Carbogen Amcis – which is part of Indian drugmaker Dishman - unveiled that it had invested in dedicated cleanroom and ADC manufacturing capacity at two facilities earlier this week, just weeks after teaming up with St Asaph, Wales-based specialist ADC Biotechnology.
Carbogen is not the only contractor to view these biopharmaceutical-small molecule hybrids as a growth opportunity, Lonza, Piramal and Novasep have all recently added capacity. However the increasingly competitive nature of the ADC services sector is not a concern for Carbogen according to CEO Mark Griffiths.
“We see a competitive environment not as a deterrent, but as a stimulant to our business,” he told BioPharma-Reporter.com, adding that Carbogen’s track record working with high-potency active pharmaceutical ingredients (APIs) combined with the new investment “gives us a strong competitive advantage.”
Griffiths also cited the drug industry’s focus on targeted therapies as a driver for the investment, particularly the increasing number of opportunities in the field of cancer treatment development.
“Over the past several years we have collaborated with a growing number of customers who operate in the ADC space. With the recent advances in highly-targeted cancer therapies, we see a lot of growth in demand for ADCs among our customers and we decided to invest in enhancing our capabilities to be better equipped to support our customers‘ ADCs projects.”
Regulatory approvals
But is it really wise to invest in ADCs? The ability to deliver high potency APIs in a more targeted manner is clearly an important advance, but as yet very few of this type of hybrid medication have gained regulatory approval.
While reports suggest that as many as 60 ADCs are in development to date only Takeda’s Adcetris – which is cleared in Europe and the US – Roche’s Kadcyla – OKed in the US and under review in Europe – and Pfizer’s Mylotarg – never passed by the EMA and withdrawn in the US – have been approved.
However, Carbogen still expects drug industry demand for ADC services to grow according to Griffiths, who said: “This is the paradigm of our industry. You always have a lot of candidates and only few successful ones, which reach the market in the end.
“This is exactly why our investment makes sense,” he continued, saying that the firm’s focus will be on enabling customers to move their clinical projects forward without taking the risk of a major CAPEX investment.
“We never compete with our customers, but do our best to support and exceed their business expectations, thereby facilitating their success rate."