Halozyme Therapeutics, Inc. and Baxter Healthcare Corporation announced that they have expanded their existing Hylenex recombinant (hyaluronidase human injection) agreements to include the use of Hylenex recombinant with Baxter proprietary and non-proprietary small molecule drugs.
Under the terms of the agreements, Baxter will pay Halozyme an initial upfront payment of $10 million and will make a $20 million equity investment. Pending the successful completion of a series of regulatory and sales events, Baxter may make further milestone payments to Halozyme. Halozyme will also receive royalties on Hylenex recombinant as a standalone product and on any kits and co-formulations of Hylenex recombinant with Baxter or other non-proprietary small molecule drugs. The agreement does not include combinations of Hylenex recombinant with cytostatic and cytotoxic chemotherapeutic agents, the rights to which have been retained by Halozyme. In addition, Baxter will now assume all development, manufacturing, clinical, regulatory, sales and marketing costs.
"Hylenex recombinant is the first and only FDA-approved recombinant human hyaluronidase drug product, and we are very proud to expand our relationship with Baxter so that they may make this important drug available to as many people as possible worldwide as a way to simplify the delivery of medications and fluids and, ultimately, provide a more comfortable patient experience," said Jonathan Lim, MD, president and CEO of Halozyme.
"Hylenex recombinant offers an innovative drug delivery technology for small molecules and hydration fluids, and given Baxter's strong relationships with clinicians and channel strength, Baxter is well positioned to bring this technology to patients," said Daniel Tasse, general manager of Baxter Pharmaceuticals and Technologies, part of Baxter's Medication Delivery business. "Our priority this year is to continue to complete clinical trials, engage key opinion leaders and build clinical foundations with centers of excellence in a number of important clinical settings in preparation for our expanded Hylenex recombinant launch this year."
Hylenex recombinant (hyaluronidase human injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs, as an adjuvant for subcutaneous fluid administration (hypodermoclysis), and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation.
Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. Discontinue Hylenex recombinant if sensitization occurs. Hyaluronidase should not be applied directly to the cornea, and should not be injected around infected or acutely inflamed areas, nor used to reduce the swelling of bites or stings. Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated. Furosemide, the benzodiazepines, and phenytoin are incompatible with hyaluronidase. Please see accompanying package insert for full Prescribing Information.