FDA Ruling Gives Actonel Boost in Osteoporosis-Drug War

Dosage Approval Heats Up Brand's Battle With Boniva in $3 Billion Market

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BATAVIA, Ohio (AdAge.com) -- The Food and Drug Administration has approved a new two-pill-a-month dose for osteoporosis drug Actonel, giving marketers Procter & Gamble Co. and Sanofi-Aventis new ammunition in their hotly contested battle in a $3 billion-plus market.
Until now P&G's Actonel had to be taken weekly; that fact put it at a disadvantage against Boniva, which only has to be taken once a month.
Until now P&G's Actonel had to be taken weekly; that fact put it at a disadvantage against Boniva, which only has to be taken once a month.

Rival osteoporosis drug Boniva from Hoffman-LaRoche and GlaxoSmithKline has grabbed share since its 2005 launch with a once-monthly dose, while category leader Merck & Co.'s Fosamax and P&G's Actonel have up to now had to be taken weekly. While it may not seem like a huge advantage, it has been the basis of a $100 million ad campaign by Havas' Euro RSCG featuring actress Sally Field extolling the convenience of the once-monthly dosage.

Not as simple as it sounds
The newly approved dosage for Actonel isn't quite so simple -- it requires two pills be taken a day apart each month. But in a statement, P&G noted that patients only need to wait a half-hour to drink coffee or have other food or drink after taking Actonel, compared to an hour for Boniva. Otherwise, P&G noted that "there are no head-to-head studies comparing the safety and efficacy" of the two drugs.

A P&G spokeswoman said the new dosage should be available by early summer, but said there are no plans for ads specifically on the dosage. "In general, this new product offering in combination with other initiatives we have going on right now should have a positive impact," she said. Omnicom Group's DDB Worldwide, New York, handles Actonel.

The bigger impact could be on Boniva ads, since they'll no longer be able to portray a weekly dose as the only alternative to Boniva's monthly dose.

Had claimed false advertising
P&G lost a bid for a preliminary injunction last year in a false-advertising suit against Boniva marketers, and along with it apparently any ability to claim superior efficacy. P&G had claimed that Boniva ads falsely implied or stated that the once-monthly dosage was as effective as weekly Actonel at preventing fractures beyond the spine, despite Boniva's lack of FDA approval for preventing such fractures.

In its ruling, the U.S. District Court for the Southern District of New York cited FDA determination in May 2006 that rejected as misleading a proposed ad suggesting Actonel works better than Boniva beyond the spine. The court said the letter left no doubt that Boniva is safe and effective "without limitation as to vertebral and nonvertebral sites." P&G has appealed the ruling.

Following the ruling, Roche replaced its former agency, Publicis Groupe's Saatchi & Saatchi Consumer Healthcare, with Euro, and ramped up support for new Boniva ads featuring Ms. Field. Boniva received $100 million in measured media support last year, according to TNS Media Intelligence, compared to $59.5 million for Actonel and $64.5 million for Fosamax.

Other wild cards
Among other wild cards facing the category is the pending loss of patent protection for Fosamax next year, which could usher in generic competition. Several lawsuits also have been filed in recent months against Merck and P&G/Sanofi-Aventis charging that their drugs cause a rare jaw-rotting condition called osteonecrosis.

In its statement, P&G said most of the rare reported osteonecrosis cases involving Actonel occurred in cancer patients undergoing dental procedures and getting the drug intravenously.
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