The deal – financial terms of which were not disclosed – will focus on applying the Florida, US-based firm’s Accu-Break tablet technology – which enables tablets to be accurately subdivided for better dose adjustment – to Alembic’s portfolio of medicines.
A version of the anti-coagulant warfarin will be first drug for which the firms will seek US Food and Drug Administration (FDA) approval according to a statement Alembic filed with the Bombay Stock Exchange.
Accu-Break executive chairman Elliot Hahn said: “Together, we are looking forward to filing the first of what we anticipate will be many New Drug Applications for products utilizing our patented Accu-Break technologies in combination with Alembic’s broad base of active pharmaceutical ingredients and formulations.”
Tablet splitting made the headlines a year or so back when it was recognised that – partly due to recommendations by insurers and physicians more and more patients were engaging in the practice to make medications further.
To try and address the issue the FDA issued draft guidance to let manufacturers know what data is required to support applications for drug tablets that are intended to be split.
A key part of the guidance focused on generic drugs and specifically the requirement that they follow the same scoring patterns as the reference products, which is something that Alembic and Accu-Break will need to keep in mind.
Alembic is not the only Indian firm to have partnered with Accu-Break. In 2006 the US firm teamed up with Strides Acrolab to develop generic drugs using its tablet tech.
However, the firms eventually split – all puns intended – due “to the evolution of ACCU-BREAK's business model to include "potential brand sales of bioequivalent products and out-licensing of certain products.”