In addition to commercializing our core therapeutic proteins, we are pursuing licensing deals with biotechnology companies that have a strategic interest in using our solution to develop longer-lasting versions of their existing therapeutic proteins or peptides.
Among these proteins:
Interferon α : The protein interferon α, produced by animal cells when they are invaded by viruses, is released into the bloodstream or intercellular fluid to induce healthy cells to manufacture an enzyme that counters the infection. Interferon has been approved for therapeutic use against hairy-cell leukemia and Hepatitis C. It has also been found effective against chronic Hepatitis B, a major cause of liver cancer and cirrhosis, as well as for treatment of genital warts and some rarer cancers of blood and bone marrow. Annual sales of Interferon α were estimated to be $2.7 billion in 2005, selling under product names Intron and PEGIntron by Schering-Plough and Roferon and Pegasys by Roche.
Granulocyte Colony Stimulating Factor (G-CSF) stimulates the body’s bone marrow to make more of a crucial type of white blood cells called neutrophils. G-CSF is administered to patients undergoing chemotherapy who develop a low neutrophil count (neutropenia), which puts them at risk for severe infections and may mandate interruptions in cancer treatment. G-CSF is administered daily via injection. G-CSF, marketed by Amgen as Neupogen/Neulasta and by Chugai Pharmaceutical Co., Ltd. as Granocyte in Europe, had estimated 2004 worldwide sales in excess of $4.4 billion. Amgen received approval for Neulasta, a longer-lasting (PEGylated) version of Neupogen, in January 2002. In its first year on the market, Neulasta sales increased 170% from $467 million in 2002 to $1.27 billion in 2003 and increased a further 38.6% to $1.74 billion in 2004, thereby exceeding 2004 sales of Neupogen, which were only $1.18 billion.
Factor VII/VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation factors VIII or IX. The worldwide market for recombinant Factor VII was approximately $1 billion in 2006, with Novo Nordisk being the only participant.
Prourokinase is the latest in a growing list of medicines being tested to dissolve blood clots in the carotid arteries and brain that can cause strokes. Strokes are the third most common cause of death and a leading cause of adult disability in the United States. Currently, there are three approved systemic biopharmaceutical treatment for strokes, the most common of which is tPA (Tissue Plasminogen Activator), a clot dissolver injected into the veins that must be given within three hours of the onset of numbness, slurred speech and other warning signs of strokes. tPA has two major limitations: most victims do not get to the hospital rapidly enough to use it and patients must have a CT (computerized tomography) scan of their head completed prior to use to make sure their stroke is the result of a clot. Other thrombolytic (clot-breaking) non-recombinant injectable therapeutic proteins include Urokinase and Streptokinase, both of which suffer from additional drawbacks to those of tPA. Prourokinase is a potent thrombolytic therapeutic protein that has the potential to be faster acting and cause fewer side effects than tPA, Urokinase and Streptokinase. However, the short life span (8 minutes) of Prourokinase means that it currently must be administered very close to the clot via a catheter threaded through an artery. We believe that Modigene’s CTP-modified Prourokinase will enable doctors to inject the hormone directly systemically into the bloodstream via a safer intravenous administration, achieving the same effect with far less cost and complexity. tPA currently comprises a $1 billion market. It is administered to approximately 10% of stroke victims per year in the United States, representing approximately 70,000 individuals, at a cost of $2,000 per dose.
Therapeutic peptides: Globally, more than 40 peptide-based products having an annual sales volume of more than $ 5 billion are commercially available. Most of therapeutic peptides such as Somatostatins, Vasopressins, Platellet aggregate inhibitors, Calcitonins, GNRH/LHRH and Immunopeptides have very short durability and need to be injected on a daily basis.
Interleukin 11 is a protein that stimulates the production of platelets, which are important for proper clotting of the blood and wound healing. Interleukin 11 is used to increase platelets and decrease the need for platelet transfusions following treatment with certain cancer chemotherapy medications in patients who are at high risk of severely low platelet levels. Interleukin 11 is currently manufactured and marketed under the name Neumega by Wyeth.
Fab antibody fragments are the targeting segments of monoclonal antibodies, and have an exceptional target binding affinity and specificity. They can be attached to various drugs that need "transportation" to certain biological targets. However, the Fab antibody fragments have a very short life span, and as a result are typically not suitable for many applications. We believe the CTP technology can prolong the life span of these Fab antibody fragments, enabling them to become therapeutic alternatives. Because we have an exclusive license to all available Fab antibody fragments, we can choose the most promising candidates from a pool of hundreds of Fab antibody fragments for development.
