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Press Release Source: Viragen, Inc.


Viragen Completes $5.5 Million Debt Financing
Tuesday July 1, 7:01 am ET


PLANTATION, Fla., July 1 /PRNewswire-FirstCall/ -- Viragen, Inc. (Amex: VRA - News) today announced that it has completed the sale of $5.55 million in secured convertible debentures to an investment group that includes current institutional stockholders. The Company intends to use the proceeds to progress with its business plan to commercialize its portfolio of healthcare technologies including Multiferon(TM), Avian Transgenic Production Technology and Oncology Projects.
After original issue discount, commissions and expenses, the Company received approximately $4.55 million in net proceeds. The debentures, issued under an original issue discount, bear interest at the rate of 10% per annum and have a maturity date of September 1, 2005. The debentures are convertible into shares of Viragen common stock at the option of the Company at a fixed price of $0.32 per share if the market price exceeds $0.42 per share. The debentures may be converted at any time, in whole or in part, at the option of the investors at $0.32 per share. The conversion price, which represents a 125% premium to the volume weighted average price of Viragen's common stock over a ten day period prior to the closing, is not subject to any price resets. The complete terms of the financing will be detailed in a registration statement to be filed with the Securities and Exchange Commission.

Viragen's Chairman, Mr. Carl Singer, stated, "This debt funding enables Viragen to continue to move forward with its commercial and scientific initiatives which are aimed at building stockholder value. We have significantly cut our cash burn rate in order to direct monies raised to priority activities and our goal remains to further strengthen the Company's financial position as we strive to attract additional key funding and partnering opportunities. With adequate financing in place, we expect to report important milestone achievements which validate the exciting market potential of our innovative healthcare products."

"The quality of Viragen's team, its products and its world-class collaborative partners have compelled our group to remain committed to ensuring that the company is appropriately capitalized," stated investor spokesperson, Mr. Andrew Reckles, General Partner of Palisades Master Fund LP. "We are impressed by Viragen's immediate ability to offer Multiferon(TM) as a rescue therapy for the many patients that have failed previous interferon treatments for diseases such as hepatitis C and cancer. Looking forward, Viragen's Avian Transgenic Technology and anti-cancer targets represent significant market opportunities. Our confidence in Viragen's future is confirmed by our continued investment."


Gruß Biene  

Viragen Files U.S. Patent Application For Natural Interferon To Target SARS

   PLANTATION, Fla., March 10 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA) today announced that it has filed a patent application in the United States covering the use of its natural human leukocyte-derived alpha interferon for the treatment and prevention of severe acute respiratory syndrome (SARS).  This is Viragen's third patent application related to the SARS indication.
   "Based on growing evidence we are obtaining that supports alpha interferon as a prime candidate for the treatment of SARS, we are moving forward with patent strategies designed to protect the global positioning of Multiferon(TM), our natural human interferon," stated Dr. Karen Jervis, Viragen's Director of Technology and Projects Coordinator.  
   While the immediate threat of SARS has been largely contained, many international health officials continue to predict that additional global outbreaks are likely to recur at some point in the future, possibly at epidemic or pandemic scales.  Viragen has been supporting SARS research by providing samples of Multiferon to international research organizations including the Genome Institute of Singapore (GIS), which last year reported positive results from in vitro studies that placed Multiferon among the most encouraging drug candidates tested.
   Dr. Jervis reviewed the Company's patent history with regards to SARS.  "We filed the original patent application with the British Patent Office in May 2003 which covers the use of natural human leukocyte-derived alpha interferon for the treatment and prevention of SARS.  We then updated our U.K. application in August 2003 to include additional data produced by the GIS which we believe significantly strengthens our position.  Now with patents pending in the U.K. and U.S., we are potentially positioned not only for the treatment of SARS, but also to include prophylactic properties which may prevent infection from occurring.  We believe we are establishing a broad proprietary position for SARS in many international jurisdictions and, therefore, continuing to enhance Viragen's growing intellectual property portfolio."

   About Alpha Interferon:
   The majority of alpha interferons that are marketed are single-subtype recombinant interferons.  Therapy resistance is not unusual with recombinant interferons with a significant percentage of patients failing to respond to standard therapy.  In some instances, recombinant interferon is rejected by the patient's immune system, usually caused by the formation of neutralizing antibodies which may lead to a loss of clinical efficacy.  Also, many patients cannot tolerate the adverse side effects sometimes associated with recombinant therapy.  High doses of recombinant interferon may cause serious, even life-threatening side effects.

   About Multiferon(TM):
   Multiferon is a highly purified, multi-subtype, natural human alpha interferon derived from human white blood cells and is approved in Sweden and Mexico for the second-line treatment of any and all diseases in which patients show an initial response to recombinant (synthetic) alpha interferon followed by treatment failure, probably due to the formation of neutralizing antibodies.  
   Viragen's natural interferon is also approved for sale in the following countries as a second-line therapy for the treatment of Hairy Cell Leukemia (HCL) and Chronic Myelogenous Leukemia (CML): Czech Republic, Egypt, Hong Kong, Indonesia, Myanmar, South Africa and Thailand.  Work is ongoing to expand the approved indications in these countries.  Regulatory approval processes are also underway in a number of other South American, Middle East and Far East territories.

