Markets
MONOCLONAL ANTIBODIES (MAbs)
EXPRESSION AND PRODUCTION OF MULTIVALENT VACCINES - The recent failure in the production of influenza vaccine for the US market in 2004 illustrates both the opportunity for a new production solution and the enormous market for such vaccines. It is likely that near term vaccine production will shift from the 19th century method of culturing vaccines in fertilized eggs and into a 21st century recombinant expression system. Of all the cell based and recombinant systems known, the Neugenesis system offers the fastest and least expensive way to produce these vaccines. For influenza alone, 100 to 200 million doses per year will be utilized in the US and worldwide sales will increase these numbers significantly.
A recent decision by the U.S. Patent and Trademark Office to re-issue a MAb production patent to Genentech (US Patent 6,331.415 by Cabilly et al.) gave Genentech a patent that covers one fundamental method of producing therapeutic antibodies. Genentech said the patent, issued after a decade-long legal dispute with Celltech, is broad. "We do expect that most antibodies are covered by this patent," said spokeswoman Sabrina Johnson (LA Times, December 19, 2001).
Neugenesis has an exclusive license to the only other known method for producing recombinant MAbs, US Patent 5,643,745 by Stuart and assigned to the University of Hawaii. Thus clients who may be blocked by the Genentech IP from producing antibodies in a competitive area have an alternative method for producing their drug and bringing it to market. In addition, as Neugenesis explores commercial MAb production in its alliance it expects that the fungal production system developed will be faster, simpler and cheaper than systems utilizing the Genentech IP for production of MAbs in mammalian cells in culture.
The market for MAb production has expanded more rapidly than anyone had predicted. By December 2001, current manufacturing capacity was shown to be woefully inadequate to handle the 25 to 50 new MAbs predicted to be approved by the FDA over the next five years. (Genetic Engineering News, Vol. 21, No. 21, December 2001) This provides an immediate opening for the Neugenesis MAb platform. The average market for a therapeutic MAb is in excess of $200 million per year. That translates to revenues from new products of between $5 -10 billion per year in the next five years.
DIRECTED EVOLUTION TECHNOLOGIES
In the major multi-billion dollar biotechnology markets, small molecule drugs, biopharmaceuticals, agriculture and industrial enzymes, Neugenesis' platform technologies will be utilized in the discovery arena to improve existing products and develop new ones.
The small molecule/ natural product pharmaceutical market was $28 billion in 1996. The market for polyketides alone is $10 billion. The biopharmaceutical market is the next largest of the markets with revenues predicted to increase to $16 billion by 2004. The barriers to entry in these markets are well known. These include required FDA approval and other developmental milestones including clinical trials.
The revenues in the agricultural biotech market are projected to increase over the next three years to $3-$4 billion in annual sales. Again, there are significant barriers in this market with the current most difficult hurdle being consumer acceptance of agricultural products modified with recombinant DNA.
The industrial enzyme market has already reached $2 billion in annual revenues. Because industrial enzyme products do not require clinical trials and FDA approval, it is possible to realize royalty revenues on sales within 24-36 months from this substantial market. Neugenesis projects a significant portion of its early major revenues will be generated in the industrial enzyme market area.