One of the Largest Facilities of its Kind in the World Will Be Capable of
Manufacturing Multiple Products
CAMBRIDGE, Mass., Aug. 1 /PRNewswire-FirstCall/ -- Biogen, Inc. (Nasdaq:
BGEN) today announced that the U.S. Food and Drug Administration (FDA) has
approved the company's large-scale manufacturing plant (LSM) in Research
Triangle Park (RTP), North Carolina for commercial production of its chronic
plaque psoriasis drug AMEVIVE(R) (alefacept). Biogen plans to use the LSM,
which has 90,000 liters of bioreactor capacity, to manufacture future products
in the company's pipeline.
(Logo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
"Biogen is proud to earn regulatory approval for one of the largest
biologic manufacturing facilities in the world. LSM provides us with the
flexibility to manufacture multiple products and reinforces our leadership in
biologics manufacturing," said Sylvie Gregoire, Pharm.D, Biogen's Executive
Vice President, Technical Operations. "Most importantly, this world-class
facility enhances Biogen's ability to provide products to patients, including
therapies such as AMEVIVE."
Biogen broke ground on the 250,000-square-foot facility in 1999 and
completed construction ahead of schedule. The LSM became operational in 2002,
manufacturing product just 32 months after groundbreaking. Since then, Biogen
has been completing the necessary steps to achieve licensure of the facility.
Licensure or approval of a facility is the last step required for the
manufacture and distribution of commercial product. Before a product can be
produced and distributed at a new manufacturing facility, the site must pass
through several phases which include start-up, validation, trial runs,
qualification lots, and FDA inspection.
The $173 million facility has received industry recognition for its
exceptional design, innovative modular construction methods, and strong safety
record. It houses six 15,000-liter bioreactors, which are needed to produce
large quantities of biologics. This brings Biogen's total capacity for
mamallian cell products to 106,000 liters. Of the more than 430 Biogen
employees in RTP, over 100 work in a variety of manufacturing functions in the
LSM. As part of the original development plan of the facility, the company is
enhancing its capability with the addition of a second purification suite,
which will allow the facility to manufacture two products simultaneously.
This purification suite is currently in the validation stage.
Biogen announced in June 2003 that it signed a merger agreement with IDEC
Pharmaceuticals Corporation, which is currently building a 90,000-liter
manufacturing facility in Oceanside, California. If the merger is completed
and IDEC's facility is ultimately approved, the combined company, to be known
as BIOGEN IDEC INC., would have one of the biotech industry's largest
manufacturing capacities at over 200,000 liters.
AMEVIVE will be manufactured in the LSM. AMEVIVE was launched in the U.S.
in February 2003 for the treatment of adult patients with moderate-to-severe-
chronic plaque psoriasis who are candidates for systemic therapy or
phototherapy. It is the only FDA-approved biologic therapy for the disease.
AMEVIVE is administered via IM or IV injection once per week for 12 doses
under the supervision of a physician. For more information about AMEVIVE,
including prescribing information and Biogen's comprehensive support services,
call 1-866-AMEVIVE or visit http://www.amevive.com.
About Biogen
Biogen is the world's oldest independent biotechnology company and a
leader in biologics research, development and manufacturing. A pioneer in
leading edge research in immunology, neurobiology and oncology, Biogen brings
novel therapies to improve patients' lives around the world through its global
marketing capabilities. For press releases and additional information about
the company, please visit http://www.biogen.com.
Forward Looking Statements
This press release contains forward-looking statements regarding the use
and expansion of the LSM. These statements are based on the company's current
beliefs and expectations. A number of risks and uncertainties could cause
actual results to differ materially. For example, the use and expansion of
the LSM may be affected by problems or delays that arise during the addition
of the second purification suite, changes in the company's strategic plans,
and events related to the company's drug development and commercialization
efforts.
For more detailed information on the risks and uncertainties associated
with these forward looking statements and the company's other activities see
the Outlook section in MD&A of the company's Annual Report on Form 10-K and
quarterly reports on Form 10-Q filed with the Securities and Exchange
Commission. The company does not undertake any obligation to publicly update
any forward-looking statements.
Media Contact:
Amy Brockelman
Manager, Public Affairs
Biogen, Inc.
Tel: (617) 914-6524
Investment Community Contact:
Christina Dillon
Manager, Investor Relations
Biogen, Inc.
Tel: (617) 679-2812
SOURCE Biogen, Inc.
 back to top
Related links:
http://www.biogen.com
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
CONTACT:
Amy Brockelman, Manager, Public Affairs,
+1-617-914-6524, or Christina Dillon, Manager, Investor
Relations, +1-617-679-2812 both of Biogen, Inc.
Logo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO AP Archive:
http://photoarchive.ap.org PRN Photo Desk, 888-776-6555 or
212-782-2840
|
