SAN DIEGO, June 4, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the European
Commission (EC) has granted Janssen-Cilag International NV
(Janssen) marketing authorization for the subcutaneous (SC)
formulation of DARZALEX® (daratumumab), for the
treatment of adult patients with multiple myeloma in all currently
approved DARZALEX® intravenous (IV) formulation
indications in frontline and relapsed / refractory settings. The
approval follows a Positive Opinion by the CHMP of the European
Medicines Agency (EMA) in April 2020.
The SC formulation is administered as a fixed-dose over
approximately three to five minutes, significantly less time than
IV DARZALEX®, which is given over several hours.
Patients currently on IV DARZALEX® will have the choice
to switch to the SC formulation.
"We are delighted that the subcutaneous formulation of
DARZALEX® has been granted marketing authorization in
the EU with a broad label so soon after the CHMP positive opinion,"
said Dr. Helen Torley.
"DARZALEX® SC has the potential to improve the treatment
experience for multiple myeloma patients and physicians in the
European Union as patients may benefit from a shorter treatment
time when compared with a multi-hour intravenous infusion."
The approval was based on data from two studies: the Phase III
non-inferiority COLUMBA (MMY3012) study, which compared the SC
formulation of daratumumab to the IV formulation in patients with
relapsed or refractory multiple myeloma, and data from the Phase II
PLEIADES (MMY2040) study, which evaluated SC daratumumab in
combination with certain standard multiple myeloma regimens. The
topline results from the COLUMBA study were announced in
February 2019 and subsequently
presented in oral sessions at the 2019 American Society of Clinical
Oncology (ASCO) Annual Meeting and the 24th European Hematology
Association (EHA) Annual Congress. Updated data of the COLUMBA and
the PLEIADES studies were presented during poster sessions at the
61st American Society of Hematology (ASH) Annual Meeting in
December 2019.
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. This delivery has been shown in studies to reduce
health care practitioner time required for administration and
shorten time for drug administration.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. Halozyme advises and
supports its biopharmaceutical partners in key aspects of new drug
development with the goal of improving patients' lives while
helping its partners achieve global commercial success. As the
innovators of the ENHANZE® technology, which can reduce
hours-long treatments to a matter of minutes, Halozyme's
commercially-validated solution has positively impacted more than
400,000 patient lives via four commercialized products across more
than 100 global markets. Halozyme and its world-class partners are
currently advancing multiple therapeutic programs intended to
deliver innovative therapies, with the potential to improve the
lives of patients around the globe. Halozyme's proprietary enzyme
rHuPH20 forms the basis of the ENHANZE® technology and
is used to facilitate the delivery of injected drugs and fluids,
potentially reducing the treatment burden of other drugs to
patients. Halozyme has licensed its ENHANZE® technology
to leading pharmaceutical and biotechnology companies including
Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers
Squibb, Alexion and argenx. Halozyme derives revenues from these
collaborations in the form of milestones and royalties as the
Company's partners make progress developing and commercializing
their products being developed with ENHANZE®. Halozyme
is headquartered in San Diego. For
more information visit www.halozyme.com.
Halozyme Safe Harbor Statement
In addition to historical information, the statements set forth
above include forward-looking statements including, without
limitation, statements concerning the possible activity, 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,
and statements concerning certain other potential benefits of
ENHANZE® including facilitating more rapid delivery of
injectable medications through subcutaneous delivery and
potentially lowering the treatment burden for patients. These
forward-looking statements also include statements regarding the
product development efforts of Halozyme's ENHANZE®
partner. These forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. The 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. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including uncertainties concerning whether
collaborative products are ultimately developed or commercialized,
unexpected expenditures and costs, unexpected results or delays in
development and regulatory review including any potential delays
caused by the current COVID-19 global pandemic, unexpected
regulatory approval requirements, unexpected adverse events or
patient outcomes from being treated with the newly-approved
ENHANZE® co-formulated product referred to in this press
release, and competitive conditions. These and other factors that
may result in differences are discussed in greater detail in
Halozyme's most recent Annual and Quarterly Reports filed with the
Securities and Exchange Commission. Except as required by law,
Halozyme undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/halozyme-announces-janssen-receives-european-marketing-authorization-for-subcutaneous-darzalex-utilizing-halozymes-enhanze-technology-for-the-treatment-of-patients-with-multiple-myeloma-301070913.html
SOURCE Halozyme Therapeutics, Inc.