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 practitioners1 -
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
tbui@halozyme.com
Samantha Gaspar
Teneo
617-877-9710
samantha.gaspar@teneo.com
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/halozyme-announces-roche-receives-european-commission-approval-of-tecentriq-sc-with-enhanze-representing-the-eus-first-subcutaneous-pd-l1-cancer-immunotherapy-for-multiple-cancer-types-302035190.html
SOURCE Halozyme Therapeutics, Inc.