Well, it is an example to express the main idea that HALO has options to expand on their SC delivery platform.
The reason Remicade might be a good candidate is that, even in the face of the SC competition I listed, Remicade IV is still a blockbuster because it is a better drug than the others.
South Korea's Celltrion is one such company. I believe they have about a $3-4 billion market cap and have solid revenues. There is no reason why HALO needs to limit its partnerships to big pharma to help them fend off biosimilars. Of course, Roche might not really appreciate HALO partnering with someone who is also trying to copy Herceptin and Rituxin. But the threat that HALO might take its technology to the competition might help to motivate big pharma to cut some deals now.
Can you do something beside ask dumb questions? Bring a fact or an idea to us please. At least read more carefully the post your are responding to.
I don't propose HALO get into the biosimilar business. I propose. HALO negotiate with the companies already producing the Remicade biosimilars. If I were HALO, I'd go knocking at their door with Prezi in hand showing them how they can steal business away from J&J faster than simply offering a cheaper version. Offer to skip the upfront and milestone payments and, perhaps, kick in a little developmental cash in exchange for a much larger percent of sales revenue.
It is a 2.5 hour IV infusion every 4 to 8 weeks, for a variety of immune mediated inflammatory conditions, that sells about $9 billion per year for J&J and Merck. Biosimilars are going thru Europe's approval process now. European and U.S. Patents end in 2015 and 2018 respectively. Now would be a good time for HALO to get involved. The market for SC Remicade is nearly certain.
For most of these diseases, patients are started on the home use of the SC drugs, Enbrel and Humira. When these fail, the superior antibody, Remicade is used. Imagine the temptation to use Remicade earlier when it also can be given at home.
If J&J and Merck aren't interested, perhaps one of the biosimilar companies would be.
The old 10% igsc uses about a third more product than the IV or Hyqvia. Not sure, but I believe that would be the same for the new 20% solution.
So, when comparing conventional SC to Hyqvia, fezz is correct, it uses more IG product. Sorry if I missed that implication. I just don't think conventional sc competes AT ALL because of the dosing frequency. It is the IV use that is far more common and it is current IV users that will be switching to Hyqvia if market share is to grow.
The Ig dose is the same, 300-600mg/kg/month, regardless if IV or Hyqvia.
That makes no sense. As you know, I work in an ER that has an infusion clinic associated with it. My name goes down as the ordering doctor on many infusion therapies per day. While the cost of the drug is often thousands per dose, the amount the hospital gets for each infusion is $222 for IV and $186 for SQ. I get a fraction of that because the nurses are doing all of the work. In fact, the hospital gets so little per dose, that it only takes giving one uninsured patient a non-reimbursed drug once to push the entire clinic into the red for the whole week. I think you can stop worrying about greedy doctors on this one. It's all about the drug company's bottom line.
I don't know. You could be right with the six month review. With all of the data they have now on the two Roche drugs, I don't anticipate any long term efficacy studies will be required.
Yes, the incentives in the U.S. are different. Most infusion clinics are pretty busy places. If they can get someone in and out faster, I think that will be an advantage. The real problem for HALO is that the generic threat is so far off. Roche can still sell the IV for four more years without US competition. I do think though they might convert sooner than later if only to lock in their SC product as SOC while they have all of the leverage.
It isn't in Baxter's interest to hold back. Same with Roche. Five percent isn't much when the improved product can take market share from others or prevent loss to bio-similar generics.
In Baxter's case, growth will be slow initially because Ig isn't plentiful. Roche should continue to grow it's SC market. I think the next surprise will be announcing trials of Genentech/Roche's US products.
Baxter started the trials for the double concentration IG product long before Hyqvia was approved. they won't stop now. there may be a niche market or they may try to develop this into a lower volume Hyqvia.
Remember that Hyqvia is a one infusion every four week product. this new 20% solution is a two infusions EVERY WEEK product.
I think it more likely that the CEO simply has her own lawyer waiting in the wings. We are likely to find out who that is it at the next quarterly report. If we are lucky enough to get a John E. Osborn, or similar, that would say a lot. I'm sure Helen has his number. We'll see.
That is exactly what happen last year when Trius was bought out by Cubist. They brought in a new lawyer about five month before the deal went down. He got some nice awards for about a year's work.
Also, tiny companies are often shorted by mysterious forces ahead of a buyout. It seems to depress the final price and it sure looks suspicious for the acquiring company.
That said, I don't want HALO to even consider a buyout until after Ph2 results. I'd like to see Torley get in the range of 10 billion for HALO, as she did with the sale of ONYX.
from the link:
One challenge in treating pancreatic cancer is that it is difficult for anticancer drugs to enter the tumors. The goal of this study is to assess the effects of the investigational drug PEGPH20 on operable pancreatic tumors. PEGPH20 is an anticancer drug that breaks down hyaluronan, the substance thought to give pancreatic tumors their “tough,” hard-to-penetrate exterior. It is hoped that breaking down hyaluronan may make a pancreatic tumor more susceptible to the effects of anticancer drugs.
In this study, researchers are assessing the following:
The use of two approaches to magnetic resonance imaging (diffusion-weighted MRI and dynamic contract-enhanced MRI) to see if these techniques can be used to image pancreatic tumor permeability (the ability of molecules to enter tumors).
The use of these imaging techniques followed by a single dose of cetuximab and examination of tumor tissue one to two days later to see how cetuximab was delivered to the tumor (stage 1 of the study). Cetuximab is an anticancer drug that targets a protein called EGFR, which is commonly found in pancreatic cancers.
The use of these imaging techniques followed by the administration of PEGPH20 and then cetuximab, with examination of tumor tissue afterward, to assess the delivery and safety of this drug combination (stage 2 of the study).
We'll know in about two weeks. Should be lots of news by then as the quarterly report will be about the same time.
Good question. Perhaps she didn't jive with the new team.
A perspective of what a company can do over years, and not simply what the next week holds, has made me a successful biotech investor. If you were to research my previous pseudonym, friendotd on YMB, you would find posts associated with many biotech companies that were bought out over the last 15 or so years. I used to get into knock down and drag out battles with posters who would largely hang back and take pot shots like "LOL... In coming years". They aren't around any more. Even the knowledgable and prolific shorts from years ago can't be found anymore. Only a handful of intelligent longs can I recognize when I stumble across them on YMB or other financial mbs. We have something in common besides our success: the long term perspective.
Any newbies to biotech investing, please take note. While I have made some money on the short side, the bets that made me were long positions with companies where the downside was relatively limited (by experienced management, sound cash positions and technology validated thru good partnerships) and potential for extreme growth. I don't fight on YMBs much any more but a year or two from now you will still find me posting occasionally but "new to the game" and his ilk will be long gone, either broke or trying their hand at a new shell game.
The future is bright for Hyqvia but AD is not a likely indication anytime soon. The neurological indications he discusses are likely to be certain kinds of MS and other demyelinating motor neuron diseases. Ig is approved for some now and used off label for others in this class.
Remember that while Hqvia is clearly a best in class product, Baxter's plan is to broaden indications and sell it for a premium, at least until they can produce more Ig. The real revenue bulge won't come to HALO for several years. Not to worry,long term investors, stock price will eventually reflect future earnings. And those future earnings are substantial. I'm hoping HALO can stay independent long enough to enjoy all the fruits of so many years of labor.
interesting find, fez
it might find more pediatric use than I originally expected