Subcutaneous formulation with ENHANZE®
reduced treatment time to 3-8 minutes compared to 30-60 minutes
for standard intravenous infusion
SAN
DIEGO, Aug. 2, 2022 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
Roche's Phase III IMscin001 study evaluating a subcutaneous (SC)
formulation of Tecentriq® (atezolizumab) with Halozyme's ENHANZE®
technology met its co-primary endpoints.
The study showed non-inferior levels of Tecentriq® in the blood
(pharmacokinetics), when injected subcutaneously, compared with
intravenous (IV) infusion in cancer immunotherapy-naïve patients
with locally advanced or metastatic non-small cell lung cancer
(NSCLC) for whom prior platinum therapy has failed. The safety
profile of the SC formulation was consistent with IV
Tecentriq®.
"These positive results further demonstrate the opportunity for
a coformulation of ENHANZE to potentially benefit patients by
reducing the treatment time of Tecentriq to 3-8 minutes as a SC
delivery from 30-60 minutes for IV treatment," commented Dr.
Helen Torley, president and chief
executive officer of Halozyme. "We are delighted to announce these
positive results, which represent our second positive Phase III
trial announcement this year for our Wave Three products."
Roche will share detailed findings of the IMscin001 study at an
upcoming medical meeting and submit the data for regulatory
approval to health authorities globally, including the U.S. 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 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.
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 600,000 patient lives
in post-marketing use in five commercialized products across 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 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 industry
leading pharmaceutical companies including Teva Pharmaceutical,
Covis Pharma, Pfizer 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 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 concerning the Company's ENHANZE®
drug delivery technology and the possible benefits and attributes
of ENHANZE®, its potential application to aid in the dispersion and
absorption of other injected therapeutic drugs and facilitating
more rapid delivery and administration of larger volumes of
injectable medications through subcutaneous delivery. Forward
looking statements also include statements concerning the future
development and commercialization efforts of the Company's
collaboration partner including plans to submit the clinical trial
data referred to in this press release for regulatory approval to
health authorities. 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 ENHANZE® business, or in the
development, regulatory review and approval or commercialization of
ENHANZE® products, including any potential delays caused by the
current COVID-19 global pandemic, 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 recently
filed Annual Report on Form 10-K and in the Company's other
periodic reports and filings 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 on the date hereof, and the
Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this press release, except as required by law.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@antarespharma.com
Dawn Schottlandt / Claudia Styslinger
Argot Partners
212-600-1902
Halozyme@argotpartners.com
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SOURCE Halozyme Therapeutics, Inc.