Newsforum zu Viragen

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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.


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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.

"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: www.Viragen.com/multiferonad.htm .

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 ?

Was halten wir davon? Ist diese Info für den Kurs / die Bewertung von Viragen von Wichtigkeit?

Gruß
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: www.nature.com/cgi- taf/DynaPage.taf?file=/embor/journal/vaop/ncurrent/abs/7400171.ht­ml

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

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Danke für Tips!

1-jahres-Chart:

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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.”  

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.