   About Viragen, Inc.:
   Viragen is a biotechnology company specializing in the research, development and commercialization of natural and recombinant protein-based drugs designed to treat a broad range of viral and malignant diseases.  These protein-based drugs include natural human alpha interferon, monoclonal antibodies, peptide drugs and therapeutic vaccines.  Viragen's strategy also includes the development of Avian Transgenic Technology for the large-scale, cost-effective manufacturing of its portfolio of protein-based drugs, as well as offering Contract Manufacturing for the biopharmaceutical industry.
   Viragen is publicly traded on the American Stock Exchange (VRA).  Viragen's majority owned subsidiary, Viragen International, Inc., is publicly traded on the Over-The-Counter Bulletin Board (VGNI).  Viragen's key partners and licensors include: Roslin Institute, Memorial Sloan-Kettering Cancer Center, Cancer Research UK, University of Nottingham (U.K.), University of Miami, America's Blood Centers and the German Red Cross.

   For more information, please visit our Web site at: 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 "expect", "potential", "suggests", "may", "will", "should", "could" 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 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.  

SOURCE  Viragen, Inc.
   -0-                             03/10/2004
/CONTACT:  Douglas Calder, Director of Communications, Viragen,
+1-954-233-8746; or fax, +1-954-233-1414, or e-mail: dcalder@viragen.com/
   /First Call Analyst: /
   /FCMN Contact: dcalder@viragen.com /
   /Photo:  http://www.newscom.com/cgi-bin/prnh/20010426/HSTH018LOGO-b
             AP Archive:  http://photoarchive.ap.org
             PRN Photo Desk, photodesk@prnewswire.com/
   /Web site:  http://www.viragen.com/
   (VRA VGNI)



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Mit der Übersetzung muss ich dir recht geben!
Der Text war halt einfach durchgeGOGGLEt.

Mit der neusten Meldung und der Patentanfrage von Viragen dürfte sich längerfristig was bewegen. Bin gespannt wie es weitergeht.

Gruß Biene  

 

Press Release Source: Viragen, Inc.


Viragen Announces $20 Million Financing Agreement
Monday April 5, 7:01 am ET


PLANTATION, Fla., April 5 /PRNewswire-FirstCall/ -- Viragen, Inc. (Amex: VRA - News) today announced that it has entered into purchase agreements for the issuance and sale of $20 million in convertible promissory notes and common stock purchase warrants. The notes, which will be convertible at market price upon their issuance, were placed with a group of new and returning institutional investors. The $20 million purchase price for the notes and warrants has been placed in escrow pending satisfaction of all conditions precedent to closing, including receipt of stockholder approval for the sale of the notes and warrants, as well as for a reverse split of Viragen's common stock. The proceeds will be used to progress the research, development, and commercialization of Viragen's portfolio of healthcare products and technologies, including an allocation to fund clinical studies for the purpose of seeking FDA approval for Multiferon(TM), its natural human alpha interferon which is currently approved for sale in certain international markets.
The Board of Directors has authorized the Company to call a Special Meeting of Stockholders in order to solicit the required stockholder approvals. The reverse stock split, which is expected to be at the rate of 1:10, would affect all shares of common stock outstanding, including those underlying stock options and warrants, immediately prior to the effective time of the reverse split. Viragen intends to disseminate a proxy statement for use in connection with the Special Meeting of Stockholders following receipt of regulatory clearance to do so. Closing of the sale of notes and warrants, at which the notes and warrants will be issued and the purchase price delivered to Viragen, is expected to take place shortly after stockholder approval is obtained.

"This significant investment in Viragen would provide us with the financial flexibility and strength necessary to support organizational growth as we move forward with our mission to build stockholder value," stated Viragen's Chairman, Mr. Carl N. Singer. "With this opportunity to add stability to our balance sheet, we are recommending a reverse stock split because we believe our stockholders would benefit from an improved capital structure that should appeal to institutional fund managers, research analysts and the professional investment community in general. With longer-term secured funding, a capital restructuring and the advent of expected commercial and scientific milestone achievements, we believe that the Company will be better positioned to create stockholder value." After placement agent fees and expenses, the Company expects to receive approximately $19 million in net proceeds.

Viragen's President and CEO, Mr. Charles A. Rice, added, "It is our immediate priority to enhance and broaden our international marketing activities in order to increase sales of Multiferon as we develop a strategy that targets its introduction into the United States. This funding would allow us to move forward with these initiatives, as well as support our important research projects."

