Investment Commentary
The Hep C Race Is Heating Up: AbbVie Vs. Gilead
Feb. 10, 2014 7:47 AM ET
by: Peter Geschek
Source - Seeking Alpha
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)
In January, AbbVie (ABBV) released positive results from the remaining Phase 3 studies of its all-oral hepatitis C regimen and said it will start submitting applications to the FDA early in the second quarter. Assuming a favorable response, AbbVie could start marketing the drugs in late 2014...
Meanwhile, Gilead (GILD) is planning to submit in the first quarter an FDA application for a fixed-dose combination of the recently approved Sovaldi with the NS5A inhibitor ledipasvir....
Both companies have a breakthrough designation from the FDA...
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Gilead: Based on the promising data obtained from the studies of ION1, ION2, and ION3, application to the FDA and the European Marketing Authorization will be filed this quarter. The studies investigated the fixed-dose ledipasvir/sofosbuvir combination in Genotype 1, new-to-treatment and previously-treated patients, combined with or without ribavirin for a duration of 8, 12, or 24 weeks....
But the company is not stopping there. They are busy working on another fixed dose combination for Genotype 1, the so-called 5816 compound combined with Sovaldi. Early data will be presented at the EASL, the International Liver Congress in April....
AbbVie is working on a Phase 2 program of its next-generation compounds, which include a potent protease inhibitor, ABT493, and the new NS5A inhibitor, ABT530...
The goal is to develop a ribavirin-free once daily combination that can be uniformly used for all genotypes....
AbbVie is also working on creating a fixed dose combination for its current treatment, by taking all three of the current direct acting antivirals and coformulate them into a once-daily pill. The prototype formulation is ready and being tested. The program is aggressively advanced by the company......
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