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Biotech / Medical : Incyte (INCY) -- Ignore unavailable to you. Want to Upgrade?


To: scaram(o)uche who wrote (3085)9/25/2015 12:39:40 PM
From: scaram(o)uche  Respond to of 3202
 
AbbVie to Advance Once-Daily ABT-494 to Phase 3 in Rheumatoid Arthritis by Year-End
- AbbVie to opt-out of collaboration with Galapagos on filgotinib

NORTH CHICAGO, Ill., Sept. 25, 2015 /PRNewswire/ -- AbbVie (ABBV), a global biopharmaceutical company, today announced that it will advance ABT-494, its internally developed investigational selective JAK1 inhibitor, to Phase 3 studies in rheumatoid arthritis. Following a thorough review of available data, AbbVie will not exercise its right to in-license the Galapagos JAK1 inhibitor, filgotinib.

"We believe ABT-494 has the potential to become a best-in-class therapy for patients," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "In our view, ABT-494 also offers a faster path to Phase 3 development with less uncertainty."

Per the terms of the agreement with Galapagos, all rights to filgotinib will revert solely to Galapagos.

(snip)



To: scaram(o)uche who wrote (3085)9/25/2015 1:08:41 PM
From: scaram(o)uche  Respond to of 3202
 
>> we will advance ABT-494 to Phase 3 studies with a once-daily formulation.<<

6 mg twice daily looks very good. A daily dose of 12 mg looks every bit as good as 36. Going forward with 24 once daily seems like a tiny risk.... maybe 50 patients or so, each group, and it still looks like there may be some noise. (ACR70, 12 mg, Balance-II).

Given this data, they certainly can't opt for 12 or 18 mg once daily?? From ct.gov, could only find evidence of one formulation having been tested. Guess they get warm and fuzzies from 24 mg ACR20 and trough levels of 494.



To: scaram(o)uche who wrote (3085)9/26/2015 4:44:40 AM
From: dalroi  Read Replies (1) | Respond to of 3202
 
so thats the reason they discontinue the collaboration with galapagos and their ra drug