struck a deal with Celgene to drop its patent litigation in exchange for Celgene allowing it to introduce a generic competitor to Revlimid in 2022 — five years before its last patent expires.
By using threat of litigation, Natco Pharma was able to agree to a settlement with Celgene that allows it to start selling a generic version of the drug in a few years.
The gaming that I see is where people are blocking generic entry by restricting access to the doses
Celgene is creating enormous barriers to entry by limiting the amount of Revlimid generic competitors can obtain.
if not for Celgene's blockade, a generic version of Revlimid should have hit the market years ago because the drug's patents would have been successfully challenged.
Customers are now forced to pay the high prices for Revlimid, as it is the only drug for multiple myeloma available.
These techniques include obtaining multiple patents — which some critics call "frivolous" — on the drugs and their distribution systems
By layering their patents, Celgene is making it extremely difficult for other companies to gain access to the market.
by winning "orphan drug" approval to sell it as one of the only drugs that could slow the progress of multiple myeloma
Orphan drug status allows Celgene to gain first-mover advantages by establishing brand loyalty right from the start.
It was considered so safe that in Germany, it was available without a prescription.
It is crazy to think that an OTC drug just a few decades ago turned into a billion dollar cure for multiple myeloma.
"Prices like this are bad for patients," said Mitchell, who last year founded the nonprofit advocacy group Patients for Affordable Drugs. "They hurt patients."
Celgene is exploiting their customers by setting their prices high and not giving them another alternative.
Celgene can keep raising the price of Revlimid because the drug has no competition
Revlimid is an inelastic product that people will pay lots of money for to obtain.
If Celgene can make Revlimed obsolete, as Mark Alles plans to do, that will be great news for investors.
It is risky for investors to invest in Celgene because the company is putting all their eggs in one basket. Once they start to diversity their product line, they will become a safer investment.
Alles said that 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.
They want to make sure that they will be fully protected and ahead of the game before they settle, that way they will have alternative drugs ready to market instead of Revlimid.
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.
Celgene is looking to cover all aspects of the market, as they are targeting cures for many blood-related diseases.
Celgene reached a settlement a couple of years ago with Natco Pharma that allows a generic version of Revlimid to be marketed in the U.S. beginning in March 2022 in limited volumes.
Celgene did not want to go through litigation, so they agreed to a settlement with another company that will allow them to sell their generic drug
If AMG-420 pulls off a repeat performance in a larger study, bluebird bio and Celgene's partnered candidate, bb2121, might be in trouble.
AMG-420 is differentiating their product and is now trying to enter the market geared towards multiple myeloma.
Before starting CAR-T therapy, patients need to hang around a hospital for at least a few days while nurses kindly wipe out their immune systems with lymphodepleting chemotherapy.
Although this is an alternative to the high-priced Revlimid, a therapy this in-depth sounds expensive as well.
Amgen's also advancing a similar candidate directed at BCMA called AMG-701, which is designed to last a lot longer in the bloodstream
Amgen could be looking to obtain an orphan drug status with their new drug.
That could eventually be a problem for Celgene, which expects its second-best-selling multiple myeloma drug Pomalyst to generate $2 billion in sales this year.
Celgene might be forced to lower its prices if a competitor successfully enters the market.