The French firm announced that it is building a dedicated unit for cryogenic chemistry, HPLC chromatography and drying to support commercial scale ADC production last week, citing demand for personalised cancer drugs as the key driver.
To date only two ADCs – which combine antibodies with APIs – have been approved by the US Food and Drug Administration (FDA): Pfizer’s Mylotarg (gemtuzumab ozogamicin) which was withdrawn in 2010; and Adcetris (brentuximan vedotin) by Seattle Genetics.
In Europe no ADCs have yet been cleared, although an MAA for Adcetris was accepted in June and Takeda’s Millinnium Pharmaceuticals unit – which is developing the drug with Seattle Genetics – received positive opinion and approval recommendation from the CHMP just last week.
But while the current market is small, there is a widely held belief that the improved targeting and therapeutic efficacy that ADCs allow, coupled with rising demand for cancer therapies, mean they have huge potential.
Evidence for this can be seen by both the large number of ADCs in development – of which Genentech’s Herceptin reboot, trastuzumab emtansine, is the most advanced – and from the numbers of venture capital groups investing the technology.
The contract manufacturing sector (CMO) has also shown support for ADCs. In 2011, for example SAFC, Goodwin Biotechnology and Piramal all invested to increase production capabilities, while Lonza has been ramping up capacity for several years.
Novasep also believes there is potential in the ADC market according to Patrick Glaser, head of the firms synthetic molecule division, who set the investment in the context of growing demand.
“Manufacturing for the life science sectors is facing a series of challenges. Drug candidates become more specific and personalized, whilst the economic climate demands more cost-effective and safe solutions” Glaser said.
“Novasep’s development strategy has enabled us to anticipate these changes in the market and today we are increasing our capability to meet future market demand.”