Company Accelerates Acquisition of Rhode Island Biotech Manufacturing Facility
SEATTLE, Nov. 7 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) and
American Home Products Corporation (NYSE: AHP) announced today that the
companies intend to transfer ownership of the manufacturing facility in
Rhode Island on or about January 1, 2002. The facility is being redesigned to
produce ENBREL(R) (etanercept).
U.S. Food and Drug Administration (FDA) approval of the facility is
anticipated in the second half of 2002.
"This manufacturing facility gives us greater commercial strength
-- positioning Immunex among the world's largest, fully integrated
biopharmaceutical companies," said Peggy Phillips, Immunex chief operating
officer and executive vice president. "It is the foundation of one of the
world's largest cell culture manufacturing centers."
Immunex will submit the FDA license application and, upon agency approval,
the Rhode Island facility will become a licensed manufacturing site for
commercial supply of ENBREL. The accelerated transfer of the facility will
allow the company to streamline the completion of validation processes and
conformance runs necessary to receive FDA approval.
"We are proud of the work we did to turn this facility into a
state-of-the-art manufacturing site," said L. Patrick Gage, President,
Wyeth-Ayerst Research (the pharmaceutical division of AHP). "It is now ready
to be integrated into the Immunex organization and will be one of the largest
protein manufacturing facilities in the world."
Efi Cohen-Arazi, senior vice president of supply operations at Immunex
said, "The early transfer also allows us to manage the development of the new
biotech manufacturing center in Rhode Island and to continue to build our team
of highly skilled biotechnology manufacturing professionals."
The facility is expected to cost more than $450 million when completed.
This includes the acquisition of the 75-acre site and current manufacturing
facility. In addition, more than 320 current employees at the plant will join
the Immunex team.
Located in West Greenwich, RI, the current 250,000 square foot facility is
being redesigned for the manufacture of ENBREL. This work involves the design
and installation of hundreds of pieces of equipment, including: eight
commercial-scale bioreactors; more than 25 miles of stainless steel pipe; and
approximately 240 miles of electrical wire. The transfer of the facility to
Immunex is subject to customary regulatory approvals.
Pending approval of permits, Immunex expects to break ground this fall on
a second cell culture manufacturing facility at this same location. The
BioNext Project(TM) will be a 500,000 square foot facility. When the facility
is completed, which is estimated to be in 2005, it will provide employment for
approximately 350 additional people. The two manufacturing plants are
expected to comprise the largest cell culture manufacturing center in the
world.
About ENBREL
Immunex recently reported that several important milestones for ENBREL
were achieved in the last quarter:
-- Record quarterly sales of ENBREL totaled $198.1 million. The company
is managing access to the drug through the ENBREL Enrollment Program
because current demand is greater than available supply.
-- The first manufacturing process improvement for ENBREL was filed with
the U.S. Food and Drug Administration (FDA). Upon FDA approval,
Immunex expects to implement this process throughout 2002 and projects
that it may increase the yield of ENBREL by 10 to 30 percent,
augmenting overall supply of the drug next year.
-- ENBREL was granted priority review for a potential new indication in
psoriatic arthritis by the FDA. Thus, the regulatory agency agreed to
act on the application by mid-January 2002. Psoriatic arthritis is a
disease which affects more than 300,000 people in the United States
(U.S.) and there is currently no therapy approved by the FDA to treat
the disease.
-- Positive Phase 2 results with ENBREL in moderate to severe psoriasis, a
serious skin disease affecting more than one million people in the
U.S., were announced. Data from this Phase 2 study of 112 patients
will be presented at a medical meeting in 2002.
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
NOTE: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines
to differ materially are risks associated with research and clinical
development, regulatory approvals, our supply capabilities and reliance on
third-party manufacturers, product commercialization, competition, litigation
and other risk factors listed from time to time in reports filed by Immunex
with the SEC, including but not limited to risks described under the caption
"Important Factors That May Affect Our Business, Our Results of Operations and
Our Stock Price" within our most recently filed Form 10-Q. The
forward-looking statements contained in this news release represent our
judgment as of the date of this release. Immunex undertakes no obligation to
publicly update any forward-looking statements.
SOURCE Immunex Corporation
 back to top
Related links:
http://www.immunex.com
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/434644.html
CONTACT:
Media, Robin Shapiro, +1-206-389-4040, or
Investors, Mark Leahy, +1-206-389-4363, both of Immunex
Corporation; or Doug Petkus of American Home Products,
+1-610-902-7336
|
