Roche and GSK hit with 'misleading advertising' claims

Procter & Gamble (P&G) and sanofi-aventis US LLC, a member of the sanofi-aventis Group, are claiming to have filed a lawsuit against Roche and GlaxoSmithKline (GSK) in the US Federal District Court allegeing that the companies engaged in 'false and misleading advertising' in marketing Boniva tablets, their prescription osteoporosis medication indicated for the treatment and prevention of osteoporosis in postmenopausal women.

However, both Roche and GSK are claiming that they have not been served with a lawsuit.

P&G and sanofi, co-marketers of Actonel, also indicated for the prevention and treatment of osteoporosis in postmenopausal women, allege that: 'advertising for Boniva falsely claims, literally or implicitly, that the drug has been proven to reduce the risk of non-spinal (non-vertebral) fractures; that the drug has demonstrated efficacy against non-spinal fracture comparable to other bisphosphonates, such as Actonel, and that the Boniva label and clinical study data do not support these claims'.

'Both Actonel and Boniva have been proven to reduce the risk of spinal (vertebral) fractures at three years in women with postmenopausal osteoporosis. However, Boniva has not been proven to reduce the risk of non-spinal fracture,' reads a P&G statement. 'In pivotal clinical trials, Actonel has been proven to reduce the risk of non-spinal fractures at three years. The medications have not been compared in head-to-head clinical studies.'

Mary Anne Rhyne, a US spokeswoman for GSK, said: 'We believe our advertising is truthful and accurate.' Martina Rupp, a US spokeswoman for Roche, said she is 'confident the advertising accurately and appropriately reflects the clinical findings'.

The allegations have made little impact on the shares of Roche and GSK as analysts predict any lawsuit is unlikely to affect sales of Boniva.