The US Food and Drug Administration has given the go-ahead for marketing of Halozyme and Baxter International’s drug-delivery booster Hylenex, an injected product that uses a human enzyme to ease dispersion and absorption of other injected drugs.
This is a particularly special achievement for Halozyme, as it marks the group’s first ever product approval, and the resulting investor enthusiasm was reflected by a 16% jump in its share price to $2.05 on the December 5 news. The firm’s partner Baxter will sell the agent in the USA, with the marketing focus likely to be on the fact that Hylenex is a human alternative to its animal-derived peers.
Commenting on the approval, Jonathan Lim, Halozyme’s chief executive, said: “This is a landmark achievement for Halozyme. We believe Hylenex will help enhance the practice of medicine by offering healthcare providers and their patients a human recombinant product as an adjuvant to increase the absorption of other injected drugs."
Daniel Tasse, general manager of Baxter’s anaesthesia, critical care and oncology business, noted that the company intends to “continue to work with Halozyme to help clinicians fully realise the drug delivery and administration benefits this product offers."