Halozyme Therapeutics granted U.S. patent for recombinant human hyaluronidase enzyme platform

Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced the issuance of U.S. Patent No. 7,767,429 claiming its proprietary recombinant human hyaluronidase enzyme platform (rHuPH20). Claims to the human PH20 glycoprotein, PEGylated variants, the glycoprotein produced by recombinant methods, and pharmaceutical compositions with other agents, including antibodies, insulins, cytokines, anti-infectives and additional therapeutic classes were awarded in the '429 patent. Additional claims are in prosecution.

In the U.S., the issued patent would expire in March 5, 2024, but the term will be extended until September 23, 2027 with the addition of patent term adjustment time of 1,297 days. A broad European counterpart, EP1603541, has also been granted to Halozyme that will provide protection until March 5, 2024. To date, similar claims have been granted in India, Japan, Eurasia, Hong Kong, Mexico, New Zealand, Singapore and South Africa.

"We are pleased to receive recognition for these biotechnology innovations," stated Gregory Frost, Ph.D., Halozyme's chief scientific officer. "These foundational patents, and the protection provided, are of significant value to Halozyme and to its development partners, and cover major pharmaceutical markets of the world."

The claims for the newly issued U.S. patent cover compositions of matter and pharmaceutical compositions for rHuPH20 including:

• The purified hyaluronidase glycoprotein
• Chemically modified forms of the hyaluronidase glycoprotein, including PEGylated variants
• Compositions comprising the recombinant hyaluronidase glycoprotein in product-by-process format
• Pharmaceutical compositions comprising the hyaluronidase glycoprotein and pharmaceutically active agents, including biologics, peptides and small molecules

Additional information about these patents may be found on the U.S. Patent and Trademark Office and on the European Patent Office Web sites.