- Horizon to use ENHANZE® subcutaneous delivery
technology for TEPEZZA® (teprotumumab-trbw) -
Horizon Therapeutics plc (Nasdaq: HZNP) and Halozyme
Therapeutics, Inc. (Nasdaq: HALO) today announced a global
collaboration and license agreement that gives Horizon exclusive
access to Halozyme’s ENHANZE® drug delivery technology for
subcutaneous (SC) formulation of medicines targeting IGF-1R.
Horizon intends to use ENHANZE® to develop a SC formulation of
TEPEZZA (teprotumumab-trbw), indicated for the treatment of Thyroid
Eye Disease, a serious, progressive and vision-threatening rare
autoimmune disease,1 potentially shortening drug administration
time, reducing healthcare practitioner time and offering additional
flexibility and convenience for patients.
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Under the terms of the agreement, Horizon will make an upfront
payment of $30 million to Halozyme and is obligated to make
potential future payments of up to $160 million in the aggregate,
subject to achievement of specified development, regulatory and
sales-based milestones. Halozyme will also be entitled to receive
mid-single digit royalties on sales of commercialized medicines
using the ENHANZE® technology.
“Our goal with all of our medicines is to optimize the patient
experience,” said Tim Walbert, chairman, president and chief
executive officer, Horizon. “As we continue to explore subcutaneous
administration for TEPEZZA to provide greater flexibility for
patients and physicians, access to the ENHANZE® technology, which
has been deployed successfully in multiple biologics, represents an
important step in our development efforts.”
“We are thrilled to announce our tenth collaboration and license
agreement for ENHANZE® and look forward to working closely with
Horizon to develop TEPEZZA with ENHANZE®,” said Dr. Helen Torley,
president and chief executive officer, Halozyme. “The launch of
TEPEZZA has been one of the most successful and exciting launches
in rare disease medicine and is making a difference in the lives of
patients suffering from Thyroid Eye Disease.”
Horizon represents Halozyme’s tenth global collaboration and
license partner for the ENHANZE® technology. These collaborations
cover more than 50 therapeutic targets and include five
commercialized products to date.
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 Horizon
Horizon is focused on researching, developing and
commercializing medicines that address critical needs for people
impacted by rare and rheumatic diseases. Our pipeline is
purposeful: we apply scientific expertise and courage to bring
clinically meaningful therapies to patients. We believe science and
compassion must work together to transform lives. For more
information on how we go to incredible lengths to impact lives,
please visit www.horizontherapeutics.com and follow us on Twitter,
LinkedIn, Instagram and Facebook.
Horizon Safe Harbor Statement
This press release contains forward-looking statements,
including, but not limited to, statements related to the potential
benefits of ENHANZE® and a subcutaneous formulation of TEPEZZA,
Horizon’s strategy, plans, objectives, expectations and intentions,
including with respect to the potential development of a
subcutaneous formulation of TEPEZZA, and other statements that are
not historical facts. These forward-looking statements are based on
Horizon’s expectations and assumptions as of the date of this press
release and inherently involve significant risks and uncertainties.
Actual results may differ materially from those in these
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks associated
with the development, regulatory approval and commercialization of
novel medicines or formulations of existing medicines, as well as
those described in Horizon’s filings with the United States
Securities and Exchange Commission, including those factors
discussed under the caption "Risk Factors" in those filings.
Forward-looking statements speak only as of the date of this press
release and Horizon does not undertake any obligation to update or
revise these statements, except as may be required by law.
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 five 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, argenx and Horizon
Therapeutics. 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 and regulatory efforts
of Halozyme’s ENHANZE® partner and Halozyme’s potential receipt of
payments associated with achievement of certain development,
regulatory and sales-based milestones, and royalties on sales of
commercialized products. 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 development, regulatory
and sales-based milestones will be achieved, uncertainties
concerning whether collaborative products are ultimately developed
or commercialized, unexpected expenditures and costs, unexpected
results or delays in development and regulatory review including
potential delays caused by the current COVID-19 global pandemic,
unexpected 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 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.
About TEPEZZA
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye
Disease.
IMPORTANT SAFETY INFORMATION Warnings and
Precautions
Infusion Reactions: TEPEZZA may cause infusion reactions.
Infusion reactions have been reported in approximately 4% of
patients treated with TEPEZZA. Reported infusion reactions have
usually been mild or moderate in severity. Signs and symptoms may
include transient increases in blood pressure, feeling hot,
tachycardia, dyspnea, headache and muscular pain. Infusion
reactions may occur during an infusion or within 1.5 hours after an
infusion. In patients who experience an infusion reaction,
consideration should be given to premedicating with an
antihistamine, antipyretic or corticosteroid and/or administering
all subsequent infusions at a slower infusion rate.
Preexisting Inflammatory Bowel Disease: TEPEZZA may cause
an exacerbation of preexisting inflammatory bowel disease (IBD).
Monitor patients with IBD for flare of disease. If IBD exacerbation
is suspected, consider discontinuation of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia
may occur in patients treated with TEPEZZA. In clinical trials, 10%
of patients (two-thirds of whom had preexisting diabetes or
impaired glucose tolerance) experienced hyperglycemia.
Hyperglycemic events should be managed with medications for
glycemic control, if necessary. Monitor patients for elevated blood
glucose and symptoms of hyperglycemia while on treatment with
TEPEZZA. Patients with preexisting diabetes should be under
appropriate glycemic control before receiving TEPEZZA.
Adverse Reactions
The most common adverse reactions (incidence ≥5% and greater
than placebo) are muscle spasm, nausea, alopecia, diarrhea,
fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and
dry skin.
For additional information on TEPEZZA, please see Full
Prescribing Information at TEPEZZAhcp.com.
References
- Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus
EUGOGO Classification, Assessment and Management. Journal of
Ophthalmopathy. 2015;2015:1-16.
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version on businesswire.com: https://www.businesswire.com/news/home/20201123005620/en/
Horizon contacts: Tina Ventura Senior Vice President,
Investor Relations Investor-relations@horizontherapeutics.com
Ruth Venning Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com
U.S. Media Contacts: Geoff Curtis Executive Vice President,
Corporate Affairs & Chief Communications Officer
media@horizontherapeutics.com
Ireland Media Contact: Gordon MRM Ray Gordon
ray@gordonmrm.ie
Halozyme contact: Al Kildani Vice President, Investor
Relations and Corporate Communications 858-704-8122
ir@halozyme.com
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