DecisionBase

March 2013

Osteoporosis and Osteopenia

Introduction:

Emerging Therapies AMG-785/CDP-781 and Odanacatib Are Poised to Overtake Teriparatide’s Status as the Clinical Gold Standard

With a prevalence of nearly 211 million, osteoporosis and osteopenia are a large and growing market, and one that has long been dominated by the bisphosphonate drug class. The first bisphosphonate to launch, alendronate Merck’s Fosamax, Teijin’s Bonalon, generics), retains a majority of patient share, despite being overtaken in sales by the still branded risedronate (Warner Chilcott/Eisai’s Actonel/Atelvia, Takeda’s Benet, generics). Despite its market dominance, the bisphosphonate class has suffered following the emergence of serious safety concerns associated with long-term use, particularly in the United States, where these concerns have been the subject of high-profile lawsuits. Although therapies are available that offer better efficacy than the bisphosphonates, such as denosumab (Amgen/GlaxoSmithKline/Daiichi Sankyo’s Prolia) and teriparatide (Eli Lilly’s Forteo/Forsteo, Asahi Kasei’s Teribone), their high cost and/or injectable delivery have relegated them to later lines of therapy. Therefore, while significant opportunity exists for the emerging anabolic osteoporosis and osteopenia agents, they face a similar challenge and must demonstrate sufficiently superior efficacy to justify their high cost relative to generic bisphosphonates.

Questions Answered in This Report:

  *   Alendronate is the 2011 major-market patient share leader for osteoporosis and osteopenia. What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated potential on the attributes that surveyed primary care physicians (PCPs) indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements in safety and efficacy over currently available therapies that surveyed managed care organization pharmacy directors (MCO PDs) seek from new therapies?

  *   Price per day and reduction in risk of vertebral and nonvertebral fractures are key drivers of physicians’ prescribing decisions and are the focus of drug development for new osteoporosis and osteopenia therapies. What trade-offs across these and other clinical attributes are U.S. PCPs willing to make when considering the use of emerging therapies for the treatment of osteoporosis and osteopenia? Based on the trade-offs in price and performance across key drug attributes that U.S. PCPs are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for osteoporosis and osteopenia?

  *   Based on its clinical profile, teriparatide is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Which drug characteristics will allow AMG-785/CDP-7851 and odanacatib to overtake teriparatide in 2021?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for osteoporosis and osteopenia:

- Reduction in risk of vertebral fractures (at 3 years)

- Reduction in risk of nonvertebral fractures (at 3 years)

- Reduction in lumbar spine BMD (at 3 years)

- Risk of severe adverse events

- Risk of gastrointestinal side effects

- Frequency of administration

- Price/day

Attributes included in assessment of U.S. payers’ receptivity to new therapies for osteoporosis and osteopenia:

- Greater reduction in risk of vertebral fractures

- Greater reduction in risk of nonvertebral fractures

- Reduced risk of gastrointestinal side effects

- Reduced risk of severe adverse events

Physicians surveyed: 60 U.S. and 30 European PCPs

Payers surveyed: 20 U.S. MCO PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Alendronate (Merck’s Fosamax, Teijin’s Bonalon, generics)

- Risedronate (Warner Chilcott/Eisai’s Actonel/Atelvia, Takeda’s Benet, generics)

- Zoledronate (Novartis’s Reclast/Aclasta, generics)

- Teriparatide (Eli Lilly’s Forteo/Forsteo, Asahi Kasei’s Teribone)

- Raloxifene (Eli Lilly/Daiichi Sankyo’s Evista, generics)

- Denosumab (Amgen/GlaxoSmithKline/Daiichi Sankyo’s Prolia)

Emerging Therapies

- Odanacatib (Merck)

- BA-058 (Radius Health)

- AMG-785/CDP-7851 (Amgen/UCB)

- Bazedoxifene/conjugated estrogen (Pfizer’s Aprela)


Search Reports

Mentioned in this report:

  • - Amgen
  • - Asahi Kasei
  • - Daiichi Sankyo
  • - Eisai
  • - Eli Lilly
  • - GlaxoSmithKline
  • - Merck
  • - Novartis
  • - Pfizer
  • - Radius Health
  • - Takeda
  • - Teijin
  • - UCB
  • - Warner Chilcott
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