GSK launches rare diseases unit: Today, GSK announced that it will move more aggressively into addressing rare diseases and set up a unit for this. The rationale is that developing medicines for diseases that have largely been neglected by the pharmaceutical industry in the past will have a good pharmaco-economic profile and ultimately be more profitable. More and more, selling pills to the masses does not appear to be the answer to Big Pharma’s patent woe and productivity cliffs. This should be very good news for RNAi Therapeutics, which offers a direct and cost-efficient way to such (often genetic) diseases, and maybe we will see this deal between GSK and Alnylam later this year.
Pfizer exercises option for Tacere’s HCV candidate: DNA-directed RNAi company Tacere, a Benitec spin-off, announced today that Pfizer has exercised its development-commercialisation option for Tacere’s HCV drug candidates. Pfizer obtained the option in the deal 2 years ago with Tacere (see blog entry here). This follows pre-clinical studies in rodents and monkeys that, according to the press release, have shown the AAV vector to penetrate the liver well and to be generally well tolerated. Pfizer will now collaborate with Tacere and fund the IND-enabling studies. This triggers undisclosed milestone payments, some of which will be due to technology licensor Benitec which, in addition, has an equity stake in Tacere. There is hope for ddRNAi Therapeutics!
After seeing PFE exercise the Tacere option on HCV, which is founded on Benitec's ddRNAi, I wonder if you have an opinion on where this leaves ALNY's liver program?
ReplyDeleteI recall your previous bullish sentiment on liver and ALNY.
ALNY has the Nucleonic's IP for this area and ALNY missed their guidance for two or more deals last year. Now PFE has chosen to go with Tacere.
This does not inspire confidence.
While I am not up to speed on exactly what GSK is doing in RNAi, PFE has been floundering. The Coley folks who came over and then the elevation and firing of Corey Goodman
ReplyDeleteshow PFE is not in the RNAi race yet.
They found the smarts to finally cut their useless R&D spending, but I am not sure they have a clue where they want to go in the RNAi space.
Anything they do in the RNAi business as as a follower not a leader.
I consider DNA-directed and synthetic siRNA RNAi Therapeutics approaches as largely complementary approaches to addressing disease, and as such I would not interpret PFE's decision to pioneer ddRNAi for the liver as a vote against Alnylam and/or liposomal siRNA delivery to the liver.
ReplyDeleteMy take on Pfizer's approach to RNAi Therapeutics is that they are watching how the IP race turns out before striking out on a large platform alliance, all the while doing some in-house research to evaluate the the various claims out there. Also, let's not forget that in addition to ddRNAi for HCV, Pfizer has two ocular phase II programs ongoing with Quark. So in terms of clinical pipeline activity, Pfizer is arguably the most active Big Pharma in RNAi Rx.
Goodman's leaving if I understand it correctly has to do with the Wyeth merger. Also not sure of whether PFE's decision to cut internal R&D is necessarily a bad thing for RNAi Rx companies.
If you are familiar though with PFE's thinking on RNAi specifically, please let us know.
Dirk
ReplyDeleteI knew some of the folks who left PFE Conn. research to go to smaller operations. I also knew PFE decided a year ago to forestall any new deals that were not accretive to the earnings hole that will be created when Lipitor leaves.
I know ALNY has been knocking on their door a lot in the past few years and your comment about them waiting to see how the IP wars are settled may be point on. I do no think the current deals with Quark are really important to them as they are not systemic delivery. And I think you may be correct on the Goodman thing as Wyeth did have a much more advanced RNAi program than PFE. But Goodman could have been casualty of the
need for immediate revenue and the internal funding may not have been there. But that's old news.
PFE spent too much for WYE. Kindler is finally realizing his in-house research for the most part does him little. CSO's always convince CEOs and the BOD that the pipeline is great. They like SNY and GSK will be doing more deals and cutting the in-house spending to pay for it.
The reduction in R&D budgets of the combined companies will fund some of the Lipitor generic hit. If I was a betting man I would say PFE could in the next year request a month or two with ALNY and send in their patent group to satisfy the IP claims.
PFE will do a deal I think within
6-12 months or they risk falling a lot further behind. I think ALNY has the inside track. But the IP is not as attractive an asset as it once was, as the price of ALNY stock bears out. ALNY will have to have some clinical success in the next 12-18 months or they risk going no where.
RNAi for me is becoming a tougher investment as the road to delivery looks a lot harder.....