Accu-Break goes for gold with Midas tie-up for Europe

Accu-Break Pharmaceuticals (ABP), the US company with a suite of tableting technologies for creating divisible dosage forms, has signed a co-operation agreement with Germany's Midas Pharma that should open new avenues for technology licensing and ABP products in Europe.

Based in Ingelheim, Midas is an independent marketing and sales company whose client base includes more than 30 manufacturers of pharmaceutical raw materials, standardised extracts, active ingredients (plant and animal origin) and pharmaceutical intermediates in the German market.

Midas offers support on active pharmaceutical ingredients, custom synthesis, biosimilars, contract manufacturing, international licensing and registration dossiers.

Under the agreement with Accu-Break, the two companies will work together both to license Accu-Break's tableting technologies to brand-name and generic pharmaceutical companies in Europe and to develop and market ABP products in Europe.

Midas, which has already been working with ABP for several months on an informal basis, will help the US company introduce, market and promote the Accu-Break technologies to potential collaboration partners.

It may also assist ABP in preparing regulatory dossiers and in " communications with health authorities and European opinion leaders " to promote the licensing of these technologies.

Nigel Norton, ABP executive director and head of the company's Monaco-based international business development group, said ABP had already been introduced through Midas to " a number of interested companies which we hope will result in licensing agreements ".

ABP believes its technologies can improve therapeutic consistency, reduce side-effects and tighten adherence to treatment regimes by addressing the problem of uneven doses when pharmaceuticals in tablet form are split by hand.

The Accu-Break tablets incorporate a drug-free 'zone' or layer that allows for more accurate, individualised dosage adjustment and titration.

With the Accu-T tablet design, the scored middle section of the tablet is inactive, serving as a breaking point for the two tablet halves.

A second option is the Accu-B tablet, comprising a scored top layer pre-divided into four equal segments, plus an inactive bottom layer, which serves as the breaking region.

According to ABP, these reformulation techniques are low-risk, low-cost and widely applicable, even to micro-encapsulated and matrix formulations.

Other claimed advantages include product differentiation, reduced tablet wastage and protection against counterfeiting.

The Accu-Break technologies also provide pharmaceutical companies with a solution to formulation challenges such as separating incompatible active ingredients to develop unique combination products, ABP says.

The company has just been issued two patents covering its Accu-Break technologies.

The first (US 7,318,935) claims a layered immediate-release tablet with at least two different active ingredients segregated by a drug-free layer.

The second patent (US 7,329,418) involves the creation of tablets that contain a half-dose of the same active ingredient (or a combination of the same actives) at each end of the tablet, separated by a drug-free break layer.

ABP has additional patent applications currently under review or awaiting review by the United States Trademark and Patent Office.

These include claims for tablets incorporating two to five or more layers, novel score patterns, and controlled-release embodiments.