Post by icemandios on Feb 25, 2020 13:58:47 GMT
Halozyme Announces FDA Has Accepted Biologics License Application For Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Enhanze® Technology
SAN DIEGO, Feb. 25, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's ENHANZE® drug delivery technology in combination with intravenous (IV) chemotherapy for the treatment of eligible patients with HER2-positive breast cancer.
"The acceptance of our partner's BLA submission is an important development for our ENHANZE® technology platform," said Dr. Helen Torley, president and chief executive officer. "This will represent the first product utilizing ENHANZE® that combines two biologics, Perjeta and Herceptin, in one fixed-dose, subcutaneous administration. We are excited that patients with HER2-positive breast cancer may now benefit from a shorter treatment administration option."
Subcutaneous administration of the fixed-dose combination of Perjeta and Herceptin is approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. Intravenous administration is approximately 150 minutes for the loading dose of Perjeta and Herceptin using standard IV formulations and between 60-150 minutes for subsequent maintenance infusions for the combination. (2,3,4)
Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
Halozyme Therapeutics is a biotechnology company focused on novel biological and drug delivery approaches. Halozyme's proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids and potentially reduce the treatment burden of other drugs to patients. Halozyme has licensed its rHuPH20 technology, called ENHANZE®, to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.