--Halozyme to Receive $40 Million Upfront Payment, Future Milestones
and Royalties--
--Provides Alexion Access to ENHANZE Technology for up to Four
Targets--
NEW HAVEN, Conn. & SAN DIEGO--(BUSINESS WIRE)--
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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"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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171207005323/en/
Alexion Contacts:
Kim Diamond
(Media), 475-230-3775
kim.diamond@alexion.com
or
Elena
Ridloff (Investors), 475-230-3601
elena.ridloff@alexion.com
or
Catherine
Hu (Investors), 475-230-3599
catherine.hu@alexion.com
or
Halozyme
Contacts:
Jim Mazzola, 858-704-8122
ir@halozyme.com
or
Chris
Burton, 858-704-8352
ir@halozyme.com
Source: Alexion Pharmaceuticals, Inc.
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