Boniva: profile and news
Latest Osteoporosis ZOOM Market Report(TM) Now Available Mar 3, 2006
In the US, Germany and the UK, where Boniva is launched, it is being promoted as the most convenient bisphosphonate, due to its' once-a-month dosing. ... - Yahoo! News (press release)
Good news about osteoporosis drugs Feb 6, 2006
It was big news in May when the FDA approved Boniva, the first once-a-month osteoporosis medication by Roche Pharmaceuticals — in stark contrast from the once ... - El Paso Times,
Keep taking calcium supplements Feb 20, 2006
Only bisphosphonate agents such as Fosamax, Actonel and Boniva and calcitonin agents such as Miacalcin can increase bone density. ... - El Paso Times,
Amgen Osteoporosis Drug Appears Effective Feb 23, 2006
...a week. Boniva from GlaxoSmithKline (GSK:NYSE - commentary - research - Cramer's Take) is administered once a month. With osteoporosis ... - TheStreet.com
Amgen building stronger bones Feb 22, 2006
If approved, denosumab would compete with Fosamax, which must be taken weekly, and with Boniva, the once-a-month treatment sold by GlaxoSmithKline and Roche. ... - Rocky Mountain News,
Auto racing tie-ins are a sure thing Feb 19, 2006
6 car since 2001. And last year, Boniva, a new medicine for the treatment of postmenopausal osteoporosis, was the primary sponsor for Bobby Labonte's No. ... - Daytona Beach News-Journal,
Older Men Surviving Heart Attack at Higher Risk of Osteoporosis Feb 21, 2006
The FDA has approved Boniva (ibandronate sodium) Injection as the first intravenous medication for the treatment of postmenopausal osteoporosis. Read more... ... - SeniorJournal.com,
EU approves Glaxo drug Hycamtin for lung cancer Jan 31, 2006
Glaxo but its approval is the latest in a string of recent good product news, including approval for an injectable form of the brittle bone drug Boniva and the ... - Reuters
Hip Fractures Reduced by Taking Vitamin D, Calcium Supplement Feb 15, 2006
...they should really discuss whether … additional bone-active agents are appropriate," she said, referring to prescription medications such as Fosamax or Boniva ... - ABC News
It is Predicted in the Next Ten Years the Demand for Drugs to ... Feb 3, 2006
...with 6.9% annual sales growth through our study period, driven by the emergence of two new agents: Roche/GlaxoSmithKline's ibandronate (Boniva/Bonviva) and ... - International News Service,
Roche 2005: Record Sales and Operating Profit Feb 1, 2006
Bonviva/Boniva, the first and only once-monthly oral bisphosphonate approved for the treatment of postmenopausal osteoporosis, was launched by Roche and its ... - PharmaLive.com (press release),
Glaxo wins approvals for drugs Feb 1, 2006
...quite a good few weeks," said Andrew Witty, Glaxo's head of pharmaceuticals in Europe, who noted an injectable form of the brittle bone drug Boniva and Arranon ... - Scotsman,
Boniva for injection cleared in USA Jan 9, 2006
Boniva for injection (ibandronate sodium), developed by GlaxoSmithKline and Roche, is aimed at people who find it hard to adhere to treatment with the current ... - Pharma Times (subscription),
Good news about osteoporosis drugs Feb 6, 2006
It was big news in May when the FDA approved Boniva, the first once-a-month osteoporosis medication by Roche Pharmaceuticals — in stark contrast from the once ... - El Paso Times,
FDA Approves First IV Treatment for Postmenopausal Osteoporosis ... Jan 6, 2006
6 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Boniva(R) (ibandronate sodium) Injection, the first intravenous (IV) medication for ... - PR Newswire (press release),
FDA Approves First IV Treatment for Postmenopausal Osteoporosis ... Jan 9, 2006
NUTLEY, NJ, and RESEARCH TRIANGLE PARK, NC -- January 9, 2006 -- The US Food and Drug Administration (FDA) has approved Boniva(R) (ibandronate sodium) Injection ... - DG News
FDA approves first quarterly IV injection for postmenopausal ... Jan 9, 2006
Drug Administration (FDA) has approved a new, quarterly intravenous (IV) injection of the potent and highly effective osteoporosis drug Boniva (ibandronic acid ... - Biotech Intelligence (press release),
