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Encouraging orphan drugs in India

  • By Abhyodaya Siddhartha
  • •  Dec 12, 2021

Patents are not necessarily the cause of soaring drug prices. Remember Martin Shkreli, a hedge fund manager who bought a drug company that made drugs for rare diseases and quickly raised prices by 5,000%? A scandalous incident. There was global anger when the price of the drug Dalaprim soared from $ 13.50 to $ 750 per tablet. There is no patent for this drug, but four years later, it is sold at the same exorbitant price because there are no competing manufacturers. Due to the limited number of patients with Dalaprim, it is impossible for new manufacturers to enter the market.

Now the new drug has diminished the shame of Dalaprim. It is a CDCA that treats patients whose liver does not produce any of the  primary bile acids, leading to critical conditions that cause neurological problems, seizures and even dementia. For the past half century, it has been relatively easy to treat such patients with off-label use (used for diseases other than those listed in official approval) Chenofalk at a cost of € 500 per year.

In 2008, Leadiant acquired the rights to Chenofalk and developed its own version known as CDCA Leadiant. Then in 2014, very cleverly, he got the EU to classify that version as an "orphan drug", giving Leadiant exclusive sales rights for 10 years. Shortly thereafter, he increased the price of CDCA Leadiant to approximately 150,000 euros for a one-year course of treatment! The similarities to Daraprim are surprising, but the latter is not an orphan drug.

 Orphan drugs are used to treat serious medical conditions that affect a small number of patients. For example, it would be  a disease that affects less than 1 in 2,000 people in the EU and less than 1 in 1,000 people in the US. Due to  limited numbers Drugs. Incentives are very important for the pharmaceutical industry to find new drugs. In the case of CDCA Leadiant, a deceptive approach was applied in that it was possible to obtain pharmaceutical benefits for orphans without participating in research and development.

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