--Halozyme to Receive $40 Million Upfront
Payment, Future Milestones and Royalties--
--Provides Alexion Access to ENHANZE Technology
for up to Four Targets--
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Halozyme
Therapeutics, Inc. (NASDAQ:HALO) announced today a collaboration
and license agreement that enables Alexion to use Halozyme’s
ENHANZE® drug-delivery technology in the development of
subcutaneous formulations for their portfolio of products. The
agreement provides Alexion with the opportunity for exclusive
development of up to four targets, including a next generation
subcutaneous formulation of ALXN1210 (ALXN1210 SC), the company’s
investigational long-acting C5 complement inhibitor, to potentially
further extend the dosing interval of ALXN1210 SC to once every two
weeks or once per month.
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the full release here:
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“Alexion’s goal is to provide continued innovation and more
treatment options that can significantly improve the lives of
patients with rare diseases,” said John Orloff, M.D., Executive
Vice President and Head of Research & Development at Alexion.
“We are excited to partner with Halozyme and look forward to
utilizing its ENHANZE technology, which enables rapid injection of
subcutaneous treatments and potentially increases bioavailablity,
in our development programs.”
“We are delighted to support Alexion’s innovative development
initiatives focused on improving the lives of patients with rare
diseases,” said Dr. Helen Torley, president and CEO of Halozyme.
“ENHANZE has become the industry standard for converting
intravenous therapies to a subcutaneous delivery, helping partners
and health care providers reduce the treatment burden and
administration time for patients.”
Under the terms of the agreement, Halozyme will receive an
initial $40 million with the potential to earn additional payments
of up to $160 million for each target developed, subject to
achievement of specified development, regulatory and sales-based
milestones. Halozyme will also receive mid-single digit royalties
on sales of commercialized products.
The Halozyme ENHANZE technology is based on a proprietary
recombinant human hyaluronidase enzyme (rHuPH20) that temporarily
degrades hyaluronan -- a glycosaminoglycan or chain of natural
sugars in the body -- to aid in the dispersion and absorption of
other injected therapeutic drugs. For Halozyme partners, this
technology may allow for more rapid delivery of injectable
medications through subcutaneous injection (just under the skin).
This delivery has been shown in studies to reduce health care
practitioner time required for administration and shorten time for
drug administration.
Alexion is Halozyme’s eighth global collaboration and license
partner for the ENHANZE technology, and the third partnership
formed in 2017. These partnerships cover nearly 50 therapeutic
targets and include three commercialized products.
About Alexion
Alexion is a global biopharmaceutical company focused on
developing and delivering life-transforming therapies for patients
with devastating and rare disorders. Alexion is the global leader
in complement inhibition and has developed and commercializes the
first and only approved complement inhibitor to treat patients with
paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic
uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR)
antibody-positive generalized myasthenia gravis (gMG). In addition,
Alexion has two highly innovative enzyme replacement therapies for
patients with life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency
(LAL-D).
As the leader in complement biology for over 20 years, Alexion
focuses its research efforts on novel molecules and targets in the
complement cascade, and its development efforts on the core
therapeutic areas of hematology, nephrology, neurology, and
metabolic disorders. Alexion’s lead development program is
ALXN1210, an innovative, long-acting C5 inhibitor that is currently
being evaluated in Phase 3 clinical studies as a potential
treatment for patients with paroxysmal nocturnal hemoglobinuria
(PNH) and atypical hemolytic uremic syndrome (aHUS) administered
intravenously every eight weeks. Alexion also plans to initiate a
single, PK-based Phase 3 clinical study of ALXN1210 delivered
subcutaneously once per week as a potential treatment for patients
with PNH or aHUS. In addition, Alexion plans to explore studying
longer dosing intervals of subcutaneous administration of ALXN1210,
including every other week and once per month, using the ENHANZE
technology. This press release and further information about
Alexion can be found at: www.alexion.com.
[ALXN-G]
About Halozyme
Halozyme Therapeutics is a biotechnology company focused on
developing and commercializing novel oncology therapies that target
the tumor microenvironment. Halozyme’s lead proprietary program,
investigational drug PEGPH20, applies a unique approach to
targeting solid tumors, allowing increased access of
co-administered cancer drug therapies to the tumor in animal
models. PEGPH20 is currently in development for metastatic
pancreatic cancer, non-small cell lung cancer, gastric cancer,
metastatic breast cancer and has potential across additional
cancers in combination with different types of cancer therapies. In
addition to its proprietary product portfolio, Halozyme has
established value-driving partnerships with leading pharmaceutical
companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly
and Bristol-Myers Squibb for its ENHANZE® drug delivery technology.
Halozyme is headquartered in San Diego. For more information visit
www.halozyme.com.
Alexion Safe Harbor Statement
This news release contains forward-looking statements, including
statements related to the potential benefits that may be achieved
through the license agreement with Halozyme, the potential
benefits, safety, efficacy and clinical effects of ALXN1210, the
timing and status of regulatory filings, and the potential of
Alexion's development programs. Forward-looking statements are
subject to factors that may cause Alexion's results and plans to
differ from those expected, including for example, decisions of
regulatory authorities regarding the adequacy of our research,
marketing approval or material limitations on the marketing of our
products, delays, interruptions or failures in the manufacture and
supply of our products and our product candidates, failure to
satisfactorily address matters raised by the FDA and other
regulatory agencies, the possibility that results of clinical
trials are not predictive of safety and efficacy results of our
products in broader patient populations, the possibility that
current rates of adoption of Soliris in PNH, aHUS or other diseases
are not sustained, the possibility that clinical trials of our
product candidates could be delayed, the adequacy of our
pharmacovigilance and drug safety reporting processes, the risk
that third party payors (including governmental agencies) will not
reimburse or continue to reimburse for the use of our products at
acceptable rates or at all, uncertainties surrounding legal
proceedings, company investigations and government investigations,
including investigations of Alexion by the U.S. Securities and
Exchange Commission (SEC) and U.S. Department of Justice, the risk
that anticipated regulatory filings are delayed, the risk that
estimates regarding the number of patients with PNH, aHUS, gMG, HPP
and LAL-D are inaccurate, the risks of changing foreign exchange
rates, risks relating to the potential effects of the Company's
restructuring and relocation of its corporate headquarters, and a
variety of other risks set forth from time to time in Alexion's
filings with the SEC, including but not limited to the risks
discussed in Alexion's Quarterly Report on Form 10-Q for the period
ended September 30, 2017 and in Alexion's other filings with the
SEC. Alexion does not intend to update any of these forward-looking
statements to reflect events or circumstances after the date
hereof, except when a duty arises under law.
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, the number of
collaborative targets actually chosen, whether such products are
ultimately developed or commercialized, whether milestones
triggering milestone payments will be achieved, and statements
concerning facilitating more rapid delivery of injectable
medications through subcutaneous delivery that involve risk 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 unexpected expenditures and costs,
unexpected results or delays in development and regulatory review,
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 Quarterly
Report on Form 10-Q 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171207005323/en/
Alexion Contacts:Kim Diamond
(Media), 475-230-3775kim.diamond@alexion.comorElena Ridloff
(Investors), 475-230-3601elena.ridloff@alexion.comorCatherine Hu
(Investors), 475-230-3599catherine.hu@alexion.comorHalozyme Contacts:Jim Mazzola,
858-704-8122ir@halozyme.comorChris Burton,
858-704-8352ir@halozyme.com
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