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Rod - as Alecensa is an oral drug that is bad news for HALO on NSCLC isn't it?
I note that the Gilead drug took over a year to be approved after the trial was stopped due to overwhelming data in its favour. No rush then for the FDA to save patients lives! Something to bear in mind.
XBI and IBB are both up but HALO is down yet again. Not much conversation on why bearing in mind all the great news that we all know is about to be released. I've never read the Jefferies reports but what is their reasoning behind their ridiculously low target price. Presumably they don't buy the PEG story - but why?
So everyone knows that the Phase 2 PEG results will be fantastic. And everyone knows that the Enhanze franchise is signing up big partners with big drugs and Roche will be introducing SQ Mabthera to the US shortly and will almost certainly be introducing SQ Herceptin to the US in the not too distant future and Shire have said that HyQ will be a blockbuster. All generally available public information that has been around for months. We know it, and analysts know it and institutions know it. So why is the share price still only $11. I can't believe that when they formally announce a PFS figure double the existing best figure that the share price will suddenly double or triple because everyone already knows what the results will be. Personally I just don't get it. What am I missing here?
I hope they're not in Russia. Those Phase 1 Russian 'patients' are all still alive.
Bio - any thoughts on who the new partner might be?
BIo - that's not how RJ Kirk operates. He'll be looking out for a buyer as soon as the PEG data confirms our wildest dreams.
It's all blockbuster this and blockbuster that but still the stock price languishes where it was 10 years ago. In reality the terrible news about the various recent early stage drug failures more than offsets the other good news. Only PEG can remedy that. But then without a highly unlikely NDA being submitted based on Phase 2 data we are in for a 2 year wait before the PEG situation becomes clearer and by that time $450m will have been spent on those PEG trials. Does anyone really think that the much touted Fezz takeover by Roche, JNJ etc is likely?
Bio - and it would need to be a blockbuster to recover the huge sums that HALO will be spending over the next 4 years trialing PEG with all the various different cancer drugs.
Bio - dismissing the Abbvie Humira loss as of little consequence compared to PEG made me smile. Humira is the world's biggest selling drug at $14b pa and forecast to grow to $20b by 2020 - or didn't you know that?
Bio - if only HALO had been tracking the XBI over the years we could all have retired.
Maumur - is it not possible that the control arm are achieving a PFS higher than expected?
Bio - so I was right that HALO and its shareholders and analysts have absolutely no idea whether the control arm patients may have higher PFS figures than the HALO patients. So why say it's not a blinded study when it is blinded to everyone except the administrators? So Helen was quite right in what she said. The way the share price has been moving recently makes me wonder whether there may be a problem with the control arm. It's not like it's never happened before.
Bio - if it's not a blinded study how come Helen couldn't say that the delay must be good news? Also how does the eventual determination of the eventual PFS figure work in a relatively small Phase 2 study? If the great majority have a PFS in line with control but say two have a PFS of 2 years how is the overall PFS arrived at?
Bio - how do you know that the patient isn't in the control group? This of course is the fear. Helen wouldn't speculate on this when asked the question numerous times at the last CC.
Just one of those days or more accurately just ANOTHER one of those days? Down 9% on a day when most biotechs were relatively unmoved (my biotech shares were actually up today even after massive HALO losses). HALO is a leaky company. The three recent partnership disasters were clearly well known to the traders before the official announcements. I fear we have more bad news in store based on the past few days of trading.
Either that Fred or somebody has actually reckoned that the Abbvie deal with the world's biggest selling drug Humira might have been worth more than squat.
So let's assume that PEG is deemed to be a winner in PC. How does HALO go about pricing it? As far as I'm aware this question has never been publicly addressed by HALO but bearing in mind that it will have cost not far short of a $1b to have developed PEG by 2020 one has to assume that it will need to be very expensive - hence Helen's blockbuster remark. But then how much will insurers be willing to pay for an extra 3-4 months of PFS. Probably not as much as HALO will be asking. I've said many times before that add-on drugs have many problems along the way. Is this going to be the next bone of contention. It works but how much is 3-4 months of PFS worth? A $1B pa?
Rod - on the basis that this is a discussion group and not a mutual admiration society can I please just say that I genuinely don't understand what you are saying and a reference to a 180 page Roche document doesn't help me much. Please explain your point in plain English because I don't get it. Does anyone else?
Rod - can you please explain what you mean by "Adds treatment time for Herceptin sc". Thanks.
Presumably the Humira trial endpoint was to be able to reduce the dose but achieve the same drug efficacy when used with Enhanze - i.e. more drug gets absorbed into the system when combined with Enhanze. It appears that Enhanze didn't help on that score, which is quite surprising isn't it?
From a fool.com article dated 12/5/15.
What do others think about HALO seemingly trying to disguise that it was Humira. Seems rather devious.
Humira is the world's biggest selling drug with sales in 2015 of $14B and projected to be $20B by 2020. This was HALO's biggest partnered target drug by far. This is a huge blow to the partnered program. Humira also accounted for nearly 60% of Abbvie's total sales so it's not going to be replaced with something similar from Abbvie.
Everyone seems very calm but personally I would like to know why it failed.
