The collaboration, financial terms of which have not been disclosed, is designed to combine Clinigene’s BA/BE testing, central lab and bioanalytical services offering with Spaulding’s TQT study and core lab capabilities.
In addition to pharmacology analysis capabilities, the new partnership will also provide pharmaceutical customers with preclinical development services through Clinigene’s sister organisation, Syngene.
Clinigene COO Abhijit Barve said that drug industry customer demand was the key motivation for establishing the partnership.
“Pharmaceutical clients globally are increasingly seeking strategies to expedite their early clinical development, streamlining processes while maintaining high quality. Our strategic partnership is designed to deliver this in a very cost-effective manner.”
This was echoed by Spaulding CEO Randol Spaulding, who predicted it will let customers “easily structure a program for their compound that delivers high-value while keeping the molecule knowledge experts involved throughout the entire early clinical development.”
Specialised service focus
Biocon will be hoping the partnership with Spaulding will generate more business for Clinigene which, like many involved in early-phase pharmaceutical development sector, has struggled somewhat of late.
For example, according to its report for fiscal 2011 , Clinigene recorded a loss of INR37m ($811,002) and saw turnover fall 28 per cent to INR289m from INR403m in the fiscal year ended March 31 2010 .
At the time Biocon said: “Clinigene is continuing to evolve and adapt its capability platforms and service offerings against a background of continued macro market pressure as global R&D spends are being reduced, consolidation of market players continues and the shift to globally preferred partnerships accelerates.”
The firm also said it had identified specialised service areas, including several covered under the Spaulding partnership like early studies, BA/BE analysis and bioanalytical testing, as opportunities to drive revenue growth at Clinigene.
What impact this has had on Clinigene’s business in fiscal 2012 so far is hard to assess given that the unit’s results are now reported in combination with those of the preclinical services group Syngene.
Nevertheless, combined revenue for the three months ended June 30 was 22 per cent higher than in the year-earlier quarter.