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.
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U.S. Patent
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.”
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