THOUSAND OAKS, Calif. and
PASADENA, Calif., Sept. 29, 2016 /PRNewswire/ -- Amgen (NASDAQ:
AMGN) and Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today
announced two license and collaboration agreements to develop and
commercialize RNA interference (RNAi) therapies for cardiovascular
disease. These are the first programs to utilize Arrowhead's
proprietary subcutaneous RNAi delivery platform. RNAi molecules may
be designed to target and shut down specific gene products that
contribute to various diseases.
Under one agreement, Amgen receives a worldwide, exclusive
license to Arrowhead's novel, RNAi ARC-LPA program. These RNAi
molecules are designed to reduce elevated lipoprotein(a), which is
a genetically validated, independent risk factor for
atherosclerotic cardiovascular disease. Under the second agreement,
Amgen receives an option to a worldwide, exclusive license for a
RNAi therapy for an undisclosed genetically validated
cardiovascular target. In both agreements, Amgen will be wholly
responsible for clinical development and commercialization.
Under the terms of the agreements taken together, Arrowhead will
receive $35 million in upfront
payments; $21.5 million in the form
of an equity investment by Amgen in Arrowhead common stock; and up
to $617 million in option payments,
and development, regulatory and sales milestone payments. Arrowhead
is further eligible to receive single digit royalties for sales of
products against the undisclosed target and up to low double digit
royalties for sales of products under the ARC-LPA agreement.
Additional financial terms of the agreements are not disclosed.
"Arrowhead's expertise in RNAi makes them a valuable partner as
we translate genetic discoveries into potential therapies that can
improve health outcomes for patients," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "This collaboration builds
upon our commitment to cardiovascular disease with targets that we
believe are uniquely suited for RNAi-based therapy."
"We have made great advances to our proprietary subcutaneous
RNAi delivery vehicle and in RNAi trigger modification and
stabilization that enable rapid development of new RNAi
therapeutics across multiple disease areas," said Christopher Anzalone, Ph.D., president and chief
executive officer at Arrowhead. "Our capabilities and platform
technologies are becoming increasingly validated, so we feel that
now is a great time to expand the reach of our technologies and
partner with other companies to maximize the value of our assets.
We are thrilled to be working with Amgen, one of the world's
leading biotechnology companies, on this collaboration. Amgen's
extensive development, regulatory, and commercial expertise makes
them an ideal partner, and we look forward to a long and productive
relationship."
The closing of the ARC-LPA transaction is subject to clearance
under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, and is expected to close before the end of the fourth
quarter of 2016.
Arrowhead Conference Call and Webcast
Details
Arrowhead will host a conference call today,
Sept. 29, 2016, at 9 a.m. ET. Investors may access a live audio
webcast on Arrowhead's website at
http://ir.arrowheadpharma.com/events.cfm. For analysts that wish to
participate in the conference call, please dial 855-215-6159 or
315-625-6887 and enter Conference ID 88684368.
A replay of the webcast will be available on the Arrowhead
website approximately two hours after the conclusion of the call
and will remain available for 90 days. An audio replay will also be
available approximately two hours after the conclusion of the call
and will be available for 3 days. To access the audio replay, dial
404-537-3406 and enter Conference ID 88684368.
About ARC-LPA
ARC-LPA is designed to reduce production
of apolipoprotein A, a key component of lipoprotein(a), which has
been genetically linked with increased risk of cardiovascular
diseases, independent of cholesterol and LDL levels. ARC-LPA is
Arrowhead's first drug candidate to use a subcutaneously
administered delivery construct.
About Amgen Cardiovascular
Building on more than three
decades of experience in developing biotechnology medicines for
patients with serious illnesses, Amgen is dedicated to addressing
important scientific questions to advance care and improve the
lives of patients with cardiovascular disease, the leading cause of
morbidity and mortality worldwide.1 Amgen's research
into cardiovascular disease, and potential treatment options, is
part of a growing competency at Amgen that utilizes human genetics
to identify and validate certain drug targets. Through its own
research and development efforts, as well as partnerships, Amgen is
building a robust cardiovascular portfolio consisting of several
approved and investigational molecules in an effort to address a
number of today's important unmet patient needs, such as high
cholesterol and heart failure.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us
on www.twitter.com/amgen.
