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Life Cycle Management - Developing New Dosage Forms for New Indications

New Indications for Existing Compounds

Pharmaceutical companies with drugs that are successful in the marketplace will look at all opportunities to extend the commercial life of their products. Numerous options for life cycle extension exist, including reformulation, new patents, new dosing regimes and chemical modifications. A seemingly underused option is the development of an existing compound for a new indication. The limited use of this option can be understood from the inherent risks attached to it. Many compounds which are on the market today can be applied in more than one disorder.

Well known examples include antibiotics and antiviral agents, cardiovascular drugs, antidepressants, immunosuppressants and anti-ulcer agents. The most compelling example is probably antibiotics as these drugs are often developed for the treatment of multiple infectious disorders. In the case of antibiotics it is often known from preclinical studies that the compound will be efficacious against certain microbes.

As a result it is very likely that the compound will be efficacious in the range of infections caused by these bacteria, provided that the bacteria are exposed to therapeutic drug concentrations in the human body. For other types of compounds the applicability in different disorders could be less apparent, and the opportunity in new indications often appears only after launch of the compound.


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By Erwin Douwes, Marketing Director of Banner Pharmacaps Europe

Erwin Douwes is Marketing Director of Banner Pharmacaps Europe, a drug delivery and proprietary health care products company owned by Sobel. After receiving a medical degree from Leiden University in the Netherlands, he worked as a physician in the Dutch Royal Navy and spent a year as a resident at the University Hospital in Maastricht. He started work as a Medical Adviser for Organon International in 1992, before moving on to Organon's Strategy & Business Development Department.

In 2001 he became Head of Organon's International Marketing Research Department, before joining Banner in 2002. He also holds a postgraduate degree in Pharmacology and Pharmaceutical Medicine and a Master of Business Administration.

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Erwin Douwes
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