The biopharmaceutical market is expanding rapidly. The figure below demonstrates the growth of biopharmaceuticals as a percentage of overall drug sales over the course of the last decade. It has moved well beyond growth hormones, insulin and red blood cell stimulating agents targeting a range of diseases from growth deficiency to arthritis, to multiple sclerosis and especially cancer. The world's six biggest-selling drugs in 2014 will all be biotech products. A total of seven of the top 10 drugs in 2014 are forecast to be biotech in origin, compared to five in 2008 and just one in 2000. Taking a wider perspective, biotech drugs will account for 50 percent of the top 100 drugs in 2014.
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Monoclonal antibodies are one of the biggest success stories of modern biotechnology. Global sales were $33 billion in 2008, expanding from $27 billion in 2007. Utilizing the technology embodied in US Patent 5,643,745, Neugenesis offers the only known alternative mAb expression technology to the Cabilly II patent owned by Genentech under US Patent 6,331,415. Neugenesis has assembled all the necessary intellectual property and know-how for expression and production of commercial levels of mAbs in fungi.
Through its demonstrated capabilities in the production of monoclonal antibodies (mAb’s), Neugenesis offers its clients the ability to profit from this trend in two ways:
- The production of antibodies that are not easily produced using traditional biotechnology platforms (CHO cells or E. coli)
- Production of biosimilars (or follow on biologics), where the NeuBIOS™ platform’s low cost and short development cycle will be extremely attractive given the low margins and price sensitivity in this marketplace
The Neugenesis approach to production of monoclonal antibodies offers some unique advantages. Our platform offers the ability to fold complex mammalian proteins correctly, to glycosylate proteins, and to secrete them into inexpensive media. The system does not express toxins and has no known viruses. Our proprietary intellectual property position is free from dominating or competing IP. The system is readily scalable and requires significantly less infrastructure than traditional methods.
Neugenesis is currently developing, on a contract basis, a broad spectrum anti-viral mAb that has great commercial potential. The antibody has proven impossible to produce using other platforms, but is successfully expressed by Neurospora crassa. This proof of concept project will be completed at the end of Q1 2010.
The current market also presents potentially rewarding opportunities in biosimilars (also known as biogenerics or follow on biologics). Neugenesis’ platform is well positioned for use by entrants to this sector because of our low cost of production, short development cycles, and strong IP position. Due to expected strong competition among generics manufacturers, price erosion will likely occur, thereby negatively affecting brand name manufacturer revenue.
