Pharmaceutical and Biopharmaceutical Manufacturing Advances in Ireland

Like its counterparts in Puerto Rico and Singapore, Ireland is seeking to diversify its base in the life sciences. It has embarked on a plan of not only attracting investment in its traditional strength in bulk pharmaceutical and finished-product manufacturing, but also investment in earlier drug-development from basic research to process development to clinical trial management. In pursuing research, the Irish government has agreed support, including financial support for several significant collaborations between academia and life science companies. These companies include Genzyme (Cambridge, MA), Schering Plough (Kenilworth, NJ), GlaxoSmithKline (London), Beckman Coulter (Fullerton, CA), Janssen (Titusville, NJ), Pfizer (New York, NY), Eli Lilly (Indianapolis, IN), Merck Sharp & Dohme, the affiliate of Merck and Co. (Whitehouse Station, NJ), and Helsinn (Lugano, Switzerland).

Pharmaceutical strength

Life sciences exports from Ireland were EUR 47 billion ($70 billion), which included EUR 33 billion ($49 billion) in pharmaceuticals, according to IDA Ireland. IDA Ireland is the government agency responsible for foreign direct investment in Ireland. For purposes of the data, pharmaceuticals include finished products, active pharmaceutical ingredients (APIs), and intermediates.

Overall, there are 83 pharmaceutical manufacturing plants in Ireland as of the end of 2006 (see Figure 1), according to IDA Ireland. Thirty-eight plants manufacture finished products for proprietary drugs and 18 for generic drugs, and 27 plants manufacture APIs. Overall, there are 32 plants approved by the US Food and Drug Administration.

Figure 1: Pharmaceutical and biotechnology activity in Ireland. Map is of January 2007. (Courtesy of IDA Ireland).

Pharmaceutical investment in Ireland

Since 2004, pharmaceutical and biopharmaceutical companies have announced investments of approximately EUR 3 billion ($4.4 billion) in Ireland. Table I outlines these key investments.

Table I: Select pharmaceutical and biopharmaceutical investments in Ireland, 2004–2007.

Some key projects announced in 2007 includes Merck & Co.'s plan to invest EUR 200 million ($296 million) in a new vaccine facility at Carlow Town, with the support of IDA Ireland, where Merck acquired the 65-acre IDA Business and Technology Park.The project will support Merck's human vaccines and biologics businesses.

Wyeth (Madison, NJ) announced plans to invest EUR 24 million ($36 million) for a new pharmaceutical development center at its Wyeth Medica Ireland facility in Newbridge, County Kildare.Wyeth's Newbridge manufacturing facility is one of the largest solid-dosage pharmaceutical plants in Europe.

The new center will be a two-scale operation: a small-scale (bench-scale, < 5 kg) for developing new processes and a pilot-scale (5–50 kg), which will be a current good manufacturing practice (CGMP) facility. The pilot-plant facility will manufacture clinical trial products, including manufacturing finished products for Phase II and Phase III clinical trials of solid-dosage products in tablets, capsules and soft-gel capsules.

Wyeth also announced in 2007 an investment of EUR 24 million ($36 million) for dedicated research and development (R&D) and process development facilities at its Grange Castle Biopharmaceutical Campus in Clondalkin, Dublin. The investment will add 6000 m² of laboratory space to the 2500 m² already in operation.

In 2007, GlaxoSmithKline announced it is investing up to EUR 250 million ($370 million) over five years in its production site at Currabinny, County Cork to manufacture products, including lapatinib, the API in "Tykerb," a new oral treatment for advanced breast cancer. GlaxoSmithKline is also investing up to EUR 14.6 million ($21.6 million) in a collaboration with the Trinity College Institute of Neuroscience and the National University of Ireland (Galway) on a R&D program for discovering new therapies to treat Alzheimer's disease.

Also, in 2007, Baxter International (Deerfield, IL) announced plants to invest EUR 75 million ($111 million) during a six-year period as part of a strategic program to introduce new technologies and higher value products to its manufacturing plants in Castlebar and Swinford, County. Mayo. This investment establishes development and innovation capability for enhancing therapies for treating patients with renal failure, introduces new generation manufacturing processes, upgrades existing manufacturing facilities and advanced drug delivery and packaging systems, and provides for reskilling of its existing workforce. The Castlebar plant produces continuous ambulatory peritoneal dialysis for kidney dialysis treatment and intravenous medication solutions. The Swinford operation manufactures medical accessories for renal therapy.

Genzyme (Cambridge, MA) announced plans to investment as much as EUR 20 million ($30 million) for additional product and process development facilities at its manufacturing campus in Waterford. Genzyme currently manufactures three products—"Renagel" (sevelamer) tablets and "Cerezyme" (imiglucerase) and "Thymoglobulin" (anti-thymocyte globulin [rabbit]) injections at its Waterford-based fill–finish facility. Genzyme is planning up to six product introductions in the next few years, both biologics and oral dose, which would bring the total number of products supplied from the Waterford facility to nine, according to a 2007 IDA press release.

