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New Drug Application Submitted to FDA for IV Form of Ibandronate

NUTLEY, N.J. and RESEARCH TRIANGLE PARK, N.C., Dec. 8 /PRNewswire/ -- Roche and GlaxoSmithKline (GSK) announced today the submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for a novel intravenous (IV) injection formulation of its bisphosphonate Boniva(TM) (ibandronate sodium) for the treatment of postmenopausal osteoporosis. The proposed IV injection regimen is 3 mg administered once every three months. Bisphosphonates, the most frequently prescribed medicines for treating osteoporosis,(1) currently are available only in once-daily or once-weekly oral dosing formulations.

"Boniva Injection is expected to be the first IV bisphosphonate treatment for osteoporosis, and may be a helpful alternative for physicians who want greater control in administering bisphosphonate therapy," said Dominique Ethgen, M.D., director, clinical development, GSK.

Keith Friend, M.D., medical director, Roche, added, "Boniva Injection may offer a new option for patients who experience gastrointestinal side effects with oral bisphosphonates, or are unable to comply with oral bisphosphonate dosing guidelines."

FDA approved a once-daily oral formulation of Boniva in May 2003, but Roche and GSK have been exploring less frequent oral dosing regimens, as well as the IV formulation, before marketing Boniva. In May 2004, a supplemental NDA was filed with FDA for a once-monthly oral dosing formulation of Boniva, which may offer added convenience for patients compared to the daily and weekly oral bisphosphonates currently available.

In December 2001, Roche and GSK announced that they would co-develop and co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan.

About Boniva Injection
Boniva Injection should not be administered to patients with hypocalcemia. The most common side effects observed in clinical trials were bone, muscle or joint pain; flu-like illness; and headache.

About Boniva Once-Daily Oral Tablets
Boniva (2.5 mg once-daily) is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Boniva increases bone mineral density and reduces the incidence of vertebral fractures. Boniva also may be considered for postmenopausal women who are at risk for developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and reduce the risk of vertebral fracture.

Boniva Tablets are contraindicated in patients unable to stand or sit upright for at least 60 minutes, patients with hypersensitivity to any component of this product, and patients with uncorrected hypocalcemia. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.

Complete prescribing information is available through Roche and GSK. Boniva 2.5 mg once-daily is approved, but not marketed.

About Osteoporosis
Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. Common and chronic conditions, osteoporosis and low bone mass (osteopenia) pose a major public health threat to more than 44 million Americans over age 50. In the U.S. today, ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have osteopenia, placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. An estimated 52 million women and men age fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 and 61 million are expected to be affected by 2020.(2)

References
(1) Stafford RS, Drieling RL, Hersh AL. National trends in osteoporosis visits and osteoporosis treatment, 1988-2003. Arch Intern Med. 2004;164:1525-1530.
(2) America's Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation. The National Osteoporosis Foundation. February 2002.

Source: Roche; GlaxoSmithKline

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