborations and/or joint-ventures with third parties; (3) Or we may expand our current facilities; (4) Or we can set-up satellite production.
Interferon production could be divided into two parts: crude production and purification. We have the capability to service one part and could contract the other to third parties through a transfer of technology agreement.
Q: When might the Avian Transgenic Project offer commercial services?
A. With over 270 monoclonal antibodies in various stages of development and clinical trials, it has now been well-established that there is a need for production facilities for protein-based drugs. Avian Transgenics is designed to offer an important production alternative. Viragen is pushing to be in a position to offer Avian Technology contract manufacturing commercial services for protein-based drugs to the biopharmaceutical industry in the next year.
Q: Why doesn't Senior Management and Directors buy more shares of Viragen on the open market more frequently?
A: Beneficial ownership is only one indicator of management's confidence. Management's willingness to hold potentially profitable stock options is another. Stock options are a major part of management's compensation and reward. If the stock price is higher than the strike price of the option and the holder does not exercise and sell, that represents a real vote of confidence because the holder must believe that the stock price is going higher. Some might suggest that options be exercised and held. However, simply exercising an option triggers an onerous taxable event to the holder.
Q: What are Viragen's plans for succession if any key members of Senior Management or from the Board of Directors decide to retire?
A: We have a very distinguished and experienced Board of Directors. This diverse group represents vast accomplishment from the business and pharmaceutical worlds and their wisdom, experience and track-record are key to the success of this organization. When an Officer or Director needs to be replaced, the most attractive candidates will be evaluated, both internally and externally, by your very capable Board of Directors.
Q: Is Viragen considering a reverse-split?
A: We have considered a reverse-split in the past. If you look at the history of companies that reverse-split, the majority were not able to maintain their new stock price and the share price fell dramatically. The circumstances would have to be ideal if we were to consider this strategy again.
Q: Last year, Viragen publicly stated that the Company believed it had identified market participants who appeared to be acting illegally in the trading of its stock. What has the Company done to ensure that the stock is trading fairly?
A: Viragen's management is determined to protect the Company and its stockholders against improper and/or illegal activities. We are working with and continue to meet with the appropriate authorities including the Securities and Exchange Commission with whom we filed a detailed complaint. Any potential evidence that is gathered has been and will be delivered to the proper authorities. This matter is in the hands of experienced professionals.
Q: Why does Viragen continue to issue shares in exchange for capital?
A: Until Viragen establishes revenues that support our expenses, then operate profitably, our stock is our only currency with which to fund our operations. We exchange our common shares for the monies required. Once revenues and profits enable us to be self-sufficient, this will diminish then eventually be eliminated.
Q: One of Viragen's stated goals for this year is to establish a partnership with a big pharmaceutical company. Is Viragen currently in discussions with anyone?
A: Yes. We are in various kinds of discussions.
About Viragen, Inc.
Viragen holds the worldwide exclusive license to commercialize Avian Transgenic Technology granted by Roslin Institute in Scotland, internationally renowned for their creation of ``Dolly the Sheep''. The project is designed to substitute chicken eggs for very expensive vessels presently used in the manufacture of protein-based drugs. Upon its successful development, flocks of specially produced chickens would lay virtually unlimited numbers of eggs expressing high volumes of the target drug in egg white. This technology is designed not only to produce Viragen's portfolio of anti-cancer drugs, but also to address the urgent drug production needs of the entire biopharmaceutical industry by promising a much faster, cost-effective and virtually unlimited production process.
Viragen produces its highly purified, multi-subtype natural alpha interferon from human white blood cells, a key part of the body's immune system. Natural interferon is one of the body's natural defensive responses to foreign substances such as viruses, and is so named because it ``interferes'' with viral growth. Viragen believes its natural interferon is immunologically virtually indistinguishable from the interferon produced by one's own body in response to a viral infection. In contrast, recombinant interferons, which currently dominate the interferon market, are genetically engineered and are sometimes recognized as ``foreign'' by the body's immune system. This may result in the formation of neutralizing antibodies which can reduce the effectiveness of treatment and/or cause adverse side-effects. Also, recombinant interferons usually contain only one subtype of interferon as compared to multiple subtypes produced by human white blood cells.
In addition to natural interferon, Viragen researches, develops and manufactures human monoclonal antibodies for the treatment of life-threatening diseases, particularly cancer. Viragen's oncology projects include collaborations with the U.S. National Institutes of Health (NIH), Memorial Sloan-Kettering Cancer Center and the United Kingdom's Cancer Research Campaign. Viragen holds the worldwide exclusive license to commercialize the drugs produced via the NIH, MSKCC and CRC collaborations.
A graphic presentation that differentiates Viragen's natural interferon from recombinant interferon is available at viragen.com
The foregoing press release contains forward-looking statements that can be identified by such terminology such as ``expects,'' ``potential,'' ``suggests,'' ``may,'' ``will,'' 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 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 Company's 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.
For more information, please visit our Web site at: viragen.com
SOURCE: Viragen, Inc. |
