UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
The Securities Exchange Act of 1934
September 28, 2009
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CRUCELL NV
(Exact name of registrant as specified in its charter)
P.O. BOX 2048 ARCHIMEDESWEG 4 2333 CN LEIDEN THE NETHERLANDS
(Address of principal executive offices)
000-30962
(Commission File Number)
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Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F:
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
JOHNSON & JOHNSON AND CRUCELL ANNOUNCE STRATEGIC COLLABORATION TO DEVELOP
INNOVATIVE PRODUCTS, INCLUDING THERAPIES FOR INFLUENZA PREVENTION AND TREATMENT
AGREEMENT ALSO INCLUDES 18% EQUITY INVESTMENT IN CRUCELL BY JOHNSON & JOHNSON
AND COLLABORATION TO DEVELOP INNOVATIVE THERAPIES FOR OTHER DISEASES
NEW BRUNSWICK, N.J., AND LEIDEN, THE NETHERLANDS, 28 SEPTEMBER 2009 - Johnson &
Johnson (NYSE: JNJ) and Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange:
CRX) today announced that Johnson & Johnson, through its subsidiary
Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Crucell have entered into a
strategic collaboration focusing on the discovery, development and
commercialization of monoclonal antibodies and vaccines for the treatment and
prevention of influenza and other infectious and non-infectious diseases.
The immediate focus of the collaboration will be the development and
commercialization of a universal monoclonal antibody product (flu-mAb) for the
treatment and prevention of influenza. The focus of the long-term innovation
collaboration will be on new discovery programs leading to the development and
commercialization of a universal influenza vaccine as well as the development of
monoclonal antibodies and/or vaccines directed against up to three other
infectious and non-infectious disease targets.
Johnson & Johnson, through its affiliate JHC Nederland B.V., has also purchased
14.6 million newly issued ordinary shares of Crucell, representing approximately
18% of Crucell's outstanding ordinary shares, for an aggregate purchase price of
(euro) 301.8 million. In addition, the companies have agreed to development
milestones and royalty payments based on the successful development and
commercialization of products in connection with the collaboration.
Under the flu-mAb collaboration, Crucell and Ortho-McNeil-Janssen
Pharmaceuticals or its affiliates will share responsibilities to develop a
universal flu-mAb product targeting all influenza A strains, including H1N1
strains (which cause seasonal flu and the current pandemic) and the H5N1 or
avian strain ('bird flu'). Crucell will be responsible for research and
development through Phase IIa of the influenza antibodies it has already
discovered, as well as newly discovered influenza antibodies that emerge from
the collaboration. Ortho-McNeil-Janssen Pharmaceuticals or its affiliates will
be responsible for late-stage development of the flu-mAb product from Phase IIb
onward.
Under the long-term innovation collaboration, Ortho-McNeil-Janssen
Pharmaceuticals or its affiliates and Crucell will jointly work to discover and
develop a universal flu vaccine for the prevention of influenza, as well as
antibody and/or vaccine products against up to three additional infectious or
non-infectious disease targets to be selected after exploratory research.
Both collaborations will leverage the vaccine/antibody know-how and technology
platforms of Crucell and the broad scientific and development expertise of
Ortho-McNeil-Janssen Pharmaceuticals and its affiliates.
Ortho-McNeil-Janssen Pharmaceuticals will hold commercialization rights for
products resulting from both collaborations in all countries throughout the
world with the exception of the European Union and certain additional European
countries, where Crucell will retain commercialization rights.
Ortho-McNeil-Janssen Pharmaceuticals' commercialization rights for products
emerging from the innovation collaboration may be expanded worldwide if Crucell
elects not to contribute toward development.
Influenza causes significant morbidity and mortality worldwide. In 2008 alone,
some 14 million people in the industrialized world were diagnosed with
influenza, with millions more being diagnosed in developing regions. Annual flu
epidemics are thought to result in 3-5 million cases of severe illness and
result in more than 350 thousand deaths every year around the world.
"Despite significant advances in prevention and treatment, influenza remains a
major health threat, and each year, vaccines must be formulated to address the
current influenza strain," said Paul Stoffels, Global Head, Pharmaceuticals
Research and Development, Johnson & Johnson. "A universal antibody or vaccine
that protects against a broad range of strains would be an important advance in
helping doctors and nurses manage the annual influenza season and control acute
epidemic and pandemic outbreaks. We are excited about this collaboration with
Crucell because it provides us access to antibody and vaccine know-how and
technology and expands our ability to offer preventive health care solutions for
unmet medical needs."
Crucell's Chief Executive Officer, Ronald Brus, said: "Crucell's innovative
technologies for the discovery, development and manufacture of antibody products
and vaccines provide avenues to develop much-needed medical solutions for global
health threats. We are delighted that this collaboration with Johnson & Johnson
will strengthen and facilitate our efforts to bring innovation to global health.
It provides an avenue to accelerate Crucell's existing 'flu-mAb' program, which
has already demonstrated the potential to deliver an antibody product for the
prevention and treatment of any type of influenza strain.
In connection with the equity investment, Crucell and JHC Nederland have entered
into a shareholder agreement setting forth certain rights and restrictions of
JHC Nederland as a shareholder, which includes a 3-year standstill requiring
Crucell's consent for an increase of JHC Nederland's interest in Crucell
(subject to customary exceptions), a 3-month lock-up on transfers of the shares
(subject to customary exceptions) and certain other provisions. The shareholder
agreement will be described in more detail in the prospectus which will be
issued by Crucell in connection with the listing of the shares issued to JHC
Nederland.
