Halozyme Announces Roche Receives European Commission Approval of Tecentriq® SC with ENHANZE® Representing the EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy for Multiple Cancer Types

Reduces treatment time by approximately 80% compared to standard intravenous (IV) infusion

Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to IV infusion and is preferred by patients and healthcare practitioners^{1 - 6}

SAN DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received European Commission (EC) marketing authorization of Tecentriq^® SC (atezolizumab) co-formulated with ENHANZE^®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20. The approval applies to all approved indications of Tecentriq^® IV and represents the European Union (EU)'s first PD-(L)1 cancer immunotherapy for subcutaneous injection.

Tecentriq^® SC reduces treatment time to approximately 7 minutes, compared to an IV infusion which can take approximately 30 to 60 minutes. In addition, it may be administered by a healthcare professional outside of the hospital, in a community care setting or at home, depending on national regulations and health systems.

"As the first subcutaneous PD-(L)1 cancer immunotherapy in Europe, Tecentriq SC can provide a new treatment option that can enhance the treatment experience for patients and caregivers while freeing up resources in constrained healthcare systems," said Dr. Helen Torley, president and chief executive officer of Halozyme.

The EC approval follows pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq^® in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The study found 90% of healthcare professionals agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation⁶.

About Halozyme

Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE^® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE^® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.

Halozyme also develops, manufactures and commercializes, 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 improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including Hylenex^® and XYOSTED^® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

Safe Harbor Statement

In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's ENHANZE^® drug delivery technology including the possible 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, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE^® including lowering the treatment burden for patients and alleviating pressure on health care system resources, including potential out-of-hospital administration of Tecentriq^® SC. Forward-looking statements regarding the Company's ENHANZE^® business may include potential growth driven by our partners' development and commercialization efforts (including anticipated regulatory submissions, PDUFA dates, potential regulatory approvals, indications and product launches). These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

Tecentriq^® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
[email protected]

Samantha Gaspar 
Teneo
617-877-9710
[email protected]

References

[1] Rummel M, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.
[2] De Cock E, et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016;5(3):389-97.
[3] O'Shaugnessy, J. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.
[4] Pivot X, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017;86:82-90.
[5] Denys H, et al. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020;181(1):97-105.
[6] Burotto M, Zvirbule Z, Alvarez R, et al. IMscin001 Part 2 updated results: Efficacy, safety, immunogenicity, healthcare provider perspectives and patient-reported outcomes from the randomised Phase III study of atezolizumab subcutaneous vs intravenous in patients with locally advanced or metastatic non-small cell lung cancer. Presented at ESMO; 23 October 2023. Poster #1447P.

SOURCE Halozyme Therapeutics, Inc.