By Dr. Joseph Rubinfeld, Chief Scientific Advisor
A Three Part Article on the Accomplishments of 2009
and the Potential of 2010 and Beyond
Part Three: Unlocking the True Potential of RapidMist(TM) Drug Delivery
WORCESTER, Mass., Jan. 8, 2010 (GLOBE NEWSWIRE) -- For most people when it comes to Generex (Nasdaq:GNBT), the focus is squarely on its flagship buccal insulin spray product, Generex Oral-lyn(TM), and its application in the diabetes arena. That focus is understandable as there is no doubt that, in order for the Company to achieve near-term large scale commercial success, Generex Oral-lyn(TM) must lead the way. I also believe that in addition to the other promising drug programs such as cancer vaccines and synthetic influenza vaccines, what is often overlooked when people evaluate Generex is that the success of Generex Oral-lyn(TM) may well validate Generex's proprietary RapidMist(TM) drug delivery method and open up a myriad of lucrative opportunities for the Company.
In order to understand the magnitude of successfully delivering a protein-based molecule through an other-than-injectable delivery method, all one has to do is look at the billions of dollars that have been spent by some of the world's largest pharmaceutical giants in failed efforts for delivering insulin through the lungs. And here is our Company, which stands on the verge of succeeding in not only accomplishing this task but, also accomplishing it without entering the pulmonary system and at a fraction of the cost of even one of the failed efforts by big pharma. Should Generex obtain FDA approval for Generex Oral-lyn(TM), it will enter the multibillion dollar market for diabetes treatment in the U.S. and it will also have the key to replicating this delivery for a broad based group of similar drug therapies for a variety of illnesses. Indeed, a complete success down the road would be the approval of the delivery system itself, enabling Generex to partner with other drug companies to extend the patent lives of their drugs through a less invasive delivery method. In each case, there would be the potential for large royalty streams on proven drugs for years to come.
Taking this one step further, if Generex were to become a large revenue generating company through the success of Generex Oral-lyn(TM), and its delivery method was also validated by use with other drug therapies, it would be then be possible for Generex to create a host of "super generic" drugs using its proprietary RapidMist(TM) drug delivery method and needing only to demonstrate bioequivalence, opening further multibillion dollar opportunities. Now of course this would be down the road a ways and a good many things would need to go in our favor for this to become a reality. However, it is not inconceivable that a multibillion dollar broad based drug company can grow out of our small and relatively unknown Company.
I chose to be the Chief Scientific Advisor to Generex because of the vast potential I see for the technologies and science possessed by this Company. People have called me "The Grandfather of the Industry" or "The Sage of Biotech" but in the end, I am just a researcher and an entrepreneur at heart. I see Generex as an opportunity for me to stay on the biotechnology rollercoaster which I love and ride it to a multibillion dollar success as everyone at the Company works diligently to have a positive impact on the lives of people with diabetes, cancers, influenzas or the many other diseases we may address down the road.
About Generex Biotechnology Corporation
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
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Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.