The purchase agreements provide that Viragen pay interest on the escrowed purchase price at the rate of 10% per annum until the date the stockholders approve the sale of the notes and the reverse stock split, at which time, the interest rate on the escrowed funds will be reduced to 7% per annum. The notes will be convertible into shares of Viragen common stock at market price, subject to adjustment depending upon the market price of Viragen common stock following the reverse split. Warrant coverage will be provided at 120% of the conversion price of the notes. The complete terms of the financing will be detailed in a Current Report on Form 8-K to be filed with the SEC.

"With the proceeds of this transaction added to our current cash balance, we will have approximately $27 million in working capital on hand," reported Viragen's Chief Financial Officer, Mr. Dennis W. Healey. "It is gratifying that we were able to obtain significant financing under such favorable terms including the notes being convertible at market and the warrants having a strike price above market. We believe that based on the positive developments of the Company and our growth prospects, we have been able to structure a transaction that is mutually beneficial to the Company and our investors."

 

Press Release Source: Viragen, Inc.


Scotland Awards Grant to Viragen for Cancer Research
Thursday April 15, 9:52 am ET


PLANTATION, Fla., April 15 /PRNewswire-FirstCall/ -- Viragen, Inc. (Amex: VRA - News) and Viragen International, Inc. (OTC Bulletin Board: VGNI - News) today announced that Viragen (Scotland) Ltd. has been awarded a prestigious Grant from the Scottish government for the approximate sum of 466,000 pounds sterling ($833,000) for the purpose of supporting the research and development of its anti-CD55 Antibody, a monoclonal antibody designed for the treatment of a broad range of cancers, either alone or in combination with other anti- cancer antibodies.
"The Scottish Executive awarded Viragen's CD55 Project the maximum dollar amount eligible to be granted by its 'SPUR Plus' program," stated Dr. Karen Jervis, Viragen's Director of Technology and Projects Coordinator. "These grants are designed to reward Scotland's most promising and innovative research programs, and we are very pleased to be recognized with this funding. We believe the anti-CD55 Antibody represents a novel and powerful approach to cancer therapy by deactivating the tumor's defense mechanism, thus allowing other anti-cancer antibodies to work better, or itself stimulating the immune system to target and kill cancer cells."

Anti-CD55 Antibody Project:

In collaboration with Cancer Research UK and the University of Nottingham (England), Viragen is developing a monoclonal antibody designed to block the protective effect of the protein CD55 on the surface of tumor cells. The protein CD55 is one of a number of proteins which protect normal healthy cells from being destroyed by the complement system, part of the human immune response against disease. The problem arises when cancer cells also express this control protein to camouflage and protect themselves from the immune system.

The anti-CD55 antibody is designed to remove the tumor's protective mechanism and, in theory, may boost patient response rates either as a stand- alone therapy or in combination with other antibodies. Viragen holds an option from Cancer Research Technology Limited to acquire an exclusive worldwide license to this platform technology with potential applications in a large number of cancer types.

About Cancer Research Technology Limited:

Cancer Research Technology Limited (CRT) is a specialist technology transfer and development company which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies.

 

Warum hilft das Viragen nicht auf die Sprünge??  

Weiß jemand, was mit dieser Aktie los ist? Die sinkt und sinkt jetzt bei 0.10 in FFN bei prakisch null Umsatz????????????  

Hi Bruchbude

- keine News
- bevorstehender Split
- keine SARS Dramatic
- neue Aktienpakete werden auf den Markt geworfen
..das läßt den Kurs drastisch fallen.

Hoffnung bleibt, da Viragen einige Investoren und ca. 20 Millionen $ durch die neuen Aktien hereingebracht hat. Das reicht nicht nur zum Überleben, sondern auch zur weiteren Vermarktung.
Ich schätze mal, dass nach dem Split die Aktie wieder nach oben kommt.

Einfach mal abwarten!
Gruß Biene


 

Wann genau ist der Split und zu welchen Konditionen?

Gruß
BB  

Bis jetzt konnte ich immer beobachten, dass sich ein Splitt nach oben (z.B. aus 50 Aktien werden 10) immer erstmal negativ auf den Kurs auswirkt. Optisch sieht der Kurs dann zwar gut aus, aber rechnet man diesen auf den alten Kurs um, dann stellt man oft fest, dass dieser nicht einmal dem alten entspricht. Solche Sachen sind immer mit Vorsicht zu genießen. Schaut mal EM.TV an, alt 0,89 EUR, nach dem Split nun 2,76 EUR. Es gab hier für 73 alte Aktien 10 neue, entspräche also einem Kurs von ca. 6,50 EUR. Rechnet man zurück ist die Aktie bei 0,38 EUR nach altem Kurs !. Das war auch bei Intershop so.

Gut, man kann EM.TV und Intershop nicht mit Viragen vergleichen, aber irgendwie läuft das bei vielen Werten so. Ich bin kein Freund davon.

Gruß Börsefan.  

Viragen kann man wirklich nicht mit EM.TV oder "Interspot" vergleichen!
Mich interessiert auch kein Umrechnungsfaktor, sondern nur das Potential!

