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Press Release

2013 FDA Approval Rates Suggest Record Year for Post-Launch Success

New EP Vantage report shows that niche products are driving commercial success

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LONDON, BOSTON, TOKYO (November 13, 2013) — A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new drugs in 2013, according to newly-released report, “FDA Approval Rates: Niche Products Driving Record Success,” from EP Vantage, the editorial arm of Evaluate. While the total tally of approved drugs and biologics for 2013 is not forecast to match last year’s record of 43, the combined US sales for this year’s approved products could surpass $18bn five years after launch.  The report, based on market intelligence and analysis from EvaluatePharma , can be downloaded at http://www.evaluategroup.com/EPVantage-FDA-Approvals.

Key findings: 

  • From January 1, to November 11, 2013, the FDA approved 27 new compounds with another seven hopefuls awaiting approval. 
  • Of the 27 drugs approved so far, combined fifth-year U.S. sales are forecast to reach $13.9bn.
  • Assuming all products awaiting regulatory decisions get a green light, 2013’s fifth-year sales could total $18.7bn, breaking the 2012 record of $16.4bn.
  • Tecfidera ranks No. 1 among top five approvals of 2013 (January to November, 11) with sales estimated at $2.9bn by 2018.
  • If approved in 2013, Gilead Sciences’ sofosbuvir stands to become this year’s most valuable new molecule, with fifth-year US sales estimated at almost $3bn

“Increased efforts on the part of the FDA to speed up drug development and also companies choosing to expand into rare diseases or niche patient populations is having a big impact on productivity,” said Lisa Urquhart, EP Vantage Editor. “One example of this is the earlier-than-expected approval of Roche’s Gazyva, which was the first drug to reach the market under the breakthrough therapy designation scheme. We have also seen the approval of big ticket drugs such as Tecfidera this year and are still waiting one of the industry’s biggest drugs, sofosbuvir. Barring any upsets this will make 2013 a year to remember in terms of future blockbuster sales.”

About EP Vantage
Written by a team of award-winning journalists, EP Vantage provides daily financial analysis of key industry catalysts including: regulatory and patent decisions, marketing approvals, licensing deals, and M&A – giving fresh angles and insight to both current and future industry triggers. Launched in 2007 by EvaluatePharma®, EP Vantage’s unique access to EvaluatePharma and EvaluateMedTech data allows unrivalled, forward-looking coverage of the pharmaceutical, biotech and medtech industries. Visit www.epvantage.com to sign up for a free trial. On Twitter: @epvantage .

About Evaluate Ltd.
Evaluate is the trusted source for life science market intelligence and analysis with exclusive consensus forecasts to 2018. We support life science and healthcare companies, financial institutions, consultancies and service providers in their strategic decision-making. Our services include EvaluatePharma, EvaluateClinical Trials and EvaluateMedTech. Our global team of dedicated healthcare analysts employs rigorous methodologies to deliver strategic commercial analysis. We make our services valuable by combining superior quality content, user-friendly reporting tools and outstanding customer service to solve client problems.

For more information visit: www.evaluategroup.com. On Twitter: @evaluatepharma, @evaluatemedtech, @epclinicaltrial, @epvantage.

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