FDA OKs First IV Osteoporosis Drug Jan 13, 2006
The drug is a new form of Boniva, an osteoporosis medicine that is already approved in pill form. Boniva pills are available to ... - WebMD
Pharmaceutical Kerfuffle: P&G and Sanofi-Aventis Allege ... Jan 27, 2006
Proctor & Gamble Pharmaceuticals and Sanofi-Aventis have alleged that Roche Pharmaceuticals and GlaxoSmithKline's advertising for Boniva is false and misleading ... - Media Buyer Planner,
EU approves Glaxo drug Hycamtin for lung cancer Jan 31, 2006
Glaxo but its approval is the latest in a string of recent good product news, including approval for an injectable form of the brittle bone drug Boniva and the ... - Reuters
European positive opinion for first quarterly IV injection for Jan 27, 2006
Efficacy on femoral neck fractures has not been established. Boniva™ Injection was approved by the US Food and Drug Administration on 6th January 2006. ... - WebWire (press release),
Synergetics Inks Agreements with Johnson & Johnson Unit and ... Jan 10, 2006
...companies GlaxoSmithKline PLC (NYSE:GSK) and Roche Holding AG said on Friday that the Food and Drug Administration has approved the use of Boniva Injection, an ... - Financial News USA (press release),
Companies say FDA approves IV version of postmenopausal ... Jan 9, 2006
Boniva Injection, formally known as ibandronate sodium, becomes the first intravenous drug for the treatment of postmenopausal osteoporosis, Roche and ... - Redlands Daily Facts,
Roche and GlaxoSmithKline develop new injection for bone ... Jan 9, 2006
CEO Division Roche Pharma William M. Burns noted that the US approval of quarterly Boniva Injection represents an important new opportunity to bring the bone ... - Kuwait News Agency,
Pharmaceutical companies sued over adverts Jan 11, 2006
Britain's GlaxoSmithKline and Swiss drug-maker Roche over allegations that their marketing embellishes the benefits of newly-launched osteoporosis pill Boniva. ... - Legalbrief (subscription),
It is Predicted in the Next Ten Years the Demand for Drugs to ... Feb 3, 2006
...with 6.9% annual sales growth through our study period, driven by the emergence of two new agents: Roche/GlaxoSmithKline's ibandronate (Boniva/Bonviva) and ... - International News Service,
Roche 2005: Record Sales and Operating Profit Feb 1, 2006
Bonviva/Boniva, the first and only once-monthly oral bisphosphonate approved for the treatment of postmenopausal osteoporosis, was launched by Roche and its ... - PharmaLive.com (press release),
Roche Holding Defends Drug Advertisement Jan 7, 2006
AG, which is being sued in an advertising dispute in the United States, said Thursday it is confident it is accurately representing its osteoporosis drug Boniva ... - Leading The Charge,
Alcoa, Mills, Equity Inns Jan 7, 2006
Roche (RHHDY) and GlaxoSmithKline Plc (GSK) said the Food and Drug Administration has approved Boniva Injection, the first intravenous medication for the ... - Investor's Business Daily (subscription)
New year brings lawsuits for pharma Jan 6, 2006
...and GlaxoSmithKline in the US Federal District Court in the Southern District of New York alleging false advertising of their osteoporosis treatment Boniva. ... - Monsters and Critics.com,
Roche and Glaxo win OK for new use of drug Jan 6, 2006
Reuters) - Swiss drug maker Roche Holding and GlaxoSmithKline won US approval for long-lasting intravenous use of their osteoporosis drug Boniva, the companies ... - Scotsman,
Roche and Glaxo win US OK for osteoporosis drug Jan 6, 2006
...drug maker Roche Holding AG and Britain's GlaxoSmithKline Plc won US approval for long-lasting intravenous use of their osteoporosis drug Boniva, the companies ... - Scotsman,
Roche and Glaxo win US OK for osteoporosis drug Jan 6, 2006
L: Quote, Profile, Research)(GSK.N: Quote, Profile, Research) won US approval for long-lasting intravenous use of their osteoporosis drug Boniva, the companies ... - Reuters.uk,
