Gilead Sciences' Sovaldi (sofosbuvir), the revolutionary oral Hepatitis C drug, received approval after Nasdaq closing on Friday, keeping any subsequent stock movements a mystery until Monday.
Sovaldi has been so hyped up because it is a liver-targeting nucleoside analogue, or "nuke" - a class of drugs which has had a long and troublesome battle with late-stage clinical trials before due to high risk of hepatic toxicity. Sovaldi is also the only oral HCV treatment which does not require co-treatment with the infamous interferon - an self-injectable drug whose side effects, such as hair loss, depression, nausea and headaches are so severe and debilitating, many patients have been putting off therapy for years in hopes for new drugs to reach the market. Prior to Sovaldi's positive news, many patients were "warehoused" by doctors on high hopes of approval, particularly following a unanimously favorable AdCom just a month prior. If only Keith Richards, Steven Tyler and Pamela Anderson had known earlier.
The Sovaldi hype also managed to suck the wind out Vertex's sales (pun intended) of Incivek (telaprevir), whose royalties the company now spun off to Janssen, cutting 370 jobs.
Sovaldi is the third ever drug to receive a Breakthrough Therapy Designation (BTD) status from the FDA, as Hepatitis C, although slow to manifest, is commonly fatal. The BTD served to significantly speed up the drug's market entry and saved Gilead a nifty sum on extensive Phase III trials. Despite this, Sovaldi is expected to cost $1,000 a day, which translates into $84,000 for a regular course of treatment or $168,000 for more severe, chronic cases of HCV. Pretty high for a drug targeting upward of 80% of a 3-million-infections-a-year market, and expected to rake in up to $7 billion a year. In the U.S., the drug will be covered by insurance.
It is not all smooth sailing from now on for Sovaldi, however. Abbvie/Enanta's non-nuke interferon-free ABT-450, which just completed Phase III, allegedly helped 96% of HCV genotype 1 variant (70% of all sufferers) patients in clinical trials, and is due to file an NDA in the first quarter of 2014. Likewise Bristol-Myers Squibb's world's first interferon-free and ribavirin-free combination of daclatasvir and asunaprevir was shown effective in treating 84.7% of interferon-ineligible patients. In an attempt to avoid the game of musical chairs in the U.S. Hep C market, BMS went straight for the 3-million-sufferer market of Japan, filing for approval there on November 4. How the nuke/non-nuke game will pan out remains to be seen.
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