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Study Results Show Positive Effect of Oral Monthly Boniva in Management of Osteoporosis

NUTLEY, N.J., and PHILADELPHIA, Jan. 13 /PRNewswire/ -- Roche and GlaxoSmithKline (GSK) announced today that the first phase III study (MOBILE) investigating more convenient once-monthly oral treatment of post menopausal osteoporosis with Boniva(R) (ibandronate) Tablets has shown positive results after one year of treatment. All doses studied (100 mg and 150 mg once monthly) were at least equivalent to the 2.5 mg daily regimen in increasing lumbar spine Bone Mineral Density (BMD). Preliminary safety evaluation indicates that all regimens were well tolerated.

The U.S. Food and Drug Administration (FDA) approved a once-daily formulation of Boniva in May 2003. The companies have been exploring more convenient dosing before launching the product.

Many currently available osteoporosis treatments restrict patients' activities before and after taking their medicine, such as requiring them to fast and prohibiting them from reclining. While Boniva also has these restrictions on patient activity, the availability of less frequent dosing of Boniva may have the potential to offer enhanced patient convenience. "We are pleased that this initial review of the data indicates that a monthly dosing regimen with ibandronate shows promise in the management of post menopausal osteoporosis," said George Abercrombie, president and chief executive officer, Roche. "We will be sharing these data with the regulatory authorities at the earliest possible opportunity to supplement the initial daily filing."

MOBILE Study Details
The MOBILE(1) (Monthly Oral Ibandronate in Ladies) is a 2 year randomised, double-blind, parallel group, multinational study in postmenopausal women that compares the efficacy and safety of the FDA approved oral daily ibandronate regimen with three different monthly regimens:

-- 100 mg on a single day
-- 100 mg as separate 50 mg doses on two consecutive days
-- 150 mg on a single day

MOBILE is a non-inferiority study with lumbar spine Bone Mineral Density (BMD) at one year as the primary endpoint. The study is currently ongoing for a second year.

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

Boniva is 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.

About Osteoporosis
Osteoporosis is a major public health threat for an estimated 44 million Americans. In the U.S. today, 10 million individuals, 8 million of whom are women, are estimated to already have osteoporosis and almost 34 million more are estimated to have low bone mass, placing them at increased risk for the disease. One in two women over age 50 will have an osteoporosis-related fracture in their lifetime. Osteoporosis is responsible for more than 1.5 million fractures annually. The need for therapies to prevent and treat osteoporosis will continue to increase, especially as the number of postmenopausal women in the population continues to rise.

Source: Roche and GlaxoSmithKline

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