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
November 13, 2007
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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]
CRUCELL'S RABIES ANTIBODY COCKTAIL GRANTED FAST TRACK STATUS
LEIDEN, THE NETHERLANDS, 13 NOVEMBER 2007 - Dutch biotechnology company Crucell
N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced that it has
been notified by the Food and Drug Administration's (FDA) Department of Health
and Human Services that its rabies monoclonal antibody cocktail has been granted
a Fast Track designation.
On 3 October 2007 Crucell presented the results of the first clinical evaluation
of the rabies cocktail at the XVIII Rabies in the Americas RITA conference in
Mexico. This first-in-man phase I study, which was conducted in the US and
started in January 2007, indicates that the cocktail is well tolerated, that it
provides the expected neutralizing activity and that it can be safely
co-administered in combination with a standard rabies vaccine.
Under the FDA Modernization Act of 1997, the Fast Track program was implemented
to facilitate the development and expedite the review of new drugs that are
intended to treat serious or life-threatening diseases and that demonstrate the
potential to address unmet medical needs. The Fast Track designation allows for
frequent communications with the FDA and the possibility of submitting portions
of the marketing application (a 'BLA') before the complete BLA is submitted.
"We are very pleased to receive the Fast Track designation for our rabies
antibody cocktail," said Dr. Jaap Goudsmit, Crucell's Chief Scientific Officer.
"Given the unmet medical need in rabies we are committed to moving as fast as
possible. This designation along with its allowance of frequent interaction with
the FDA and possible priority review mechanisms clearly signal the importance of
expanding rabies treatment availability. People deserve to be protected against
rabies."
Crucell is developing the rabies antibody cocktail for the post-exposure
prophylaxis of rabies. The antibody cocktail is a combination of two human
monoclonal antibodies and it is produced with the use of Crucell's MAbstract(R)
and PER.C6(R) technologies. Based on market needs, peak sales for Crucell's
cocktail are expected to exceed $300 million.
A second phase I study with the aim to assess the safety and efficacy of the
antibody cocktail started in India in April 2007. The results of this study will
be presented on November 30, 2007 at the Joint International Tropical Medicine
Meeting 2007 in Bangkok, Thailand.
Crucell already contracted DSM Biologics, its alliance partner for the PER.C6(R)
technology platform, for the process validation and manufacturing of antibody
batches for phase III clinical efficacy studies.
ABOUT RABIES
Rabies is a viral disease of mammals most often transmitted through the bite of
a rabid animal. The virus infects the central nervous system, causing
encephalitis (inflammation of the brain) and ultimately death if medical
intervention is not sought promptly after exposure. There is no proven treatment
for rabies once symptoms of the disease have appeared. Lethal rabies is
prevented by post-exposure prophylaxis (PEP) via the combined administration of
a rabies vaccine and RIG following the bite of a rabid animal. Current supply
and quality of rabies vaccine is sufficient, but RIG is in short supply and
carries certain safety risks.
Rabies is prevalent in Europe, Asia, North and South America as well as Africa.
Every year, approximately 10 million people are vaccinated worldwide. With the
exception of the US and Europe, most of these people do not receive RIG due to
shortages and are therefore not adequately protected. As a result, an estimated
40,000 to 70,000 people die of the disease each year, mainly in Asia.
ABOUT CRUCELL'S RABIES ANTIBODY COCKTAIL PROGRAM
Crucell develops the antibody cocktail using its PER.C6(R) technology, which
offers large-scale manufacturing capabilities and production under serum-free
culture conditions. Crucell's rabies monoclonal antibody cocktail offers the
potential for replacing the traditional serum-derived products that are
currently still used for the treatment of rabies. Based on market needs, peak
sales for Crucell's cocktail are expected to exceed $300 million.
ABOUT PER.C6(R) TECHNOLOGY
Crucell's PER.C6(R) technology is a cell line developed for the large-scale
manufacture of biopharmaceutical products such as recombinant proteins including
monoclonal antibodies. Compared to conventional production technologies, the
strengths of the PER.C6(R) technology lie in its excellent safety profile,
scalability and productivity under serum-free culture conditions.
ABOUT MABSTRACT(R) TECHNOLOGY
Crucell's proprietary MAbstract(R) technology can be used to discover drug
targets, such as cancer markers or proteins from infectious agents including
bacteria and viruses, and identify human antibodies against those drug targets.
ABOUT CRUCELL
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology
company focused on research, development and worldwide marketing of vaccines and
antibodies that prevent and 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 aluminium-free hepatitis A vaccine on the
market. The Company has a broad pipeline, with several products based on its
unique PER.C6(R) production technology in development. The Company licenses this
and other technologies to the biopharmaceutical industry. Important partners and
licensees include DSM Biologics, sanofi aventis, Novartis, Wyeth and Merck & Co.
Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in
Switzerland, Spain, Italy, Sweden, Korea and the US. The Company employs over a
1000 people. For more information, please visit www.crucell.com
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements that involve inherent
risks and uncertainties. We have identified certain important factors that may
cause actual results to differ materially from those contained in such
forward-looking statements. For information relating to these factors please
refer to our Form 20-F, as filed with the U.S. Securities and Exchange
Commission on June 13, 2007, and the section entitled "Risk Factors". The
Company prepares its financial statements under International Financial
Reporting Standards (IFRS) with reconciliation to the generally accepted
accounting principles in the United States (US GAAP).
FOR FURTHER INFORMATION PLEASE CONTACT:
MEDIA: INVESTORS/ANALYSTS:
Barbara Mulder Oya Yavuz
Director Corporate Communications Director Investor Relations
Tel: +31-(0)71-519 7346 Tel. +31-(0)71-519 7064
press@crucell.com ir@crucell.com
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)
November 13, 2007 /s/ LEON KRUIMER
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(Date) Leon Kruimer
Chief Financial Officer