Egal, ob jetzt Viragen in die Knie geht, oder doch noch einen Aufschwung erlebt. Ich verkaufe erst zum Schluss - hoffenlich!

Für mich hat die Aktie enormes Pötential - FDA etc - und nur das zählt!
Viragen ist im Krebs-, Viren-, Hepatitis, und Medikamentenbereich tätig, sodass nur noch der Startschuss fehlt.
Abwarten....
Gruß Biene

P.S.: Bis zum 3.05.04 war Abtimmung, ob ein Split gewünscht wird. Es sieht ganz danach aus, dass dieser Split nicht zustande kommt. Warten wir die Endergebnsse ab.  

Viragen and University of Miami to Advance Anti-Cancer Study

PLANTATION, FLORIDA – May 12, 2004 – Viragen, Inc. (AMEX: “VRA”) today announced that the Company extended its agreement with the University of Miami and UM/Sylvester Comprehensive Cancer Center to develop a novel form of an immune enhancing drug (IEP 11) that has shown promise in animal studies by inhibiting tumor growth in a broad range of cancers.  The agreement continues to provide Viragen with an option to acquire an exclusive worldwide license to commercialize the technology.

“This small peptide molecule called ‘IEP 11’ holds the potential of being a platform technology for the treatment of a broad range of cancers,” stated Dr. William H. Stimson, Viragen’s Director of Research (Emeritus).  “Initial studies in animals have shown the peptide elicits a powerful immune response against various types of cancer cells.  Additionally, those animals that were ‘IEP 11 immunized’ were found to form much smaller tumors or not at all.  Our results to date are highly promising and further pre-clinical research studies will be carried out to confirm our preliminary data.”

Over the next year, Viragen and their University of Miami collaborators plan to carry out a series of pre-clinical studies designed to demonstrate therapeutic efficacy.  IEP 11 has already shown to be able to protect against tumor formation in non-human evaluations, so if it also proves efficacious in treatment regimes, the project is expected to move forward towards human clinical evaluations.

UM/Sylvester was founded in 1992 to provide comprehensive cancer services and today serves as the hub for cancer-related research, diagnosis, and treatment at the University of Miami School of Medicine.  UM/Sylvester handles more than 1,100 inpatient admissions annually, performs 2,800 surgical procedures, and treats 2,900 new cancer patients.  All UM/Sylvester physicians are on the faculty of the University of Miami School of Medicine, South Florida’s only academic medical center.  In addition, UM/Sylvester physicians and scientists are engaged in more than 150 clinical trials and receive more than $30 million annually in research grants.  UM/Sylvester at Deerfield Beach recently opened to better meet the needs of residents of Broward and Palm Beach Counties.  This 10,000 square-foot facility at I-95 and S.W. 10th Street offers appointments with physicians from six cancer specialties, complementary therapies from the Courtelis Center, and education and outreach events. http://www.sylvester.org  

About Viragen, Inc.:

Viragen is a biotechnology company specializing in the research, development and commercialization of natural and recombinant protein-based drugs designed to treat a broad range of viral and malignant diseases.  These protein-based drugs include natural human alpha interferon, monoclonal antibodies and a peptide drug.  Viragen’s strategy also includes the development of Avian Transgenic Technology as a biomanufacturing platform for the large-scale, cost-effective production of therapeutic proteins.

Viragen is publicly traded on the American Stock Exchange (VRA).  Viragen’s majority owned subsidiary, Viragen International, Inc., is publicly traded on the Over-The-Counter Bulletin Board (VGNI).  Viragen’s key partners and licensors include: Roslin Institute, Memorial Sloan-Kettering Cancer Center, Cancer Research UK, University of Nottingham (U.K.), University of Miami, America’s Blood Centers and the German Red Cross.


--------------------------------------------------

Viragen, Inc. Corporate Contact:

Douglas Calder, Director of Communications
Phone: (954) 233-8746; Fax: (954) 233-1414
E-mail: dcalder@viragen.com

 

Erstmal nen schönen Gruß an Dich, hab Dich noch gut in Erinnerung vom letzten Ariva-Treffen. Wie lang hälst Du eigentlich schon die Viragen-Aktien und was war Dein EK ?

Gruß
Börsenfan.  

schönen Gruß an dich.
Ich halte seit Mai 2003 und habe mir immer noch einige Stücke zugelegt. Im EK liege ich bei ca 0,30.
Ich denke, dass Wert höher liegen müsste, denn die Aktie wurde im Amiland übertriebenerweise heruntergeprügelt ohne den inneren Wert der Firma zu kennen. Dann haben die noch einige Forschungsvorhaben laufen ohne Aussicht auf ein Erfolgsmedikament!
Warum werden diese Forschungsbereiche nicht stillgelegt, zumal das Geld bis zur Marktreife eines Medikaments ( ausser Multiferon ) nicht ausreichen kann! Da dürfte wohl mehr dahinterstecken. Z.B. wäre es denkbar, dass ein Medikament demnächst gut vermarktet werden kann und die Kosten für die neuen Medikamente dadurch erwirtschaftet werden können. Desshalb bleibe ich hartnäckig.


