Subcutaneous formulation with ENHANZE® treatment time reduced to 3-8 minutes compared to 30-60 minutes for standard intravenous infusion
SAN DIEGO, August 2, 2022 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Roche’s IMscin001 Phase III study evaluating a subcutaneous (SC) formulation of Tecentriq® (atezolizumab) with Halozyme’s ENHANZE® technology met its co-primary endpoints.
The study showed non-inferior blood levels of Tecentriq® (pharmacokinetics), when injected subcutaneously, compared to intravenous (IV) infusion in cancer immunotherapy naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom previous platinum-based therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq®.
“These positive results further demonstrate the potential for a co-formulation of ENHANZE to potentially benefit patients by reducing the treatment time of Tecentriq to 3-8 minutes for SC administration from 30-60 minutes for IV treatment,” commented the dr. Helen Torley, President and CEO of Halozyme. “We are delighted to report these positive results, which represent our second positive Phase III trial announcement this year for our Wave Three products.”
Roche will share the detailed results of the IMscin001 study at an upcoming medical meeting and will submit the data for regulatory approval to health authorities around the world, including the US Food and Drug Administration and the European Medicines Agency.
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 administered subcutaneously (just under the skin). Using rHuPH20, certain intravenously administered biologics and compounds can instead be administered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections.
Halozyme is a biopharmaceutical company that delivers breakthrough solutions to dramatically improve patient experience and outcomes for emerging and established therapies. As innovators of ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme’s commercially validated solution is used to facilitate the delivery of medications and injected fluids to reduce the burden of treatment on patients. After impacting more than 600,000 patient lives with five products commercialized in more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies, including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and markets, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as convenience and tolerability. improved patient comfort and grip. The Company has a proprietary product commercial portfolio, including XYOSTED®, TLANDO™ and NOCDURNA®, as well as partner commercial products and ongoing product development programs with industry-leading pharmaceutical companies, including Teva Pharmaceutical, Covis Pharma , Pfizer and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, California and has offices in Ewing, New Jersey and Minnetonka, MN. Minnetonka is also the site of its operating facility.
For more information, visit www.halozyme.com and connect with us on LinkedIn and Twitter.
SAFETY STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
In addition to historical information, the statements set forth in this press release include forward-looking statements, including, without limitation, statements regarding the Company’s ENHANZE® drug delivery technology and possible benefits and attributes of ‘ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and the facilitation of faster delivery and administration of larger volumes of injectable drugs by subcutaneous administration. Forward-looking statements also include statements regarding the Company’s collaboration partner’s future development and commercialization efforts, including plans to submit the clinical trial data discussed in this press release for regulatory approval to health authorities. These forward-looking statements are generally, but not always, identified by the use of the words “believe”, “enable”, “may”, “will”, “could”, “intend”, “estimate”, ” anticipate”, “plan”, “predict”, “likely”, “potential”, “possible”, “should”, “continue” and other words of similar meaning and involve risks and uncertainties that could cause that actual results differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements due to a number of factors, including unexpected results or delays in the growth of the Company’s ENHANZE® business, or in the development, regulatory review and approval or commercialization of ENHANZE ®, including any potential delays caused by the current global COVID-19 pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may cause differences are discussed in more detail in the company’s most recent annual report on Form 10-K and in other periodic reports and filings by the company with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company as of the date hereof, and the Company undertakes no obligation to revise or update such forward-looking statements to reflect events or circumstances after the date hereof. press release, unless necessary. by the law.
Vice President, Investor Relations and Corporate Communications
Dawn Schottlandt / Claudia Styslinger
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SOURCE Halozyme Therapeutics, Inc.