SOURCE: Roche and GSK

September 26, 2005 16:01 ET

Roche and GSK Announce Head-to-Head Study of Osteoporosis Therapies

Trial Compares Efficacy and Safety of Once-Monthly Boniva® Versus Weekly Fosamax®

NUTLEY, NJ and RESEARCH TRIANGLE PARK, NC -- (MARKET WIRE) -- September 26, 2005 -- Roche and GlaxoSmithKline (GSK) today announced the start of a large-scale clinical trial that, for the first time, directly compares Boniva® (ibandronate sodium), the companies' new monthly osteoporosis treatment, against the market leader, Merck's Fosamax® (alendronate sodium). The one-year trial is expected to include 1,900 women with postmenopausal osteoporosis.(1)

The MOTION trial (Monthly Oral Therapy with Ibandronate for Osteoporosis INtervention), a non-inferiority study, will compare the efficacy and safety of once-monthly oral Boniva and weekly oral Fosamax.(1) The MOTION study design was presented today at the 27th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

"This is a very important study because these two treatment regimens have never before been directly compared," said Felicia Cosman, M.D., medical director of the Clinical Research Center, Helen Hayes Hospital in West Haverstraw, NY. "This trial will measure each treatment's ability to increase bone mineral density, an accepted surrogate for determining the risk of fracture -- the most relevant consequence of postmenopausal osteoporosis."

"We are confident that the large head-to-head study between Boniva and Fosamax will help physicians choose the treatment option that will meet their patients' needs," stated Keith E. Friend, M.D., senior medical director, Roche.

About MOTION(1)

The MOTION trial is designed to compare the efficacy of once-monthly oral ibandronate with weekly oral alendronate. In MOTION, a randomized, double-blind, double-dummy study, close to 1,900 women with postmenopausal osteoporosis will receive either 150 mg once-monthly oral ibandronate or 70 mg once-weekly oral alendronate for one year. To maintain blinding, participants will also receive once-monthly or weekly oral placebo, plus daily calcium (500-1500 mg) and vitamin D (400 IU). The primary endpoints are percent change from baseline in lumbar spine and total hip bone mineral density (BMD) at one year. Secondary endpoints include percent change in hip trochanter BMD at one year and biochemical markers of bone turnover in a subset of patients at day seven and months three, six and 12. Clinical vertebral and non-vertebral fractures will also be assessed, and their respective rates compared. Adverse events will be monitored throughout the study.

About Osteoporosis

Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. 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 (osteopenia),(2) 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. Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020.(2) Direct medical costs of osteoporosis total nearly $18 billion in the U.S. each year.(3)

About Once-Monthly Oral Boniva

Once-monthly Boniva is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take Boniva with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink and other medications for at least 60 minutes.

Patients who take Boniva are eligible to sign up for MyBONIVA, a program designed to help enhance compliance (taking therapy as directed) and persistence (staying on therapy) with this unique once-monthly regimen. For more information on this program call 1-800-4BONIVA or visit www.myboniva.com.

Important Safety Information

Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of Boniva. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Boniva is not recommended in patients with severe renal impairment. Adequate intake of calcium and Vitamin D is important in all patients.

Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures. The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent).

For complete prescribing information for Boniva Tablets, see contact information at the end of the news release or go to www.boniva.com.

Roche and GSK Collaboration

In December 2001, F. Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan. The Roche and GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche

Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. For further information, visit www.rocheusa.com.

About GSK

GSK, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GSK on the World Wide Web at www.gsk.com.

Fosamax is a registered trademark of Merck & Co., Inc.

References

(1)  Cosman F, McClung M, Rosen C, Epstein S, Devas V, El Azzouzi B,
     Bonvoisin B, Zanchetta J, Cooper C, Delmas PD. Rationale And Design
     Of The MOTION Study (Monthly Oral Therapy With Ibandronate For
     Osteoporosis Intervention). Poster M359 presented at: 27th Annual
     Meeting of the American Society for Bone Mineral Research, September
     23-27, 2005, Nashville, TN.
(2)  America's Bone Health: The State of Osteoporosis and Low Bone Mass
     in Our Nation: The National Osteoporosis Foundation; February 2002.
(3)  Bone Health and Osteoporosis: A Report of the Surgeon General.
     Rockville, MD: U.S. Department of Health and Human Services, Office
     of the Surgeon General; 2004.

Contact Information

  • For more information or full prescribing information, contact:
    Roche:
    Terence Hurley
    (973) 562-2882

    GSK:
    Veronica Grosshandler
    (919) 483-2839