Earnings Preview: Procter & Gamble Jan 26, 2006
...against European drug makers Roche Holding and GlaxoSmithKline in US federal court, accusing the companies of false advertising of Boniva, an osteoporosis drug ... - BusinessWeek
Glaxo wins approvals for drugs Feb 1, 2006
...quite a good few weeks," said Andrew Witty, Glaxo's head of pharmaceuticals in Europe, who noted an injectable form of the brittle bone drug Boniva and Arranon ... - Scotsman,
Osteoporosis Information Now Online at NIHSeniorHealth Jan 27, 2006
The FDA has approved Boniva (ibandronate sodium) Injection as the first intravenous medication for the treatment of postmenopausal osteoporosis, Roche and ... - SeniorJournal.com,
European Stocks May Rise, Led by BP, BHP, Commodity Producers Jan 8, 2006
...and Roche Holding AG, the Swiss drugmaker, may advance after the US Food and Drug Administration approved their postmenopausal osteoporosis injection Boniva. ... - Bloomberg
Swiss shares move higher in morning trade tracking Wall St; Adecco ... Jan 9, 2006
In the healthcare sector, Roche fell 1.20 sfr to 196.80 on profit-taking, with news that its and GlaxoSmithKline's osteoporosis treatment Boniva has received ... - Forbes
European stocks - Factors to watch on Jan 9 Jan 8, 2006
ROCHE (ROG.VX: Quote, Profile, Research) The drug makers won US approval for long-lasting intravenous use of their osteoporosis drug Boniva, the companies said ... - Reuters.uk,
Ask the Pharmacist: Do you want healthy bones? Pour out that glass ... Dec 6, 2005
By SUZY COHEN, Special to the Eagle. Q: I was told that I have osteoporosis, and now I'm taking a prescription drug called Boniva. ... - Marconews (subscription),
Avenues to pursue for emphysema Dec 7, 2005
Why? -- BT. Dear BT: Pamidronate, trade name Aredia, is a close relative of three other Paget's disease drugs -- Fosamax, Actonel and Boniva. ... - Sarasota Herald-Tribune,
Hospital in West Haverstraw tests new treatments for osteoporosis Dec 1, 2005
A second study seeks to see if the drug Boniva, which has been shown to help stop bone loss in the spine, can also prevent bone loss in the hip area. ... - The Journal News.com,
Osteoporosis: compliance is the key Nov 25, 2005
This maturation in the pipeline begun in the last 12 months with the introduction of Servier's Protelos in Europe and Roche/GlaxoSmithKline's Boniva. ... - Pharmaceutical Business Review
Pharma Reformulates Dec 5, 2005
Byetta, Wyeth's injectable antibiotic Tygacil, GSK's leukemia/lymphoma therapy Arranon, and Roche and GSK's once-monthly osteoporosis drug formulation Boniva. ... - Chemical & Engineering News
A Growing Medical Problem May Be a Growth Opportunity Nov 30, 2005
...for osteoporosis, but there is a handful of medications that help prevent and treat the disease.The flagship drugs in this arena, Fosamax, Boniva, and Actonel ... - New York Sun,
Swiss shares continue lower in afternoon trade, led by Adecco ... Nov 16, 2005
Gilead. Good data on Boniva, the intravenous osteoporosis drug co-developed with GlaxoSmithKline, also helped the stock earlier. ... - Forbes
Many Patients with Osteoporosis Do Not Continue Their ... Nov 21, 2005
...be improved.". The study was funded by GlaxoSmithKline, which manufactures ibandronate (Boniva) in partnership with Roche. The medication ... - DG News
Surviving the Consolidation Rampage Nov 17, 2005
...a company built on the acquisition of bankrupt ERP vendor Baan, has also been busy recently, acquiring CRM software vendor E.piphany and Boniva, a provider of ... - CIO Today,
Bonviva intravenous injection for postmenopausal osteoporosis ... Nov 19, 2005
...released in July 2004. The NDA for Boniva IV injection was submitted to the FDA in the US in December 2004. The MAA for Bonviva ... - Medical News Today (press release),
Roche, GSK's Boniva to go head-to-head with Merck's Fosamax Sep 26, 2005
ZURICH (AFX) - Roche Holding AG and GlaxoSmithKline PLC said they plan a large scale clinical trial comparing their osteoporosis drug Boniva with the market ... - Forbes
