Dallas, Texas 12/12/2013 (FINANCIALSTRENDS) – Gilead Sciences, Inc. (NASDAQ:GILD) continues its bio-pharmaceutical dominance for Hepatitis C virus treatment, with the development of Sovaldi, which medical experts judge to change the way this disease has been treated thus far.
Of the several types of hepatitis across the world, Hepatitis C virus causes near fatal liver cancer. Treatment for the same is limited, involving a combination of therapies and drugs as there are few drugs with known efficacy. In the U.S. one of the other options adopted, is Liver transplant.
Therefore, every new drug developed for the treatment of Hepatitis C virus, such as, Gilead Sciences, Inc.(NASDAQ:GILD) Sovaldi, is the next step to bringing quicker, faster and better quality of treatment to patients suffering from this disease.
FDA for quick approval
FDA, had in fact, moved the drug applications pending before it for the treatment of patients infected by this virus for the four types of genotypes- 1, 2, 3 or 4, to a fast-track for approval.
The new drug was submitted for approval in April. First it was approved by an advisory panel for the FDA, in early October 2013, with Dec 8, set as the ‘target date’ by which FDA had to finally approve the drug. Sovaldi, will now be available in the name of ‘Sofosbuvir’.
Sovaldi positive data from phase 3 studies encourage
Gilead Sciences, Inc. (NASDAQ:GILD) has been in the process of Phase 3 studies along the four- Neutrino, fission, positron as well as Fusion. Besides, Valence and Photon-1 from earlier Phase 3 studies were also considered while making the award.
The timing of ‘Sovaldi’ for approval was perfect. FDA considered the various phases of drug tests, and the quality results it produced, to endorse the use of the drug in combination with another drug Ribavirin, especially for the treatment of virus 2 or 3 types. This was the first time an all-oral drug treatment was approved for this virus and genotype. The phase of treatment would be 12 weeks as well as 24 weeks respectively for both the types.
Sovaldi- breakthrough in Heptatitis C treatment
Sovaldi, when administered along with ribavirin, can also be used for patients who are awaiting liver transplant treatment. This would prevent the recurrence of the virus during the waiting period of the transplant.
The success of the drug will be in lowering the time-line for the treatment. Post the use of Sovaldi, the time line would be reduced to just 12 weeks, besides lowering the need for peg-IFN injections. Under current treatment timelines, the treatment extends to 48 weeks. Besides, the current products cause a range of side-effects which prevents patients from undergoing long term treatment.
Sovaldi in combination with Ribavirin, is expected to help patients manage the pain as well as prevent further recurrence, besides lowering the side-effects that such drugs typically cause.
Pending patent allegations
One bitter news for Gilead Sciences, Inc. (NASDAQ:GILD) post approval of the drug is the allegation of patent infringement by competitive pharmaceutical, Idenix Pharmaceuticals Inc (NASDAQ:IDIX). It has filed two suits: First – in the District Court of Boston alleging patent infringement’ and Second-patent infringement and interference lawsuit in District Court of Wilmington.
Idenix claims that it too co-owns two US patents for the use of 2′-methyl nucleosides.
Therefore, the use of 2′-methyl nucleosides in Gilead’s sofosbuvir, infringes on the patents that Idenix co-owns currently.