Accentus threat to patented drugs
use its novel predictive crystallisation technology to discover and
market variations of patented drugs without infringing the original
patent.
>Accentus will also be licensing its CrystalGEM technology to generics companies for the same purpose, David Hipkiss, general manager, C3 Technology, Accentus, told In-PharmaTechnologist.com.
"We have already been approached by several companies in this regard," said Hipkiss.
The potential of this technology and the company's plans to exploit it commercially to open new avenues for generic competition, will strike fear in the boardrooms of pharmaceutical companies, who may have to brace themselves for an onslaught of future market challenges in hitherto protected products.
Accentus is taking advantage of a recent EU legislative change called the "Bolar provision" allowing manufacturers to research and develop generic versions of a drug while that branded version is still under patent.
The availability of this technology opens up new avenues for research and development.
The CrystalGEM reduces the total time for conducting a crystallisation screen from three months to about three weeks, according to Hipkiss.
Salts exist in different crystalline forms (polymorphisms) and crystallisation processes can be used to discover new polymorphs of patented drugs.
Traditionally this has been an exhaustive process, as thousands of experiments need to be undertaken - under many different experimental conditions - in order to identify the desired crystal.
The CrystalGEM pinpoints a prioritised list of crystallisation conditions, predicted to be worthwhile to experimentally explore, and thus reduces screening possibilities from thousands to hundreds.
"With CrystalGEM, viable crystallisations have been achieved in over 80 per cent of predicted conditions, compared to 5-10 per cent with high throughput methods," said Dr George Tranter, director of UK company Chiralabs that developed the system and licensed it to Accentus.
Accentus launched its novel in silico predictive crystallisation technology last year in a move to revolutionise drug development laboratories and make current high throughput crystallisation screening methods obsolete.
The technology is available at a little under half the price of high-throughput methods, costing typically less than £50,000 (€73,100) for a full-service screen, said Hipkiss.
This could therefore serve to accelerate the rise of generic products in patent-protected markets.
There have already been a number of high-profile patent challenges in the drug industry, where generics companies have been able to overturn the originator's exclusivity by developing forms of the drug that got around existing patents.
The CrystalGEM now opens the door for a flood of research and development activity amongst companies hoping to cash in on pharmaceutical company innovations.
