DSM and Crucell Sign Agreement with Avid Bioservices to Serve as
First Pre-Approved U.S. Contract Manufacturer of PER.C6® Cell Line
Proteins
Leiden, The Netherlands/Parsippany, USA, 25 June 2008 - DSM Biologics
and Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX)
announced today that they have entered into an agreement with Avid
Bioservices, Inc. of Tustin, California to join their Vendor Network.
Under the terms of the agreement, Avid will be a pre-approved
contract manufacturer (CMO) for licensees of the PER.C6® cell line
located in the western U.S. Avid is the first U.S.-based contract
manufacturer to be awarded this status.
Karen King, president of DSM Biologics notes, "We are confident that
Avid's excellent reputation and service level will be instrumental in
making the PER.C6® technology available to licensees on the West
Coast, bringing our technology to a wider regional base as we
continue to grow globally."
Steven W. King, president of Avid Bioservices added "We are honored
to achieve the distinction of being the first pre-approved U.S.-based
CMO to manufacture proteins and antibodies using the PER.C6® cell
line. The PER.C6® technology is recognized throughout our industry as
providing important advantages compared to other platforms, including
serum-free medium, scalability and high productivity levels making
the system an ideal fit for Avid."
Crucell and DSM last week announced a breakthrough in the production
of IgG antibodies using Crucell's PER.C6® technology. By employing
the PER.C6® human cell line and DSM's proprietary XD(TM) technology,
a record yield of over 27 grams per liter has been achieved.
The PER.C6® technology platform has been developed for the
large-scale manufacture of biopharmaceutical products such as
recombinant proteins, including monoclonal antibodies. Compared to
conventional production technologies, the strengths of PER.C6®
technology lie in its excellent safety profile, scalability and
productivity under serum-free culture conditions.
Other terms of the agreement were not disclosed. Avid Bioservices is
a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. (NASDAQ:
PPHM).
About PER.C6® technology
Crucell's PER.C6® technology platform has been developed for the
large-scale manufacture of biopharmaceutical products such as
recombinant proteins including monoclonal antibodies. Compared to
conventional production technologies, the strengths of PER.C6®
technology lie in its excellent safety profile, scalability and
productivity under serum-free culture conditions.
About XD(TM) technology
DSM's XD(TM) technology has been developed as a proprietary system to
drive yield improvements in mammalian systems. "XD" stands for
extreme density, as the process is able to push the cell density
within the bioreactor to maximum productivity.
About Avid Bioservices, Inc.
Avid Bioservices provides a comprehensive range of cGMP manufacturing
services for the biotechnology and biopharmaceutical industries. Avid
manufactures cGMP commercial product, as well as clinical supplies
for all phases of clinical trials. The company's comprehensive range
of cGMP services includes cell banking, stability testing, clinical
product manufacturing and purification, bulk packaging, final product
filling and regulatory support. Avid also provides a variety of
process development activities, including cell line optimization,
analytical method development and product characterization. Avid has
over 10 years of antibody manufacturing experience producing
monoclonal antibodies and recombinant proteins in batch, fed-batch
and perfusion modes. For more information about Avid, visit
www.avidbio.com.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of innovative product candidates in clinical trials for the
treatment of cancer and hepatitis C virus (HCV) infection. The
company is pursuing three separate clinical programs in cancer and
HCV infection with its lead product candidates bavituximab and
Cotara®. Peregrine also has in-house manufacturing capabilities
through its wholly owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and bio-manufacturing
services for both Peregrine and outside customers. Additional
information about Peregrine can be found at www.peregrineinc.com.
About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a
global biopharma company focused on research, development, production
and marketing of vaccines, proteins and antibodies that prevent and
treat primarily 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® production technology. The Company licenses its
PER.C6® technology 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 1000 people. For more information, please visit
www.crucell.com.
About DSM Biologics
DSM Biologics, a business unit of DSM Pharmaceutical Products, is a
global provider of manufacturing technology & 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. 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.
DSM - the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates innovative products and services in Life
Sciences and Materials Sciences that contribute to the quality of
life. DSM's products and services are used globally in a wide range
of markets and applications, supporting a healthier, more sustainable
and more enjoyable way of life. End markets include human and animal
nutrition and health, personal care, pharmaceuticals, automotive,
coatings and paint, electrics and electronics, life protection and
housing. DSM has annual sales of almost EUR 8.8 billion and employs
some 23,000 people worldwide. The company is headquartered in the
Netherlands, with locations on five continents. DSM is listed on
Euronext Amsterdam. More information: www.dsm.com.
DSM Forward-looking statements
This press release contains forward-looking statements that involve
inherent risks and uncertainties. These statements are based on
current expectations, estimates and projections of the management of
DSM and Crucell and information currently available to both
companies. The statements involve certain risks and uncertainties
that are difficult to predict and therefore DSM and Crucell do not
guarantee that their expectations will be realized. Furthermore, DSM
and Crucell have no obligation to update the statements contained in
this press release.
Crucell N.V. has 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 the Form 20-F, as filed by Crucell N.V. with the U.S.
Securities and Exchange Commission on May 7, 2008, and in particular
the section entitled "Risk Factors". Crucell N.V. prepares its
financial statements under International Financial Reporting
Standards (IFRS).
For further information please contact:
DSM Pharmaceutical Products Crucell N.V.
Karen King Oya Yavuz
President Director Corporate Communications &
DSM Biologics Investor Relations
Tel: +1-973-257-8427 Tel: +31-71-519 7064
Karen.King@dsm.com ir@crucell.com
DSM Biologics Avid Bioservices
Marcel Lubben Candice Fliedner
Vice President Tel: +1 714-508-6188
Marketing, Sales & NBD cfliedner@avidbio.com
Tel: +31-46-477 3343
marcel-m.lubben@dsm.com Avid Bioservices
Media
Barbara Lindheim
Tel: +1- 212-918-4650
