on the move

SciGen wins regulatory approval in India for insulin product
19/07/04 By: Rikki Bannan

SciGen Limited (SIE) shares rocketed in morning trade after it said today it has received regulatory approval from India for the commercial sale of its insulin product, SciLin. The Singapore-based biopharmaceutical company commented they the approval was a key milestone for SciGen.

"The insulin market in India is very large, with the incidence of diabetes in the country estimated at approximately 8% and rising," SciGen managing director and chief executive officer Mark Compton said.


He also noted that medical treatment was also becoming much more affordable in India, being one of the fastest growing economies in the Asia Pacific Region.

SciGen said it had commercialisation agreements in place with India's largest pharmaceutical company and global giant in generic drugs Ranbaxy Laboratories. In addition, it has teamed up with Indian marketing and sales company Shreya Life Sciences.

SciGen said both partners have indicated they are ready to take the insulin to the Indian market soon, after supply is received within a fortnight.

Mr Compton said the registration of human insulin in India represented a very significant success for SciGen's already-proven regulatory affairs team.

"The registration of biological pharmaceuticals in particular is a highly specialist area and SciGen's team has demonstrated again that the company has these skills and can use them to the benefit of its stakeholders," he stated.

In addition to this approval for insulin in India, SciGen highlighted that it has recently received approval in India for its human growth hormone, SciTropin TM, and that steps were being taken to launch the product within the next 90 days.

The company has also recently submitted the registration dossier for human insulin in China, an agreement that SciGen expects will bring minimum sales of US$21 million over three years.

The company's results for the 2004 financial year are expected to be announced on 27 August 2004.

At 1206 AEST SciGen shares had jumped 1.2c or almost 20% to 7.3c.