GSK relying on Ph3 strategy in R&D comeback bid

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GlaxoSmithKline ($GSK) was one of the first of the Big Pharma companies to concede that its R&D effort needed to be completely revamped. Over the last couple of years GSK responded by breaking its research ops into smaller teams, vowing to take a biotech approach to development that would allow the company to mount a swift response to changing circumstances in the clinic. And in today's second quarter report the pharma giant hoped to make the case that it was beginning to profit from its new pipeline strategy, breaking the news that one of its late-stage hopefuls had posted positive late-stage data for a hepatitis C-related ailment.

In its section on R&D activities GSK highlighted its success on Benlysta, the new lupus drug partnered with Human Genome Sciences ($HGSI). Benlysta finally paid off with a European approval, which followed an FDA OK in the first quarter. The epilepsy drug Potiga (in collaboration with Valeant) was approved in June and new data was released on Relovair. And while there was no new data posted, GSK announced that Promacta (eltrombopag) proved promising in the first of two late-stage studies for hepatitis C-related thrombocytopenia. Promacta was given an accelerated approval in 2008 for chronic ITP. And news of its success in hepatitis C also buoyed San Diego-based Ligand, GSK's partner on the drug.

"Promacta is a very important program for Ligand, and the expansion of the franchise into this indication could contribute substantial new revenue to Ligand in the coming years," said Ligand CEO John Higgins.

GSK has 15 late-stage treatments in its pipeline, and it touted positive results for four out of 5 so far this year.

"Multiple Phase III data read-outs are anticipated from the other 10 assets by the end of 2012," GSK reports, "together with additional Phase III data on IPX066, Votrient, Relovair and Promacta. Overall, by the end of 2012 we expect more than 30 further Phase III read-outs on 14 of the 15 assets."

GSK needs new products to deliver on CEO Andrew Witty's promise of boosting sales in 2012. Sales dipped in the second quarter. But the downward slide wasn't as deep as before, indicating that the big hit it's been taking from new generic competitors has begun to ease.

- here's the second quarter release from GSK, R&D on page 22
- check out the Reuters story
- and see the release from Ligand

Related Articles:
Promacta gets FDA approval
FDA provides conditional OK for GSK/Valeant's epilepsy drug
GSK's Witty: Development must be radically restructured in R&D revolution