Altana Pharma Solid Dosage Finishing Plant, Carrigtwohill, Cork, Republic of Ireland

The Altana Pharma solid dosage plant in Carrigtwohill, County Cork, Republic of Ireland, was completed in October 2005 and officially opened in July 2006. The plant is currently used to produce tablets and capsules for worldwide pharmaceutical markets.

Altana Pharma chose the 11ha site at the IDA Business and Technology Park because of the economic incentives offered by the Irish government, the excellent central location offered by Carrigtwohill in County Cork and the availability of a well-educated potential workforce. The 14,000m² plant required an investment of €67m and received planning permission from the county of Cork in late 2003, with construction work commencing in January 2004.

The campus consists of a tablet production building, quality control laboratories, administration building, canteen facilities and warehousing and utilities buildings. The new facility is one of the company's major global manufacturing sites and its only site outside Germany that focuses on worldwide tablet supply.

The site will initially produce tablets containing Pantoprazole (Protium), a fully approved treatment for acid-induced gastrointestinal conditions and oesophagitis. In addition, the plant will also at a later stage produce tablets with Roflumilast (Daxas), a drug for the treatment of chronic pulmonary obstructive disease (COPD) and asthma.

Daxas is currently in Clinical Development Phase III. The facility is expected to produce three billion tablets per year. The German tableting plant is in Oranienburg.

CHANGE OF OWNERSHIP

In December 2006 Altana Pharma was sold to the Danish company Nycomed for a purchase price of €4.6bn. The operations at Carrigtwohill will be unaffected producing pantoprazole tablets for the world market. Pantoprazole itself is produced as a bulk API (active pharmaceutical ingredient) by Zydus Altana Private Limited, a joint venture of Altana and Cadila Healthcare in Thane, Maharashtra, India. The Altana name is being retained and the branding of any products is unaffected.

CONTRACTORS AND CONSTRUCTION

The preliminary design, permitting / licensing and fire engineering was carried out by ARUP Cork. The plant was designed by Meier Architekten of Germany. The construction for the plant was carried out by a joint venture of Cleary and Doyle Contracting Ltd (Wexford, Ireland) and Ed Zueblin (Germany). The construction contract was worth €33.8m. Imtech NV (Gouda, Netherlands) provided and installed the cleanroom facilities, the air conditioning, climate technology, purified water system and building management system.

The plant is a paperless one with Werum Pharma installing its PAS-X pharma software to provide a full manufacturing execution system (MES) with electronic batch recording and full traceability throughout the production and packaging of the produced tablets.

The plant was constructed on the IDA Business and Technology Park, with the site infrastructure being prepared for the new plant between December 2003 and January 2004 by ARUP and Sorensen Civil Engineering in a contract worth €2m. This required the installation of 1.5km of service road, sewer and water mains and service utility ducting.

PANTOPRAZOLE

Pantoprazole (Protium) is available in almost 100 countries worldwide. It is used for the treatment of acid-induced gastrointestinal diseases, such as gastroesophageal reflux disease (GERD). The aim of therapy is to heal the lesions, achieve sustained freedom from symptoms and improve the quality of life for patients.

Pantoprazole is available in both intravenous and oral forms. Since its market launch 11 years ago, more than 300 million patients have been treated with Pantoprazole. The high global demand makes pantoprazole currently the most successful patent-protected medicine from German research laboratories. Thanks to its impressive product profile, Pantoprazole is now market leader in 13 countries.

ROFLUMILAST

Roflumilast (Daxas) is an anti-inflammatory medicine for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). Chemically the drug is a phosphodiesterase type-4 inhibitor (PDE4), which is being co-developed by Altana AG and Pfizer Inc (US) and Tanabe Seiyaku (Japan) as a treatment for COPD and late-stage chronic asthma. This is an orally administered treatment that only needs to be taken once-daily.

Both Roflumilast and its major metabolite roflumilast N-oxide, are pharmacologically active and studies are well advanced into the drugs safety. It is forecast that the COPD market will double in size by 2011, due to an ageing population and new product launches. This means that Roflumilast may well have the potential to become a blockbuster product. Studies into Roflumilast were continuing into 2007.