Roche, Glaxo Show Confidence On Boniva Sep 27, 2005
0812 GMT [Dow Jones] Roche (RHHBY), Glaxo (GSK) trialing osteoporosis drug Boniva, head-on versus Merck (MRK) market leader Fosamax, is a show of confidence ... - New Ratings
Roche and GSK's Boniva takes on Merck's Fosamax in trial Sep 28, 2005
Roche and GlaxoSmithKline have jointly commenced a large-scale clinical trial that, for the first time, directly compares Boniva, their new monthly ... - Pharmaceutical Business Review
Study Shows Women Prefer Once-Monthly Osteoporosis Medicine Over a ... Sep 26, 2005
Another Study (MOBILE) Confirms Once-Monthly Boniva(R) is Effective and Generally Well-Tolerated Over Two Years NASHVILLE, Tenn., Sept. ... - PR Newswire (press release),
Study Shows Women Prefer Once-Monthly Osteoporosis Medicine Over a ... Sep 26, 2005
Nearly three-fourths of women with postmenopausal osteoporosis, who expressed a preference, preferred once-monthly dosing with Boniva® (ibandronate sodium ... - Market Wire (press release)
Roche and GSK Announce Head-to-Head Study of Osteoporosis ... Sep 26, 2005
...- Trial Compares Efficacy and Safety of Once-Monthly Boniva(R) Versus Weekly Fosamax(R) - NUTLEY, NJ, and RESEARCH TRIANGLE PARK, NC, Sept. ... - PR Newswire (press release),
Roche and GSK Announce Head-to-Head Study of Osteoporosis ... Sep 26, 2005
Roche and GlaxoSmithKline (GSK) today announced the start of a large-scale clinical trial that, for the first time, directly compares Boniva(R) (ibandronate ... - PharmaLive.com (press release),
Monthly bone-building pill remedies osteoporosis Oct 6, 2005
...report. Ibandronate is a bisphosphonate drug, taken by mouth, and goes by the brand name Boniva or Bonviva, depending where you live. ... - Reuters.uk,
Two-Year MOBILE Data Show Once-Monthly Oral Ibandronate to be ... Oct 6, 2005
SAN DIEGO, CA -- October 6, 2005 -- Women who have taken once-monthly oral ibandronate (Boniva) for up to 2 years tolerate treatment as well as do those on the ... - DG News
Women with postmenopausal osteoporosis prefer new once monthly to ... Oct 1, 2005
Bonviva (known in the USas Boniva), was approved by the US Food and Drug Administration in March 2005. In the US, Boniva 150mg ... - Medical News Today (press release),
POST OF THE DAY Sep 21, 2005
...it. Now those ads you see for once-monthly Boniva? THAT'S FOSAMAX, repackaged as a still-way-overpriced once-monthly pill. Meanwhile ... - Motley Fool
Once-monthly Oral Bonviva Approved for Postmenopausal Osteoporosis ... Sep 19, 2005
1. Bonviva (known in the US as Boniva) 150mg once-monthly oral is indicated for the treatment of postmenopausal osteoporosis in Europe. ... - PharmaLive.com (press release),
GSK, Roche to test osteoporosis drug Sep 26, 2005
The Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention trial will compare the efficacy and safety of once-monthly Boniva, Roche and GSK's ... - Raleigh Triangle Business Journal,
UPDATE 2-Roche, Glaxo once-a-month bone drug approved in EU Sep 19, 2005
Bonviva, which is known as Boniva in the United States, had already been recommended for approval by a panel of EU medical experts, whose advice the EU ... - Reuters
SSA Global Launches SSA Open Architecture 5.1, Delivering on ... Sep 20, 2005
In addition, the applications of the recently acquired Boniva Software and pending acquisition, Epiphany, are based on a service-oriented architecture and have ... - CCNMatthews (press release),
Swiss shares higher midafternoon, tracking US futures Sep 9, 2005
...up 1.3 at 177.8, and heavyweight Roche, up 1.2 at 181.9, adding to gains yesterday on news of Swiss approval for osteoporosis drug Boniva, made together with ... - Forbes
Swiss shares close higher, tracking Wall St - UPDATE Sep 9, 2005
Swatch, up 2.2 at 178.7, and heavyweight Roche, up 1.4 at 182.1, adding to gains yesterday on news of Swiss approval for osteoporosis drug Boniva, which it ... - Forbes
Other information
Indication
For the treatment and prevention of osteoporosis in postmenopausal women. Also used to treat tumor induced hypercalemia.
