US Regulatory Trends During 2010: A Rapidly Changing Environment

Date: January 22, 2011
Pages: 28
US$ 580.00 US$ 490.00
Report type: Strategic Report
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US Regulatory Trends During 2010: A Rapidly Changing Environment
A Rapidly Changing Environment

Current Landscape The US Food and Drug Administration (FDA) approved 21 new molecular entities (NMEs) in 2010, the lowest since 18 new drugs were approved in 2007.

Despite this drop in registrations, BMI notes that five potential blockbusters received approval during 2010, highlighting promising revenue growth opportunities for the drugmakers concerned: Genentech, Novo Nordisk, Amgen, Novartis and Dendreon. Of the potentially new blockbuster drugs approved, most are biological therapies, including Agmen’s Prolia (denosumab) to treat osteoporosis in menopausal women, Genentech’s Actemra (tocilizumab) to treat rheumatoid arthritis, and Dendreon’s Provenge (sipuleucel-T), an immunetherapy for prostate cancer.
US Regulatory Trends During 2010
A Rapidly Changing Environment
Current Landscape
  Chart: Quality Over Quantity?
Number of new Molecular Enities Approved by the US FDA
  Chart: Bloo Mberg co Nsensus Sales Forecast (US $MN)
for Selected Drugs Approved by the us fda in 2010
key Developments and Competitive Landscape
Amgen’s Prolia
First Drug to Delay Bone Metastases Enthuses Investors
  Chart: Underperfo Rming
Amgem’s Share Performance Relative to S&P Healthcare & S&P 500 Index
  Chart: Revenue BOO ST
Denosumab Sales Forecast (US$MN) 500 Index
Drug Repositioning
Genentech’s Actemra
Arthritis Prevalance to Expand Rapidly
  Chart: High Burden of Arthritis
Number of Registered Disabled People in the us According to Condition (MN)
the Race for the Next Arthritis Drug
Pipeline Developments
Enjoying Blockbuster Status - a Couple of Examples
Boehringer Ingeleheim’s Pradaxa
Potential Replacements for Warfarin
Will Pradaxa or Pending Xarelto Become the Market Leader?
  Chart: Full Steam
Clinical Trials for Arthritis Related Conditions
  Chart: Demand for Warfarin Replacement
Market Research Results
Other Drugs in the Race
Dendreon’s Provenge
Increasing Concerns Over Affordability of Biological Drugs
  Chart: 8 out of 10 Recovered R&D Investment Within two Years
Total us Sales* (US$BN) of top Selling Biological Drugs
do the Drug’s Benefits Outweigh Their Costs?
  Chart: us Market Drives Glob al Development of Medicines
Number of Drug Candidates* in Development
Generic Biological Drugs
Possible Difficulties to Accessing Low-cost Biological Drugs
Novo Nordisk’s Victoza
Threatens eli Lilly’s Byetta
Outlook not so Rosy
Pipeline Uncertainty Worries Investors
  Chart: Spikes and Troughs Tied to fda ’s Decisions
Eli Lilly’s Stock Performance Relative to S&p500 and S&P Healthcare Indexes
Challenging Scenario
Setbacks to Roche/ipsen
Once Weekly Diabetes Drug
Diabetes Offers Strong Market Growth Potential
  Chart: Increasing Burden
Global Burden of Diabetes (dalys*)
  Chart: Emerging co Untries to Outpace Developed co Untries
top 10 Countries for Incidence of Diabetes in 2010 and 2030
Novartis’s Gilenya
A Potential Blockbuster
Sanofi-aventis Jevtana
Pharmaceutical R&D Productivity Increasing?
  Chart: Trend Reversing?
Number of new Molecular Enities Approved by the us Fda
Accorda Pharmaceutical’s Amprya
Approval of its Multiple Sclerosis Drug
hra Pharma’s Ella
A Superior Emergency Contraceptive
Astra Zeneca’s Brillinta
Approval Delayed Into 2011
  Chart: Hurt by us Rejection of Ticagrelor
Astrazeneca Stock Price (gbp)
Investor Reaction and Outlook
  Chart: Astrazeneca Underperfo Rming
Astrazeneca Stock Performance Relative to the S&P 500 Index , the S&P Healthcare Index
and Another Setback
  Chart: co Mpany Revenues Under Threat
Astrazeneca Patent Expiries*
and More Setback
Marketing Approval for Weight-loss Drugs Denyed in 2010
the Race for the Next Obesity Drug
  Chart: do Ubtful Prospects for Arena’s Weight-lo ss Drug
Relative Share Performance
Obesity Epidemic
  Chart: Americas Leading the Ranking
Obesity* Rates (% of the Population)
Glaxosmithkline/ Human Genome’s Benlysta
fda Delays Appoval of Lupus Drug
  Chart: High Expectations
Benlysta Sales Forecast (US$MN)
What Treatments are Currently Available?
The Disease and the Drug
Fda’s Marketing Authorisation Withdrawals
Roche’s Avastin
Regulatory Setbacks Worsen Growth Prospects
The Drug
  Chart: Follow ing its European co Mpetitors?
Roche’s Share Performace Relative to S&P 500 & the S&P Healthcare Indexes
Cost-cutting Will Accelerate
Recent Setbacks:
Glaxosmithkline’s Avandia
Hits Financial Results
  Chart: Flat
GSK Financial Snapshot (US$MN)
Sales Hurt By…
1) Avandia
  Chart: Divergences
GSK Product Sales in Q310
2) us Healthcare Reform
  Chart: us and Europe: dow n, Emerging Markets: up
GSK Sales by Region and Segment (us$mn)
3) European Austerity Measures
Sales Boosted by Emerging Markets
  Chart: Emerging Markets Grow ing in Importance
GSK Sales by Region (%)
  Chart: Underperfo Rming
Relative Share Performance GSK and the S&p500 Index, the S&P Healthcare Index
Investor Reaction
Abbot’s Meridia
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