SAN DIEGO, Feb. 25, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S.
Food and Drug Administration has accepted a Biologics License
Application (BLA) from Genentech, a member of the Roche Group, for
the fixed-dose combination of pertuzumab (Perjeta®) and
trastuzumab (Herceptin®) for subcutaneous administration
using Halozyme's ENHANZE® drug delivery technology in
combination with intravenous (IV) chemotherapy for the treatment of
eligible patients with HER2-positive breast cancer.
"The acceptance of our partner's BLA submission is an important
development for our ENHANZE® technology platform," said
Dr. Helen Torley, president and
chief executive officer. "This will represent the first product
utilizing ENHANZE® that combines two biologics, Perjeta
and Herceptin, in one fixed-dose, subcutaneous administration. We
are excited that patients with HER2-positive breast cancer may now
benefit from a shorter treatment administration
option."
The BLA submission is based on positive results from the global
Phase III FeDeriCa study conducted by Genentech, which demonstrated
non-inferior levels of Perjeta in the blood (pharmacokinetics) and
comparable efficacy and safety to standard IV infusions of Perjeta
plus Herceptin and chemotherapy.(1)
Subcutaneous administration of the fixed-dose combination of
Perjeta and Herceptin is approximately eight minutes for the
initial loading dose and approximately five minutes for each
subsequent maintenance dose. Intravenous administration is
approximately 150 minutes for the loading dose of Perjeta and
Herceptin using standard IV formulations and between 60-150 minutes
for subsequent maintenance infusions for the combination.
(2,3,4)
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 Therapeutics is a
biotechnology company focused on novel biological and drug delivery
approaches. Halozyme's proprietary enzyme rHuPH20 is used to
facilitate the delivery of injected drugs and fluids and
potentially reduce the treatment burden of other drugs to patients.
Halozyme has licensed its rHuPH20 technology, called
ENHANZE®, 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. 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, unexpected regulatory approval
requirements, unexpected adverse events 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.
References:
(1) Tan A, et al. Subcutaneous
administration of the fixed-dose combination of trastuzumab and
pertuzumab in combination with chemotherapy in HER2-positive early
breast cancer: primary analysis of the phase III, multicenter,
randomized, open-label, two-arm FeDeriCa study. Presented at SABCS,
2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.
(2) European Medicines Agency. Summary of Product
Characteristics for Herceptin. [Internet; cited November 2019]. Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf.
(3) European Medicines Agency. Summary of Product Characteristics
for Perjeta. [Internet; cited November
2019]. Available from:
https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf.
(4) US Food and Drug Administration. Prescribing Information for
Herceptin. [Internet; cited November
2019]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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