The Swiss drugmaker announced its plan to build a CHF190 ($208m) antibody-drug conjugate (ADC) production plant in Basel earlier today as part of a wider investment in biopharmaceuticals production capacity.
Roche spokesman Luke Willats told in-Pharmatechnologist.com the “site will support commercial manufacturing for Kadcyla, alongside future antibody-drug conjugates.”
The facility will offer a surface area of around 15,000 m2 and house two antibody-drug conjugate production lines according to Willats, who added that: “Construction is planned to begin in January 2014 and be ready for use by August 2016, subject to official approval.”
News of the investment follows just days after Roche’s Swiss neighbour Novartis singed a second licensing deal with US ADC specialist ImmunoGen, under which it will use the latter’s tech to develop a candidate anticancer therapeutic, details of which were not disclosed.
The move comes after a string on ADC-focused investments by the contract services sector the most recent of which, by another Swiss firm Carbogen Amcis, also involved the creation of dedicated manufacturing capacity.
We asked Roche why there is this interest in ADC, particularly given the fact that its own product Kadcyla - which is cleared for the treatment of breast cancer in the US and under review in Europe - is one of just a handful of combined small molecule antibody drugs to have gained regulatory approval to date.
Therapeutic potential
In response Willats said in Roche’s case the investment was driven by the therapeutic potential of ADCs.
“We believe that ADCs have the potential to redefine the treatment of cancer, and ultimately, help improve the lives of patients with cancer” he said.
“The goal of ADCs is to reduce the effects of chemotherapy on healthy cells, and therefore their development has the potential to play an important role in improving the lives of patients with cancer.”
At DIA in Boston earlier the US Food and Drug Administration (FDA) confirmed that the hybrid drugs must comply with rules governing small molecule medicines and therapeutic antibodies.
However, Roche is confident it can navigate the additional regulatory hurdles that ADCs face according to Willats, who said: “We will work closely with regulatory authorities to ensure patients are able to access our medicines as soon as possible.”