>Chickens had some advantages over other animals for "pharming" because their lifecycles were shorter, said Dr Sang.<
But chickens have some major drawbacks too. There are good reasons why no avian-transgenics company is even close to GTCB and Pharming in commercializing drugs.
>But it could be another five years before patient trials get the go-ahead and 10 years until a medicine is fully developed, the Roslin Institute cautioned.<
[VRA issues a PR every time a transgenic hen lays an egg. The avian portion of this PR can be summed up by saying that, after all these years, VRA still has a heck of a lot of work to do to be considered a serious contender in transgenic production of proteins drugs.]
PLANTATION, Fla., Jan. 25 /PRNewswire-FirstCall/ -- The following is Part II 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 I of Mr. Rice's letter was issued yesterday.
Dear valued Stockholder,
In Part I of my letter, I focused on our plans for Multiferon®, which will remain a priority for the Company due to its potential to generate licensing and sales revenues in the immediate term. Now I will review our plans for our anti-cancer candidates and the OVA(TM) System. [I omitted the cancer stuff—please see the link above if interested.]
OVA(TM) System: Avian Transgenic Biomanufacturing
The concept of efficiently and cost-effectively producing therapeutic proteins in the eggs of transgenic chickens is certainly revolutionary, and the OVA(TM) System is receiving much attention with the successful production of three functional protein-based drugs in hen's eggs thus far. We continue to work closely with our partners at Roslin Institute, creators of "Dolly the Sheep", to make this vision a reality. Earlier this week, we reported the recovery of our third OVA(TM)-expressed protein, interferon alpha-2a, and we expect to report on a fourth protein later this year.
With each OVA(TM)-expressed protein, we are evaluating the consistency, quality and quantities of each product candidate expressed over multiple generations of hens. These data will help us determine which types of proteins are best suited for this manufacturing platform. The next important step for our development plan will be to select a first product candidate that we will take into production and into the registration process.No kidding.]
While there is considerable industry and public interest in the OVA(TM) System, this is still pioneering science with much to prove. It appears likely that we should have an OVA(TM)-expressed product candidate at a more advanced stage in clinical development, at least through the initial regulatory processes in the U.S. or the EU, in order to generate realistic licensing opportunities. This will require significant additional funding and a number of years of work by our avian transgenics team. However, we will strive to choose a first commercial product candidate that permits us to take advantage of "expedited" regulatory processes that may be available to us, so that the overall time required can be reduced.
…In Closing:
The Management of Viragen expresses our sincere thanks to our stockholders, for your patience and perseverance, even in the face of dissatisfaction with our share valuation and past sales results. We have positioned our projects and resources in expectation that 2007 and future years will yield vastly improved results.
Our success is dependent upon our ability to secure adequate funding to support our activities. We are exploring various alternatives including financings, grants and new strategic initiatives. Additionally, we aim to execute a funding strategy that will return Viragen to compliance with the Amex's maintenance criteria, as we must do so by March 20, 2007 to remain compliant with the plan we submitted to the Amex. While we intend to become compliant by this deadline, our ability to do so will be dependent upon the availability of funding on satisfactory terms and other factors outside of our control, and we cannot provide assurances that our efforts in this regard will be successful.
Our plans are ambitious, but also flexible, so that we can react quickly should changes be necessary, and we are highly confident that we will be able to build the kind of Company our stockholders can be proud of. <<
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