BiologicsMD™ Selected for $2.3 Million Department of Defense Contract
Company Developing Next Generation Osteoporosis Treatment
FAYETTEVILLE, Ark.– Feb. 9, 2011 – BiologicsMD™, a drug development company based in Fayetteville, Arkansas, has been selected to receive a $2.3 million research contract from the Department of Defense, announced Paul Mlakar, chief executive officer at BiologicsMD.
BiologicsMD is a start-up drug development company led by Mlakar; Misty Stevens, Chief Operating Officer; Robyn Goforth, Chief Scientific Officer; Jim Shook, Chief Development and Regulatory Affairs Officer; Rob Gensure, Chief Medical Officer; and Michael Thomas, Chief Marketing Officer. The team has expertise in medicine, biochemistry, bioengineering, business, marketing, product development and regulatory affairs.
The group is developing a new prescription osteoporosis medication called PTH-CBD™, which promises three times the efficacy of available bisphosphonate treatments with fewer side effects. According to the National Osteoporosis Foundation, one in two women and one in four men will be diagnosed with osteoporosis in their lifetime.
Each year Congress mandates priorities for the Department of Defense to direct their research programs through the awarding of grants. Since the Department of Veteran Affairs is the largest healthcare provider in the United States, osteoporosis and related bone disease are a long-term health care and cost concern and as a result are a congressionally directed research topic. The U.S. Department of Defense Peer Reviewed Medical Research Program of the Office of the Congressionally Directed Medical Research Programs (CDMRP) received more than 600 applications and fewer than 10 percent were recommended for funding.
Funds from the contract will be used to develop the manufacturing platform for PTH-CBD™. The next step for the company is to complete the animal toxicology testing and then conduct a Phase I study in patients with osteoporosis according to FDA requirements. BiologicsMD’s goal is to develop the product through a Phase I human clinical trial and then sub-license it to a major pharmaceutical company to conduct large safety and efficacy trials, obtain FDA approval and begin marketing to osteoporosis patients.
Reviews from the technical review committee highlight BiologicMD’s expertise in drug development, stating that “the investigators show a clear and concise understanding of bone biology, drug discovery and drug development… This proposal could have wide ranging consequences. Each stage of the proposed research is carefully crafted in a logical sequence.” Mlakar believes that “this approval process provides validation for the science behind a compound that could help millions by improving quality of life and saving lives.”
The Department of Defense contract would be the first for the company, which has operated on funding from private investors and awards from successful business plan competitions.
BiologicsMD won the Grand Prize at the Rice University Business Plan Competition in 2010, hosted by the Rice Alliance for Technology and Entrepreneurship and the Jesse H. Jones Graduate School of Business at Rice University. The company also won the Best Life Science Award, the Heinlein Prize Trust for Space Commercialization, the Courageous Woman Entrepreneur Award, and Best Elevator Pitch Life Sciences. BiologicsMD also won the Global Moot Corp Business Plan Competition in 2010 hosted by the University of Texas.