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Prospective Budget The prospective budget outlined here is directed primarily toward the research, keeping in mind that the administrative costs will be supported as well. By outsourcing the research, Immugen's overhead will be kept to a minimum, particularly in the early stages of funding. Dr. Massey has experience in the successful "virtual" development of drugs. By concentrating on core capabilities and outsourcing the components that can be performed effectively by contract research organizations (CROs) and academic researchers, Immugen can make the most of every dollar without spending money on unecessary infrastructure (e.g., rent, utilities, etc.) that does not add value in advancing the drug candidates. We promise that we will undertake our research in the most transparent manner. By supporting our research, you will have the right to know exactly how your money is being spent. Immugen is a different type of pharmaceutical company, and we will proudly prove it.Synthesis Scale-up synthesis for small animal studies: $1,000.00 per gram of material for 20 grams of each of the two lead compounds. This price will drop significantly with the increased amount to be synthesized. ADME/TOX The initial screening protocols for ADME/Tox will determine which of the two drugs will emerge as the lead compound. Formulation Once the lead compound is identified, it will undergo testing for the appropriate formulation, i.e., tablets, nasal spray, vaginal or rectal suppositories. In-vitro Studies Macrophage chemotaxis and lymphocyte homing studies. (UTMB) In-vivo Studies Influenza studies - $10,000. These studies will be performed by Jiri Mestesky and his colleagues at the University of Alabama - Birmingham (UAB). Pig-tailed macaques $25,000 per animal plus husbandry. Minimum of 12 animals for the HIT study (six treated with the ARVs and CBs and six treated with ARVs and no CBs). These studies will be conducted by Preston Marx, Ph.D., at the Tulane Primate Center. Regulatory Affairs As Dr. Massey has extensive regulatory experience, Immugen will perform as many regulatory functions "in-house", saving precious resources for the conduct of the development program. Utilizing Immugen's in-house expertise will save a significant amount of money that can be applied toward other essential tasks. Pre-Clinical IND-Enabling Toxicology Program In order to perform human clinical research, the drug candidates have to be shown to be safe in animals. Once proven safe in animals, an Original Investigational New Drug Application will be submitted to FDA. FDA approval of the IND allows for a drug to be shipped interstate for approved human studies. The IND-enabling toxicology program is estimated to cost approximately $1.5 million and can be completed in 10 months. Phase I Clinical Trial Initial human clinical studies are designed to confirm safety in healthy adult volunteers. These studies will delineate the actions of the drug candidates in the body. The studies will focus on identifying metabolites, how the drugs are distributed in the body, how they're eliminated from the body and their safety. These studies can be conducted in approximately six months at a cost of approximately $1 million. Phase II Clinical Trial These studies are designed to demonstrate that the drug candidate is effective and provide the basis for more extensive clinical testing. The studies provide information on the proper doses to be employed and the characteristics of their clinical response that is of benefit therapeutically. The costs of these studies vary, depending upon the disease targeted. An approximate ballpark estimate of their costs would be in the $2-3 million range. Phase III Clinical Trial These studies form the basis for FDA approval, and their design and conduct resemble the clinical conditions in which they will be utilized. FDA requires that two adequate and well-controlled trials show the drug candidates to be safe and effective for marketing approval. These studies are very expensive and accurate estimates of their cost are not feasible at this time. However, it is reasonable to expect the costs to be in the tens of millions of dollars. Summary Drug development is a costly endeavor. However, you can be assured that Immugen will be as efficient as possible in the development of its drug candidates.
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