According to a recent Bloomberg report, Gilead Sciences, Inc. (NASDAQ:GILD) has chosen the legal route to protect sofosbuvir — its candidate for treating the hepatitis C virus, or HCV — after Merck & Co., Inc. (NYSE:MRK) demanded a 10% royalty on sales, a move Gilead considers tantamount to threatening. Gilead Sciences is asking a California court for an order that it does not require to license the drug as the patents in question are neither infringed nor enforceable.
Merck & Co., Inc. (NYSE:MRK) is not alone in making claims on this potential game-changing drug. Gilead Sciences, Inc. (NASDAQ:GILD) got hold of sofosbuvir when it acquired Pharmasset for $11 billion, but Roche believes that it has rights over sofosbuvir under a 2004 partnership pact with Pharmasset and has demanded arbitration on the issue. Also, a small biopharmaceutical company, Idenix Pharmaceuticals Inc (NASDAQ:IDIX), is trying to prove that it is the original inventor of sofosbuvir.
A detailed report on claims on sofosbuvir can be accessed here.
Scientists have long tried to find an all-oral, interferon-free HCV treatment. Interferon is not only difficult to take but also leads some to discontinue treatment because of the side effects associated with it.
At stake is a big slice of the $20-billion HCV market as roughly 150 million suffer from hepatitis C globally. Sofosbuvir, which has recently reported extremely positive late-stage results, has caught the imagination of scientists particularly because its potential as an all-oral and interferon-free treatment regimen.
HCV replicates mainly in the liver, leading to liver damage (sometimes to cancer) and high level of immunological disorders. On the basis of genetic differences, the virus is classified into seven genotypes. Genotypes 1 and 4 are less responsive to interferon-based treatments.
In phase 2 trials, sofosbuvir demonstrated that an all-oral treatment regimen to patients with genotype 1 is extremely effective in removing the virus and is also well tolerated.
This is considered as an extremely positive development that can potentially bring about a dramatic change in how HCV is treated. Earlier, in June this year, the drug showed high efficacy in genotypes 2 and 3.
With recent data establishing the potential supremacy of sofosbuvir over competition, investors should be most encouraged by its efficacy for genotype 1 HCV infection, which accounts for almost 70% of all cases.
Review of sofosbuvir by the Food and Drug Administration is scheduled for Dec. 8. The European regulator, too, has announced an “accelerated assessment.”