| | | | | | SynVax Pharmaceuticals, Inc.
| | | | | | | | SynVax Pharmaceuticals, Inc., in engaged in biopharmaceutical research in infectious diseases, cardiovascular diseases and pain management. The company intends to develop and assist in the commercialization of several new classes of therapeutic products.
The key chronic disease states for which the company’s products are designed to provide treatment include: (i) fungal infections in patients who are immunosuppressed as a result of HIV infection, cancer therapy or bone marrow and organ transplantation, and pregnancy; (ii) bacterial infection due to Staphylococcus Mycobacterium tuberculosis, and Bacillus anthracis; (iii) edematous conditions e.g., congestive heart failure (CHF), hypertension, diabetes insipidus etc., using water diuretics; and (iv) chronic and neuropathic pain.
Management contents that the company has, at present, at least five significant discoveries ready for development with several more in the pipeline. These products are based on advanced peptide structure-function analyses and expertise in peptide synthesis. The company has received a U.S. Patent (#5,616,327) for one product and has another pending. To date, management has obtained National Institutes of Health grants totalling $1.8 million.
Such grants have enabled the company to assemble a portfolio of early and later stage product opportunities all of which have the potential to service either a sizable niche market or meet the needs of a large unserved market. Management believes that most of these products have either broad patent coverage or the likelihood that such coverage can be obtained.
The company expects to file an Investigational New Drug (IND) application for at least four compounds within the next 12 to 18 months. Management’s strategy is to optimize the value of its drug candidates by completing at least Phase II clinical trials. At this point, management believes the company has several options which it can pursue, e.g., complete the development studies and market alone, form a strategic alliance with a major pharmaceutical company (domestic or foreign) or license out and retain co-marketing rights in the U.S. The specific strategy chosen may vary by product type, medical specialties addressed and geographic areas.
The company contends it has identified significant opportunities in the drug development area. Through its research, management believes that the drug leads discovered by the company have multi-billion dollar market potential and anticipates it can conservatively claim at least 20 to 25 percent of the targeted markets. Management estimates the total value of these niche markets to exceed $10 billion annually.
After filing IND applications, the company plans to seek a pharmaceutical partner to conduct the clinical trials on humans. Management plans to seek an initial licensing payment and then milestone payments and has identified several pharmaceutical companies as partnership candidates to be approached at the point where preclinical toxicology studies are completed. |
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