"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 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."
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.
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 arthritis.