Off-patent drugs to get lease of life

SPI Pharma, the fully-owned subsidiary of the UK's Associated British Foods, which opened its India development and testing centre in Bangalore is working on platforms to revive some of the off-patent drugs through effective personalised formulation and dosages.

Rana Kayal, president SPI Pharma, said that through the company's efficient drug delivery platforms, some generic drugs are being developed from off-patent drugs and a few old neglected drugs are also being revived.

"Our products are being made available to pharma companies across the globe. We are presently working with Indian companies like Cipla, Novartis, Pfizer and Dr Reddy's. We are also in discussion with major active pharma ingredients producers like Matrix and Biocon," he added.

SPI Pharma presently sells in over 50 countries, supplying to global firms, like Glaxo, Pfizer, Aventis, Novartis and Bayer. Technical support is provided by experienced scientists based in the US, France and India.

The company has developed and specialises on novel drug delivery systems like fast melt tablet, fast melt wafer, medicated chewing gum, dry powder suspension and taste masking of bitter formulations.

According to Sarath Chandar, SPI Pharma's vice-president-drug delivery, with improvised new dosage and delivery mechanism, drugs for children, the elder and the terminally ill are possible.

"With the existing formulations and dosage forms, currently some drugs are difficult to administer on them, he added. Globally drug delivery business is valued around $60-70

billion.

With many drugs going off-patent has given opportunity to pharma companies to outsourcing their drug delivery models. The company through its investment of Rs 4 crore (Rs 40 million) has set up an India development centre in Bangalore at Veerasandra Industrial Estate on Hosur road.

Housed in a 16,000 square feet building, the company plans to utilise formulation and analytical equipment to enable finished product development in unique dosage forms.

"The facility will enable SPI Pharma to conduct stability studies as per the ICH guidelines and include provisions for a cGMP pilot-manufacturing unit. The laboratory will function under Good Laboratory Practice standards," said John Burrow, CEO, SPI Holdings.

"With India fast becoming a scientific powerhouse in the global pharma market, the facility is significant to our operations in India. SPI Pharma will be in a position to speed up customised projects using several of its proprietary platforms. SPI's strategy in India is to develop and test finished drugs using its proprietary drug delivery technologies as well those acquired through strategic partners."

In India, SPI Pharma will focus on working with manufacturers of APIs (active pharma ingredients) to come out with easily delivered and low-dosage models of customers' products, said Rana Kayal.

"Indian pharma market is seeing a lot of value addition and the need is to bring differentiated products at a shorter period of time to the market," he added.