Orphan Drugs: Rescue From the Patent Cliff

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Description: This reports looks at big pharma and how it has been affected by the patent cliff and the patent-loss of many of its biggest-selling blockbuster drugs and examines how the development of orphan drugs may help return companies to growth.



Research Report Overview

Published Date: 03/12/2013
Category: Drug Discovery & Development

Research Report Decription

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  • Orphan drugs treat diseases that affect fewer than 1 in 2,000 Europeans & fewer than 200,000 Americans. Research into orphan drugs benefits from incentives provided by the 1983 Orphan Drug Act, such as tax breaks, faster regulatory reviews and assistance from FDA reviewers. Orphan drugs are less likely to face competition and provide a high return on investment. Cinryze costs $487,000 annually
  • This reports looks at big pharma and how it has been affected by the patent cliff and the patent-loss of many of its biggest-selling blockbuster drugs.
  • ¬†Orphan drugs are granted certain incentives at the development stage, which encourages Big Pharma to invest in them.
  • Orphan drugs can be very lucrative as companies can charge a large amount for them. Much of the costs are covered by governments/insurance companies

Key Questions Answered:

What drugs have lost their patents/are due to lose their patents, and what are they worth?

Why is the orphan drug market attractive to pharmaceuticals companies?

How have companies attempted to enter this market?

Are the high prices of orphan drugs sustainable?

Companies Mentioned:

Alexion Pharmaceuticals, ViroPharma

Paper Highlights:

Global orphan drug sales increased at a rate of 7.1% to be worth $83bn in 2012 compared to the previous year. Orphan drugs are expected to bring in revenues of $127bn by 2018 and will account for almost 16% of total prescription drug sales, compared to 12.9% in 2012.

The most expensive drug in the world in 2013, Cinryze, is used by patients with hereditary angioedema, and is sold by ViroPharma. The drug\'s annual cost per patient is $487,000 per year. The second most expensive drug, Soliris, is sold by Alexion Pharmaceuticals, treats patients with paroxysmal nocturnal hemoglobinuria, & costs $486,000 annually.

According to patient advocacy group, Eurodis, around one third of EU patients can\'t get access to, or have difficulty accessing, the orphan drug they need.