Abbott Opens New Biotechnology Manufacturing Facility in Puerto Rico

Apr 10, 2007, 01:00 ET from Abbott

    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.
     About HUMIRA
     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
     About Abbott
     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