It is a fair question but it is only important if the answer reflects poorly on the platform. And I highly doubt that with the momentum the platform has.
I have suspected for a long time (but I don't know) that MabThera has too many side effects to make SC administration strongly advantageous. We, in the States, give IV Rituxin (same thing as IV MabThera) and find the slow IV drip is a way to manage side effects. Perhaps the Euro docs feel like giving a bolus of SC MabThera (that cannot be retrieved) and still having to monitor the pt for over an hour doesn't save them anything. Because, you are correct, MabThera is ramping slowly.
That said, once again, in the grand scheme of things, MabThera is not too important to HALO's future.
I remember getting a call in the mid-90s from someone with a strong NY accent in a room clearly filled with other similar callers. He wanted me to buy this new company called Pixar. Of course, his whole approach was repulsive and I asked how he got my name. He became angry fairly rapidly.
I've wondered about that call many times since. Turns out, Pixar would've been a killer investment. His angle, IMO, was to try to get my business with him as my broker. He was suggesting up and coming growth stocks to get my attention. Perhaps, after developing a relationship, he would have tried to dump junk on me (like The Wolf of Wall Street) but there is no way someone pumps a stock with cold calls. I can't think of a less efficient way to do so. Remember, HALO trades over $20 million per day. If your story is true, it does not reflect on HALO in any way other than it was 'hot' today.
You are completely wrong. The FDA easily approved Hyqvia, as soon as it had the info it needed. That information strengthens with every dose given. It was reasonable to be concerned about titers a few years ago. No longer. That theoretical threat is understood now as harmless. The pace of Enhanze product development has more to do with our partner's goals than anything else..
Titers are likely a consideration in any approval for long term daily use, such as would be the case with insulin. The main problem with the insulin indications was that they were going to require more studies, costing more $$$. Also, there wasn't really the burning need with the ultra-fast acting insulins coming on to the market. I think the pump indication might have a shot - eventually - but even you would agree HALO made the right decision to redirect their resources away from DM.
So, in my opinion, the titer specter is a giant red herring when brought up on products that will be given for a short time or used less than once or twice per month long term. And those ARE the indications we are talking about with Enhanze partnerships these days.
And any mention of titers in the PEG discussion is flat out off topic.
Pentech, your hands were slapped when you brought up titter fears in the context of PEG. Titters and PEG have nothing to do with each other. Regarding Enhanze, the titter question is at least pertinent but since the multiple approvals now in the US as well as Europe, it seems the issue is best viewed in the rear view mirror.
I was thinking the "almost" might refer to MabThera. LOL
Seriously, though, there are many links from HALO to AMGN, 'Braveheart' the most prominent. The "bolt-on Onyx" was referred to specifically in the article as an example of what Amgen is looking to repeat. Once again, Torley comes to mind.
Not saying it's likely, but it is possible. My point is that, even if you are correct in your five year estimate on the blockbuster PEG, you can't be sure of reaping the rewards if you wait until the 4th year to buy in.
HALO probably isn't quite far enough along yet, but:
"Amgen, one of the four largest US biotech groups, is on the hunt for potential acquisitions, according to people familiar with the situation, as it prepares to end its self-imposed exile from the boom in pharmaceuticals mergers and acquisitions.
... a person familiar with the company’s thinking said it had recently “opened the aperture” and was now evaluating companies worth up to $10bn, with drugs that have been proven in clinical testing and are almost ready to bring to market."
a nice reminder of another iron in the fire
don't get too excited, its only mice...
Exactly. Because of its potential across so many tumors in combination with so many other chemo drugs, PEG is likely a blockbuster, like Torley says. Many small biotechs worry the cash will run out while getting their primary drug to market. HALO is de risked from this financial worry. It is a great buy and hold stock.
That said, pentech is correct that the clock was set back a bit with recent news. One problem with cancer drugs these days is that immunotherapy is changing the landscape so fast it is hard to know what the goal line is for any new drug. HALO risks trialing their drug with the current best only to find some new therapy is the new darling. That is what is happening with NSCLC. Expect more resources to go toward the Keytruda trials this year and to hear less about the docetaxel trial. Pancreas will be by far the main focus this year. While waiting for the 2H16 efficacy numbers on 202, I hope to be surprised by some news from SWOG or possibly a new indication driven by another company similar to our Japanese partnership.
The promise wasn't HALO's. It was Hingorani's. It was his abstract and the language was similar, if not the same, as with ASCO - that there would be OS numbers at the meeting. Could it be a simple mistake by Hingorani's lab? Don't know but HALO never PR'd this meeting or poster. And it was clear to anyone who had access to the ASCO presentation that the OS numbers were mature. Promising an update on that data can only be described as an error. I'm not ready to blame HALO too much for Fezz hyping upcoming OS numbers based upon an abstract. Perhaps the change in HALO PR personnel has to do with some of this miscommunication.
I believe most of the share price decline is due to the overall biotech market. Almost all of my biotech portfolio is down - for no good reason. Of course, much of it was up more than it (probably) should have been this past year.
The ESMO abstract promised an update on OS. That promise was in error. They presented the exact same K-M curve that was presented at ASCO. Nothing about the ESMO poster was any different than the ASCO presentation. Not sure how Hingorani got away with that as we all assumed the only way to get a poster accepted with the ECC was to have some new data. I'm not sure when HALO put that KM curve up on their site, I may have missed it for a few months, but I didn't see it until I started asking HALO and Hingorani's lab about the "new" OS data. Neither ever responded to my phone calls or emails but the issue became mute when I saw the curve in Sept.
So, short answer, they didn't have any new ESMO data to present and, unless you believe they were a bit quiet about the OS curve since ASCO, have not hidden anything.
As I said before, the OS curve is fine, and even has a good excuse for not being as stellar as the PFS curve because of the dose interruption, but we should hope for better from stage 2 of 202.
I'm not sure what you mean. The stage 1 data is complete and out there, such as it is. The stage 2 is not mature. While researchers and the company might have an idea how things are progressing on this open label study, they cannot officially "look" at results until they reach a certain number of events. They estimate TE data early in 2016 and efficacy data late in 2016.
nah - it's the market, mainly
today, it takes next to nothing for an excuse to sell
If you are looking for a ghost in the machine, with this company it always comes back to PEG prospects. I didn't think the OS K-M chart for 202 was as good as I'd hoped for. Good enough for approval if ph3, certainly, but not a home-run (due to drop-outs, primarily). There is every reason to believe the stage 2 202 results will be better since the dosing is uninterrupted. The 202 stage-1 OS results were known in June after Hingorani's ASCO presentation and share price continued to climb. Share price peaked in late July and then started falling with all the other biotechs. In this biotech sell-off, all the companies with the greatest YOY gains are the ones giving the most back.
And I didn't say nothing has changed. I indicated we would sell off this AM when the slowness of the return of the 202 efficacy numbers sank in. I will say this, at a 2 billion dollar valuation, this company is a steal. There is nothing substantial that has changed about he basic story here. Halozyme has a blockbuster, multibillion dollar drug in PEG and a growing income stream from Enhanze to fund its development. It just might take longer to get there than the hype. Those posters here who have been shouting about breakthrough status and "oh, the humanity of it all" should pancan pts be deprived of this drug for another year.
Patience will pay off.