Stonehouse saying "its the govt" is misleading. Read the article (www.acs.cen.org) and you will see that Gilead has pulled out all the stops on this and has produced a drug that works 100% in Ebola on monkeys, and may just have cured the Scottish nurse. It seems that USAMRIID prefers larger companies, especially ones with proven antivirals. It's just the way it is. Keep in mind, the ultimate goal is to get a pan-anti-RNA-virus drug, and I believe Biocryst has a shot. Just don't hold your breath waiting.
Pardon folks, but this seems to be the only way I can get a post to stick this morning
Treat Biocryst development of BCX4430 as a long-shot extra. It is a good thing that USAMRIID is funding the project - it means there is more than a passing interest. Don't count on it for the future of Biocryst.
Read "Hard Lessons in Ebola Research" now appearing in the Nov. 16 issue of Chemical and Engineering News. Sina Bavari, chief scientific officer of USAMRIID, talks about Gilead's GS-5734: "If we wouldn't have found the Gilead compound, I would probably still have nightmares like I did a year ago." Scottish nurse Cafferkey was given GS-5734. She's OK now. BCX4430 is only mentioned in a "Sparse Pipeline" table.
Again, and I quote the article - " The only new addition to the field is Gilead's GS-5734, a nucleoside inhibitor that has done a great job of helping even the sickest of infected monkeys." The text of the article mentions Tekmira, ZMapp, Fujifilm, but not Biocryst.
So you were into Savient (nee Bacteriological (my pet name) General), too. I thought their gout drug was pretty good. What do you recall of the safety profile?
What's going on is that clinicaltrials website lists 4430 as still recruiting for phase 1 since last December. Biocryst has not updated the website. And Gilead gets to jump at the chance to test their drug.
I'm beginning to wonder about the management of this company, and I would guess, so is the street!
Compound is a nucleotide analogue currently in phase 1 testing. Monkeys (kind not mentioned) given drug on day 3 resulting in 100% animal survival. Type of monkey important, since BCX4430 did not work 100% in one type of monkey.
Nurse is off critical list. Effect of drug?
Reuters: "Staff reviewers of the U.S. Food and Drug Administration have raised questions about the safety of AstraZeneca Plc's gout treatment".
Remember RDEA? "Reviewers pointed to higher death rates, cardiovascular issues and kidney-related side effects in patients who took the drug, lesinurad, a preliminary review published on Wednesday showed. "
The timing of their announcement that the cancer study hasn't begun has been a pr disaster. How do they keep stepping in doodoo? Positive trial result = pps meltdown.
Has not been this low since May, 2014. Yet, they are miles ahead of where they were then developmentally. Market does not reflect the future of this company. Market in panic mode, I believe. Just note that the pps almost recovered this morning with the bio indices green. And now, with the indices red, BCRX is down big.
I think we are at the mercy of the indices. What to do? I have no idea.
Kiwi et al: Rob said yesterday that typically the carcinogenicity studies are the last thing on the plate. All the near term tox studies are completed and OK. It's rare for the FDA to demand a 2 yr carcinogenicity study before NDA submitted. However, is a drug that will be taken for life. Sort of absurd that this and AE's might be an issue. The competition also has to do carcinogenicity studies for their NDA!!! AE's were generally grade 1, and generally were for higher doses than would be used in the clinic. 7353 was a successful phase 1 trial.
I think I have the answer for this pps drop. It's mr. market picking on the first biotech to open their mouth. Ah, we have a target. Maybe it didn't matter what Biocryst said.
I think it's the 2 year carcinogenicity study delay request - will take 2 years - that caused the panic. They did not mention this until now? Been experimenting with this drup for over a year with NO carcinogenicity studies? OY!!!! 2 years? With competitors hot on our tail?