Halozyme Announces Approval of Roche's Tecentriq® Subcutaneous (SC) with ENHANZE® in Great Britain

First subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain

Tecentriq^® subcutaneous formulation with ENHANZE^® reduces treatment time to seven minutes compared to 30-60 minutes for standard intravenous infusion

SAN DIEGO, Aug. 29, 2023 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced the approval of Roche’s Tecentriq^® SC (atezolizumab), using Halozyme’s ENHANZE^® drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Tecentriq^® subcutaneous (SC) is co-formulated with Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq^® SC will be available to patients in Great Britain for certain types of lung, bladder, breast, and liver cancer.⁷

Multiple oncology studies suggest that most cancer patients prefer to receive their treatments via subcutaneous delivery, instead of intravenous infusion because of reduced discomfort, ease of administration, and shorter duration of treatment.^2,4,11

“We are delighted that Roche has received approval of Tecentriq SC in Great Britain. Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources,” said Dr. Helen Torley, president and chief executive officer of Halozyme. “We look forward to additional regulatory approvals of our partner products utilizing ENHANZE.”

Tecentriq^® SC is the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain and is Roche’s fourth subcutaneous cancer therapy using Halozyme’s ENHANZE^® drug delivery technology.^8-10 The approval is based on clinical 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.¹² While the IMscin001 trial was conducted within the hospital setting, the SC formulation may be suitable for out-of-hospital administration by a healthcare professional.

The U.S. Food and Drug Administration (FDA) is currently evaluating Tecentriq^® SC for regulatory approval.

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 700,000 patient lives in post-marketing use in six 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 and Chugai Pharmaceutical.

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 XYOSTED^®, TLANDO^® and NOCDURNA^® 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]

Dawn Schottlandt

Argot Partners

212-600-1902

[email protected]

Shannia Coley

CG Life

443-471-6830

[email protected]

References

1. 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.

2. 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, randomized crossover PHranceSCa study. Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.

3. 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 randomized, two-cohort PrefHer study. Eur J Cancer. 2017;86:82-90.

4. 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.

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. Anderson, K C, et al. Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics. Future Oncol. 2019;15(28):3267-3281.

7. UK Electronic Medicines Compendium (EMC). Tecentriq: package leaflet. Last updated 5 July 2022. https://www.medicines.org.uk/emc/files/pil.8442.pdf. Accessed April 2023.

8. UK EMC. Phesgo SC: package leaflet. Last updated 16 March 2022. https://www.medicines.org.uk/emc/files/pil.11989.pdf. Accessed April 2023.

9. UK EMC. Herceptin SC: package leaflet. Last updated 28 September 2021. https://www.medicines.org.uk/emc/files/pil.3856.pdf. Accessed April 2023.

10. UK EMC. MabThera: package leaflet. Last updated 24 January 2022. https://www.medicines.org.uk/emc/files/pil.5333.pdf. Accessed April 2023.

11. Franken M, et al. Hospital-based or home-based administration of oncology drugs? Breast. 2020 Aug; 52: 71–77.

12. Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 (Part 2: Randomized Phase III): Pharmacokinetics (PK), efficacy and safety of atezolizumab subcutaneous (SC) vs intravenous (IV) in previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC). Presented at ESMO IO; 7-9 Dec 2022. Abstract #61MO.