This morning, Abbvie (ABBV) disclosed positive results from the remaining phase III studies of its all-oral hepatitis C regimen and said regulatory submissions would begin early in the second quarter. That's new and faster regulatory filing guidance and implies a commercial launch in the fourth quarter of this year, or perhaps sooner if FDA moves quickly to approve. [Abbvie's regimen has Breakthrough Therapy status.]
Gilead Sciences (GILD) has already said it will seek regulatory approval for its fixed-dose combination therapy (Sovaldi+ledipasvir) in the first quarter.
Both the Abbvie and Gilead hepatitis C regimens are equally effective, with SVR (cure) rates in the high 90% range for both treatment naive and experienced patients. That means the choice for doctors and patients will likely come down to convenience and price. (Insurance companies may have a big say in the latter, too.)
The Gilead hepatitis C regimen consists of a single pill taken once per day. Simple. If ribavirin is required (which it may for some patients), that adds a second pill taken twice per day.
Abbvie's regimen requires two pills to be taken in the morning, plus a second pill at night. Again, if ribavirin is necessary, the patient takes two pills in the morning, and two pills at night. Remember, Enanta Pharmaceuticals (ENTA) is Abbvie's hepatitis C partner.
Pricing? We don't know yet? Will Abbvie try to discount its therapy to make it more attractive? What will the insurance companies do with respect to access and prior authorization? For certain, the launch of these two competing hepatitis C therapies will be one of the most closely followed story lines in 2014.
Here is a snapshot of the Abbvie hepatitis C data announced today:
About 10 days ago I suggested based on early IMS data that GILD is likely to annihilate 2014 consensus numbers and that for 2014 I'm having a hard time getting to a number below $5B and that the actual 2014 reported US sales number could be $5B or even more. Sell side consensus hep C sales for 2014 are now at ~$3B and according to my most recent survey buy side expectation for 2014 US hep C sales is now ~$3.5B.
03/14/14 - 08:04 PM EDT
03/14/14 - 12:45 PM EDT
03/14/14 - 10:54 AM EDT
03/12/14 - 11:03 AM EDT
03/12/14 - 09:57 AM EDT
03/15/14 - 16:25 PM EDT
03/15/14 - 06:00 AM EDT
03/14/14 - 11:04 AM EDT
03/13/14 - 11:24 AM EDT
03/12/14 - 12:00 PM EDT
David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.
Access the tool that DOMINATES the Russell 2000 and the S&P 500.