Amgen's candidate looks like a potential threat to bb2121 in terms of efficacy.
A good news for all of us, but not Celgene.
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- Nov 2018
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Even if AMG-420 doesn't end up matching bb2121 on efficacy, keeping its safety profile intact could make it a popular option in earlier treatment settings.
The worst case when AMG-420 is not working and failed compare to bb2121, it still sets a foundation for Amgen or companies in this industry to keep develop (of course not consider to Celgene). By saying that, Celgene should be concerned more than just dealing with publicity, government, FDA, etc. It should also consider the innovation of Amgen, or other virals. It is not easy for Celgene to just block any viral as the way they want.
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Amgen's also advancing a similar candidate directed at BCMA called AMG-701, which is designed to last a lot longer in the bloodstream
There are more than 1 product is used. Amgen also developed another "candidate" to enter this drug fight with Celgene. It can be a good way, because it increase successful chances for Amgen, as well as to break down Celgene to stop the monopoly on this drug market.
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f AMG-420 pulls off a repeat performance in a larger study, bluebird bio and Celgene's partnered candidate, bb2121, might be in trouble.
a potential risk for for Celgene, but a hope for all of us.
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Eliciting minor responses from just a couple would be impressive, but AMG-420 went way beyond and helped five patients treated with a higher dosage achieve complete remission.
Amgen is kind of a rival of Celgene. And now it released AMG-420, which also cures cancer, sucessfully performed on 5 patients, "multiple myeloma so agressive that their diseases didn't bak down after four to six previous lines of treatment," "higher dosage complete remission."
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Alles seemed to be most excited about the prospects for bb2121, a cell therapy that Celgene licensed from bluebird bio (NASDAQ:BLUE). He described the drug as "first in class" and "best in class" for treating multiple myeloma, another of Revlimid's key approved indications. Alles said that he thinks bb2121 will "transform" the treatment of multiple myeloma.
This might be a potential Revlimid ver 2.0 for Celgene, "first in class," "the best in class," and "'transform' the treatment of multiple myeloma."
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Celgene acquired Impact Biosciences earlier this year, picking up fedratinib in the process. The biotech expects to file for Food and Drug Administration approval for the drug in treating myelofibrosis by the end of this year. Like beta-thalassemia, myelofibrosis is a blood disorder for which Revlimid isn't approved.
This is what Revlidmid failed to perform, and they picked up from there to extend their "tentacles octopus"
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Celgene's multipronged strategy of reducing its dependence on Revlimid by launching new hematology drugs is a smart one. However, the company also has other ways of replacing revenue that will be lost after generic rivals begin taking away market share from Revlimid.
If we ever think that they are giving this game, we are wrong. Celgene just gives up Revlimid, does not mean that they give up everything. They have plans to make up loss from Revlimid. It is not that simple like what we wee and what they announced.
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Celgene will defend its patents against all potential generic rivals "until conditions are acceptable to settle." He insisted that the biotech won't give up even one month of continued revenue from Revlimid if it doesn't have to do so.
As long as there is any potential generic rival, Celgene will "destroy" them all, and the term "until conditions are acceptable to settle" is like when there is no more potential virals for them, and when they are well-prepared for another game after Revlimid, which they have tools and know how to defense legally to have a full protection shelf.
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study of the drug in treating myelodysplastic syndromes (MDS), one of the top approved indications for Revlimid. The companies followed up in July with more positive late-stage study results for luspatercept in treating beta-thalassemia.
uhhh isn't it another innovated version of Revlimid???
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The bottom line is that Celgene plans to replace Revlimid, but not with just one drug. Instead, Alles pointed to four hematology drugs in Celgene's pipeline that he thinks will take the baton from Revlimid and become blockbuster franchises.
It is pretty obvious that Celgene wants to replace 1 block buster with 4 block busters, and instead of having 1 product with multiple layers of protections, it is now having 4, also with multiple layers of protections.
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With Revlimid, Celgene got more years of exclusive market access, and more more years of patent protection
More evidences to indicate that the development of Revlimid was planned ahead, maybe the failure of Thalomid was also planned. You know it makes more sense when you have the first fail product, and the second one is way better and people agree more on it.
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Before its exclusive rights to market the drug for multiple myeloma expired — and before a generic drugmaker could put a competitor on the market — the company tweaked Thalomid to turn it into Revlimid, which also treats multiple myeloma, but with fewer side effects. It was first approved by the FDA in 2006, according to the company's website.
This is exactly what I mentioned earlier, when they already knew about Revlimid, but they did not want to develop it until the use of Thalomid is no more.
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Celgene has been granted 14 patents for its REMS plan.
Celgene tries to create/link to as many patents as possible for each product it owns. In this way, the company is always able to monopoly/control the market as the way they want.
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Celgene, in its response, argued that the FDA has no authority to force it to sell its drugs to competitors, and that its liability is too high if the other companies don't take adequate safety measures.
It is funny to say that FDA is hit by its own rules. Celgene uses legal rules and laws to protect its illegal act.
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Celgene, in its response, argued that the FDA has no authority to force it to sell its drugs to competitors, and that its liability is too high if the other companies don't take adequate safety measures.
Because Celgene keeps the secret formulas and everything, it has the right and it sounds rationale when it shows it "concerns" to the patient, anyone who use the drug. It is kind of like "Oh for your safety, no one knows the right to do better than us so we just keep it!"
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Celgene has used multiple tactics — all legal — to make it nearly impossible for a generic drug to reach the market.
It has been such a long time that Celgene is aware how to make things legally. IT is harder for government, FDA or any agencies to "attack" it legally.
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U.S. patent and drug-approval systems are set up specifically to encourage and reward this kind of innovation. Companies that develop new drugs are awarded a monopoly for a handful of years to profit from their invention.
This is a knife with two edges. Yes it is a good incentive, but look what we are dealing today with Celgene situation.
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A few years after Thalomid hit the market, Celgene altered it a bit by removing an oxygen atom and adding a nitrogen atom, creating a new amino group. The company called the new drug Revlimid.
It could be coincidence, or it could be done intentionally. Maybe Celgene thought about monopoly the market back then. They could have figured out Revlimid, but they just did not do it at very of beginning, be cause they want to use it as a tool to extend the legal life time being exclusive in the market (by "creating a new amino group").This can be a clue to show that they were well-prepared.
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Revlimid's legal monopoly is now in year 14.
It has been such a long period time, 14 years and still counting more. The longer it dominates the market, the harder to break it down.
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a series of initiatives the FDA is taking to try to limit what companies like Celgene can do to thwart competition for years.
FDA is aware how this octopus has been doing for awhile.
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companies game the system by taking advantage of certain rules and laws," FDA Commissioner
I am pretty sure Celgene is not the only company who knows about rules of this game, and they all know how to take advantage of certain rules and laws, which makes everything legal. By saying this, it means that it's harder to break the company down by rules and legality, and FDA is also aware of this.
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both Revlimid and Thalomid are derived from a decades-old drug, thalidomide, that was once sold over the counter in Europe before it was pulled from the market.
Again as mentioned earlier, Celgene has been in the market for too long that it is sophisticated enough for them to know how to dominate this drug market with Thalidomide, a drug which was pulled from the market in Europe.
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It's been around for more than a decade and its original patent expires next year. But today it looks like another four years could pass with no generic competitor to Revlimid.
It has been there for more than a decade, an it seems having a potential extra 4 years. This means it is not the first time Celgene and the public have been in this fight, "the frug war." And we can tell that the company might have prepared everything to extend the legal time."
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