Under the deal Menarini will manufacture and lead clinical development of five ADC candidates from OBT’s portfolio and – if proof of concept is achieved – the firm will commercialise the drugs in Europe, CIS, Asia and Latin America. OBT will do likewise in the US and Japan.
The Italian drugmaker has committed €800m ($1.03bn) to support the development and manufacturing work and – according to Andrew Slade, president of Menarini Biotech – intends to both leverage existing capacity and expand.
“Menarini has in-house biologics development and manufacturing capability of the right scale to execute this project. We also have clinical and regulatory and marketing expertise," he said, adding that “our intention is to build on what we already have.”
Menarini is one of several manufacturers to invest in ADCs. Yet, to date only one ADC Adcetris by Seattle Genetics is on the market in the US - Pfizer’s Mylotarg was withdrawn in 2010 – and in Europe no ADCs have been approved, although Adcetris has been submitted for review.
We put this to OBT’s CEO, Christian Rohlff, who suggested the lack of ADCs on the market reflects that the idea of combining a targeting antibody with a drug in this way is still a relatively new idea.
“Few products have been approved because the technology has only recently proven its worth, not because there are a lot of clinical failures. We believe that with OBT we can combine the right target, technology, preclinical, clinical expertise to be successful.
“In addition, the superior efficacy and safety of ADCs like Adcetris and TDM1 are setting new standards in cancer care, which are met with a lot of excitement in the cancer community.”
For Menarini the investment is also about developing products that are unlikely to face generic completion according to Slade who said: “We wish to move more to speciality high value medicines like those that will be developed in this collaboration.”
One interesting aside for contract manufacturing organisation’s (CMOs) with ADC capacity - such as Lonza SAFC, Novasep and Fujifilm Diosynth Biotechnologies through its partnership with established ADC player, Piramal - is that Menarini does not look likely to contract out any manufacturing, at least for this project.
Slade said: “It is not only a cost aspect but a matter of speed and flexibility. In-house manufacture enables you to be flexible and swift and keep the knowledge in-house to apply to other similar products."