Here Comes an Osteoporosis Drug With Once-a-Year Dosage

Just-Approved Reclast Could Shake Up Ultra-Competitive Market

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BATAVIA, Ohio (AdAge.com) -- Considering how Sally Field raves over only having to take an osteoporosis drug once a month, how excited will she get over only having to take one once a year?
Reclast's once-yearly dose comes from an intravenous infusion, not a pill.
Reclast's once-yearly dose comes from an intravenous infusion, not a pill.

Probably not very. The once-yearly dose comes from a new competitor -- Novartis' Reclast, which could shake up an osteoporosis market where Ms. Field's favorite, Boniva, has been gaining considerable ground.

A big caveat
In a business where fewer doses have amounted to heftier market shares, Novartis may have scored big with Food and Drug Administration approval for its osteoporosis drug Reclast, which need only be administered once annually. One big caveat: Reclast's one dose comes from an intravenous infusion, not a pill.

Novartis has yet to say when it will begin marketing Reclast for osteoporosis following the FDA approval, which came late last week. Interpublic Group of Cos.' Regan Campbell Ward/McCann, New York, already handled Reclast for another condition -- Paget's disease. The shop also does work on a variant of the drug, Aclasta, which is used to treat cancer.

The drug enters a $3 billion-plus U.S. market led by Merck & Co.'s Fosamax but also heavily contested by Actonel, co-marketed by Procter & Gamble Co. and Sanofi-Aventis; along with Boniva, from Hoffman La Roche and GlaxoSmithKline.

Aggressive Boniva campaign
Boniva has grabbed an estimated 15% of the market since its U.S. launch in 2005, backed by the segment's most aggressive media campaign. It features Ms. Field touting the benefits of once-monthly dosing vs. the alternatives, which include a twice-monthly dosing of Actonel and once-weekly doses of Fosamax and Actonel.

Boniva got $100 million in media support last year, according to TNS Media Intelligence, compared to $59.5 million for Actonel and $64.5 million for Fosamax.

Actonel received FDA approval earlier this year for more-convenient twice-monthly dosing. But the drug has lost share to Boniva, prompting P&G and Sanofi-Aventis to file a false-advertising lawsuit against Boniva's marketers last year. Actonel backers lost a bid to get a U.S. District Court judge to halt Boniva ads.

P&G said the ads implied Boniva was as effective at preventing fractures beyond the spine as Actonel, despite not getting FDA approval to treat nonspinal bones. The court, citing a subsequent FDA letter, said Boniva appears to be safe and effective "without limitation as to vertebral or nonvertebral sites." The ruling remains under appeal.

P&G's biggest prescription drug
While Actonel is the No. 2 osteoporosis drug, it is P&G's biggest prescription drug and the only to reach the $1 billion sales mark. Several anonymous posters to the company's message board on Cafepharma.com, a site for pharmaceutical sales reps, speculated that the Reclast approval will deal Actonel a substantial blow.

Also looming over the market is the pending loss of patent protection next year for the leading osteoporosis drug, Fosamax. When the drug lost its Canadian patent approval in 2005 and generic competition emerged, prices of the branded product dropped 40%. Interpublic's Draft FCB Healthcare, New York, handles Fosamax advertising. Omnicom Group's DDB Worldwide, New York, handles Actonel, and Havas' Euro RSCG handles Boniva.
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