VENLO, Netherlands and
MELBOURNE, Australia, April 3, 2011 /PRNewswire/ -- QIAGEN N.V.
(NASDAQ: QGEN; Frankfurt, Prime
Standard: QIA) has reached an agreement to acquire Cellestis
Limited (CST: AU) for approximately A$341
million (US$355 million) in
cash, providing QIAGEN with access to a novel "pre-molecular"
technology that offers a new dimension in disease detection not
currently possible with other diagnostic methods.
The acquisition of Cellestis, a publicly listed, profitable
company headquartered in Australia, will provide QIAGEN with exclusive
rights to QuantiFERON® technology, a proprietary approach for
disease detection and monitoring.
Cellestis has successfully commercialized this technology with
QuantiFERON®-TB Gold In-Tube (QFT), a leading test for latent
tuberculosis (TB), and is in the early stages of commercializing
QuantiFERON®-CMV for monitoring of disease risk from the
life-threatening cytomegalovirus (CMV). These tests are approved
and commercialized in various countries and are believed to have
significant untapped market potential.
QuantiFERON® is a patent-protected platform technology that can
provide information on diseases far earlier than possible with
other diagnostic methods. QuantiFERON® tests whole blood samples
for the presence of systemically amplified molecular analytes which
provide information from the immune system's memory.
Based on its ability to provide diagnostic information far
earlier than DNA-based molecular tests, QuantiFERON® is considered
a "pre-molecular" testing technology. As a result, tests based on
QuantiFERON® can even provide critical information on latent
infections, where pathogens (bacteria, viruses, fungi) are present
in such low amounts that they are not detectable with traditional
DNA-based molecular diagnostics.
QuantiFERON® is complementary to QIAGEN's portfolio of molecular
diagnostics. Its high sensitivity and ability to provide clinically
relevant information means that this technology can be used ahead
of DNA- or RNA-based molecular testing. Greater use of QuantiFERON®
technology can help guide and drive the use of traditional DNA- and
RNA-based molecular diagnostics. For example, patients identified
through QuantiFERON®-based tests to be at risk for certain diseases
could then proceed for subsequent testing or increased monitoring
with corresponding DNA- or RNA-based molecular diagnostics to
assess disease activity levels and guide treatment decisions.
"We believe next-generation DNA- and RNA-based molecular testing
can benefit from greater use of QuantiFERON® technology, which has
a unique ability to identify patients at risk from potentially
life-threatening diseases. The power of QuantiFERON® can help save
lives by enabling medical treatment through earlier, deeper and
much more sensitive disease detection than previously possible,"
said Peer Schatz, Chief Executive
Officer of QIAGEN N.V. "Cellestis has developed a technology that
is highly complementary to our portfolio and which we expect to
migrate onto our QIAsymphony, QIAensemble and our point of need
platforms, thereby adding a new, unique assay menu to these QIAGEN
platforms. We believe the addition of Cellestis will further
strengthen our capabilities to offer innovative sample and assay
technologies that are making improvements in life possible."
"Cellestis has succeeded in developing QuantiFERON® as a
breakthrough technology, via the QFT-TB test that is becoming the
standard for latent TB diagnosis," said Cellestis CEO Anthony Radford. "We believe QIAGEN as an
industry-leading company provides the best strategic fit in terms
of capabilities and resources. As part of QIAGEN, we will be able
to accelerate our growth much faster than as a stand-alone company
and offer even greater benefits to patients and healthcare
providers."
Following successful completion of the transaction, QIAGEN plans
to migrate QuantiFERON® onto QIAensemble, a next-generation
high-throughput automation system in development and nearing market
entry; QIAsymphony, a highly versatile automation system for low-
to mid-throughput volumes available around the world; and QIAGEN's
point of need testing platforms acquired from ESE GmbH.
Successful commercialization of QuantiFERON®
technology
Cellestis has launched, depending on regional regulatory
approvals and clearances, two commercial diagnostic products and
has several new products based on QuantiFERON® technology under
evaluation. It has also developed an extensive R&D program
targeting other diseases and conditions. In the fiscal year ending
June 30, 2010, net sales rose 17% to
A$40.4 million (US$42.0 million). Profit from operations before
tax and non-recurring items in FY2010 was A$10.2 million (US$10.6
million), up 26% from FY2009.
Its flagship product, QuantiFERON®-TB Gold In-Tube (QFT),
accounts for the majority of current sales and was launched in 2006
as a third-generation test for detection of latent tuberculosis
(TB). QFT is recommended in many national guidelines since the test
overcomes significant shortcomings of the previous standard test
used to detect latent TB: the 110-year-old Tuberculin Skin test
(TST). Benefits of QFT include its accuracy and significantly
improved workflow, making it the only next-generation assay which
has been widely commercialized in an instrument and kit format.
