Roche and partner GlaxoSmithKline can continue a direct-to-consumer advertising campaign for its osteoporosis drug Boniva in the USA, according to a federal judge, despite objections from rivals Procter & Gamble and Sanofi-Aventis.
Sanofi-Aventis and P&G’s pharmaceuticals division had objected to DTC advertising for Boniva (ibandronate sodium), a bisphosphonate drug used to increase bone mineral density in people with osteoporosis, saying that it was misleading and inflated the efficacy of the product.
P&G and Sanofi-Aventis market a competing bisphosphonate called Actonel (risedronate sodium), and both brands are jostling for market share in a sector currently dominated by Merck & Co’s ageing Fosamax (alendronate), which makes around $3 billion a year in sales.
In the latest development in the case, district judge Paul Crotty ruled that Roche and GSK were entitled to continue their promotion of Boniva as being as effective as Actonel and Fosamax.
"Given the vigour with which P&G attempted to preserve its market share by denigrating Boniva, Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented," he said in written comments on the case.
Specifically, P&G and Sanofi-Aventis take issue with claims that Boniva has been proven to reduce the risk of non-vertebral fractures. They insist that Boniva was unsuccessful in a clinical trial at reducing fractures affecting the wrist, hip and other bones in women after three years of treatment. Actonel labelling indicates that it has shown efficacy in these fractures at three years, they claim.
Actonel sales have risen to more than $1 billion a year since its debut in 2000, and Boniva is still a minnow in comparison, with GSK booking $61 million from the drug in the first half of 2006. Meanwhile, in its interim 2006 report Roche notes that sales of oral Bonviva/Boniva increased to 167 million Swiss francs ($134m), an advance of more than 660%, with the product’s share of the US bisphosphonate market advancing to over 10%.