The pharmaceutical industry's annual revenue base has reached approximately US$415 billion. A growing portion of this, currently US$20 billion in sales, is generated by biologically-derived therapeutics. This growth is fueled by advances in genomics and proteomics as well as innovations in drug delivery technologies. There are now several successful billion dollar biopharmaceuticals and vaccines on the market, providing breakthrough treatments for millions of grateful patients. These novel drugs also provide pharmaceutical companies with new, lucrative product entries into markets, with sustainable profitability. Examples of a few highly successful biopharmaceuticals and vaccines are: (i) Eli Lilly’s US$ 1.8 billion product line for diabetics (including “Humalog” insulin); (ii) Amgen’s US$ 1.2 billion “Nupogen”, an immune booster for cancer patients; (iii) Schering-Plough’s US$ 1.2 billion Alpha Interferon product for treating hepatitis C and various cancers; and (iv) Glaxo Smith- Kline’s US$750 million Hepatitis B vaccine. There are currently more than 400 new biopharmaceuticals in various stages of development, which will contribute to the continued growth of this segment.

In order to discover and characterize new biopharmaceutical products, and to develop them into therapeutic products, the ability to produce moderate to large quantities of diverse types of proteins is needed. Dyadic believes that its integrated C1 technology platform (More at Technology Platform) has an enormous potential to fill this need. This integrated technology platform, which utilizes Dyadic’s proprietary fungal host organism, C1, can produce sufficient quantities of protein for animal studies, clinical trials, and ultimately for product manufacturing. (More at Bottleneck Table-.pdf file 37KB- This file requires Acrobat Reader.) Dyadic’s C1 technology platform can help pharmaceutical companies discover and characterize novel genes and proteins of therapeutic interest that can lead to the development of protein therapeutics, antibody drugs and diagnostic products.

Dyadic is in the advanced stage of development of its C1 integrated technology platform (More at Technology Platform), which is expected to become one of the most efficient discovery and development tools for moving novel drugs from lab concept to clinic, and ultimately to market. Furthermore, Dyadic will continue to enhance its C1 protein expression system (More at Gene Expression) to virtually assure that newly-discovered therapeutic proteins can be mass-produced for medical use. Collectively, these new and powerful methods make up Dyadic’s Functional Proteomics Program (More at Technology Platform).

Dyadic expects to work with strategic partners in the biopharmaceutical industry to translate breakthrough science into breakthrough treatments for patients.

Dyadic’s goal is to become a significant technology provider to pharmaceutical and biotechnology companies to help them discover, develop, and manufacture protein-based drugs. Dyadic’s expertise will speed the transfer of its partners’ drugs from laboratory to clinic to market. Because the same C1 host organism is used from new protein-drug discovery to commercial-scale manufacturing, the probability of success in bringing drug candidates from the research program to the market is enhanced.

We expect to develop strategic partnerships to identify and develop novel human protein drugs and vaccines and new improved versions of existing biotherapeutics. Dyadic is looking for partners who have proven expertise and the infrastructure to successfully shepherd a protein-drug candidate through the FDA approval process, and then successfully commercialize it. Dyadic is particularly interested in those companies that have the breadth and experience in developing highly specialized assays that are critical to the screening efforts for any new drug candidate. (More at Robotic Screening).