AstraZeneca and Ardea Biosciences, Inc. (NASDAQ: RDEA) today
announced that they have entered into a definitive merger
agreement, pursuant to which AstraZeneca will acquire Ardea, a San
Diego, California-based biotechnology company focused on the
development of small-molecule therapeutics. Ardea's clinically most
advanced product candidate, lesinurad (formerly known as RDEA594),
is currently in Phase III development as a potential treatment for
the chronic management of hyperuricaemia in patients with gout.
Under the terms of the agreement, AstraZeneca will acquire Ardea
for $32 per share which represents a total cash value of
approximately $1.26 billion. This represents a premium on the value
of Ardea's stock of 50% based on the one month volume-weighted
average price (VWAP) and 54% based on the closing price on Friday,
20 April 2012.
Lesinurad is a selective inhibitor of URAT1, a transporter in
the proximal tubule cells of the kidney that regulates uric acid
excretion from the body, which is being developed as an oral,
once-daily treatment for the chronic management of hyperuricaemia
in patients with gout. Lesinurad is being studied in an ongoing
Phase III clinical development programme as an add-on treatment to
allopurinol in patients not reaching target serum uric acid levels
on allopurinol alone, as monotherapy for those patients who are
intolerant to allopurinol or febuxostat and as an add-on treatment
to febuxostat in patients with tophaceous gout. Filings for a New
Drug Application (NDA) in the US and a Marketing Authorisation
Application (MAA) in the EU are planned for the first half of 2014.
AstraZeneca also plans to develop and commercialise lesinurad in
China and Japan. AstraZeneca will supplement Ardea's existing
capabilities to progress lesinurad Phase III development programme
and regulatory submissions. The company will seek to absorb the
further development costs of the Ardea compounds in its existing
R&D programme.
Through this acquisition, AstraZeneca would also add to its
pipeline RDEA3170, a next-generation selective URAT1 inhibitor
currently in Phase I development.
"This attractive Phase III programme is an excellent opportunity
to leverage AstraZeneca's global specialty and primary care sales
and marketing capabilities," said David Brennan, Chief Executive
Officer of AstraZeneca. "The Ardea team has done a great job
developing lesinurad along with a promising next-generation gout
programme. These compounds have real potential to benefit
patients."
"We are delighted to be joining AstraZeneca," said Barry D.
Quart, President and Chief Executive Officer of Ardea. "From our
earliest interactions, we were impressed with the quality of
AstraZeneca's people and we are confident their commercial strength
and global reach will help realise the full potential of our
programmes. The Ardea team and I are committed to helping complete
development and working to secure registration for lesinurad."
The Boards of Directors of AstraZeneca and Ardea have
unanimously approved the terms of the agreement, and Ardea's Board
has recommended that its shareholders approve the transaction.
Subject to the approval of Ardea's shareholders as well as other
conditions including customary regulatory approvals, the
transaction will close in the second or third quarter of 2012.
Ardea shareholders representing approximately 30% of the current
total shares outstanding have entered into a voting agreement with
AstraZeneca to vote in favour of the transaction.
About Gout Gout is a painful, debilitating
and progressive disease caused by abnormally elevated levels of
uric acid in the blood stream. This leads to the deposition of
painful, needle-like uric acid crystals in and around the
connective tissue of the joints and in the kidneys.
It is estimated that there were approximately 14.7 million
diagnosed prevalent cases of chronic gout in the major markets in
2009, which is forecast to grow to 16.6 million in 2019.