About Arrowhead Pharmaceuticals
Arrowhead
Pharmaceuticals develops medicines that treat intractable diseases
by silencing the genes that cause them. Using a broad portfolio of
RNA chemistries and efficient modes of delivery, Arrowhead
therapies trigger the RNA interference mechanism to induce rapid,
deep, and durable knockdown of target genes. RNA interference, or
RNAi, is a mechanism present in living cells that inhibits the
expression of a specific gene, thereby affecting the production of
a specific protein. Arrowhead's RNAi-based therapeutics leverage
this natural pathway of gene silencing. The company's pipeline
includes ARC-520 and ARC-521 for chronic hepatitis B virus
infection, ARC-AAT for liver disease associated with alpha-1
antitrypsin deficiency, ARC-F12 for hereditary angioedema and
thromboembolic disorders, ARC-LPA for cardiovascular disease, and
ARC-HIF2 for renal cell carcinoma.
For more information please visit www.arrowheadpharma.com, or
follow us on Twitter @ArrowheadPharma. To be added to the Company's
email list and receive news directly, please visit
http://ir.arrowheadpharma.com/alerts.cfm.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including its most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing
this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for
Amgen to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects
similar variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints Amgen has selected. Amgen develops
product candidates internally and through licensing collaborations,
partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as Amgen may
have believed at the time of entering into such relationship. Also,
Amgen or others could identify safety, side effects or
manufacturing problems with its products after they are on the
market.
Amgen's results may be affected by its ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing its products and global
economic conditions. In addition, sales of Amgen's products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, Amgen's research,
testing, pricing, marketing and other operations are subject to
extensive regulation by domestic and foreign government regulatory
authorities. Amgen or others could identify safety, side effects or
manufacturing problems with its products after they are on the
market. Amgen's business may be impacted by government
investigations, litigation and product liability claims. In
addition, Amgen's business may be impacted by the adoption of new
tax legislation or exposure to additional tax liabilities. If Amgen
fails to meet the compliance obligations in the corporate integrity
agreement between it and the U.S. government, Amgen could become
subject to significant sanctions. Further, while Amgen routinely
obtains patents for its products and technology, the protection
offered by its patents and patent applications may be challenged,
invalidated or circumvented by its competitors, or Amgen may fail
to prevail in present and future intellectual property litigation.
Amgen performs a substantial amount of its commercial manufacturing
activities at a few key manufacturing facilities and also depends
on third parties for a portion of its manufacturing activities, and
limits on supply may constrain sales of certain of its current
products and product candidate development. In addition, Amgen
competes with other companies with respect to many of its marketed
products as well as for the discovery and development of new
products. Further, some raw materials, medical devices and
component parts for Amgen's products are supplied by sole
third-party suppliers. The discovery of significant problems with a
product similar to one of Amgen's products that implicate an entire
class of products could have a material adverse effect on sales of
the affected products and on its business and results of
operations. Amgen's efforts to acquire other companies or products
and to integrate the operations of companies Amgen has acquired may
not be successful. Amgen may not be able to access the capital and
credit markets on terms that are favorable to it, or at all. Amgen
is increasingly dependent on information technology systems,
infrastructure and data security. Amgen's stock price may be
volatile and may be affected by a number of events. Amgen's
business performance could affect or limit the ability of the Amgen
Board of Directors to declare a dividend or its ability to pay a
dividend or repurchase its common stock.
The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by the U.S.
Food and Drug Administration, and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
candidates.
Arrowhead Safe Harbor Statement under the Private Securities
Litigation Reform Act:
This news release contains
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.
These statements are based upon our current expectations and speak
only as of the date hereof. Our actual results may differ
materially and adversely from those expressed in any
forward-looking statements as a result of various factors and
uncertainties, including the success of the Amgen collaboration, as
well as actual amounts received under that collaboration.
Arrowhead's most recent Annual Report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q discuss some of the important risk
factors that may affect our business, results of operations and
financial condition. Arrowhead assumes no obligation to update or
revise forward-looking statements to reflect new events or
circumstances.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead
Pharmaceuticals, Inc.
CONTACT:
Amgen
Kristen Davis,
805-447-3008 (media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
Investor Relations:
The Trout Group
Chad Rubin
646-378-2947
ir@arrowheadpharma.com
Media:
Russo Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
|
|
|
|
|
|
|
|
1 World
Health Organization. Cardiovascular diseases (CVDs) fact sheet.
http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed
August 2016.
|
Logo - http://photos.prnewswire.com/prnh/20081015/AMGENLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/amgen-and-arrowhead-pharmaceuticals-announce-two-cardiovascular-collaborations-300335914.html
SOURCE Amgen