LAKEWOOD RANCH -- A 4-year-old pharmaceutical company about to begin clinical human trials of a new antimicrobial has raised $5.5 million to get its signature product one step closer to market.
Lakewood-Amedex, which has its corporate office at 7267 Delainey Court, announced last week it raised the money on its second round of preferred stock sales.
Steve Parkinson, the company's chief executive officer, said the money will be used to fund two rounds of clinical trials of its marquee product, Biophosphocin. The antimicrobial, which can be administered orally, intravenously or topically, will be tested for its effects on diabetic foot ulcers and urinary tract infections.
If the drug proves effective and safe, the trial's results could be used to raise more capital or attract a larger pharmaceutical partner to market, Biophosphocin.
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"Once we prove this is safe and works in humans, that makes it much easier to get additional funding," Parkinson said.
Lakewood-Amedex moved to Lakewood Ranch in 2010 as a fusion of Portland, Ore.-based company Amedex Therapeutics and Parkinson's local company, Lakewood Pharmaceuticals.
One of the company's founding partners, Roderick Dale, accidentally discovered the first Biophosphocin while in the midst of $6 million research and development project into a "gene slicing"
approach to combat infectious diseases.
Parkinson said the drug selectively destroys the membranes that protect bacteria. His company claims Biophosphocin is not subject to the drug-resistance issues that have plagued antibiotics in recent years.
Lakewood-Amedex has remained a small operation since its founding, despite early estimates it might bring hundreds of jobs to the Manatee-Sarasota area. Just five employees run the company.
Parkinson said initial employment numbers were based on a model under which Lakewood-Amedex would have established its own research and manufacturing facilities. Instead, it has adopted a "semi-virtual" model where research and development is contracted out to labs in the United States and Canada.
If the company does get approval for its drug from the U.S. Food and Drug Administration, it will likely partner with a larger drug maker to produce Biophosphocin .
Without a production partner, Parkinson said his company will need at least $30 million in new capital to get to market. Either way, it will be two or three years before Lakewood-Amedex sells its first batch of Biophosphocin.
James Humprey, chief operating officer of Manatee County biotech research company Roskamp Institute and a science co-chair of the Bradenton-Sarasota chapter of BioFlorida, said partnership is a common way for small drug developers to get to market. The fact that Lakewood-Amedex has reached clinical trials will garner interest in its product.
"Any small company that manages to get to a clinical trial stage is an indication that they have a very promising product," Humphrey said.
Wilbur Milhous, a professor of experimental therapeutics at the University of South Florida, said the virtual model of drug development is becoming more "popular and relevant." Some virtual drug companies have brought drugs to market, taking advantage of small size to indulge in research that generally doesn't interest larger companies until effectiveness becomes more than theoretical.
"Big pharma can't afford to start up a lot of things," Milhous said.
If Biophosphocin goes on the market, Parkinson said Lakewood-Amedex could grow to 20 employees. The company would likely continue to use its semi-virtual model of research and development to bring other pharmaceuticals to the market.
The company could start selling other products before Biophosphocin goes into production. Parkinson said Lakewood-Amedex is experimenting with non-drug uses for antibiotics, including as sterilizing agents. He has already begun discussions with possible partners for these products.
As of the end of last week's stock offering, the company has about 120 shareholders. The company finished its first preferred stock offering last year, selling $2.5 million in shares.
Matt M. Johnson, Herald business reporter, can be reached at 941-745-7027, or on Twitter @MattAtBradenton.