By Chris Silva(Staff Reporter)
Chang Ahn knows what it takes to get the FDA approval to get a drug to market.
After all, he worked at the food and Drug Administration for 13 years as a project leader and expert regulatory pharmacologist.
Now he’s working on the drugs themselves-and he just got his first big boost.
Rexahn, the company Ahn founded in March 2001, signed a licensing deal that injects $1.5 million in cash into the company.
The deal, signed early last month, gives Rexgene Biotech in Seoul, Korea, exclusive Asian marketing rights to Rexahn’s lead developmental drug, which is dubbed RX-0201. Rexahn retains global marketing rights outside Asia.
With the extra cash in hand, Rexahn plants to start clinical trials on the anti-cancer drug this fall.
First, the company must tackle the laborious tack of submitting data to the FDA for approval. But Ahn isn’t worried.
“We can handle FDA matters, which can be stumbling blocks to most companies,” he says. “The key is reading thier mind-what they’re thinking and what they want.”
Indeed, Ahn says Rexahn is already working on its second licensing agreement, a five year deal with a “major” company that could be worth $15 million to $19 million.
Ahn hopes to close the deal by the end of july. He declined to name the company since negotiations are still open. But he says chances of it getting done are 70 percent.
“This is part of our strategy with how to bring in revenue,” Ahn says.
Rexahn(www.rexahn.com) has 13 employees and occupies space at the Maryland Technology Development Center(MTDC) in Rockville.
Although Rexahn is a newcomer on the biotech scene, the company has made a name for itself with veterans of the industry.
“They certainly are a young company, but Chang Ahn has shown wisdom in developing the company to this stage,” says John Holaday, chair of the Maryland Bioscience Alliance and co-founder and former CEO of EntreMed (www.entremed.com), a bioscience company in Rockville that has its own pipeline of oncology drugs – some in phase II clinical trials. “They are among the many young biotech companies showing promise in Maryland.”
Holday warns Rexahn and other young companies must be aware of market conditions as they develop their business.
“It’s an enormously exciting field as long as people have a realistic expectation of the cost of drug development and the timelines” it takes to get a drug to market, Holaday says.
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