Contract manufacturer SAFC also unveiled an ADC investment this week joining Lonza, Piramal, Novasep, Catalent and Carbogen Amcis on the list of services firms that have added capabilities in anticipation of drug industry demand.
There are several reasons for this surge in ADC interest according to Gerry MacKay, CEO of analytical services CRO BioOutsource, who told BioPharma-Reporter.com that these complex drugs are a good opportunity for drugmakers to leverage existing technology and knowhow.
“The ADC technology can be applied to molecules for which there is already a proven mechanism of action that reduces the risk of failure, but recent advances in both the linker technology and novel cytotoxic drugs has opened new doors for drug manufacturers.
“We have a fairly large, previously redundant, pipeline of drugs that have failed for a variety of different reasons that have the potential to represent promising ADC candidates.”
Regulatory progress made by products like Roche’s Kadcyla – which is approved in the US and under review in Europe – combined with promising clinical trial data are also factors driving interest in ADCs according to Dominik Werner from contractor Lonza.
He told BioPharma-Reporter.com that: “There is interest because we see good advancement of clinical programs and first ADCs are now approved.”
Werner also said: “There are a lot of unmet needs in cancer therapy. New cancer drugs can make a big difference for cancer patients and if there is a benefit, broader investments will make sense as it also comes with a business benefit.”
This was echoed by a Carbogen Amcis spokeswoman who told us “ADCs carry the promise of targeted therapy for cancer, which is still the second largest cause of death in North American and Europe. Major oncology players involved in cancer research believe that ADCs represent the future in the fight against cancer.”
Patent cliff protection?
It makes sense that growing regulatory acceptance, the ability to use internal resources and the chance to cater for unmet or growing therapeutic needs would attract the interest of Big Pharma firms scrambling to refill dwindling pipelines.
The other oft cited rationale for ADC investment – and indeed Big Pharma investment in any complex biopharmaceutical product – is that such drugs are harder to copy and less likely to face generic competition.
But, while there may be some truth in this at the moment, in the longer investment in ADCs may not give Big Pharmas the protection they seek according to MacKay.
“It will undoubtedly be more difficult to create biosimilar versions of the molecules, but technology moves on and by the time patents expire, I expect that people will have found ways to replicate the processes correctly.
“I personally think it is about creating better targeted drugs. In a commercial sense it comes down to the years of experience and challenges we have seen with the monoclonals and the current technology offers many solutions to the problems we have seen in the past.”
So the rational for Big Pharmaceutical firms to invest in ADCs – either their development or production – is clear.
The drivers for the contract manufacturing sector’s interest are also pretty obvious – they expect drugmakers to outsource ADC development and production, at least that is according to Lonza’s Dominik Werner.
“There are 25 clinical programs and a lot of new compounds in development. The capacity currently provided is limited and it is expected that new capacity need to come on stream in the future. To that end Lonza is expanding its ADC capacities in Visp, coming on stream by Q2 2014.”
Carbogen Amcis is of a similar view. The firm told us that: “There are only a handful of CMOs specialized in the development and manufacture of new targeted cancer treatments…Thanks to our recent investment in ADC, we are well positioned to offer our customer superior service for ADC programmes.”
“Developing ADCs is a complex process and outsourcing to an experienced CMO offers a variety of advantages, such as access to expertise in process development and scale-up for drug conjugates to support toxicological studies and clinical trials as well as fill-&-finish capabilities to address solubility and formulation challenges during the development phase.”
Gerry MacKay also thinks anticipated drug industry demand has driven services firms to invest in ADC.
“Our experience in the biosimilar world has told us that the certain components of CMO/CRO industry may have missed a trick and I think that companies are now doing their best to make sure that they don’t get left behind again.
While MacKay recongised this as a driver, he predicted that the sudden increase in ADC contract capacity may end up out stripping demand.
“There may well be capacity currently, but it is certainly a growth opportunity and for the companies that do it well, it will be worth the return – I imagine there may be additional capacity as everyone appears to be converging on the same space.