IN 1993, JOHN McMICHAEL, a Ph.D. immunologist and virologist, founded Milkhaus Laboratory, Inc. (MLI), a for-profit biopharmaceutical company specializing in low-dosage medicines which produce placebo-level adverse effects. MLI has successfully completed FDA-authorized clinical evaluations of products for the treatment of respiratory, urologic, and oncologic disorders.
 In great measure, this success can be attributed to Dr. McMichael’s network of practicing physicians, veterinarians, and medical scientists, a network that is now part of the Institute. This support has allowed for unusually efficient discovery and evaluation of potential new therapeutic products. The expertise of this multi-disciplinary team is evidenced by MLI’s growing portfolio of more than 100 issued patents and twice that number of patents pending worldwide.
Based on Dr. McMichael’s work, MLI’s patent position led to a licensing agreement with Elan Corporation, plc, a multi-national pharmaceutical company. Under that agreement, Elan obtained rights to MLI’s intellectual property relating to the treatment of Alzheimer’s Disease. Elan then embodied that technology in FDA-authorized clinical trials which are in progress. Early results have appeared in the scientific and popular presses.
Reflecting its degree of diversity, in late 2002 MLI spun off its veterinary subsidiary to form an independent corporation, Milkhaus Veterinary Products, Inc. (MVI). The mission of MVI is to bring to animal health what MLI is bringing to human health.
Using the approach described above, MVI has completed a successful USDA-authorized evaluation of its product LDI-100 for the treatment of mast cell tumors in dogs. In addition, MVI is conducting preliminary trials for the treatment of kennel cough in dogs and cats, heaves (respiratory distress) in horses, reproductive disorders in horses, and connective tissue disorders in horses and pigs.
While these accomplishments attest to the efficiency of the novel discovery process of Dr. McMichael’s team, product candidates and medical patents are being generated faster than can be exploited by the expensive and time consuming formal development phases that are required for marketing. To enhance the discovery-to-market process, The Institute for Therapeutic Discovery was created to permit discovery and early-stage development of potential therapeutic agents which can then be licensed to MLI, MVI, or other appropriate company partners who complete the required clinical and scientific work to bring products to market.
The laws that govern not-for-profit (tax-exempt) organizations engaged in such research require that the results be applied to the public good. Through its network of practitioners, academic and corporate partners, and a dedicated staff, the Institute is poised to provide the public safe and effective medicines.
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