FAYETTEVILLE, Ark. –– BiologicsMD, a drug development company based in Fayetteville and fostered through research at the University of Arkansas, has been selected to receive a $2.3 million research contract from the Department of Defense.

Biologics MD is partnering with the Virtual Incubation Co. to develop a new prescription osteoporosis medication called PTH-CBD, which is based on the work of chemistry and biochemistry professor Joshua Sakon and has a patent with the University of Arkansas. The drug 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 health care 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 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, which is trademarked. The next step for the company is to complete 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.”

Paul Mlakar, chief executive officer of BiologicsMD said, “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 is a start-up company that, in 2010, won more than $121,000 in cash, $190,000 worth of in-kind awards and $300,000 in investments in six major entrepreneurial business plan competitions.

The company was mentored by Carol Reeves, now associate vice provost for entrepreneurship in the University of Arkansas office of research and economic development. The team members participating in the competitions included: Paul Mlakar, chief executive officer; Misty Stevens, chief operating officer; andMichael Thomas, chief marketing officer, all graduates of the Sam M. Walton College of Business managerial MBA program; and Robyn Goforth, chief scientific officer, a biological sciences research professor at the University of Arkansas and a participant in the Certificate in Entrepreneurship program. In addition, the company now includes Jim Shook, chief development and regulatory affairs officer, and Rob Gensure, chief medical officer. The team has expertise in medicine, biochemistry, bioengineering, business, marketing, product development and regulatory affairs. 

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. In addition, BiologicsMD won the Global Moot Corp Business Plan Competition hosted by the University of Texas; first place in the University of Louisville Cardinal Challenge; first place in the University of Cincinnati Spirit of Enterprise MBA Business Plan Competition; second place in the Arkansas Donald W. Reynolds Governor’s Cup; and second place in the Tri-State Donald W. Reynolds Business Plan Competition.

“Biologics MD is an example of the extraordinary talent at the University of Arkansas,” said Reeves, who also holds the Cecil and Gwendolyn Cupp Applied Professorship in Entrepreneurship. “They have the rare combination of deep science knowledge, business acumen and the work ethic to make their company a reality.”

For more information on BiologicsMD, please visit www.BiologicsMD.com.