DSM and Crucell Celebrate Opening of PERCIVIA PER.C6® Development
Center in Cambridge, Mass.
New facility exclusively dedicated to research and development of
PER.C6® human cell line platform for licensees
Parsippany, USA/Leiden, The Netherlands, November 8, 2006 - Dutch
biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss
Exchange: CRX) and technology partner DSM Biologics, a business unit
of DSM Pharmaceutical Products announced today the opening of the
PERCIVIA PER.C6® Development Center, a product of an earlier
announced joint venture between the two Dutch companies. The
official opening ceremonies will take place at the PER.C6®
Development Center (1 Hampshire Street, Cambridge, Mass.) on Tuesday,
November 14 at 11 a.m.
PERCIVIA was conceived and designed to further develop the PER.C6®
cell line and provide turnkey solutions for the production of
pharmaceutical proteins to licensees utilizing the PER.C6® human cell
line in the biotech industry - currently a $35 billion USD industry.
"PERCIVIA's state-of-the-art facility will generate the know-how and
support for the use of PER.C6® cells in the manufacturing of human
therapeutic proteins," said Dr. Marco Cacciuttolo, Chief Executive
Officer of PERCIVIA. "With over 20 companies licensing the
technology for protein and monoclonal antibody production, we
anticipate that the PER.C6® cell line will become the leading choice
for many biotechnology and pharmaceutical companies, and PERCIVIA is
well-positioned to support this growing market."
"The tremendous promise and potential of PER.C6® technology has
become apparent not only from our own work, but particularly from
customer and licensee feedback," commented Leendert Staal, Chief
Executive Officer of DSM Pharmaceutical Products. "This R&D center
dedicated to the further development of the PER.C6® technology
platform will play a key role in establishing the PER.C6® cell line
as a new standard in the production of human therapeutic proteins."
Ronald H.P. Brus, President & CEO of Crucell added: "Our current and
future PER.C6® technology licensees will be able to continuously
benefit from the know-how generated in the PERCIVIA PER.C6®
Development Center. The recombinant protein market is very large and
still growing, and we believe that this center will provide an
important service to licensees in this progressive industry."
The PER.C6® technology platform and protein production
The PER.C6® technology platform, optimized at PERCIVIA, will be
comprised of cell line generation technology, cell culture media
development, upstream and downstream processes, equipment selection,
scale-up, technology transfer, and regulatory support.
The key benefits of the PER.C6® cell line are:
Ø Rapid development - Crucell, DSM and their vendor network
have worked closely together to offer customers a serum-free,
suspension adapted PER.C6® cell line in three months, and move from
clone to Phase I material in less than 12 months.
Ø Regulatory acceptance & safety in the clinic - Many
PER.C6® produced products have been tested in clinical trials, with
several heading towards Phase III trials. In the clinic, not a single
adverse event has been documented due to the use of PER.C6® produced
materials. The complete history of the cell line is documented in an
FDA-filed Biologics Master File (BMF), in greater detail than any
other cell line.
Ø Human-like glycosylation - PER.C6® cells provide
human-like glycosylation for monoclonal antibodies. Products
produced in rodent-derived cell lines, such as NS/0 and CHO, do not
have human glycosylation profiles like the PER.C6® cell line.
Ø Scalable and high yields - The PER.C6® cell line has
successfully performed up to a 20,000L scale. For IgG1 monoclonal
antibodies, production levels of 3.5g/L (and up to 40pg/cell/day)
have been achieved with PER.C6® cells.
About PERCIVIA
PERCIVIA PER.C6® Development Center LLC is a joint venture between
DSM and Crucell. The Center has approximately 47,000 square feet of
laboratory space in Cambridge, Mass, and will have a staff of 50
highly skilled staff engaged in the development and optimization of
the human PER.C6® cells as an expression platform for proteins and
monoclonal antibodies for therapeutic use. This center of excellence
will provide a fully integrated technology platform, and true
turn-key solutions for the production of pharmaceutical proteins, to
the biotech industry and scientific community. This PER.C6®
technology platform will comprise cell line generation technology,
cell culture media development, upstream and downstream processes,
equipment selection, scale-up, technology transfer, and regulatory
support. PERCIVIA will have dedicated space for PER.C6® cell line
users to experience the technology hands on. For more information,
please visit www.PERCIVIA.com.
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 and the only aluminum-free hepatitis A
vaccine on the market. The Company has a broad development pipeline,
with several Crucell products based on its unique PER.C6® production
technology. The Company licenses this and other technologies to the
biopharmaceutical industry. Important partners and licensees include
DSM Biologics, sanofi aventis, GSK and Merck & Co. Crucell is
headquartered in Leiden (the Netherlands), with subsidiaries in
Switzerland, Spain, Italy, Korea and the US. The Company employs
about 900 people. For more information, please visit www.crucell.com.
About DSM Biologics
DSM Biologics, a business unit of DSM Pharmaceutical Products, is a
leading provider of manufacturing technology and services to the
biopharmaceutical industry. In addition to offering world-class
biopharmaceutical manufacturing services, DSM Biologics has
co-exclusive rights, along with Dutch biotech company Crucell N.V.,
to license the high-producing PER.C6® human cell line as a production
platform for recombinant proteins and monoclonal antibodies. DSM
Biologics' FDA-approved facility in Groningen, The Netherlands, was
established in 1986 and has a strong track record in using a broad
range of cell lines (PER.C6®, CHO, hybridoma, etc.) in
biopharmaceutical manufacturing, and has a wide range of experience
using multiple manufacturing (batch, fed-batch and continuous
perfusion) and purification techniques. The combination of the
PER.C6® human cell line and DSM's manufacturing services provides
companies with a turn-key biologic manufacturing solution reducing
cost, risk and time to market. For more information, please visit
www.dsmbiologics.com.
About DSM
DSM is active worldwide in nutritional and pharma ingredients,
performance materials and industrial chemicals. The company creates
innovative products and services that help improve the quality of
life. DSM's products are used in a wide range of end markets and
applications such as human and animal nutrition and health,
cosmetics, pharmaceuticals, automotive and transport, coatings,
housing and electrics & electronics (E&E). DSM's strategy, named
Vision 2010 - Building on Strengths, focuses on accelerating
profitable and innovative growth of the company's specialties
portfolio. Market-driven growth, innovation and increased presence in
emerging economies are key drivers of this strategy. The group has
annual sales of over EUR 8 billion and employs some 22,000 people
worldwide. DSM ranks among the global leaders in many of its fields.
The company is headquartered in the Netherlands, with locations in
Europe, Asia, Africa and the Americas. More information about DSM can
be found at www.dsm.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 July 6,
2006, and the section entitled "Risk Factors". The company prepares
its financial statements under generally accepted accounting
principles in the United States (US GAAP) and Europe (IFRS).
For further information please contact:
Crucell N.V. DSM Biologics
Paul Vermeij Brad Carlson
Director Investor Relations and Corporate Vice President, Marketing,
Communications Sales & NBD
Tel. +31 (0)71 524 8718 Tel. +1 (585) 624-3844
p.vermeij@crucell.com Brad.Carlson@dsm.com
Agency Contact, USA
Michelle Tsai, Hill & Knowlton, Inc.
Tel. 1 212 885 0366
Fax. 1 212 885 0570
michelle.tsai@hillandknowlton.com