News:
Shelf-Life for Multiferon Extended as Viragen Advances Marketing Campaign
Thursday May 13, 8:30 am ET


PLANTATION, Fla., May 13 /PRNewswire-FirstCall/ -- Viragen, Inc. (Amex: VRA - News) today announced that the Swedish Medical Products Agency (MPA) has approved extending the shelf-life of Multiferon(TM) to 18 months from its previously approved labeling of 12 months. Additionally, the Company reports that it has initiated a new sales and marketing campaign for Multiferon in Sweden. The campaign promotes the theme "Multiferon -- the natural choice," highlighting its natural source (human leukocytes), its competitive attributes and its approved uses in Sweden.
"It is our priority objective to increase sales of Multiferon around the world," stated Viragen's President and CEO, Mr. Charles A. Rice. "The prolonged shelf-life provides us with increased flexibility in production and distribution, and we are working to implement this new labeling in our existing and pending markets. Through our own sales staff in Sweden, our growing network of international distributors and our evolving strategy for the future of the product, we expect Multiferon to become recognized as a leading brand of natural alpha interferon."

The print advertising campaign will debut in a series of Scandinavian and Swedish medical publications, including Acta Oncologica, a leading journal in clinical oncology and the official journal of the five Nordic oncological societies.

For a preview of the Multiferon advertising campaign, please visit: http://www.Viragen.com/multiferonad.htm .

 

Press Release Source: Viragen, Inc.


Viragen's CEO, Charles A. Rice, Outlines Growth Strategy to Stockholders
Tuesday May 25, 6:59 am ET


PLANTATION, Fla., May 25 /PRNewswire-FirstCall/ -- The following is a letter from the President and CEO of Viragen, Inc. (Amex: VRA - News). 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 upon request by contacting the Company.
ADVERTISEMENT


Dear Stockholder,

Nearing the completion of my first 60 days as President and CEO, I would like to report to you on some progress we are making at Viragen.

I believe there is an existing foundation here that is ripe to create immediate and long-term value for our stockholders. While there are significant challenges which need to be navigated to be successful, we are making changes now that will direct us toward that success. I am establishing a renewed focus to maximize the value of our assets for our stockholders.

Because some of our growth strategies are in the process of being negotiated, I cannot discuss all of my plans in this letter. However, I would like to update you on certain activities, including some new initiatives designed to enhance and complement those which have been ongoing and progressing. There are two things that we must do, these being: 1) increase revenues and 2) continue to control expenses.

Multiferon(TM)

Manufacturing -- We have previously announced the ongoing process of modernizing our production capabilities for the manufacturing of Multiferon(TM) in Sweden. I am pleased to report that we are on schedule to complete the validation of the new construction and subsequent inspection by Swedish authorities before the end of this year. I would like to congratulate our team for their excellent work on this important project.

I would also like to stress the importance of state-of-the-art and fully compliant manufacturing facilities, equipment and processes for the production of Multiferon. We can be very proud of our Ersboda and Umea sites. Continuous improvement in our manufacturing systems is one of the best possible uses of our capital.

Marketing -- There is no better short-term means to build value in Viragen than to increase the sales of Multiferon. This is a great product but it has been under the radar screen of high prescribers in territories where it is approved. It requires new marketing initiatives to meet our expectations. I am pleased to report that we have put into effect several changes in order to achieve our new objective of making Multiferon the world's most prescribed natural human alpha interferon.

First, our analysis of the current market situation in Sweden indicates this is the opportune time to boost our sales activity. We recently announced a new advertising campaign coupled with a sales strategy that we are confident will result in sales increases over the coming months. We will ensure our return on this reasonably small investment is accounted for in a very short period of time. Sweden is the only territory, at the current time, where Viragen or one of its subsidiaries is in direct control of selling Multiferon. We must take advantage of this unique opportunity now.

Second, we are conducting a critical review, or "rationalization", of all our international distribution agreements. As part of this review, we will be making determinations as to whether to continue in certain territories or whether to halt our activities. As our marketing and regulatory resources are limited, we cannot afford to maintain product registrations in territories unless the financial return justifies the expense. Our approach will be to focus our attention on higher value opportunities.

Third, we are evaluating packaging alternatives for Multiferon in order to improve our competitiveness. Our glass ampoule presentation represents a classic approach to biological product manufacturing. However, most of our competitors use pre-filled syringes, adding to end-user convenience. While any such changes will require approvals by local authorities, this is a necessary step in managing the expectations of physicians, nurses and patients as well as positioning Multiferon for future growth.

Fourth, we are currently reviewing the regulatory alternatives for our clinical assessment of Multiferon in malignant melanoma. We are in the process of additional data collection and we expect to provide updates to you later this year on this important part of our strategy.

