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August 27, 2007 »»» P&G Job Got Foot in the Door

Procter & Gamble Co.'s decision in early 2006 to stop all internal drug discovery activities spelled opportunity for Joseph Gardner.

Gardner, former director of chemistry and intellectual property for the company's pharmaceutical division, made a bid to develop some of P&G's fledgling drug projects.

Eighteen months later, he is co-owner of Akebia Therapeutics, a pharmaceutical startup that has obtained exclusive worldwide license for two former P&G drug programs, now in late discovery stages.

"We originally went for four drugs, but two were licensed to major pharmaceutical companies," Gardner said. "It was difficult for a startup company to get its foot in the door, but the people at P&G knew me, and so I had some credibility."

Gardener and Bob Shalwitz, Akebia's other founder, felt they could make their new company work with the two drug programs, which they say have major market potential.

The first would be an oral compound to treat severe anemia, and might replace the injections that are today's best therapy. The second would promote blood vessel growth with specific application to treating peripheral artery disease, which can lead to amputation.

The past year has been a busy one for Gardner. He left P&G last summer and by fall of 2006 was working with Triathlon Medical Ventures to put the new company in place. Before Akebia was incorporated in February, Shalwitz was on board, and the founders focused their energies on finding startup capital.

"We closed the seed round in May of 2007, having secured more than $1 million," Gardner said. It came mostly from CincyTech and local venture capital firms Triathlon, Blue Chip Ventures, Sigvion Capital, Fort Washington Capital and Queen City Angels.

CincyTech president Robert Coy said his organization invested $100,000 in seed money.

"Then, based on the results of our research, which indicated that these drugs held a lot of promise, two other organizations followed our lead with about $150,000 in seed money," Coy said.

Drug development, by Gardner's own admission, is long, expensive and risky. The company hopes to file its first investigational new drug application with the U.S. Food and Drug Administration in late 2008 and start human testing at about the same time. From there, the company will look for partners among established drug companies to take the products through the last stage of clinical development and into the market.

"There is far more sales capability than new drugs in development right now," Gardner explained. "What we would plan to do is essentially to rent a sales force."

As Akebia proceeds with its drug development process, it's also looking for a second round of funding with a goal of raising $10 million to $12 million.

"We just talked to the state's Third Frontier program and may apply for a grant," he said. "We'll go back to the same venture capital programs that gave us seed money, but we'll also need to approach firms in other areas, like Boston and California."


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