Pharmacology
Ibandronate is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. Ibandronate is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Mechanism Of Action
The action of ibandronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate also targets farnesyl pyrophosphate (FPP) synthase. Nitrogen-containing bisphosphonates (such as pamidronate, alendronate, risedronate, ibandronate and zoledronate) appear to act as analogues of isoprenoid diphosphate lipids, thereby inhibiting FPP synthase, an enzyme in the mevalonate pathway. Inhibition of this enzyme in osteoclasts prevents the biosynthesis of isoprenoid lipids (FPP and GGPP) that are essential for the post-translational farnesylation and geranylgeranylation of small GTPase signalling proteins. This activity inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.
Drug Category
Antiresorptives; Bisphosphonates; Antihypocalcemic Agents; ATC:M05BA06
Brand Names/Synonyms
Boniva; Ibandronate; Ibandronate Sodium; Ibandronate Sodium Monohydrate; Ibandronic Acid; Ibandronic Acid [Ban:Inn]; None
Dosage Forms
LIQUID
Absorption
Poorly absorbed (oral absorption is about 1% of what IV absorption is)
Interactions
Interactions for Ibandronate:
Calcium Supplements/Antacids
Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with absorption of Ibandronate. Ibandronate should be taken at least 60 minutes before any oral medications containing multivalent cations (including antacids, supplements or vitamins).
H2 Blockers and Proton Pump Inhibitors (PPIs)
Of over 3500 patients enrolled in the Ibandronate osteoporosis Treatment and Prevention Studies, 15% used anti-peptic agents (primarily H2 blockers and PPIs). Among these patients, the incidence of upper gastrointestinal adverse experiences in the patients treated with Ibandronate was similar to that in placebo-treated patients. Similarly, of over 1600 patients enrolled in a study comparing once-monthly with daily dosing regimens of ibandronate, 14% of patients used anti-peptic agents. Among these patients, the incidence of upper gastrointestinal adverse experiences in the patients treated with Ibandronate 150 mg once monthly was similar to that in patients treated with Ibandronate 2.5 mg once daily.
Aspirin/Nonsteroidal Antiinflammatory Drugs (NSAIDs)
In the large, placebo-controlled osteoporosis Treatment Study, aspirin and nonsteroidal anti-inflammatory drugs were taken by 62% of the 2946 patients. Among aspirin or NSAID users, the incidence of upper gastrointestinal adverse events in patients treated with ibandronate 2.5 mg daily (28.9%) was similar to that in placebo-treated patients (30.7%). Similarly, in the 1-year monthly comparison study, aspirin and nonsteroidal anti-inflammatory drugs were taken by 39% of the 1602 patients. The incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking ibandronate 2.5 mg daily (21.7%) and 150 mg once monthly (22.0%). However, since aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with Ibandronate.
Drug/Laboratory Test Interactions
Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate have not been performed.
Chemical IUPAC Name
morpholin-4-yl-[4-(trifluoromethyl)phenyl]-methanone
Chemical Formula
C9H23NO7P2
Half Life
10-60 hours
Drug Type
Approved Drug
# Accession No
APRD00231
CAS Registry Number
138926-19-9