Finally, there are discussions and negotiations currently in progress on License and Supply Agreements for Multiferon in territories where we currently do not have a market presence, and where significant opportunities exist. These include selected areas of Asia, South America, Europe and North America. We are changing our strategy on these agreements, including our selection of collaborators. We are not going to be satisfied with merely signing agreements. Performance and growth are our priority expectations.

Based upon these and other activities, I am confident that we will realize significant improvements in revenues from Multiferon.

The U.S. Market -- With respect to the U.S. market, we have stated that, upon closing our $20 million financing agreement, we intend to use a portion of the proceeds to seek a market registration for Multiferon in the U.S. While we recognize that this process will take time and money, we know there are many different regulatory pathways available to us. We will be as creative and innovative as possible in developing a U.S. strategy. Where possible, we will make use of tools available to small businesses, tools available for niche market opportunities, and potential partnerships, whereby we may share costs of the registration processes.

If approved by Congress and the President, Project BioShield could provide a new alternative for accelerated registration, provided our products demonstrate utility in treating biological, chemical or radiation contamination. Multiferon has been demonstrated to have significant anti- viral activity in SARS in cell-based assays, and we may expect this to be active against a variety of viruses that could be used in bio-terrorism. We have been working on an international level to generate the necessary scientific data in support of Multiferon just for these purposes, and this work will continue. The critical parameter here is not just to talk about it, but to find a way to do it, and we will.

Avian Transgenic Biomanufacturing Technology

The most obvious question is, "When will the flocks of our genetically- engineered chickens be capable of producing therapeutic proteins faster, cheaper and more efficiently than conventional methods?" There is no simple answer. This is a major research project that aims to revolutionize a drug manufacturing process. The market opportunity appears to be enormous and the competition fierce. So, while we, with our partners, strive to meet internal deadlines, it is important to realize that this is discovery research. It is difficult to predict and it is not guaranteed. We are extremely encouraged by our accomplishments to date, and we believe these are but a precursor of achievements to come. We have some of the most outstanding people, partners and patents in this field, and our team is working hard to prove commercial viability. We are determined to provide our research team with the resources necessary to deliver this important technology.

Anti-Cancer Projects

We have three promising anti-cancer candidates that are being developed in collaboration with four separate and prestigious institutions, each recognized leaders in fields of cancer and immunology research. The recent grant from the Scottish Executive confirms both the credibility and innovative nature of our anti-CD55 Antibody and provides incremental funding ($833,000 over 3 years) so that we can move forward with development. Whenever possible, we will continue to utilize creative financing efforts for all of our projects. The industry is quite crowded with product candidates for the treatment of cancers. It is important that we develop sound scientific data on our candidates on as timely a basis as practical so that we can either move forward with development or stop spending money on them if they do not work. In order to realize value from these projects, we have to invest in them.

Financing

We are currently seeking stockholder approval to complete a $20 million financing agreement and to effect a 1-for-10 reverse stock split. Our Board believes these actions are necessary to enable the Company to meet its goals and build stockholder value. The intent is to recapitalize the Company in order to make our capital structure more attractive to institutional investors and professional fund managers. Adding these types of investors to our stockholder mix can help to reduce the volatility that we experience now. Coupled with improving business conditions, such as increasing sales, we expect this new financing to provide sufficient funding to allow us to move forward on our projects and ultimately build value. I believe the financing and reverse split are necessary to adequately fund our operations and to advance our development projects and I fully support these actions.

The Future

I am focused on building the business. To my knowledge, there are no sales or marketing initiatives that can be guaranteed to generate immediate revenues, short of introducing a completely new product. It will take a number of months for us to realize significant increases in sales revenues, but I am confident it will happen.

In the past two months, I have had the opportunity to meet only a few of our stockholders. Some of you have been holding shares for many years and some of you are new investors, but all of you are keenly interested in seeing your investment grow. In the coming months, I hope to be able to announce a number of events that could represent major advancements in our business.

As part of our communications, I intend to ensure that we maintain an active investor information program to report to you, the stockholder, our progress -- good or bad -- factually, accurately and as timely as possible, within the laws that govern our business.

Approaching my first 60 days as the President and CEO of Viragen, I am excited about the prospects for our Company. I also believe that tangible business accomplishments will speak louder than any predictions, and that is what you can expect from Viragen management.

   Sincerely yours,


   Charles A. Rice
   President & CEO

 

gibt es schon Einschätzungen/Kommentare Eurerseits dazu ?

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RR  

Associated Press
Viragen Holders OK Reverse Stock Split
Monday June 14, 7:58 am ET  
Viragen Shareholders OK $20 Million Financing, Reverse Stock Split


PLANTATION, Fla. (AP) -- Viragen Inc. reported Monday that its shareholders agreed to complete the sale of $20 million in convertible promissory notes and common stock purchase warrants to eight institutional investors, approved a reverse stock split and agreed to change the number of shares that Viragen will issue.
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The maker of interferon therapies for cancer treatment said the shareholder approvals move the company forward toward meeting final conditions of a financing agreement, including the authorization of a one-for-ten reverse stock split on June 15.

