FDA Refuses to Accept Adventrx Pharma’s New Drug Application

Adventrx Pharmaceuticals (NYSE Amex: [[ticker:ANX]]), the San Diego biotech that sprang back to life in January with a new drug application, says in a statement today that it has received a “refuse to file letter” from the FDA—which basically means it’s back to the drawing board.

Adventrx cut its workforce to just two employees almost a year ago, after its development of a co-factor drug for treating metastatic colorectal cancer failed. Brian Culley, who is now the company’s CEO, told me the biotech then made a “bet the company” decision to restart its development of ANX-530, a formulation of the chemotherapy drug vinorelbine (Navelbine). Much of the drug development work already had been done, and Culley told me Adventrx merely needed to show the FDA it could maintain tight manufacturing controls. When Adventrx announced in January it had filed a new drug application for ANX-530, investors rushed enthusiastically to buy shares in the penny stock.

Once a new drug application is filed, however, the FDA has 60 days to preliminarily review the submission and assess whether the NDA is sufficiently complete to permit a substantive review. The agency issues a refuse to file letter to the applicant if it determines that the application is not sufficiently complete.

Adventrx says in its statement that the FDA letter focuses on the company’s intended commercial manufacturing site. The FDA says the biotech’s application does not include enough information to show the plant can produce the drug in a way that meets drug expiration date requirements. In its statement, Adventrx says, the “FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.”

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.