In a Detour From Device Strategy, Zogenix Edges Closer to New Drug Application

San Diego-based Zogenix, a specialty pharma that has been selling its first product (a fast-acting migraine drug in a single-dose injector) for 22 months, is getting ready to diversify its portfolio.

As we reported in August, Zogenix successfully completed its late-stage safety and efficacy trials for an extended-release formulation of the painkilling drug hydrocodone bitartrate (Zohydro). Earlier this month, Zogenix executives told me they are doing the final analyses of their clinical findings for the drug, which is intended to provide lasting relief for people with chronic pain. Zogenix says it plans to submit a new drug application (NDA) in early 2012.

If Zogenix wins FDA approval, the company says it could begin marketing for its second product in 2013, calling it the first extended-release painkiller in the hydrocodone class—a drug category that includes acetaminophen/hydrocodone (Vicodin) and acetaminophen/oxycodone (Percocet). Zogenix says its pain-killer also would be the first “single-entity” hydrocodone (i.e. acetaminophen-free), which became a relevant selling point earlier this year, when the FDA announced a limit on how much acetaminophen could be used in combination drugs and required liver toxicity warnings.

With its clinical trials basically completed, Zogenix CEO Roger Hawley says the company plans to meet with FDA regulators in coming weeks in preparation for its NDA submission sometime after January 1. (The company also plans to release its third-quarter earnings on Nov. 10.)

Zogenix has based its core, long-term strategy on its needle-free DosePro technology, which uses pressurized nitrogen gas to drive a liquid jet of a prescribed drug under the skin in less than 1/10th of a second. The FDA cleared the company to sell its first drug-and-device product, the DosePro with a fixed dose of the painkiller sumatriptan, in 2009. Zogenix plans to build its business on a series of similar drug-and-device combinations focused on diseases and disorders of the central nervous system, and could even license its DosePro technology.

The bad news is that each drug-and-device combo will require a separate FDA review. The good news, however, is that each combo is considered unique—and therefore eligible for patent protection. Even if patent protection for a particular drug has expired, Zogenix says it

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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.