DUBLIN and SAN DIEGO, Nov. 23,
2020 /PRNewswire/ -- 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.
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.
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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SOURCE Halozyme Therapeutics, Inc.