Abbott Opens New Biotechnology Manufacturing Facility In Puerto Rico
Abbott has 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® (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 product."
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 Biotechnology 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. Aníbal Acevedo-Vilá, 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.
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.
Source: Abbott