Novartis will launch Reclast (zoledronic acid) for treatment of Paget's disease in June 2007, the firm told "The Pink Sheet" DAILY April 17.

The Swiss firm is billing the therapy, which is given as an injection, as the first new treatment in almost 10 years for Paget's. Reclast will compete against Procter & Gamble's Actonel (risedronate), which Novartis said is currently the standard of care.

Zoledronic acid is already marketed by Novartis under the name Zometa for treatment of hypercalcemia of malignancy, and multiple myeloma and bone metastases of solid tumors.

Novartis is aiming to differentiate Reclast from Actonel based on Reclast's single-dose infusion, improved efficacy, and faster onset of action.

Data submitted as part of the NDA package included two head-to-head studies of Reclast versus Actonel examining therapeutic response after six months. In the trials, patients were randomized to either a single dose of zoledronic acid or 30 mg of risedronate given daily for 60 days.

Results, which were published in the New England Journal of Medicine in September 2005, showed that at six months, 96 percent of patients taking Reclast responded to treatment compared to 74 percent in the Actonel group. Also, Reclast patients showed a shorter median time to therapeutic response - 64 versus 89 days - compared to Actonel patients.

"A single infusion of zoledronic acid produces more rapid, more complete, and more sustained responses in Paget's disease than does daily treatment with risedronate," study authors conclude in the NEJM article.

Novartis also told "The Pink Sheet" DAILY that at 24 months after treatment, 98 percent of Reclast patients continued to show a therapeutic response.

Reclast could also have an overall cost advantage versus Actonel. According to Novartis, Reclast will be priced at $1,041 for the single dose, compared to $1,067 for a two-month regimen of Actonel, assuming 30 mg once daily.

Novartis also submitted an NDA for Reclast (marketed outside the U.S. as Aclasta) for the treatment of postmenopausal osteoporosis--a much larger market for the drug--in October and is currently pending before the agency with a review date anticipated in the second half of the year.

If approved for the osteoporosis indication, which calls for a once-a-year infusion, Reclast would compete against several other treatments, including Roche/GlaxoSmithKline's Boniva (ibandronate), which is given monthly as a tablet or quarterly as an injection, and Merck's Fosamax (alendronate).

In November, Novartis Global Pharma Development Head James Shannon said he anticipated that comprehensive claims included in Reclast's labeling for osteoporosis could provide a potential competitive advantage (¹ Also see "Novartis On The Move: Firm Files Tasigna, Aclasta Ahead Of Schedule" - Pink Sheet, 28 November, 2006.).

According to Novartis, data from the three-year HORIZON trial show that Reclast patients had a 70 percent risk reduction in new spine fractures and a 41 percent risk reduction in hip fractures compared to placebo, meeting both primary endpoints.

- Jonathan M. Block (j.block@elsevier.com)

Novartis Plans June Launch For Paget’s Disease Therapy Reclast

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