Indian Generic Players & Gilead’s Sovaldi (Sofosbuvir)

Touted to be among “the biggest breakthroughs in medicine in the last 10 years”, Sofosbuvir (brand name Sovaldi) was approved on December 6, 2013 by the U.S. Food and Drug Administration (FDA) as a new treatment for chronic infection with the liver-destroying hepatitis C virus (HCV).

It won approval under the FDA’s “breakthrough therapy” designation (it grants priority review status to drug candidates that may offer major treatment advantages over existing options) just as Genentech Inc.’s chronic lymphocytic leukemia drug Gazyva (obinutuzumab) and Pharmacyclic’s cell lymphoma drug Imbruvica (Ibrutinib).

The New Drug Application (NDA) for Sofosbuvir was submitted on April 8, 2013.

Background Information:

Sovaldi (sofosbuvir) is the first in a new class of medications known as nucleotide NS5B polymerase inhibitors or “nukes”. It was first discovered by US-based Pharmasset.  It went under Gilead’s ownership, world’s largest maker of HIV medicines Atripla and Truvada, after it acquired Pharmasset for $11 billion in 2011.

Competition for Sovaldi:

      a.  Janssen (a subsidiary of Johnson & Johnson)’s NS3/4A protease inhibitor Olysio (simprevir). It is available in the US market at $66,000 for a standard 12-week course

     b.  Also, other companies including AbbVie and Merck & Co are working to develop new hepatitis C treatments with some in advanced stages of clinical studies.

Why a Blockbuster Drug?

Sovaldi is projected as a mega-blockbuster expected to be generating $1.9 billion in revenue in 2015 and $6.6 billion in 2016 primarily because as per World Health Organization estimates-

   a.  ~3% of the world’s population has been infected with the hepatitis C; and

   b.  More than 184 million chronic carriers are at risk of developing liver cirrhosis, liver cancer or both.

It has been estimated that Sovaldi sales will generate close to $1.9 B in 2014 and $6.6 billion in 2016. It already touched the figure of $139 million in 2013.

Dosage, Availablity & Price:

Sovaldi (sofosbuvir), taken as a once-a-day pill, will be available in 400 mg strength tablets in 28-count bottles.  Sovaldi (sofosbuvir) will cost $28,000 for a 28-day (4 weeks) wholesale supply, or $84,000 for a 12-week course of treatment or $168,000 for a 24-week course of treatment or $1,000 for a daily pill.

Prices in Europe are lower than in the United States. The cost for treatment in the United Kingdom is about $57,000 while the price in Germany is around $66,000.

Patents Battles:

Several patent battles for Sovaldi are currently being pursued in different countries.

In India, Gilead’s patent on sofosbuvir is being contested at the Kolkata patent office. The opposition was filed by US-based legal group I-MAK (Initiative for Medicines, Access & Knowledge).

For several US patents of Sovaldi, such as

  a.  US patent number 7964580

  b.  US patent number 8415322

  c.  US patent number 8334270

  d.  US patent number 7429572

  e.  WO 2013066748 A1 entitled “methods and compositions for treating hepatitis C virus”, also published as US20130109647

Companies like Merck, Roche and Idenix Pharmaceuticals have filed patent infringement suits.

Availability in India:

Gilead Sciences plans to license Sovaldi to a number of Indian generic pharmaceutical manufacturers. This shall allow Gilead to establish “tiered pricing” for the drug. However, it might take at least 2 years before the drug is available in India.

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