Technology
The key technology that the development stage company focuses on is a platform pharmaceutical formulation that enhances drug uptake through the inner lining of the mouth. This is accomplished through a special compact inhaler that contains proprietarily formulated drug in aqueous solution, which is delivered in droplets at an optimal angle to maximize the impact with the buccal mucosa (mucous membrane of the inside of the cheek). The size of the droplets is created by a uniquely designed mechanical device specifically for oral (NOT lung) drug absorption. The combination of these features offers a simple and convenient way for patients to take accurate and reliable amounts of medications. Furthermore, the buccal absorption route, having access to a large bed of blood vessels, allows drugs to enter the circulation of the body rapidly, effectively, and without pain, an advantage especially desirable for patients (a lot of them kids) who face the discomfort and fear behind multiple daily injections of medicines such as insulin. Non-invasive therapies lead to improved patient compliance and therefore positively reduce the dollars (estimated $8.5B in the US alone) associated with noncompliance.Currently, Generex is targeting the metabolic disease market with its lead product, Generex Oral-lyn™, an oral insulin spray intended for diabetes treatment. Oral-lyn™ is already approved for sale in India, Algeria, Lebanon and Ecuador, and is in global Phase III clinical trials with over 347 patients being enrolled in 74 clinical sites around the world, including sites in the United States, Canada, Bulgaria, Poland, Romania, Russia and Ukraine. In addition, with the remarkable efforts of Generex's regulatory team, the oral insulin, demonstrating the potential of efficacy through clinical testing without unreasonable risks, recently (September, 2009) became the only developmental drug intended to treat diabetes to receive the FDA's approval under the Treatment Investigational New Drug program. This successfully positions Oral-lyn™ as an extremely favourable product candidate for near future FDA approval of the drug’s marketing in the US. According to a close physician friend specializing in diabetes patient care, “the compact size [of Generex’s insulin delivery device] and avoidance of [insulin] lung deposit are no doubt advantages [for more convenient and safer glucose management]”. Importantly, these will help prevent the oral insulin from following the footsteps of Pfizer's failed inhaled insulin product, Exubera, criticized for its bulky appearance and carcinogenic risks to the lungs.
As another arm of operation, Generex’s wholly owned subsidiary, Antigen Express, Inc. focuses on developing proprietary vaccine formulations that work by stimulating the immune system to either attack offending agents (i.e., cancer cells, bacteria, and viruses) or to stop attacking benign elements (i.e., self proteins and allergens). Products already in mid-stage development include Antigen’s synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with HER-2/neu positive breast cancer (potential application in personalized medicine) in a Phase II clinical trial and patients with prostate cancer and against avian influenza in two Phase I trials. Further research programs also encompass areas in seasonal influenza virus, H5N1, HIV, HPV, melanoma, ovarian cancer, allergy and Type I diabetes mellitus.
Management
Worthy of note within Generex’s management is the newly addition of Dr. Joseph Rubinfeld, one of the original founders of Amgen Inc. (world’s largest independent biotech firm) as the company's Chief Scientific Advisor.In addition to his contribution in founding Amgen, Dr. Rubinfeld has a fifty year history in pharmaceutical and consumer product development, including the development of the multi-billion dollar antibiotic Amoxicillin as well as the invention and development of the first synthetic biodegradable detergent. In 1984, Dr. Rubinfeld won the prestigious Common Wealth Award for Science and Invention, recognition of his determination in achieving major inventions, represented by the numerous patents obtained during his distinguished career. Dr. Rubinfeld co-founded the IBA (Industrial Biotechnology Association) in 1981, which was the precursor to today's BIO (Biotechnology Industry Organization). He has also served as an advisor or board member to a number of biotech companies including AVI BioPharma, Quark Pharmaceuticals, and Cytrx Corporation. In 1991, he founded Supergen, a drug development company based in Dublin, California, where he served as Chairman, CEO and President until 2003 and as a member of the board of directors until 2005.
Dr. Rubinfeld will assist Generex in developing and implementing product commercialization strategies for its proprietary drug delivery platform and its synthetic vaccine platform technology programs.
"Generex is at a very pivotal position in its history, as the Company transitions from a pure research and development organization to the commercialization of its drug delivery platform and significant sales growth. After a substantial review of the Company's intellectual property, I am convinced that what is unique to Generex is that its delivery method can be applied to a host of drugs already on the market. Its Generex Oral-lyn™ diabetes product just scratches the surface of the potential benefits for patients, by providing a simple pain-free alternative to injectable drugs or other difficult drug delivery systems. Partnership opportunities for improved delivery of such drugs could significantly benefit patients and also extend the longevity of intellectual property protection, which is critical for pharmaceutical company revenues." says Dr. Rubinfeld when asked about the prospect of Generex. He further states, "I am equally intrigued with the synthetic vaccine technologies in development at the Antigen Express subsidiary. The cancer vaccines are showing promising results in initial human testing. Also, with the global concerns of the current flu pandemic, I believe there will also be partnering opportunities. The technology, which can reduce the time to get new vaccines available to the public, is a very attractive proposition. I am excited to assist in all of these areas. I feel rejuvenated to apply my knowledge to a company with such a vast potential."
With the joining of Dr. Rubinfeld along with his belief in Generex’s technologies, wealth of experience in early stage biotechnology development, and exceptional track record in large pharmaceutical companies, Generex is optimistic that they will achieve goals of becoming a rapid-growing, well-rounded, and profitable drug company of the future.
Finance
Data provided by Capital IQ, as of Jan. 31, 2010
Summary
Although it may not be apparent from the current financial numbers due to premature product marketing, Generex is prepared to surface to the top with the Company's flexible and well-protected technologies that allow drugs to be absorbed through the inner lining of the mouth as an alternative to needle injection, ongoing cancer/flu vaccine programs, extensively experienced leaders, and upward-trending estimated income. All of these substantially appreciate the value of the company, making it an attractive subject for acquisition, partnership, and immense growth.
Data provided by Capital IQ, as of Jan. 31, 2010
Summary
I am long Generex and am anticipating painless absorption of profits from this company.
