I took away a couple of important points:
Igloo is 90% recruited on its original topline estimates, but won't have enough PCR positive patients based on their estimates of differences predicted.
Related to that, the company seems to be estimating another season to recruit in Phase 2 then a year for Phase 3, so IND not until second half 2017.
That's a poor outcome in a strong influenza season.
Another year's delay to recruit about 100 PCR + patients is pretty poor. Not only in patent terms - a year's delay costs tens (?hundreds) of millions in sales/royalties. I don't have access to the statistical assumptions, so can't tell if a strongly positive clinical outcome could influence this decision. But I hope it does.
BARDA should only care enough to get an IND to FDA. I'm not sure how BARDA can assess what the FDA will think about the power in this Phase 2 based on recruited numbers and outcomes. I'm not even sure why 80mg was ever considered worth chasing, when 40mg is doing fine in Japanese registration trials and in post-marketing.
Looks like buying in assets is expensive at present, so no cheap deals on offer.
We need a deal here. Same as it ever was. Either LANI or Vapendavir or RSV - we need to strike some partnership deals so the market can start attributing some valuations, even if the timing might be uncertain.
Wednesday 12 March 2014
Wednesday 5 March 2014
Alas poor Relenza, I knew it well
Biota earned 4 million dollars from GSK last quarter on Relenza royalties.
Relenza Royalties: a pleasant alliteration, isn't it?
Alas, that looks to be about the last time that phrase will be uttered on a financial record or anywhere else.
If there was a television program that was the biopharmaceutical business equivalent of Air Crash Investigation, Relenza would be in it.
Critical issues missed at planning, inexperienced pilots, greedy airline, happy passengers (shareholders) in the back, optimistic takeoff, quick heights, unexplained turbulence, plane falling, futile struggles, and finally crashing. Should have killed off the company but somehow the same guys were allowed to fly again.
My rough estimate is that Relenza sold under a billion dollars all together (ever), and Biota made maybe 70 million in royalties and milestones. That's mostly from two stockpile seasons. It never penetrated the seasonal market.
Tamiflu did better (lol).
Why? Well the legal case outlined it all.
1. The diskhaler was an outdated, cumbersome piece of equipment that should never have been used. GSK are world leaders in inhalers and they kept the diskhaler in use for relenza when they had ditched it for every other drug they made.
2. They (GSK) decided that vaccines to treat the whole population every year were better profit drivers than an effective treatment for a smaller group of infected people. I'm as pro-immunisation as the next guy, except for influenza. Only the drug companies could mount an argument for funding a vaccine that changes every year, is based on best guess components, isn't tested in its new formulations, and needs to cover the entire population annually to achieve herd immunity - for a year.
3. They didn't come up with a quick, easy POC flu diagnostic to support the drug. Actually Biota did, and sold it to Thermo who ran with it for a few years then ditched it.
So unenthusiastic were GSK about influenza treatments that they also passed on Flunet, which is essentially Biota's backup LANI. Handed the option back.
Interesting that GSK didn't give Relenza back to Biota in the negotiations around the law suit. They didn't just want to shelve it, they wanted it dead.
What a sad and sorry debacle.
Biota's share price has improved over the last month. It's not clear why other than increased exposure with the Baker Bros purchase.
However, as I have stated before, at any price up to $10, I don't understand why Daiichi Sankyo wouldn't purchase the company rather than do a deal on ROW Inavir. We await some guidance on the ROW deal.
Let's hope the contract trial centres have lifted their game with the Phase 2 LANI trial. Not only is it important for this year, but the same centres will probably be used for Phase 3 and if it's a quieter flu season next year it will be a serious problem.
Relenza Royalties: a pleasant alliteration, isn't it?
Alas, that looks to be about the last time that phrase will be uttered on a financial record or anywhere else.
If there was a television program that was the biopharmaceutical business equivalent of Air Crash Investigation, Relenza would be in it.
Critical issues missed at planning, inexperienced pilots, greedy airline, happy passengers (shareholders) in the back, optimistic takeoff, quick heights, unexplained turbulence, plane falling, futile struggles, and finally crashing. Should have killed off the company but somehow the same guys were allowed to fly again.
My rough estimate is that Relenza sold under a billion dollars all together (ever), and Biota made maybe 70 million in royalties and milestones. That's mostly from two stockpile seasons. It never penetrated the seasonal market.
Tamiflu did better (lol).
Why? Well the legal case outlined it all.
1. The diskhaler was an outdated, cumbersome piece of equipment that should never have been used. GSK are world leaders in inhalers and they kept the diskhaler in use for relenza when they had ditched it for every other drug they made.
2. They (GSK) decided that vaccines to treat the whole population every year were better profit drivers than an effective treatment for a smaller group of infected people. I'm as pro-immunisation as the next guy, except for influenza. Only the drug companies could mount an argument for funding a vaccine that changes every year, is based on best guess components, isn't tested in its new formulations, and needs to cover the entire population annually to achieve herd immunity - for a year.
3. They didn't come up with a quick, easy POC flu diagnostic to support the drug. Actually Biota did, and sold it to Thermo who ran with it for a few years then ditched it.
So unenthusiastic were GSK about influenza treatments that they also passed on Flunet, which is essentially Biota's backup LANI. Handed the option back.
Interesting that GSK didn't give Relenza back to Biota in the negotiations around the law suit. They didn't just want to shelve it, they wanted it dead.
What a sad and sorry debacle.
Biota's share price has improved over the last month. It's not clear why other than increased exposure with the Baker Bros purchase.
However, as I have stated before, at any price up to $10, I don't understand why Daiichi Sankyo wouldn't purchase the company rather than do a deal on ROW Inavir. We await some guidance on the ROW deal.
Let's hope the contract trial centres have lifted their game with the Phase 2 LANI trial. Not only is it important for this year, but the same centres will probably be used for Phase 3 and if it's a quieter flu season next year it will be a serious problem.
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