DecisionBase

March 2014

Methicillin-Resistant Staphylococcus Aureus Complicated Skin and Skin Structure Infections

Introduction:

In The Crowded MRSA cSSSI Market, How Will Emerging Therapies Differentiate Themselves from Current Standard of Care?

Methicillin-resistant Staphylococcus aureus (MRSA) is a clinically important pathogen in complicated skin and skin structure infections (cSSSIs). Over the past 15 years, the MRSA cSSSI market has become highly competitive with new entrants typically restricted to later lines of therapy. However, given the large cSSSI patient population and achievability of high clinical efficacy rates, many developers seek to gain more rapid entry into the marketplace through regulatory approval in this indication. With an increasingly crowded market landscape, agents will need to differentiate themselves based on improvements in key drug efficacy, safety, and delivery attributes to capitalize on current areas of unmet need.

Questions Answered in This Report:

  *   A drug’s performance on three key efficacy end points, including clinical response rate in the intent-to-treat population, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European infectious disease (ID) specialists weight efficacy measures and other drug attributes in their prescribing decisions for MRSA cSSSIs?

  *   Linezolid (Pfizer’s Zyvox/Zyvoxid) is the 2012 major-market sales leader for MRSA cSSSIs. What weaknesses exist in its profile that would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated potential on the attributes that surveyed ID specialists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed hospital pharmacy directors (PDs) seek from new therapies?

  *   By 2017, Cubist’s tedizolid will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is tedizolid most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by tedizolid?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for MRSA cSSSIs:

- Early clinical response rate.

- Investigator-assessed clinical response rate at the TOC visit.

- Clinical response rate in patients with microbiologically confirmed MRSA cSSSIs.

- Average length of therapy.

- Dosing frequency.

- Formulation.

- Price.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for MRSA cSSSIs:

- Investigator-assessed clinical response rate at the TOC visit.

- Clinical response rate at TOC visit in patients with microbiologically confirmed MRSA cSSSIs.

- Length of therapy.

- Dosing frequency.

Physicians surveyed: 61 U.S. and 31 European ID specialists.

Payers surveyed: 21 U.S. hospital PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Linezolid (Pfizer’s Zyvox/Zyvoxid)

- Vancomycin (generics)

- Daptomycin (Cubist/Novartis/Merck’s Cubicin)

- Ceftaroline (Forest’s Teflaro/AstraZeneca’s Zinforo)

- Telavancin (Theravance/Clinigen’s Vibativ)

- Trimethoprim/sulfamethaxozole (Roche’s Bactrim/Monarch’s Septra, generics)

Emerging Therapies

- Tedizolid (Cubist/Bayer Healthcare)

- Dalbavancin (Durata’s Dalvance)

- Oritavancin (The Medicines Company)

- Delafloxacin (Melinta)


Search Reports

Mentioned in this report:

  • - AstraZeneca
  • - Bayer HeatlhCare
  • - Clinigen
  • - Cubist
  • - Dong-A Pharmaceutical
  • - Durata
  • - Eli Lilly
  • - Forest
  • - InterMune
  • - Melinta
  • - Merck
  • - Monarch
  • - Novartis
  • - Pfizer
  • - Rib-X
  • - Roche
  • - Targanta
  • - The Medicines Company
  • - Theravance
  • - Trius
  • - Vicuron
  • - Wakunaga
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