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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Halozyme will receive an initial payment of $15 million for Enhanze, its technology that enables biologics to be delivered as a simple subcutaneous injection.
Halozyme Therapeutics announced on Dec. 17, 2014 that the company is partnering with Janssen Biotech to combine Janssen’s proprietary compounds with Halozyme’s Enhanze, its drug delivery platform based on the recombinant human hyaluronidase enzyme (rHuPH20).
rHuPH20 modifies hyaluronan, a matrix component in the skin. The enzyme facilitates the dispersion and absorption of injected biologics, allowing drugs that are typically only administered intravenously to instead be delivered just under the skin. The enzyme works by temporarily making the tissue beneath the skin more permeable, allowing fluids to be more readily absorbed into the blood vessels. The technology is said to alter dosing regimens, allowing full monthly doses of biologics to be administered less frequently, reducing the need for multiple injections.
Janssen will pay Halozyme $15 million upfront to develop and commercialize products for up to five targets combining rHuPH20 with Janssen’s compounds in its pipeline, and will obtain the exclusive license for products resulting from the collaboration. Halozyme will also be eligible for royalty payments based on the sales of products using Enhanze technology and will be eligible to receive additional fees of up to $566 million based on the success of the co-developed products.
"We are pleased that Janssen, a global leader in the development of novel therapeutics, has selected our Enhanze technology to further augment their development pipeline," said Dr. Helen Torley, president and CEO, Halozyme. "This new global licensing agreement further validates our Enhanze platform technology, which we believe may benefit a growing number of patients worldwide by making therapies more convenient."
Halozyme already has similar partnerships with Roche, Pfizer, and Baxter. In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's patented Enhanze technology to Roche's biological therapeutic compounds. Roche's oncology products Herceptin SC (trastuzumab) and MabThera SC (rituximab) already use the technology, and the company has elected to explore the use of rHuPH20 for up to a total of five exclusive targets.
Baxter uses the rHuPH20 platform in Hyqvia (immune globulin infusion 10% with recombinant human hyaluronidase), its subcutaneous immunoglobulin treatment for adult patients with primary immunodeficiency. Baxter also exploits the technology in a similar product, Hylenex recombinant (hyaluronidase human injection) for pediatric rehydration, but in 2010 Halozyme delivered Baxter a breach notice after a recall due to particulate matter in some vials of the hydration adjuvant. A few months after the initital action, however, Halozyme lifted the notice of breach.
Pfizer entered into an agreement with Halozyme in December 2012 for the development and commercialization of up to six targets using Halozyme's drug delivery platform.