SAN DIEGO , Nov. 13, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche's Phesgo ® , a fixed-dose combination of Perjeta ® (pertuzumab) and Herceptin ® (trastuzumab) utilizing ENHANZE ® , administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.
"We are delighted that Phesgo ® , the first combination of two established monoclonal antibodies with our ENHANZE ® technology, administered in just 5-8 minutes, is one step closer to becoming available for patients with HER-2 positive breast cancer in the EU," said Dr. Helen Torley , president and chief executive officer.
Phesgo ® 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 ® and Herceptin ® using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines 2,3 .
The recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo ® showing non-inferior levels of Perjeta ® in the blood during a given dosing interval (C trough ), when compared to IV administration of Perjeta ®. The safety profile of Phesgo® with chemotherapy was comparable to IV administration of Perjeta ® plus Herceptin ® 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 U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment center or in a patient's home.
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 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 ® 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 five 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 ® 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 ® 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 ® . 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 and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development and regulatory approval 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, approved 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 ENHANZE ® 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.
References:
[1] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited October 2020 ]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf .
[2] European Medicines Agency. Summary of Product Characteristics for Perjeta. [Internet; cited October 2020 ]. Available from: https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf .
[3] European Medicines Agency. Summary of Product Characteristics for Herceptin. [Internet; cited October 2020 ]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.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.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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