BARCELONETA, Puerto Rico, April 10 /PRNewswire-FirstCall/ -- Abbott
(NYSE: ABT) today announced the official opening of its new
state-of-the-art biologics manufacturing facility in Puerto Rico to support
the long-term supply of its leading biologic agent, HUMIRA(R)(adalimumab),
and other future biologics. The new facility, Abbott Biotechnology Limited
(ABL), received U.S. Food and Drug Administration (FDA) approval in
February to commercially produce HUMIRA for the U.S. market.
"This new facility is a key milestone for Abbott as we move to focus
our resources and future growth on biologic and potent-drug manufacturing,"
said Lawrence Kraus, vice president of manufacturing, global pharmaceutical
operations, Abbott. "The advanced, high-quality infrastructure of ABL can
meet the exceptionally challenging and stringent processes of biologic
manufacturing. With this state-of-the-art facility, we can supply HUMIRA to
the growing number of patients who have come to rely on this breakthrough
ABL is now the main production facility for HUMIRA, the only fully
human monoclonal antibody approved for the treatment of rheumatoid
arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS)
in the U.S. and Europe. The drug is also approved in the U.S. to treat
Crohn's disease. This new plant has significantly more production capacity
than the other manufacturing facility for HUMIRA, the Abbott Bioresearch
Center (ABC) in Worcester, Mass. The ABC site will now serve as a
supporting production facility for HUMIRA and will focus on Abbott's
growing biologics research and development portfolio.
"Abbott's new facility expands Puerto Rico's growing presence as the
Bio Island. We fully support Abbott's operations in Puerto Rico and will
continue to improve our business climate to facilitate future investment
among high technology companies like Abbott," said Hon. Anibal
Acevedo-Vila, Governor of the Commonwealth of Puerto Rico. "Puerto Rico has
been a global leader in manufacturing pharmaceutical products for more than
40 years. Our unique combination of incentives, skilled workforce, strong
infrastructure and excellent business climate enable us to partner with
global industry leaders like Abbott. With the growing presence of Abbott
and others, we have the necessary tools to become a global leader in
biotechnology as well."
The new plant is Abbott's single-largest capital investment to date,
costing approximately $450 million. With this investment, Abbott can
achieve large-scale production volumes in biologic manufacturing. In
addition to producing HUMIRA, the 330,000-sq.-ft. facility is designed for
large-scale production of future products in Abbott's pipeline that will
require advanced manufacturing technologies.
"Abbott is committed to Puerto Rico and proud to help the commonwealth
emerge as a world-class base for biotechnology innovation," said Neil
Aylward, divisional vice president of Puerto Rico operations, Abbott. "ABL
and our other operations in Puerto Rico will continue to play an important
role in supporting Abbott as we continue to bring important, life-changing
products to patients around the world."
About Abbott Puerto Rico
Since establishing operations on the island in 1968, Abbott has
invested more than $1 billion in its Barceloneta, Puerto Rico, site. The
company also has manufacturing operations in Puerto Rico at Jayuya and
Dorado, as well as commercial operations in San Juan and a distribution
center in Guaynabo. Abbott is one of the top five health care companies in
Puerto Rico, employing approximately 2,400 people. In addition to producing
HUMIRA at the new ABL plant, Abbott also manufactures Biaxin, Depakote and
Synthroid in Puerto Rico.
HUMIRA is Abbott's leading pharmaceutical product, with 2006 sales
exceeding $2 billion.
HUMIRA is the only fully human monoclonal antibody approved for the
treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), Crohn's
disease and ankylosing spondylitis (AS) in the U.S. and Europe. HUMIRA
resembles antibodies normally found in the body. It works by blocking tumor
necrosis factor alpha (TNF-a), a protein that when produced in excess,
plays a central role in the inflammatory responses of many immune-mediated
diseases. To date, HUMIRA has been approved in 67 countries and more than
180,000 people worldwide are currently being treated with HUMIRA.
Clinical trials are currently under way evaluating the potential of
HUMIRA in other immune-mediated diseases. Abbott plans to begin trials of
HUMIRA in children and adolescents with psoriasis later this year.
