THOUSAND OAKS, Calif. and
SOUTH SAN FRANCISCO, Calif.,
Sept. 18, 2013 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced that the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended (HSR), in connection
with Amgen's proposed acquisition of Onyx, was terminated early on
Sept. 18, 2013, by the United States
Federal Trade Commission. The waiting period was scheduled to
expire on Sept. 23, 2013.
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As previously announced on Aug. 25,
2013, Amgen and Onyx entered into an agreement under which
Amgen will acquire all of the outstanding shares of Onyx for
$125 per share in cash, with the
transaction to be effected through a tender offer. The termination
of the HSR waiting period satisfies one of the conditions to
consummate the tender offer. Other closing conditions remain to be
satisfied, including, among others, a minimum tender of at least a
majority of outstanding Onyx shares on a fully diluted basis.
The tender offer is scheduled to expire at 12:00 midnight,
New York City time, on
Oct. 1, 2013 (one minute after
11:59 p.m., New York City time, on Sept. 30, 2013), unless it is extended pursuant
to and in accordance with the terms of the merger agreement between
Amgen and Onyx. The complete Offer to Purchase dated Sept. 3, 2013, related to the tender offer has
been filed with the U.S. Securities and Exchange Commission and can
be viewed online at www.sec.gov.
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 biologics manufacturing 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 the world's
largest independent biotechnology company, 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 Onyx
Based in South
San Francisco, California, Onyx Pharmaceuticals, Inc. is a
global biopharmaceutical company engaged in the development and
commercialization of innovative therapies for improving the lives
of people with cancer. The company is focused on developing novel
medicines that target key molecular pathways. For more information
about Onyx, visit the company's website at www.onyx.com. Onyx
Pharmaceuticals is on Twitter. Sign up to follow Onyx's Twitter
feed @OnyxPharm at http://twitter.com/OnyxPharm.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on Amgen's
current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual
results to differ materially from those described. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including statements about the planned completion of the tender
offer and the merger, 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 (SEC) reports
filed by Amgen, including Amgen's most recent annual report on Form
10-K and any subsequent periodic reports on Form 10-Q and Form
8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and
8-K for additional information on the uncertainties and risk
factors related to Amgen's business. Unless otherwise noted,
Amgen is providing this information as of Sept. 18, 2013, and expressly disclaims any duty
to update information contained in this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects.
Risks and uncertainties include whether the proposed transaction
described in this press release can be completed in a timely
manner, and whether the anticipated benefits of the proposed
transaction can be achieved. 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. Amgen develops product candidates
internally and through licensing collaborations, partnerships,
joint ventures and acquisitions. Product candidates
that are derived from relationships or acquisitions 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 Amgen's products after
they are on the market. Amgen's business may be impacted by
government investigations, litigation and product liability
claims. If Amgen fails to meet the compliance obligations in
the corporate integrity agreement between Amgen and the U.S.
government, it could become subject to significant
sanctions. Amgen depends on third parties for a significant
portion of its manufacturing capacity for the supply of certain of
its current and future products and limits on supply may constrain
sales of certain of its current products and product candidate
development.
In addition, sales of Amgen's products are affected by the
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 as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and
others' regulations and reimbursement policies may affect the
development, usage and pricing of Amgen's products. In
addition, Amgen competes with other companies with respect to some
of its marketed products as well as for the discovery and
development of new products. Amgen believes that some of its
newer products, product candidates or new indications for existing
products, may face competition when and as they are approved and
marketed. Amgen's products may compete against products that have
lower prices, established reimbursement, superior performance, are
easier to administer, or that are otherwise competitive with its
products. In addition, 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 and there can be no guarantee of
Amgen's ability to obtain or maintain patent protection for its
products or product candidates. Amgen cannot guarantee that
it will be able to produce commercially successful products or
maintain the commercial success of its existing products.
Amgen's stock price may be affected by actual or perceived market
opportunity, competitive position, and success or failure of its
products or product candidates. Further, 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
Amgen's business and results of operations.
Additional Information
This communication is neither
an offer to purchase nor a solicitation of an offer to sell any
shares of the common stock of Onyx Pharmaceuticals, Inc. or any
other securities. Arena Acquisition Company and Amgen Inc.
have filed a tender offer statement on Schedule TO, including an
offer to purchase, a letter of transmittal and related documents,
with the United States Securities and Exchange Commission (the
"SEC") and a Solicitation/Recommendation Statement on Schedule
14D-9 has been filed with the SEC by Onyx. The offer to purchase
shares of Onyx common stock will only be made pursuant to the offer
to purchase, the letter of transmittal and related documents filed
as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE
URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE
SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY
MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION. Investors and security holders may obtain a
free copy of these statements and other documents filed with the
SEC at the website maintained by the SEC at www.sec.gov or by
directing such requests to Innisfree M&A Incorporated, the
Information Agent for the tender offer, toll-free at (888)
750-5834.
Onyx Forward-Looking Statements
This news release
contains "forward-looking statements" of Onyx within the meaning of
the federal securities laws. These forward-looking statements
include, without limitation, statements regarding the expected
timing of the completion of the transaction, Amgen's operation of
the Onyx business following completion of the transaction, and
statements regarding the future operation, the anticipated growth
of our business, global expansion and increases to our
international capabilities, our launch of Kyprolis in the United States, our investments in Phase 3
clinical trials, contributions from our kinase inhibitor business
and future cost of goods sold with respect to Kyprolis. These
statements are subject to risks and uncertainties that could cause
actual results and events to differ materially from those
anticipated, including, but not limited to, risks and uncertainties
related to: uncertainties as to the timing of the
transaction; uncertainties as to the percentage of Onyx
stockholders tendering their shares in the offer; the possibility
that competing offers will be made; the possibility that various
closing conditions for the transaction may not be satisfied or
waived, including that a governmental entity may prohibit, delay or
refuse to grant approval for the consummation of the transaction;
the effects of disruption caused by the transaction making it more
difficult to maintain relationships with employees, collaborators,
vendors and other business partners; the risk that stockholder
litigation in connection with the transaction may result in
significant costs of defense, indemnification and liability;
Nexavar® (sorafenib) tablets, Kyprolis® (carfilzomib) for Injection
and Stivarga® (regorafenib) tablets being the only approved
products from which we may obtain revenue; competition; failures or
delays in our clinical trials or the regulatory process; dependence
on our collaborative relationship with Bayer; supply of Nexavar,
Stivarga or Kyprolis; market acceptance and the rate of adoption of
Nexavar, Stivarga and Kyprolis; pharmaceutical pricing and
reimbursement pressures; serious adverse side effects, if they are
associated with Nexavar, Stivarga or Kyprolis; government
regulation; possible failure to realize the anticipated benefits of
business acquisitions or strategic investments; protection of our
intellectual property; and product liability risks; and other risks
and uncertainties discussed in Onyx's filings with the Securities
and Exchange Commission (the "Commission"), including the "Risk
Factors" sections of Onyx's most recent annual report on Form 10-K
and subsequent quarterly reports on Form 10-Q, as well as the
tender offer documents to be filed by Arena Acquisition
Corporation, a wholly owned subsidiary of Amgen, and the
Solicitation/Recommendation Statement to be filed by Onyx. Onyx
undertakes no obligation to update any forward-looking statements
as a result of new information, future developments or otherwise,
except as expressly required by law.
Contacts:
Amgen
Ashleigh Koss,
805-313-6151 (media)
Arvind Sood, 805-447-1060
(investors)
Onyx
Lori Melançon, 650-266-2394 (media)
Amy Figueroa, 650-266-2398
(investors)
SOURCE Amgen