Overview

Background

The incidence of cancer and cancer-related pathologies will continue to rise, due to the aging population and a number of other factures, such as adoption of Western diets and smoking trends. The World Health Organization estimates that the global incidence of cancer will increase 50% in the next 2 decades, from 10 million cases to 15 million cases, from 2000 to 2020. An increasing cancer incidence will lead to a much larger population of patients requiring products that treat the side-effects of cancer therapy-the oncology supportive care market.

Quality-of-life-enhancing drug and biotechnology products introduced into medical practice in the 1980’s and 1990’s, have lost patent protection in the U.S., Europe and Japan. Billion dollar drugs used to treat chemotherapy-induced nausea and vomiting, products such as ondanestron and granisetron, have recently come off patent while biotechnology products,such as human growth hormone, erythropoietin, and the colony stimulating factors and the interferons, that previously had a combined global sales in 2001 of over $13.5 Billion have lost patent protection over the past few years.

Because the patents protecting the blockbuster drugs and first-generation biotech products have now expired, they will be soon replaced by lower-cost generics and biogenerics (generic biopharmaceuticals, also known as "biosimilars" or "follow-on biologic" products).

In many parts of the world, especially in China, India, Eastern Europe, the Middle East, Africa, Latin America, and other countries where patents do not provide protection, biotech products have been manufactured and sold in the market for over a decade. But in the major pharmaceutical markets, the U.S., Japan, and in the European Union, the absence of a specific regulatory path for biogeneric approvals has shut off access to lower-cost versions of these life-saving, quality-of-life-enhancing recombinant DNA-produced products.

However since 2005-2007, clear guidelines now exist in the E.U. for approval of “biosimilar” products, and FDA has approved biosimilar versions of growth hormone products under the 505b2 regulations. The FDA regulations and guidelines are about to be established in the U.S. for other “follow-on biologics”.

Because of its unique relationships with pharmaceutical and biotech companies in India and South Korea who have a decade of experience manufacturing high-quality drug and biotech products, and companies with novel, "needle-free" drug delivery systems, GenBioPro is positioned to be a major player in the emerging biosimilars and "super-generics" industry.

The near-term revenue from commercializing low-risk, quick-to-market "super-generic" drugs and the longer-term upside potential of being a leader in marketing lower-cost "super-biosimilars" provides several key factors that add value and distinguishes GenBioPro from traditional generic drug companies and up-start biosimilars companies.