Also, Gilead Sciences (Foster City, CA) invested EUR 62 million ($92 million) in acquiring and upgrading a facility in Cork.

These projects, announced in 2007, follow several major projects unveiled in 2006. In 2006, Eli Lilly announced a EUR 400-million ($592-million) investment by for a biopharmaceuticals manufacturing facility at its existing site in Dunderrow, Kinsale, County Cork. The Kinsale facility manufactures the active ingredients for several Lilly pharmaceuticals, including "Zyprexa" (olanzapine) for treating schizophrenia and "Evista"(raloxifene) for osteoporosis.

Merck Sharp & Dohme (Ireland) Ltd., a wholly owned subsidiary of Merck & Co., announced in 2006 an investment of EUR 100 million ($148 million) for a formulation R&D and manufacturing facility in Ballydine.

Servier (Paris, France) announced an investment of EUR 184 million ($272 million) for a new high-value manufacturing pharmaceutical facility at Belview, County Kilkenny and an expansion of its existing operation in Arklow, County Wicklow. The investment breaks down as EUR 115 million ($171 million) for a bulk active pharmaceutical ingredients facility at Belview. It will manufacture half the active ingredients for four products for treating osteoporosis, depression, angina, and hypertension and will supply both the Arklow facility and the parent company with its products. The facility will also act as a strategic back-up facility to the company's main plant in France and a new product launch site where Servier plans to manufacture 50% of all new products emerging from R&D. Servier is also investing EUR 69 million ($102 million) to expand its Arklow facility to increase production of existing products.

One potential setback for Ireland is Amgen's (Thousand Oaks, CA) decision in October 2007 to indefinitely postpone its planned design and build-out of a bulk manufacturing facility in County Cork. Amgen had announced earlier in January 2006 plans to invest more than $1 billion in new process development, bulk manufacturing, and fill–finish facilities in Cork. Amgen said in October 2007 that it will not have an active work force in Cork in 2008. The company said the decision was based purely on developments relating to Amgen's global business and was no way reflective of the business environment in Ireland or of the high caliber staff it had hired. For the foreseeable future, Amgen has retained ownership of the property in Cork.

"We are still hopeful that Amgen will proceed with an investment at some future date," says Barry O'Dowd, manager, pharmaceuticals and biotechnology at IDA Ireland.

Ireland's strategy for further investment

Ireland is moving forward to increase biotechnology investment, seek investment in basic research, clinical research, and process development, and also attract companies from China and India to set up operations in Ireland.

"Ireland has distinct competence in development and manufacturing," says O'Dowd, "and we are looking to broaden investment in the value chain in discovery and research." The country's recent project announcements in discovery from GlaxoSmithKline and Wyeth are illustrative at that approach.

Several collaborative research projects between academia and industry that were announced in 2007, further reflect Ireland's efforts to build its investment in research. Examples include:

• Genzyme, Sigmoid Biotechnology (Dublin), and Warick Effect Polymers (Coventry, UK) are collaborating with the University College Dublin, Trinity College Dublin, and the Royal College of Surgeons in Ireland to develop novel drug-delivery methods for large molecules and biologics.

• Beckman Coulter and the National University of Ireland (Galway) are establishing a permanent R&D facility in Ireland for molecular diagnostics

• GlaxoSmithKline is collaborating with the Trinity College Institute of Neuroscience and National University of Ireland (Galway) to establish an integrated research program for treating Alzheimer's disease

• Janssen Pharmaceuticals, Eli Lilly, Merck Sharp & Dohme, Pfizer, Helsinn Chemicals Ireland, Schering-Plough, Coviden (St. Louis, Mo), and GlaxoSmithKline are collaborating with several universities on research in small-molecule synthesis and crystal formation.

Ireland is also pushing for investment in biotechnology. "Not only is backward integration in the drug-development process important, but so is expansion of the country's role in biotechnology. Major biotechnology sites for manufacturing and process development now exist for companies such as Genzyme, Wyeth, Pfizer, and Centocor, and this continues to be an important area for the country," says O'Dowd.

As competition for pharmaceutical and biopharmaceutical investment intensifies, Ireland is taking a proactive role. "We have to be nimble and be able to respond to the changing environment for foreign direct investment," says O'Dowd. To that end, IDA Ireland opened an office in China in 2005 to attract Chinese companies seeking to set up operations in the West. IDA Ireland also opened up an office in Mumbai, India in 2008.

For more on this topic, see:

Manufacturing Investment in Puerto Rico

Singapore Attracts Pharmaceutical Manufacturing Investment