Most latent infections today cannot be detected using DNA-based
molecular diagnostics. QFT is available in many markets and has
been approved in many countries, including the U.S. (pre-market
approval, or PMA), Canada and
Japan and has been CE marked for
use in Europe.(3)
Cellestis' other commercialized diagnostic product is
QuantiFERON®-CMV(4) which was launched in 2009 and is the first
commercially available test designed to allow physicians to monitor
a person's risk of cytomegalovirus (CMV) disease. CMV is one of the
most common and problematic viral infections in immunosuppressed
patients (in cancer, transplantation, HIV therapies). QIAGEN has
DNA-based molecular diagnostic tests for CMV viral load testing
which could be complemented by QuantiFERON®-CMV to monitor patients
for risk of CMV-induced disease.
Products based on QuantiFERON® technology can enhance QIAGEN's
leading portfolio in DNA- and RNA-based molecular diagnostics:
- Prevention example: QFT is rapidly expanding as a new treatment
standard for testing asymptomatic patients for latent TB infection
(and identifying those at risk for active disease), and it is
expected to be synergistic with QIAGEN's leading portfolio of
real-time PCR and Pyrosequencing DNA-based molecular diagnostic
detection technologies which, depending on the indication are use
as adjunct tests or reflex/subsequent tests.
- Profiling example: QuantiFERON®-CMV has the potential to
accelerate the fast-growing leadership position of QIAGEN in
providing a broad range of diagnostic testing solutions for use in
monitoring immunosuppressed patients for life-threatening
infectious diseases. These patients are being treated with
medicines that suppress the body's immune system, which increases
the risk for infections. QuantiFERON®-CMV is expected to be
synergistic with QIAGEN's DNA- and RNA-based molecular tests used
in transplantation medicine. QIAGEN plans to submit a PMA
application with the U.S. Food and Drug Administration (FDA) in
2011 for approval of the artus RG PCR CMV test.
- Personalized healthcare examples: Several new classes of
medicines require patients to be free of latent TB in advance of
treatment initiation, creating new opportunities for QFT. In
addition, a number of medicines require patients to be free of
viral infections and other pathogens or clinical profiles, which
could be verified with tests based on QuantiFERON® technology.
- Point of need example: QuantiFERON® technology will be adapted
for use with QIAGEN's ESE detection technology, a battery-operated
mobile device, and in particular QFT for latent TB testing in areas
without immediate access to a laboratory.
Transaction summary
QIAGEN and Cellestis have entered into a Scheme Implementation
Deed (SID) pursuant to which QIAGEN, or a wholly owned subsidiary,
will acquire all of the ordinary shares in Cellestis for
approximately A$341 million in cash,
or A$3.55 per share. Based on an
exchange rate of A$1.00 =
US$1.04(5), the transaction value is
approximately US$355 million.
Under the SID, the consideration offered may be structured to
include a fully franked, special dividend (payable only if the
Scheme becomes effective and upon receipt of a favourable ATO
ruling, and subject to Cellestis Board approval). The cash
consideration payable under the Scheme would be reduced by the cash
amount of any dividend paid.
The acquisition will be implemented by way of a Scheme of
Arrangement pursuant to which Cellestis shareholders will receive a
cash payment for their shares. Full details of the transaction will
be set out in the Scheme booklet.
The offer for Cellestis' shares represents a premium of:
- 24.3% to the one-month volume weighted average share price
prior to this announcement;
- 31.5% to the three-month volume weighted average share price;
and
- 39.2% to the six-month volume weighted average share
price.
The Cellestis board of directors unanimously recommends
shareholders vote in favour of the Scheme in the absence of a
superior proposal and subject to an Independent Expert concluding
that the Scheme is fair and reasonable and in the best interests of
Cellestis shareholders. All members of the Cellestis board of
directors intend to vote or cause to be voted all of their direct
and indirect interests in Cellestis in favour of the Scheme
(subject to the same qualifications as their recommendations),
which in aggregate amount to approximately 27% of Cellestis'
outstanding shares.
QIAGEN and Cellestis have agreed to customary exclusivity
arrangements in relation to the SID, including that unless the SID
is terminated, Cellestis will not solicit any competing transaction
or (subject to the fiduciary duties of the Cellestis directors)
participate in any discussions or negotiations in relation to any
competing transaction. QIAGEN also has a right in the SID to match
a competing offer prior to Cellestis entering into any other
agreement regarding a superior proposal. Under certain
circumstances set out in the SID, Cellestis has agreed to pay
QIAGEN a break fee of A$3.5
million.
In addition, QIAGEN has entered into an option deed with each of
the two founders of Cellestis – Anthony
Radford and James Rothel –
and their respective controlled entities and joint shareholders.
Pursuant to this deed, QIAGEN has been granted an option to acquire
a total of 14.9% of the ordinary shares in Cellestis for
A$3.55 per share, and to acquire a
further 5% at the same price subject to approval by the Australian
Foreign Investment Review Board (FIRB) where a competing
transaction is matched by QIAGEN under the matching rights included
in the SID or in certain circumstances where a competing
transaction is not matched by QIAGEN.
The Scheme is subject to a number of conditions, including FIRB
approval, court approval and the approval of Cellestis
shareholders. A full copy of the Scheme Implementation Deed has
been released to the Australian Securities Exchange (ASX).