About Ardea Ardea is a biotechnology
company based in San Diego, California, focused on the development
of small-molecule therapeutics for the treatment of serious
diseases. Ardea's most advanced clinical-stage product candidates
include lesinurad, formerly known as RDEA594, a selective, oral
URAT1 transporter inhibitor for the chronic management of
hyperuricaemia in patients with gout and BAY 86-9766, formerly
known as RDEA119, a specific inhibitor of mitogen-activated ERK
kinase (MEK) for the treatment of cancer which is being developed
under a global license agreement with Bayer HealthCare. For more
information please visit: www.ardeabio.com
Ardea Shareholder Information In
connection with the proposed acquisition and required stockholder
approval, Ardea will file with the SEC a proxy statement. The proxy
statement will be mailed to the stockholders of Ardea. Ardea's
stockholders are urged to read the proxy statement and other
relevant materials when they become available because they will
contain important information about the acquisition and the
company. Investors and security holders may obtain free copies of
these documents (when they are available) and other documents filed
with the Securities and Exchange Commission at the SEC's web site
at www.sec.gov. In addition, investors and security holders may
obtain additional details on the transaction as well as free copies
of the documents filed with the SEC by Ardea by going to Ardea's
Investor Relations page on its corporate website as above.
Ardea and its officers and directors may be deemed to be
participants in the solicitation of proxies from Ardea's
stockholders with respect to the acquisition. Information about
Ardea's executive officers and directors and their ownership of
Ardea stock is set forth in the proxy statement for the Ardea 2012
Annual Meeting of Stockholders, which was filed with the SEC on
April 10, 2012. Investors and security holders may obtain more
detailed information regarding the direct and indirect interests of
Ardea and its respective executive officers and directors in the
acquisition by reading the preliminary and definitive proxy
statements regarding the merger, which will be filed with the
SEC.
About AstraZeneca AstraZeneca is a global,
innovation-driven biopharmaceutical business with a primary focus
on the discovery, development and commercialisation of prescription
medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information please visit: www.astrazeneca.com
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
the timing and anticipated completion of the proposed merger, the
benefits and synergies expected to result from the proposed merger,
the anticipated customer base for Ardea following the completion of
the proposed merger, Ardea's plans and goals, the expected
properties and benefits of lesinurad, BAY 86-9766 (RDEA119),
RDEA3170 and Ardea's other compounds and the timing and results of
Ardea's preclinical, clinical and other studies, and other
statements that are not purely statements of historical fact. These
forward-looking statements are made on the basis of the current
beliefs, expectations and assumptions of the management of the
Company and are subject to significant risks and uncertainty.
Investors are cautioned not to place undue reliance on any such
forward-looking statements. Risks that contribute to the uncertain
nature of the forward-looking statements include any operational or
cultural difficulties associated with the integration of the
businesses of the Company and AstraZeneca, potential adverse
reactions or changes to business relationships resulting from the
announcement or completion of the proposed merger, unexpected
costs, charges or expenses resulting from the proposed merger,
litigation or adverse judgments relating to the proposed merger,
risks relating to the consummation of the contemplated merger,
including the risk that the required stockholder approval might not
be obtained in a timely manner or at all or that other closing
conditions will not be satisfied, any difficulties associated with
requests or directions from governmental authorities resulting from
their reviews of the transaction, and any changes in general
economic and/or industry-specific conditions, risks related to the
outcome of preclinical and clinical studies, risks related to
regulatory approvals, delays in commencement of preclinical and
clinical studies, costs associated with Ardea's drug discovery and
development programs, and risks related to the outcome of Ardea's
business development activities, including collaboration or license
agreements. Certain of these and other risks and uncertainties are
described more fully in Ardea's most recently filed SEC documents,
including Ardea's Annual Report on Form 10-K and Ardea's Quarterly
Reports on Form 10-Q, under the headings "Risk Factors." All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Ardea undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were
made.
ARDEA CONTACTS Stephen Davis (858)
652-6528 sdavis@ardeabio.com John Beck (858) 652-6523
jbeck@ardeabio.com ASTRAZENECA CONTACTS
Media Enquiries Esra Erkal-Paler +44 20 7604
8030 Sarah Lindgreen +44 20 7604 8033 Investor
Enquiries UK James Ward-Lilley +44 20 7604 8122 mob: +44 7785
432613 Karl Hard +44 20 7604 8123 mob: +44 7789 654364 Nicklas
Westerholm +44 20 7604 8124 mob: +44 7585 404950
Investor Enquiries US Ed Seage +1 302 886 4065 mob: +1
302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612
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