Alembic-Accu-Break alliance targets dosage convenience
This article was originally published in Scrip
India's Alembic Pharmaceuticals and Accu-Break Pharmaceuticals have entered into a development and licence pact to develop new branded products based on the US firm's Accu-Break tablet technologies. The alliance is seen opening a new front in Alembic's strategy to target incremental but important innovations in areas such as drug delivery, product strength and dosage.
Confirming the strategic thrust, Pranav Amin, director and president of the international business at Alembic and part of the firm's founding family, told Scrip that Alembic was looking at partnering on platform technologies to develop more innovative products. "We are looking at various drug delivery technologies that would meet unmet medical needs and improve patient compliance," Mr Amin said.
The US firm's patented Accu-Break tablets can be split easily by hand into exact smaller doses to provide maximum flexibility, and to make it easier and safer for patients and caregivers to adjust their dosage. Accu-Break's technologies can be used with single-drug and combination products and both standard and controlled-release formulations.
The first product that the alliance will seek US FDA marketing approval for is an Accu-Break version of the anticoagulant warfarin. "The activities for filing are being initiated and we hope to file it next year. The new warfarin product would give flexibility to patients for dose titration and eliminate the need for multiple SKUs [stock keeping units], thereby reducing medication costs," Mr Amin explained.
Accu-Break said that it anticipated many US 505(b)(2) new drug applications for products using its Accu-Break technologies in combination with Alembic's broad base of pharmaceutical ingredients and formulations. A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted".
Applications for a change of dosage form or route of administration generally qualify for a 505(b)(2) application. Mr Amin expects the alliance to file at least two products each year within the next three years.
Alembic, which partners with international generics firms to access their marketing and sales capabilities, has been keen to ramp up in the US. It has commercialised a clutch of products there including fluoxetine, famotidine, lamotrigine, meprobamate, ropinirole and theophylline through its partners, and made paragraph IV filings (though not first-to-file) for rivastigmine tartrate and pregabalin (scripintelligence.com, 10 February 2012).