The funding, arranged by HPC Capital Management and expected to close in about one week, will increase Viragen's cash position to about $25 million. The company will use proceeds to grow research, development and marketing of its healthcare products and technologies.

"By significantly strengthening our balance sheet, we are far better positioned to move forward with global marketing initiatives designed to increase revenues of Multiferon, while supporting our research projects to determine their commercial potential," stated Viragen's president, Charles A. Rice.



 

Press Release Source: Viragen, Inc.


Viragen Publication Alert:
Monday June 21, 8:03 am ET  
Gene Delivery System Results in High Success Rate in Avian Transgenics Program


PLANTATION, Fla., June 21 /PRNewswire-FirstCall/ -- Viragen, Inc. (Amex: VRA - News) today announced that a scientific article reporting on its Avian Transgenic Biomanufacturing Program is available as an advance online publication of EMBO reports (European Molecular Biology Association, McGrew et al, VOL 5, NO 7). The article, titled "Efficient production of germline transgenic chickens using lentiviral vectors," reports data that demonstrates that lentiviral vectors can be used to generate transgenic lines with an efficiency in the order of 10 to 100-fold higher than any previously published method.
In collaboration with Roslin Institute and Oxford Biomedica PLC, Viragen aims to develop this technology for the efficient, large-scale and cost- effective manufacturing of pharmaceutical protein-based drugs in the eggs laid by flocks of transgenic chickens.

Project Leader, Roslin Institute's Dr. Helen Sang, commented, "Our results to date are very encouraging. The efficiency is such that transgenic lines of chickens can be established with ease, and studies measuring expression of the transgene suggest that predictable levels of expression will be obtained. In order to achieve our goal of producing therapeutic proteins in hens' eggs, we must accomplish tissue specific expression of the transgene in the oviduct -- a goal we are diligently working toward."

The abstract of the article is available at: http://www.nature.com/cgi- taf/DynaPage.taf?file=/embor/journal/vaop/ncurrent/abs/7400171.ht­ml

New! -- For Avian Transgenic Technology Profile, please visit: http://www.Viragen.com/aviantechprofile.pdf

 

Press Release Source: Viragen, Inc.


Forum Alert: Viragen, Inc. Presentation at Informed Investors Biotechnology & Pharmaceuticals Stocks Forum at the Princeton Club in NYC on Wednesday, June 23, 2004, 11:00 am ET
Monday June 21, 11:18 am ET


PLANTATION, Fla., June 21 /PRNewswire/ -- Charles Rice, President & Chief Executive Officer of Viragen, Inc. (Amex: VRA - News), will present at the following forum:
   What:     Informed Investors Biotechnology & Pharmaceuticals Stocks Forum

   When:     June 23, 2004 @ 11:00 AM Eastern Time

   Where:    The Princeton Club of New York, 15 West 43rd St. (Between 5th
             and 6th Avenues) New York, NY 10036

   How:      To attend the live event, pre-registration is necessary. To
             register contact Cary Loeser, cloeser@wilink.com, 804-327-3407
             or call Customer Service at 888-301-6618.


If you are unable to attend the live event, the forum will be available via webcast at http://www.informedinvestors.com/CustomEvent/...ex.asp?ForumID=85117.

Viragen is a biotechnology company specializing in the research, development and commercialization of natural and recombinant protein-based drugs designed to treat a broad range of viral and malignant diseases. These protein-based drugs include Multiferon(TM), monoclonal antibodies, peptide drugs and therapeutic vaccines. Viragen's strategy also includes the development of Avian Transgenic Technology for the large-scale, cost-effective manufacturing of its portfolio of recombinant protein-based drugs, as well as offering Contract Manufacturing for the biopharmaceutical industry. Viragen is publicly traded on the American Stock Exchange (VRA). Viragen's majority owned subsidiary, Viragen International, Inc., is publicly traded on the Over-The-Counter Bulletin Board (VGNI). Viragen's key partners and licensors include: Roslin Institute, Memorial Sloan-Kettering Cancer Center, National Institutes of Health, Cancer Research UK, University of Nottingham (U.K.), University of Miami, America's Blood Centers and the German Red Cross.



 

Reuters
Transgenic chickens help UK's Oxford Biomedica fly
Monday June 21, 11:51 am ET


LONDON, June 21 (Reuters) - A potential breakthrough in the production of protein-based drugs in the eggs of genetically modified chickens lifted shares in British biotech firm Oxford Biomedica (London:OXB.L - News) eight percent on Monday.
Biomedica said it and U.S. partner Viragen (AMEX:VRA - News) had managed to generate transgenic chicken lines with an efficiency of the order of 10 to 100-fold higher than any previously published method.