On August 18, 2009, Crucell announced that it had received a US National
Institutes of Health (NIH) contract aimed at advancing the development of
monoclonal antibodies for the treatment of seasonal and pandemic influenza. The
contract provides funding of up to $40.7 million, with additional options worth
a further $28.4 million that may be triggered at the discretion of the NIH,
bringing the potential total award amount to $69.1 million. This funding will be
used for Crucell's work in the flu-mAb collaboration announced today between
Crucell and Ortho-McNeil-Janssen Pharmaceuticals to expedite the potential
availability of a universal antibody product for the treatment and prevention of
influenza in humans.
The transaction is expected to have an estimated dilutive impact of $0.02 to
$0.04 on Johnson & Johnson's 2009 adjusted earnings per share.
Barclays Capital acted as financial advisor to Crucell.
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Crucell Conference Call and Webcast for media
At 09:00 Central European Time (CET), Crucell's management will conduct a
conference call for all media, which will also be webcast. To participate in the
conference call, please call one of the following telephone numbers 15 minutes
prior to the event:
+44 203 003 2666 for the UK;
+1 646 843 4608 for the US; and
+3120 794 8426 for the Netherlands
Following a short introduction on the collaboration with Johnson & Johnson, the
lines will be opened for a question and answer session.
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Crucell Conference Call and Webcast for analysts/investors
At 14:00 Central European Time (CET), Crucell's management will conduct a
conference call for analysts and investors, which will also be webcast. To
participate in the conference call, please call one of the following telephone
numbers 15 minutes prior to the event:
+44 203 003 2666 for the UK;
+1 646 843 4608 for the US; and
+3120 794 8426 for the Netherlands
Following a presentation of the collaboration with Johnson & Johnson, the lines
will be opened for a question and answer session.
Both live audio webcasts can be accessed via the homepage of Crucell's website
at www.crucell.com and will be archived and available for replay following the
event.
ABOUT JOHNSON & JOHNSON
Caring for the world, one person at a time..inspires and unites the people of
Johnson & Johnson. We embrace research and science - bringing innovative ideas,
products and services to advance the health and well-being of people. Our
approximately 117,000 employees at more than 250 Johnson & Johnson companies
work with partners in health care to touch the lives of over a billion people
every day throughout the world.
ABOUT CRUCELL
Crucell N.V. is a global biopharmaceutical company focused on research
development, production and marketing of vaccines, proteins and antibodies that
prevent and/or treat infectious diseases. Its vaccines are sold in public and
private markets worldwide. Crucell's core portfolio includes a vaccine against
hepatitis B, a fully-liquid vaccine against five important childhood diseases
and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel
vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine
and the only aluminum-free hepatitis A vaccine on the market. The Company has a
broad development pipeline, with several product candidates based on its unique
PER.C6(R) production technology. The Company licenses its PER.C6(R) technology
and other technologies to the biopharmaceutical industry. Important partners and
licensees include DSM Biologics, Sanofi-Aventis, Novartis, Wyeth, GSK, CSL and
Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with
subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S. The
Company employs over 1000 people. For more information, please visit
www.crucell.com.
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from Johnson & Johnson's and Crucell's expectations and
projections. Risks and uncertainties include the potential that market segment
growth will not follow historical patterns; general industry conditions and
competition; business and economic conditions, such as interest rate and
currency exchange rate fluctuations; technological advances and patents attained
by competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign healthcare reforms and
government laws and regulations; and trends toward healthcare cost containment.
A further list and description of these risks, uncertainties and other factors
can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for
the fiscal year ended December 28, 2008, and Crucell's Annual Report/ Form 20-F
for the fiscal year ended December 31, 2008, as filed with the U.S. Securities
and Exchange Commission on April 22, 2009, as well as other subsequent filings.
Crucell prepares its financial statements under International Financial
Reporting Standards (IFRS). Copies of all referenced filings, as well as
subsequent filings, are available online at www.sec.gov, www.jnj.com,
www.crucell.com, or on request from Johnson & Johnson or Crucell. Neither
Johnson & Johnson nor Crucell undertakes to update any forward-looking
statements as a result of new information or future events or developments.
FOR FURTHER INFORMATION PLEASE CONTACT:
CRUCELL N.V. - MEDIA & INVESTORS
Oya Yavuz
Vice President
Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
ir@crucell.com
www.crucell.com
JOHNSON & JOHNSON - MEDIA
Frederik Wittock
Johnson & Johnson
Tel. + 32 14 60 57 24
Mob. + 32 476 92 5077
Seema Kumar
Tel. +1 (908)218 6460
Mob. +1 (908) 405 1144
Bill Price
Tel. +1 (732) 524 3922
Mob. +1 (732) 668 3735
JOHNSON & JOHNSON - INVESTORS
Louise Mehrotra
Tel. +1 (732) 524 6491
Stan Panasewicz
Tel. +1 (732) 524 2524
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CRUCELL NV
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(Registrant)
September 28, 2009 /s/ OYA YAVUZ
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(Date) Oya Yavuz
Director of Investor Relations