The Hindu Business Line : US co Aptuit unveils tool for accelerating drug discovery, cutting costs

Snapshot
The company claims it can ensure API (Active Pharmaceutical Ingredients) to IND (Investigative New Drug) submission in 26 weeks.
It has, through a joint venture with Laurus Labs of Hyderabad, established R&D facilities to carry out various stages of drug discovery work.

M. Somasekhar

Hyderabad, March 13 For drug start-ups with bright ideas and large companies looking at outsourcing vital stages in new drug development to cut down time and costs, some interesting options are emerging.

The key to lowering time and costs in new molecules research is testing their efficacy in man as early as it is safe and practicable. Researchers and pharma giants have been devising their own routes for this.

The $350-million turnover Aptuit, the US-based pharmaceutical service company, has come up with precisely such a tool (called proof of concept), which promises to evaluate the potential molecule, establish its safety at pre-clinical stage and facilitate drug companies to take the molecule to human studies at the fastest.

Aptuit claims it can ensure API (Active Pharmaceutical Ingredients) to IND (Investigative New Drug) submission in 26 weeks. In the case of candidate selection to IND, including API and synthesis, the time is 52 weeks to first in human studies.

The appropriate costs for such an exercise are in the range of $5.5 million, against an industry average of $30 million using conventional methods and $3 million by the best of class, said Mr Michael J. Butler, Chief Scientific Officer of Aptuit.

At present, there are two other western competitors in this league — Azopharma and Patheon. However, they are late entrants and Aptuit has competitive advantage, Mr Butler told Business Line.

Aptuit, which is a contract development organisation in the pharma space for both large and small innovators, has invested about $400,000 in developing the tool called INDIGO, with Prof. Stephen R. Byrn, who is Chairman of its Scientific Advisory Board and a pioneer in solid state chemistry of drugs at Purdue University, US.

Prof. Byrn said: “We used amorphous dispersion screen for the studies. The procedure also gives the innovator the option of patenting. It can be applied to any kind of new, small or large molecule to generic monoclonal antibodies as well as for the emerging bio-similars”.

The company has found interest from venture capitalists based out of the US and Europe and also a large European drug major to test the method. The European company wants to cut the drug development cycle from 12 to 8 years.

“We are bringing the company to India in April to explain, how we can leverage our India facilities and expertise to help them achieve this,” Mr Butler said.

Aptuit has, through a joint venture with Laurus Labs of Hyderabad, established R&D facilities and employs over 350 people to carry out various stages of drug discovery work.

Interestingly, Merck & Co, as part of its strategy to accelerate drug discovery and reduce costs, has forged an agreement with Nicholas Piramal in the area of oncology. Accordingly, NPIL is involved in IND-enabling non-clinical and clinical trials demonstrating proof-of-concept.

With the game of new drug discovery to market becoming high risk (93 per cent failure) and high cost (average of $802 million) and average time of 10 years, tools and processes that can reduce time, improve success rates (up from 7 per cent) and bring down costs are definitely most welcome.

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