Halozyme Announces Roche Receives FDA Approval For Phesgo(TM) (Fixed-Dose Combination Of Perjeta(R) And Herceptin(R) For Subcutaneous Injection) Utilizing Halozyme's ENHANZE(R) Technology For The Treatment Of Patients With HER2-Positive Breast Cancer
SAN DIEGO, June 29, 2020 -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has approved Roche's Phesgo(TM) (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, a fixed-dose combination (FDC) of Perjeta(R) and Herceptin(R) with Halozyme's ENHANZE(R) technology, administered subcutaneously in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with early and metastatic HER2-positive breast cancer. This is the first time a product has been approved combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE(R) technology.
"We are excited that HER2-positive breast cancer patients in the U.S. will now have the option to receive this important therapy in a meaningfully shorter period of time," said Dr. Helen Torley, president and chief executive officer. "This subcutaneous delivery was shown to be preferred to IV administration by 85% of patients in the PHranceSCa study due to less time in the clinic and more comfortable treatment administration. Phesgo(TM) is the second product to receive FDA approval this year, and the first demonstrating the ability to combine two monoclonal antibodies, utilizing our ENHANZE(R) technology."
Phesgo(TM) is available in single-dose vials and can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.(1) This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta(R) and Herceptin(R) using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.(2,3) Phesgo(TM) can be administered by a healthcare professional in a treatment center or at a patient's home.
The approval is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo(TM) showing non-inferior levels of Perjeta(R) in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta(R). The safety profile of Phesgo(TM) with chemotherapy was comparable to IV administration of Perjeta(R) plus Herceptin(R) and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia.(1,4)
The phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.(1)
About ENHANZE(R) Technology
Halozyme's proprietary ENHANZE(R) 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(R) 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 is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE(R) technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via four commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE(R) technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE(R) technology 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(R). 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(R), the possible method of action of ENHANZE(R), its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE(R) including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE(R) 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 including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the newly-approved ENHANZE(R) co-formulated product referred to in this press release, 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.
(1) US Food and Drug Administration. Prescribing information for Phesgo.
(2) US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.
(3) US Food and Drug Administration. Prescribing Information for Perjeta [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf
(4) 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.
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