The highly potent end of the API market has become an attractive area for API companies as they cope with the overcapacity that has developed in the sector over the last few years and seek new routes to profitability, according to a spokesman for the company.
High potency drugs are in themselves a growth category, with new data presented at the INFORMEX meeting earlier this month suggesting that around 10 per cent of drugs in development now come under this category, up from about 5 per cent in the 1990s.
Until recently, API companies have thought long and hard before specialising in this sector, as there are high barriers to entry in terms of capital expenditure and training.
One of the factors driving the development of high potency market has been a shift in the average doses of all drugs from around 100mg/day in the 1980s to around 40mg/day now, as companies strive to develop drugs with more specific action and fewer side effects.
Another has been the growth of the market for cytotoxic cancer drugs, although Tetrionics believes traditional cytotoxics have reached an effectiveness plateau and most development activities are now focused on drugs with different mechanisms of action, such as interrupting the growth of blood vessels within tumours (angiogenesis).
Tetrionics' capacity expansion is expected to be completed by the summer of 2005, and will include expanded R&D suites, new analytical laboratories, additional current Good Manufacturing Practice-compliant kilolab manufacturing suites and increased warehouse space The company hopes to break ground on the extension in the fourth quarter of this year.
Tetrionics will also expand capabilities in its existing pilot plant facility through the installation of a 200-gallon reactor and the addition of a filter/isolator system that will increase its ability to make category III and IV APIs in its existing facility. These additions are expected to be complete and operational by third quarter of 2004.
"There are very few companies that understand the unique intricacies involved with the manufacture of highly potent APIs," said Peter Johnson, the founder and president of Tetrionics, adding that this new capacity takes it into the top rank of companies working in this area.
Other players in the highly potent API sector include Helsinn, EaglePicher, Irix, Solutia, Lonza, Aerojet and Torcan (part of Avecia).