Halozyme Announces FDA Has Accepted Biologics License Application For Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Enhanze® Technology

- U.S. Food Drug and Administration Expected to Decide on Approval by October 18, 2020 -

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Feb 25, 2020, 01:20 ET

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."

The BLA submission is based on positive results from the global Phase III FeDeriCa study conducted by Genentech, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.⁽¹⁾

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)

About ENHANZE^® Technology
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.

About Halozyme
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.

Halozyme Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE^®, the possible method of action of ENHANZE^®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE^® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE^® partner. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

References:
(1) Tan A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS, 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.
(2) European Medicines Agency. Summary of Product Characteristics for Herceptin. [Internet; cited November 2019]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf.
(3) European Medicines Agency. Summary of Product Characteristics for Perjeta. [Internet; cited November 2019]. Available from: https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf.
(4) US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited November 2019]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.