Magene Life Sciences expects operational breakeven this year

To launch new services for pharmaceutical industry shortly

City-based Magene Life Sciences, which commenced contract research services in the latter-half of last year, is hoping to achieve operational breakeven with revenues of around Rs 5 crore this year.

The revenues are to accrue from the existing bioservices division and the soon-to-be-launched new services for pharmaceutical industry.

T R Bhoopathy, managing director and chief executive officer of Magene Life Sciences, told Business Standard that the two-year-old company had so far invested close to Rs 10 crore in infrastructure, R&D equipment and personnel.

Bio services like cloning of gene, protein expression and downstream processes of protein purification to identification of a different or unique protein would contribute around Rs 2 crore, Bhoopathy said.

The company was targetting a revenue of Rs 3 crore from the 'Invitro pre-clinical screening services' to be launched soon, he said.

The company has recently shifted into a new state-of-the-art facility built up at a cost of Rs 3 crore in the Genome Valley near the city.

Bhoopathy said that Magene would become the first company in the country to offer invitro pre-clinical screening services as a whole package and on a commercial basis in the country. The pharma companies in the country were getting these services from the foreign companies at present, he said.

Earlier, Magene concentrated solely on basic research and developed interferon but decided to enter the services segment to sustain itself, he said. The company will pursue its own programmes for basic research to identify novel targets and create novel therapeutics and diagnostics, he said.

Explaining the invitro pre-clinical services, Magene described the process as "screening services for novel chemical entities as putative drug candidates."

Assaying (a chemical test to establish what a substance contains) is an integral part of the drug discovery process. It involves the production of a test system that can be used to detect and/or measure the chemical or biological activity of a defined target and compound.

As part of the assay for lead molecule identification, Magene can help in cloning and expression of protein to which a drug is targeted.

This enables the new drug discovery group to validate its drug molecule and to take an informed decision for future development of this new chemical entity.

Next comes the process "� cell permeation assay "� which helps evaluate if a molecule can be absorbed by the body, if it enters the blood stream and if it retains the blood brain barrier.

To evaluate this, Magene offers CaCo Cell and MDCK cell permeation assays which are recommended as invitro models by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The CYC P450 assay process helps the drug discovery group take a decision on whether the drug is safe or not for human use.

Also, two toxicity studies "� cytotoxicity assay & mutagenicity assay "� are carried out to evaluate if the drug molecule is completely safe. If any molecule passes these tests, the chances of its subsequent failure in pre-clinical and clinical studies is minimal.

Bhoopathy said that the expertise in these areas was developed in-house by a 25-strong R&D team led by Geeta Sharma who had a vast experience in industrial biotechnology area.

The company plans to double the R&D strength in the next one year. The services now range from lab-scale to taking the drug up to the clinical stage, he said. For the animal toxicity studies, Magene is tying up with the city-based National Institute of Nutrition (NIN).

With an eye on the international markets, Magene has made all its processes comply with GLP (good laboratory practices) norms and is slated to get accreditation from National Accreditation Board for Testing and Calibration Laboratories (NABL) in December or January next year.

The company has also tied up with a contract research company, CivintiChem in North Carolina, for marketing its services in the US, Bhoopathy added.