– Phase III FeDeriCa Study Met Primary Endpoint of Non-inferiority — New Subcutaneous Fixed-dose Combination Significantly Reduced Administration Time — Data to be Submitted to Health Authorities including the U.S. Food and Drug Administration and European Medicines Agency –
SAN DIEGO, Sept. 13, 2019 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that the global phase III FeDeriCa study conducted by Genentech, a member of the Roche Group, met its primary endpoint. The FeDeriCa study investigated a fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme’s ENHANZE® drug delivery technology in combination with intravenous chemotherapy. The study results demonstrated non-inferior levels of Perjeta® in the blood (pharmacokinetics) compared to standard intravenous (IV) infusion of Perjeta® plus Herceptin® and chemotherapy in patients with HER2-positive early breast cancer.
“The results of the phase III FeDeriCa study represent an important development for our ENHANZE® drug delivery technology,” said Dr. Helen Torley, President and CEO. “This is the first study to combine two therapeutic antibodies as a single fixed-dose subcutaneous formulation utilizing our ENHANZE® technology, thereby providing patients with HER2-positive breast cancer the possibility of a faster treatment option.”
Subcutaneous administration of the fixed-dose combination of Perjeta® and Herceptin® is approximately 8 minutes for the initial loading dose and approximately 5 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.
The study also demonstrated that the safety profile of the fixed dose subcutaneous combination of Perjeta® and Herceptin® was consistent with the safety profile of Perjeta® and Herceptin® administered intravenously.
Full data from the FeDeriCa study will be submitted for presentation at an upcoming medical meeting and to health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).1 2
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.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for the treatment of several cancers and has the potential to be used in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx for its ENHANZE® drug delivery technology. 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.
Vice President, Investor Relations and Corporate Communications
1 European Medicines Agency. Summary of Product Characteristics for Herceptin. [Internet; cited 2019 September]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf.
2 European Medicines Agency. Summary of Product Characteristics for Perjeta. [Internet; cited 2019 September]. Available from: https://www.medicines.org.uk/emc/product/2993/smpc.
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