Several biotech groups are working on new ways to produce antibodies and other complex protein drugs in milk, eggs or farm crops, as a cheap alternative to making them from cell cultures in stainless steel vats.


 

PLANTATION, Fla., July 6 /PRNewswire-FirstCall/ -- Viragen, Inc. (Amex: VRA - News) and Oxford BioMedica (LSE: OXB - News) today announced a license agreement for Oxford BioMedica's LentiVector gene delivery technology. The agreement provides Viragen with worldwide exclusive rights to utilize the proprietary LentiVector technology in its collaboration with Roslin Institute (Scotland) to develop Avian Transgenic Technology as a novel platform for the efficient and economical manufacturing of therapeutic proteins in chicken eggs.
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"Manufacturing protein-based drugs through an avian transgenic expression system should offer certain advantages to traditional production systems -- likely in terms of speed, efficiency and cost," stated Viragen's CEO, Mr. Charles A. Rice. "As indicated in a recent press release, results to date have been exceptional and warrant our licensing the exclusive rights to the LentiVector system for our Avian Transgenics Program. We are hopeful that continuing progress will confirm the commercial significance of this approach."

Viragen and Roslin Institute have conducted preliminary studies evaluating Oxford BioMedica's LentiVector technology which have yielded promising results, demonstrating the ability to generate transgenic generations with an efficiency on the order of 10- to 100-fold higher than any previously published methods.

Oxford BioMedica's CEO, Professor Alan Kingsman, added, "Viragen's Avian Transgenics Program has made substantial progress over the past two years and we are delighted that Oxford BioMedica's LentiVector technology has contributed to this success. We look forward to further developments following the signing of this agreement."

Under the agreement, Oxford BioMedica receives an upfront license fee and annual maintenance payments. In addition, Oxford BioMedica will receive milestone payments on the achievement of technical goals by Viragen and royalties on commercialization of the Avian Transgenic Technology. Further financial details were not disclosed.

For an Avian Transgenic Biomanufacturing Technology Profile, please visit: http://www.Viragen.com/aviantechprofile.pdf

 

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Viragen Granted U.S. Patent for Manufacture of Multiferon™

PLANTATION, FLORIDA – July 29, 2004 – Viragen, Inc. (AMEX: “VRA”) and Viragen International, Inc. (OTC BB: “VGNI”) today announced it has been granted U.S. Patent 6,743,624 from the United States Patent & Trademark Office for a process relating to the manufacture of Multiferon™, its natural human alpha interferon drug derived from human white blood cells.

The issued patent titled, “Process For Continuous Purification And Concentration Of Leukocytes From Blood”, relates to a novel process used to concentrate leukocytes (human white blood cells) during the production of Multiferon, which results in an enhanced yield of interferon from the cell preparation.

“Obtaining patent protection for this key aspect of our manufacturing technology represents one step in providing Viragen with an important competitive advantage as we continue our evaluation of ways to bring Multiferon to the United States,” stated Viragen’s Executive Vice President, Mr. Mel Rothberg.  “We continue to review the multiple options available to us for this part of our Multiferon strategy.”  

 

Viragen Issues Progress Report

PLANTATION, FLORIDA – August 19th, 2004 – Viragen, Inc. (AMEX: “VRA”) today issued a progress report updating the status of new growth strategies for its natural human alpha interferon drug, Multiferon™.

Viragen previously reported promising preliminary data from a Phase II/III clinical trial conducted in Germany that evaluated the use of Multiferon for the treatment of malignant melanoma.  “The final data collected from our melanoma study has been delivered to an independent Contract Research Organization for statistical determinations and we anticipate receiving the final results in the coming weeks,” stated Viragen’s President and CEO, Charles A. Rice.  “If the evidence supports, we intend to submit a registration filing with the Swedish regulatory authorities for this new indication, which if approved, would strongly enhance our position to negotiate strategic partnerships in Europe.”

Mr. Rice also commented on current partnering initiatives, “We continue to be engaged in active negotiations with multiple business partners for Multiferon that have the potential to change the business of Viragen in a significant and lasting manner.  This progress has been steadily encouraging and, subject to the result of these discussions, it appears that we are on the verge of announcing key new agreements.”

The Company also reports that it is in the final stages of negotiation with a supplier of pre-filled syringe products, and has tentatively scheduled validation runs in order to be prepared for registration filings early in 2005.  “We expect a rapid approval of this change, hopefully in Sweden within the second quarter of 2005, followed closely by other territories in which we have approvals,” stated Executive Vice President of Operations, Mel Rothberg.  “This Project is consistent with our earlier announcement on a more aggressive and competitive positioning of Multiferon.”

“In addition, our new Ersboda Multiferon manufacturing facility’s final validation program remains on schedule.  The Swedish regulatory authorities have agreed with our validation plans and have informed us that we are not required to have any additional inspections before we return to production in September,” Mr. Rothberg reported.