Roche Release: New Phase III Study Shows Intravenous Boniva(R) Given Once Every Two Or Three Months Effective In The Management Of Osteoporosis
NUTLEY, N.J., July 8 /PRNewswire/ -- Roche announced today that the phase III study (DIVA) investigating Boniva(R) (ibandronate), administered as an intravenous injection with extended intervals between-dosages for the treatment of postmenopausal osteoporosis, has shown positive results after one year of treatment. Both regimens studied (2mg every two months and 3mg every three months) were at least equivalent to the 2.5 mg daily regimen in increasing spine Bone Mineral Density (BMD). Preliminary safety evaluation also indicates that all regimens were well tolerated. Dosing by intravenous injection is expected to provide advantages to patients who would find it helpful for compliance or for tolerance of therapy.
The U.S. Food and Drug Administration (FDA) approved a once-daily administration of Boniva in May 2003. A supplemental new drug application (sNDA) for once-monthly oral Boniva in osteoporosis was submitted to the FDA in May 2004 and is currently under review. The company has been exploring more convenient dosing regimens before launching the product.
"This study demonstrates Boniva given once every two or three months as an injection shows promise in the management of postmenopausal osteoporosis. If approved, it will be the first bisphosphonate that gives doctors and patients the flexibility to choose between an oral or an I.V. treatment," said George Abercrombie, president and chief executive officer, Roche. "We will be sharing this data with the regulatory authorities at the earliest possible opportunity to supplement the oral filings."
DIVA Study Details
DIVA (Dosing IntraVenous Administration) is a two-year multinational study in postmenopausal women that compares the efficacy and safety of the FDA approved oral daily ibandronate regimen with intravenous injections of ibandronate: 2mg every two months and 3 mg every three months. DIVA is a non-inferiority study assessing lumbar spine 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.
In December 2001, Roche and GlaxoSmithKline announced that they would co-develop and co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries, except Japan.
About Osteoporosis
Osteoporosis is a major public health threat for an estimated 44 million Americans. In the U.S. today, 10 million individuals, eight 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.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche U.S. pharmaceuticals business, visit the company's web site at: http://www.rocheusa.com/
RocheCONTACT: Terry Hurley of Roche, +1-973-562-2882,terence_j.hurley@roche.com
Web site: http://www.rocheusa.com/