A Scheme booklet with full details of the transaction, including
an Independent Expert's Report, is expected to be distributed to
Cellestis shareholders in May 2011.
The shareholder meeting to approve the Scheme is expected to be
held in June 2011.
A more detailed timetable for the approval and implementation of
the transaction will be announced in due course.
QIAGEN will fund this acquisition from existing cash. On an
adjusted basis, which excludes one-time charges, integration and
restructuring costs, and amortization of acquisition-related
intangible assets, the transaction is expected to be moderately
dilutive to full-year 2011 adjusted EPS due to planned large
investments in sales capabilities and R&D initiatives for
migration of existing Cellestis products onto QIAGEN platforms as
well as for new product developments.
For 2012, QIAGEN expects double-digit sales growth from
QuantiFERON® products and accretion of approximately US$0.02-0.03 to adjusted EPS.
Barclays Capital is acting as exclusive financial adviser and
Freehills is acting as legal adviser to QIAGEN in relation to the
transaction.
Further information on this transaction can be found in the
Investor Relations section of the QIAGEN website at
www.qiagen.com.
About Cellestis
Cellestis Limited is a listed Australian biotechnology company
commercialising QuantiFERON® technology for diagnosing TB and other
diseases worldwide. QuantiFERON® - TB Gold tests for the presence
or absence of a protein (gamma-interferon) produced by a patient's
white blood cells after stimulation with specific TB proteins. The
test has received regulatory and policy approvals in the
USA, Japan, Europe
and elsewhere. The Company operates through subsidiaries in the
USA, Europe, Australia, Singapore and Japan.
Further information about Cellestis can be found at
http://www.cellestis.com.
About QIAGEN
QIAGEN N.V., a Netherlands
holding company, is the leading global provider of sample
and assay technologies. Sample technologies are used to
isolate and process DNA, RNA and proteins from biological samples
such as blood or tissue. Assay technologies are used to make
such isolated bio-molecules visible. QIAGEN has developed and
markets more than 500 sample and assay products as well as
automated solutions for such consumables. The
company provides its products to molecular diagnostics
laboratories, academic researchers, pharmaceutical and
biotechnology companies, and applied testing customers for
purposes such as forensics, animal or food testing and
pharmaceutical process control. QIAGEN's assay technologies
include one of the broadest panels of molecular diagnostic tests
available worldwide. This panel includes the digene HPV Test, which
is regarded as a "gold standard" in testing for high-risk types of
human papillomavirus (HPV), the primary cause of cervical cancer,
as well as a broad suite of solutions for infectious disease
testing and companion diagnostics. QIAGEN employs nearly 3,600
people in over 30 locations worldwide. Further information about
QIAGEN can be found at http://www.qiagen.com/.
Certain of the statements contained in this news release may
be considered forward-looking statements within the meaning of
Section 27A of the U.S. Securities Act of 1933, as amended, and
Section 21E of the U.S. Securities Exchange Act of 1934, as
amended. These forward-looking statements, which may
include, but are not limited to, statements concerning the
financial condition, results of operations and businesses of QIAGEN
and Cellestis and the benefits expected to result from the
contemplated transaction, are based on management's current
expectations and estimates and involve risks and uncertainties that
could cause actual results or outcomes to differ materially from
those contemplated by the forward-looking statements.
Factors that could cause or contribute to such differences may
include, but are not limited to, the risk that the conditions
relating to the required approvals and clearances might not be
satisfied in a timely manner or at all, risks relating to the
integration of the technologies and businesses of QIAGEN and
Cellestis, unanticipated expenditures, changing relationships with
customers, suppliers and strategic partners, failure to achieve
anticipated growth in sales, conditions of the economy and other
factors described in QIAGEN's most recent reports on Form 20-F,
Form 6-K and other periodic reports For further information,
refer to the discussions in these reports that QIAGEN has filed
with, or furnished to, the U.S. Securities and Exchange Commission
(SEC).
QIAGEN has included adjusted financial measures in this
release to give additional insight into QIAGEN's anticipated
financial performance for periods in which the corresponding
measures prepared in accordance with generally accepted accounting
principles cannot yet be determined.
(1) Based upon 96.15 million ordinary shares and excludes any
cash payments to option holders.
(2) The Cellestis board of directors unanimously recommends
shareholders vote in favour of the Scheme in the absence of a
superior proposal and subject to an Independent Expert concluding
that the Scheme is fair and reasonable and in the best interest of
Cellestis shareholders.
(3) QFT is indicated for use in the
United States as an in vitro diagnostic (IVD) test using a
peptide cocktail simulating ESAT-6, CFP-10 and TB7 7(p4) proteins
to stimulate cells in heparinized whole blood drawn directly into
specialized blood collection tubes. Detection of interferon-y by
enzyme-linked immunosorbent assay (ELISA) is used to identify in
vitro responses to these peptide antigens that are associated with
mycobacterium tuberculosis infection.
(4) QuantiFERON®-CMV is IVD CE marked for clinical use in the
European Union and is a Research Use Only Product in the United States.
(5) Foreign exchange rates as of April 1,
2011.
SOURCE QIAGEN N.V.