In the U.S., HUMIRA is approved by the FDA for reducing signs and
symptoms, inducing major clinical response, inhibiting the progression of
joint structural damage, and improving physical function in adult patients
with moderately to severely active RA. HUMIRA is indicated for reducing the
signs and symptoms of active arthritis, inhibiting the progression of
structural damage and improving physical function in patients with
psoriatic arthritis. HUMIRA can be used alone or in combination with
methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
HUMIRA is also approved for reducing signs and symptoms in patients with
active AS. On Feb. 27, 2007, HUMIRA was approved for reducing the signs and
symptoms and inducing and maintaining clinical remission in adults with
moderately to severely active Crohn's disease who have had an inadequate
response to conventional therapy.
In Europe, HUMIRA, in combination with methotrexate (MTX), is indicated
for the treatment of moderate to severe, active RA in adult patients when
the response to disease-modifying anti-rheumatic drugs (DMARDs) including
MTX has been inadequate, and for the treatment of severe, active and
progressive RA in adults not previously treated with MTX. HUMIRA can be
given as monotherapy in case of intolerance to MTX or when continued
treatment with MTX is inappropriate. HUMIRA has been shown to reduce the
rate of progression of joint damage as measured by x-ray and to improve
physical function, when given in combination with MTX.
Additionally, HUMIRA is indicated for the treatment of active and
progressive PsA in adults when the response to previous DMARD-therapy has
been inadequate and for the treatment of severe, active AS in adults who
have had an inadequate response to conventional therapy.
On April 2, 2007, Abbott submitted regulatory filings in the U.S. and
Europe seeking approval for HUMIRA in psoriasis. HUMIRA is also being
studied in juvenile rheumatoid arthritis, ulcerative colitis as well as
pediatric Crohn's disease and pediatric psoriasis.
Important Safety Information
Globally, prescribing information varies; refer to the individual
country product label for complete information.
Serious infections, sepsis, tuberculosis (TB) and rare cases of
opportunistic infections, including fatalities, have been reported with the
use of TNF-blocking agents, including HUMIRA. Many of these serious
infections have occurred in patients also taking other immunosuppressive
agents that in addition to their underlying disease could predispose them
to infections. Treatment with HUMIRA should not be initiated in patients
with active infections. TNF-blocking agents, including HUMIRA, have been
associated with reactivation of hepatitis B (HBV) in patients who are
chronic carriers of this virus. Some cases have been fatal. Patients at
risk for HBV infections should be evaluated for prior evidence of HBV
infections before initiating HUMIRA. The combination of HUMIRA and anakinra
is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare
cases with demyelinating disease and severe allergic reactions. Infrequent
reports of serious blood disorders have been reported with TNF-blocking
agents. More cases of malignancies have been observed among patients
receiving TNF blockers, including HUMIRA, compared to control patients in
clinical trials. These malignancies, other than lymphoma and non-melanoma
skin cancer, were similar in type and number to what would be expected in
the general population. There was an approximately four fold higher rate of
lymphoma in combined controlled and uncontrolled open-label portions of
HUMIRA clinical trials. The potential role of TNF-blocking therapy in the
development of malignancies is not known.
Worsening congestive heart failure (CHF) has been observed with TNF-
blocking agents, including HUMIRA, and new onset CHF has been reported with
TNF-blocking agents. Treatment with HUMIRA may result in the formation of
autoantibodies and rarely, in development of a lupus-like syndrome.
The most frequent adverse events seen in the placebo-controlled
clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection
site reactions (20 percent vs. 14 percent), upper respiratory infection (17
percent vs. 13 percent), injection site pain (12 percent vs. 12 percent),
headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and
sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse
events were 7 percent for HUMIRA and 4 percent for placebo. As with any
treatment program, the benefits and risks of HUMIRA should be carefully
considered before initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic
arthritis and Crohn's disease, the safety profile for patients treated with
HUMIRA was similar to the safety profile seen in patients with rheumatoid
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals and devices. The company employs
65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.