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Adventrx Returns From The Brink

http://www.sandiego.com/business/adventrx-returns-from-the-brink

San Diego Business
Adventrx Returns From The Brink
San Diego biotech was close to bankruptcy; now thriving
By Eilene Zimmerman
Posted on Sat, Jan 16th, 2010
Last updated Fri, Jan 15th, 2010

Last June, things were looking pretty grim for Mira Mesa-based biotech company Adventrx (AMEX: ANX). The company was down to just two full-time employees, both executives, after its leading drug candidate failed during clinical trials. In the words of principal executive officer Brian Culley, “We were teetering on the edge of bankruptcy.” Fortunately for Culley, the company never went over.




Adventrx exec Brian Culley.

Courtesy photo


Earlier this month, Adventrx submitted a new drug application, or NDA, to the Food and Drug Administration for its anti-cancer drug, ANX-530. It's a reformulated version of a widely used chemotherapy drug known as Vinorelbine, which causes pain and inflammation about 30 percent of the time at the site of injection into a patient’s arm. ANX-530 has the same amount of the drug that is in Vinorelbine, but it does not irritate the vein.

Adventrx’s turnaround began this summer when three small private financing rounds raised about $3.5 million. At the time, Culley said the question was whether or not to use the money to manage through an orderly wind-down of the company or invest it in manufacturing. He and his partner decided to take a risk and invest it in manufacturing the 530 drug.

“We knew the compound itself was very good and could be developed, but the problems we had were in commercial scale manufacturing of the drug, and those hurdles needed to be overcome in order to file a new drug application,” says Culley.

It was a big risk because there was only enough money to do the manufacturing, but not any preliminary testing.

“We had to fly a little blindly, but we had tremendous confidence in our manufacturer, BSP Pharmaceuticals in Italy," says Culley. "We told them, ‘We have one chance to do this right. Can you do it?’ And they did, they nailed it.”

With the manufacturing challenges overcome, the company had the information it needed to file an NDA with the FDA. And that led to another round of private equity financing in October, which raised $11 million. That cash will fund the company through the submission and review of their NDA, which typically takes about 10 months, says Culley.

Adventrx still has two full-time employees (in addition to Culley, there is the company’s principal financial officer), but now it also has about 40 contractors. Its next drug is ANX-514, a detergent-free formulation of another widely used chemotherapy drug, Taxotere.

“We will be investing in 514 now to get that to the NDA stage as quickly as possible,” says Culley.

Business Sector Biotechnology
URL http://www.adventrx.com/


Eilene Zimmerman About the author: Eilene Zimmerman is a journalist based in San Diego who writes about a variety of topics, including business, social and political issues and family life. Her work has been published in national magazines and newspapers including The New York Times, The San Francisco Chronicle, The Christian Science Monitor, FORTUNE Small Business, CNNMoney.com, CBS MoneyWatch.com, Wired, Harper’s, Salon.com, Slate.com, Psychology Today and others. She blogs at www.trueslant.com.

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