BMS Withdraws New Drug Application for Asunaprevir
Isiscat2011 said
Oct 10, 2014
Investment analysts are naturally hovering over the BMS news like vultures. The savvy analysts appreciate that this move will heat up the competition and bring the price down for HCV tx one way or another. Either Gilead will be forced to keep its costs for Harvoni closer to the cost of Sovaldi alone or BMS will move in with Declatasvir to use in combination with Sovaldi.
These moves will impact availability of HCV drugs to patients so they are worth paying attention to.
BMS has withdrawn its NDA for asunaprevir. As you may recall the BMS combo of asunaprevir/declatasvir was scheduled for approval in December. BMS does intend to pursue the approval of declatasvir alone, however. This is actually good news because Declatasvir has been used in combination with Sovaldi with impressive results that rival the Sovaldi/Ledipasvir combo. This move may heat up the competition and ultimately help to reduce prices.
Some of you may also remember that Declatasvir was the DAA used with Sovaldi in clinical trials a few years ago with great success. Gilead opted to develop its own 2nd DAA, which was Ledipasvir, and is scheduled for FDA approval tomorrow in the one pill S/L combo.
The BMS asunaprevir/declatasvir combo is particularly effective with gt 1b. BMS has already made a deal to distribute it in Japan which has a predominantly 1b HCV population. The combo would be less marketable in the US which has a huge 1a population.
The Sovaldi/Declatasvir combo should be effective with most gts, including 1a which is the predominate gt in the USA. BMS will be presenting its clinical trial findings at the AASLD annual convention next month.
All in all, a good bit of news for HCV patients, and a very smart move by BMS to give Gilead a run for its money, IMO. I'll bet BMS has been planning this for some time. HCV docs should definitely have good tx combo choices soon. The S/D combo should be neck-in-neck with the S/L combo and the S/D combo could actually dominate the market if the price is right. Exciting news for us!
I just read about this here and will keep you updated:
Investment analysts are naturally hovering over the BMS news like vultures. The savvy analysts appreciate that this move will heat up the competition and bring the price down for HCV tx one way or another. Either Gilead will be forced to keep its costs for Harvoni closer to the cost of Sovaldi alone or BMS will move in with Declatasvir to use in combination with Sovaldi.
These moves will impact availability of HCV drugs to patients so they are worth paying attention to.
http://www.fool.com/investing/general/2014/10/09/bristol-myers-regroups-hepatitis-c-fight-with-g.aspx
BMS has withdrawn its NDA for asunaprevir. As you may recall the BMS combo of asunaprevir/declatasvir was scheduled for approval in December. BMS does intend to pursue the approval of declatasvir alone, however. This is actually good news because Declatasvir has been used in combination with Sovaldi with impressive results that rival the Sovaldi/Ledipasvir combo. This move may heat up the competition and ultimately help to reduce prices.
Some of you may also remember that Declatasvir was the DAA used with Sovaldi in clinical trials a few years ago with great success. Gilead opted to develop its own 2nd DAA, which was Ledipasvir, and is scheduled for FDA approval tomorrow in the one pill S/L combo.
The BMS asunaprevir/declatasvir combo is particularly effective with gt 1b. BMS has already made a deal to distribute it in Japan which has a predominantly 1b HCV population. The combo would be less marketable in the US which has a huge 1a population.
The Sovaldi/Declatasvir combo should be effective with most gts, including 1a which is the predominate gt in the USA. BMS will be presenting its clinical trial findings at the AASLD annual convention next month.
All in all, a good bit of news for HCV patients, and a very smart move by BMS to give Gilead a run for its money, IMO. I'll bet BMS has been planning this for some time. HCV docs should definitely have good tx combo choices soon. The S/D combo should be neck-in-neck with the S/L combo and the S/D combo could actually dominate the market if the price is right. Exciting news for us!
I just read about this here and will keep you updated:
http://hepatitiscnewdrugs.blogspot.com/2014/10/bristol-myers-withdraws-fda-nda-for.html