Halozyme Gets Key Validation of Enzyme Tech in HyQvia Approval

Halozyme logo used with permission

Shakespeare wrote, “The course of true love never did run smooth,” and San Diego’s Halozyme Therapeutics (NASDAQ: [[ticker:HALO]]) could say pretty much the same thing about the FDA approval process.

When the FDA said Friday that it was approving HyQvia for adult patients with primary immune disorders, you could practically hear the uplifting music swelling in the background. It was the culmination of an ordeal that began over two years ago, when U.S. health regulators asked Halozyme and Illinois-based Baxter International to halt use of the drug in human patients until additional pre-clinical studies could be completed.

HyQvia is a drug that combines a biologic drug, Baxter’s disease-fighting immunoglobulin product, with Halozyme’s flagship product, a proprietary synthetic enzyme called recombinant human hyaluronidase, or rHuPH20.

Based on the FDA request, Baxter and Halozyme went back to the drawing board. After conducting more tests, the partners amended the Biologics License Application (BLA) they had submitted in mid-2011 with the additional data the FDA had requested. After reviewing the re-submitted BLA, the FDA’s Blood Products Advisory Committee concluded in a 15-1 vote in July that HyQvia “has a favorable risk/benefit profile.”

Based on the FDA’s approval Friday and the strength of the committee’s findings, it would appear that Baxter and Halozyme have mostly allayed the concerns that prompted health regulators to halt clinical studies with HyQvia in 2012.  The concerns raised by the FDA in 2012 focused primarily on antibodies that patients were generating against rHuPH20—“and the possible effects of these antibodies on reproduction, [fetal] development, and fertility.” The agency’s September 12 approval letter, which provides advisory warnings and precautions to prescribing doctors, says: “It is unknown whether these antibodies may interfere with fertilization in humans. The clinical significance of these antibodies is not known.”

“With this approval, it’s clear that the FDA feels the risk/benefit profile is acceptable for adults,” Halozyme CEO Helen Torley told me earlier this week. Getting the FDA’s clearance to

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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.