market HyQvia represents a significant milestone for the company, and a crucial validation of Halozyme’s core technology, Halozyme said.
In a joint statement, the companies said Baxter would launch HyQvia in the U.S. in coming weeks.
For Halozyme, HyQvia’s route to market actually began 16 years ago, when a predecessor company saw the opportunity to develop genetically engineered versions of hyaluronidases, human enzymes that degrade hyaluronic acid, a substance that makes cells impermeable. The big idea was to use these synthetic hyaluronidases in combination with drugs already approved by the FDA—making the cells temporarily more permeable—so drugs could penetrate more quickly and efficiently into tissue.
As a result, drugs combined with rHuPH20 can be given at a lower dose and can be delivered more easily. HyQvia, for example, is the first drug for primary immune disorders that can be administered into tissue just beneath skin, using a hypodermic infusion that can be administered relatively quickly at home every three to four weeks instead of an intravenous infusion that takes hours and must be administered weekly or biweekly in a doctor’s office or treatment center.
While HyQvia is the second product using Halozyme’s rHuPH20 enzyme to gain approval in the United States (and the fourth to be approved in global markets), it represents the first biologic using Halozyme’s flagship product to gain FDA approval. The FDA approved the recombinant formulation of hyaluronidase in 2005 to facilitate subcutaneous fluid administration for achieving hydration.
HyQvia was approved last year by the European Commission for all countries in the European Union.
Roche already has used Halzoyme’s enzyme in combination with MabThera for follicular lymphoma and diffuse large B-cell lymphoma, and for a subcutaneous form of Herceptin for breast cancer. Both drugs are currently available for patients in Europe, and Halozyme’s partnership with Roche enables the companies to work together to develop combination drugs for as many as six additional target diseases.
Under a separate partnership with Pfizer, Halozyme has been working to identify large molecule drugs in Pfizer’s portfolio that would be suitable for use with Halozyme’s rHuPH20 enzyme.
Halozyme also has been working on its own to advance some new drug candidates. One program that some investors view as a bellwether for the company combines rHuPH20 with insulin to create an “ultrafast insulin” that could be absorbed more rapidly and in less time. As the company puts it, “We believe that an ultrafast insulin profile may provide best-in-class mealtime insulin coverage for patients using intensive insulin therapy to manage their diabetes.”
