Boniva Ad Campaign Prompts Procter & Gamble/Sanofi-Aventis Suit

Procter & Gamble/Sanofi-Aventis allege that Roche and GSK's campaign for Boniva is misleading because it fails to state that Boniva is not approved for treatment of nonspinal fractures.

Procter & Gamble and Sanofi-Aventis have filed suit over an ad campaign utilized by Roche and GlaxoSmithKline for promotion of its osteoporosis therapy Boniva (ibandronate).

The suit alleges that Boniva advertising efforts claim that the drug has been proven to reduce the risk of nonspinal (nonvertebral) fractures and that it is more convenient than other bisphosphonates.

P&G and Sanofi-Aventis co-market the osteoporosis therapy Actonel (risedronate). P&G/Sanofi-Aventis filed suit under the Lanham Act on Jan. 4 in the U.S. District Court in New York.

Actonel and Merck's Fosamax (alendronate), the only other bisphosphonate drugs on the market, are approved for treatment of nonvertebral fractures.

However, Boniva's effect on nonvertebral fractures is still undetermined; its label states that "there was a similar number of nonvertebral osteoporotic fractures at 3 years reported in women treated with Boniva 2.5 mg daily."

Roche and GSK began airing two 60-second television commercials for Boniva in July 2005 touting the monthly dosage form as more convenient than the weekly osteoporosis drugs on the market.

"Because those other drugs have been clinically proven to deliver nonvertebral fracture benefits while Boniva has not, this claim is false and misleading," P&G/Sanofi-Aventis state in the suit.

In addition to the promotional television commercials, the Boniva website said that osteoporosis patients may experience nonvertebral fractures, particularly hip, back and wrists, but that "Boniva has been shown to prevent further bone loss and even increase bone density, lessening your risk of fractures."

P&G/Sanofi-Aventis argue in the suit that "the literal meaning and necessary implication of this page, when read in its entirety, is that Boniva is proven to 'lessen the risk' of all fractures, including hip fracture," a false claim.

Finally, P&G/Sanofi-Aventis notes that the centerpiece of the Boniva marketing campaign, the "Primary Sales Aid," an eight-page brochure addressed to healthcare professionals, highlights "the 'convenience of less frequent dosing' while conveying the message that Boniva is otherwise comparable to the weekly bisphosphonate drugs."

P&G/Sanofi-Aventis said they have contacted FDA's Division of Drug Marketing, Advertising & Communications three times and FDA has declined to intervene.

Lilly recently agreed to pay $36 mil. to settle a misdemeanor charge related to off-label promotion of its osteoporosis drug Evista (¹ (Also see "Lilly Pleads Guilty To Off-Label Evista Promotion" - Pink Sheet, 21 Dec, 2005.)).

P&G/Sanofi-Aventis seek a preliminary and permanent injunction against Roche and GSK as well as monetary damages of various forms.

-Kathryn Phelps