San Diego’s Zogenix Moving Fast to Commercialize Drug-and-Device Combo

drug-device combination. “The device really has global potential,” Hawley says. “No one else can do what we do”

The DosePro injector resembles a pen and each one comes filled with a fixed dose of sumatriptan. The device uses the sudden release of nitrogen gas to drive a piston at a fixed pressure. The piston, in turn, pushes the drug through a laser-drilled hole at the tip of a capsule, where a small amount of the drug forms a liquid jet. The drug is delivered just under the skin—as a liquid—in less than 1/10th of a second. The “hole” in the skin is about 0.3mm, similar or smaller to a hypodermic needle. Because there is no needle, nothing beneath the skin gets pierced—including blood vessels, according to Zogenix spokeswoman Catherine O’Connor.

Of course, O’Connor adds that “Needle-free” doesn’t necessarily mean “pain-free.” Patients in three Zogenix studies described the sensation of the needle-free injection as mild discomfort to mild pain. O’Connor says they rated the pain as a “2” on a 1-to-10 pain scale (with 0 being no pain).

DosePro’s big advantage, Hawley says, is that “it’s single-use, needle-free and fully disposable.” Zogenix’ studies also show that 98 percent of patients could get it right on their first try at home, and Hawley says, “for a drug-device combination, that’s unusual.”

DosePro Demo
DosePro Demo

The Zogenix technology is currently more expensive than rival needle-free, pin-based auto-injectors that patients can buy for $5 to $7 apiece to self-administer injections. But Hawley says it is usually necessary for patients to load the drug into those devices themselves. As for the cost, Hawley says, “The difference in cost, quite honestly, is that those auto-injectors are now made at scale; a lot of companies are using them. Our technology is new; we’re the only one who manufactures it. We think over time, with more volume, we can actually get fairly close to those auto-injector costs with much more convenience.”

What’s less clear, to me at least, is what advantages the DosePro device has over an existing pen-style, auto-injector, which comes with a pre-filled drug dose.

Hawley says the needle-free design addresses patients’ needle anxiety and eliminates needle disposal issues and the risk of needle stick injuries. Zogenix marketing materials suggest another important reason could be that the DosePro technology, as a

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.