"If all goes well, the deal could bring in a total of $130 million in milestone payments plus double-digit royalties of future sales." Double digit royalties on $20B! I want to cry.
I'm confused. Fezz is tweeting that the failure has nothing to do with Humira. I've always thought he must be living in Colorado so I guess this confirms that! But if it is Humira that's a major loss for HALO whatever way you want to think about it. Why was the HALO PR so confusing? They said that it was a Phase 1 Humira trial that commenced earlier this year but now try to confuse us as to which drug has failed. Not the best way to convince the market that this is a serious biotech company.
With 3 Enhanze failures and one PEG halt (subsequently reinstated) over the past 6 months HALO is looking a little accident prone. As far as the Abbvie partnership is concerned I can only remember being told about a Phase 1 trial with Humira, which commenced earlier this year. I presume/hope that today's reported failure had nothing to do with that Humira trial.
FOTD - thanks. Good to hear that. And it's good to have you back on board again. I always found your posts interesting and incisive. Please keep us up to date with your knowledgeable views as we enter this crucial period.
CUVITRU
I see that Shire has just launched its own SQ version of CUVITRU, which is seemingly in competition with its very own HyQ. Can someone please explain whether we should be worried about this? Will Shire be promoting CUVITRU ahead of HyQ, which lets face it hasn't really taken off yet. I note in the prescribing information there is a section for dosing of patients being switched from HyQ to CUVITRU. I always said you should never trust Baxter (or now their successors).
BI 1 - if you were in the control group and still alive it could be you that's holding up the release of the data. Not wishing you bad luck but .....
All positive except that we are spending 4 times more than our current royalties and have just lost two potential blockbuster drugs! You can see why there is an alternative view like Jefferies one with a sell recommendation and a PT of just $6. On the other hand let's stay positive and assume that we'll get accelerated approval of PEG because if we don't ....
Well it could be that patients in the control arm are living longer, which is extremely unlikely. So if we discount that there can only be one other explanation, which is the one that we want to hear. For once a delay in reporting a trial result is likely to be good news.
Xena - the problem is that you don't know what other secret compounds these partners have named to HALO but are developing SC versions themselves. We know that Roche for instance are building a huge new manufacturing facility just to produce their new SC compounds. Some of those compounds were no doubt on the original list of secret compounds given to HALO. So far Roche has only come good on Mab and Herceptin and those were from 8 years ago. What has happened to the rest of their named compounds? For sure they're producing the SC versions themselves.
Xena
See page 12
http://investors.shire.com/~/media/Files/S/Shire-IR/quarterly-reports/2015/q3-2015-presentation-23-october-2015.pdf
Also Viropharma ran a study in 2012. See
http://www.fiercebiotech.com/biotech/viropharma-provides-update-on-phase-2-clinical-evaluation-of-subcutaneous-cinryze®-c1
Also Baxter tried to do their own SC version of Gammagard. It failed. Even Roche ran trials on their own SC versions of Mabthera and Herceptin. Everyone loves the idea of SC but doesn't want to pay HALO the royalties. No doubt PFE will go it alone too. Hopefully they will fail too.
Just wait - PFE will have their own SC version of Rivipansel in trials shortly just like Viropharma did with Cinryse.
Now Pfizer dump Rivipansel for no apparent reason. Anyone think they are playing us?
Royalties only up to $13m from $12.3m in Q2. That makes no sense to me. We keep hearing about the success of switching patients to SQ on our three partnered products but where are the royalties?
Minninv - that's a different job. Someone must have been responsible for seeking out new partnerships etc - surely.
Is this a new role or have they fired the predecessor recently? You'd have thought or at least hoped that someone must have been doing this job for years. Seems rather strange to me. Clearly the lack of new partnerships is unsatisfactory to both Kirk and me!
There a lot of posts about potential revenues - most (other than Mab SQ) kicking in from 2020 onwards. In the meantime we are where we are. This is going to be a record loss quarter for sure. How high - well depending on the huge PEG expenditure it could be between $35m - $40m.
Fred - $60m pa in royalties when you're spending $250m pa leaves one big black hole. HALO need to show in the PEG data shortly to be released that this level of expenditure is worth it. I've calculated that HALO will be spending $600m on PEG trials before its gets a penny in sales. So far we haven't really had it made clear to us whether that's a sound investment strategy. To me it's seems crazy and I'm not sure the market is convinced either. The old HALO mantra of paying for In-house products out of partnered royalties is well and truly out of the window.
I did a google search on the definition of mid single digit. Interestingly the only company that I could find that defined what they meant when referring to this type of term was Gap Inc. For mid single digit it was 3.5 - 6.4%
http://media.corporate-ir.net/media_files/IROL/11/111302/reports/guidance_legend.pdf
Based on the disappointing royalties that HALO has earned to date I would reckon that the 3.5% is highly likely. I admit my 2% was too low - or at least hope it was!
Maumur - what royalty percentage are you assuming? I was doing the same calculations today at 2% and came out with a much lower figure. When you look at the royalties currently being received on EU sales and try to extrapolate the likely royalty percentage it doesn't appear to be anything like 5%, which is the figure that I'm assuming you are using.