GSK plans six new product filings this year

The reorganisation of its r&d activities is delivering 'a large and diverse pipeline', according to GlaxoSmithKline ceo Dr Jean-Pierre Garnier.

The company now has 147 projects in clinical development, including 82 nces, 45 product line extensions and 20 vaccines. Of the nces 44 are in Phases II and III, almost double the 23 at the same stage in October 2001. The company expects to make up to 16 significant product filings in 2004-5.

Among the potential new products in the near term is alvimopan, a peripherally acting mu-opioid receptor antagonist to restore bowel function in post-operative patients, reducing the length of hospital stay. Developed with Adolor Corporation, an application for approval of alvimopan for the management of postoerative ileus is targeted for filing with the FDA late in the first half of 2004.

Another near-term product opportunity is Boniva/Bonviva, a bisphosphonate for osteoporosisco-developed with Roche, which was approved in May 2003 in the US for daily oral dosing. The product will be filed for intermittent IV and for monthly oral dosing in 2004. Solifenacin succinate, to be co-promoted with Yamanouchi, is being developed to treat overactive bladder. Solifenacin received an FDA approvable letter in October 2003, and was filed in Europe in January 2003.

Highlights of the longer term pipeline include:

• 572016 - first dual kinase inhibitor for the treatment of solid tumours. It targets the ErbB1 and ErbB2 kinases found in 30-80% of cancer tumours. GSK expects to file for regulatory approval of this once-daily, oral therapy in 2005.

• Cervarix - first vaccine with potential for 100% efficacy against two types of human papillomavirus implicated in cervical cancer. GSK believes Cervarix has the potential to prevent more than 70% of cervical cancers. Phase III trials enrolling 25,000 women will begin in 2004. Filing is expected in 2008.

• 480848 - first Lp-PLA2 inhibitor targeting a newly identified risk factor for heart disease. It dramatically lowers Lp-PLA2 activity in atherosclerotic plaque, which is expected to reduce inflammation in arterial walls. '848 is scheduled to move into Phase III in 2004, and filing is expected in 2008.

• 406381 - the first dual-action COX-2 inhibitor targeting inflammatory and neuropathic pain by acting both centrally and peripherally. Currently in Phase II, '381 is targeted for filing in 2006.

'By radically redesigning our r&d organisation we are tackling the problem of r&d productivity that currently plagues the industry,' said Garnier. GSK's r&d is structured to take advantage of size at the beginning and the end of the process where large-scale research is needed, while to bridge the interface between discovery and development, the organisation is divided into new, small, business units - Centres of Excellence for Drug Discovery (CEDDs) - that can take full advantage of flexibility and focus.

'Our new CEDD structure is working well. We are developing more quality compounds than ever before. This is enabling us to renew our pipeline in disease areas where we are leaders - like respiratory and psychiatry - and to build strong portfolios in areas like oncology and cardiovascular disease,' added Dr Tadataka Yamada, chairman of r&d.