By Nick Taylor Dec 4 2019 / Outsourcing-Pharma.com
Inceptua Group and Bendalis join forces to supply generic cancer drugs for use in clinical trials.
Bendalis is a German manufacturer of generic oncology medicines, including the chemotherapy drug doxorubicin and an off-patent version of Pfizer’s colon cancer drug Camptosar (irinotecan). Inceptua, formerly known as Multipharma, is a provider of clinical trial services, including study drug procurement.
The companies have come together to supply cancer drugs for clinical trials. Inceptua will serve as the exclusive distributor of Bendalis’ products for use in clinical trials around the world.
In a statement to disclose the deal with Bendalis, Inceptua described the partnership as a way for clinical trial sponsors to get “quick access to Brexit-safe oncology standard of care medicines produced within the European Union (EU).”
The comment reflects the potential for Brexit to disrupt supplies of clinical trial materials. As part of the EU, the UK is in a customs union that enables clinical trial supplies to move easily across borders.
Manufacturers based in the UK can send study drugs to clinical trial sites in the other 27 EU Member States without encountering bureaucracy that impedes the progress of the shipments – that may change after Brexit.
If the UK leaves the EU without a deal at the end of January it will immediately cease to be part of a customs union with the 27 Member States, resulting in the erection of trade barriers. Drugs sent from the UK to the EU may be subject to customs clearance, delays and extra costs.
Leaving the EU with a deal would create a transition period that keeps the UK in a customs union for a period of time. Under the current proposal, the transition period will run until the end of 2020.
Beyond that, the UK may leave the customs union, potentially erecting some or all of the barriers to trade that will happen in a no-deal scenario. The political party that is ahead in the polls with around one week to go until a general election is against staying in the customs union and committed to fully leaving the EU at the end of 2020.
The upshot is there are many scenarios in which it will become harder to use the UK as a base from which to send study drugs around the EU. Recognition of that fact has led service providers to take action.
Almac, for example, opened a site in Ireland to serve as an EU distribution centre for study materials and Inceptua has allied with Bendalis to access medicines made in one of the remaining 27 member states.