Schering-Plough has extended its relationship with enterprise content management specialist Documentum by taking out a non-exclusive license to GXPharma, a product jointly developed by Documentum and IBM.

GXPharma enables companies to manage content in compliance with the US Food and Drug Administration's regulatory requirements for electronic records and signatures (21 CFR Part 11), requirements for electronic submissions of New Drug Applications and record-keeping required for compliance with Good Clinical Practices and Good Manufacturing Practices.

S-P has had a troubled time over the last couple of years, with regulatory compliance problems at its manufacturing facilities delaying the approval of new products (for example holding back the launch of new prescription antihistamine Clarinex [desloratadine] by several months), and eventually culminating in a $500 million fine. This delay was particularly damaging, as S-P had been relying on building up Clarinex sales to weather the storm caused by patent expirations in the USA on former blockbuster allergy drug Claritin (loratadine) and its conversion to an over-the-counter brand.

Sales at the group slumped 19 per cent to $2.1 billion (€1.78 billion) in the first quarter of this year.