The Generics move Fast! Do Something JT!!

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anonymous

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LONDON, March 31, 2020 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma, Group), the multinational generic pharmaceutical company, today confirms that the United States District Court for the District of Nevada has ruled that Hikma's generic version of Amarin Corporation's Vascepa® (icosapent ethyl) 1 gm capsules does not infringe six United States Patents, as asserted by Amarin, because the asserted claims of these patents were held to be invalid.

Hikma is working closely with the U.S. Food and Drug Administration (FDA) to gain approval for its Abbreviated New Drug Application (ANDA) for its generic version of Vascepa®. The company is evaluating its options for launching the product following FDA approval, including an at-risk launch in the event the District Court's decision is appealed.

"We are very pleased with the District Court's decision, which demonstrates our continued ability to successfully litigate to bring greater value to our customers and patients in the US," said Brian Hoffmann, President of Generics, Hikma. "We look forward to providing patients and health care providers in the US with a generic version of this important medicine."

Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

According to IQVIA, US sales of Vascepa® were approximately $919 million in the 12 months ending February 2020.
 






anonymous said:
LONDON, March 31, 2020 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma, Group), the multinational generic pharmaceutical company, today confirms that the United States District Court for the District of Nevada has ruled that Hikma's generic version of Amarin

HaHaHaHaHaHaHaHa your dead HaHaHaHaHaHaHaHa

Corporation's Vascepa® (icosapent ethyl) 1 gm capsules does not infringe six United States Patents, as asserted by Amarin, because the asserted claims of these patents were held to be invalid.

Hikma is working closely with the U.S. Food and Drug Administration (FDA) to gain approval for its Abbreviated New Drug Application (ANDA) for its generic version of Vascepa®. The company is evaluating its options for launching the product following FDA approval, including an at-risk launch in the event the District Court's decision is appealed.

"We are very pleased with the District Court's decision, which demonstrates our continued ability to successfully litigate to bring greater value to our customers and patients in the US," said Brian Hoffmann, President of Generics, Hikma. "We look forward to providing patients and health care providers in the US with a generic version of this important medicine."

Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

According to IQVIA, US sales of Vascepa® were approximately $919 million in the 12 months ending February 2020.
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No clue if I’m correct, but I did some research on at risk launches and the past. It looks like a judge can smack a pretty quick 30 month hold on a generic during an appeal, which could stretch out. This buys 2.5 years of the 10 remaining, at the worst.
 





































It's so funny to see bitter former employees who were fired because they are worthless come on the internet and attempt to troll. You literally write the same thing in the same font and the same color on every post. What a tool.

For everyone else, the company is in good shape, no one is getting laid off and we will appeal. Don't listen to the losers who couldn't hang on to their job at this very good company.
 






anonymous said:
It's so funny to see bitter former employees who were fired because they are worthless come on the internet and attempt to troll. You literally write the same thing in the same font and the same color on every post. What a tool.

For everyone else, the company is in good shape, no one is getting laid off and we will appeal. Don't listen to the losers who couldn't hang on to their job at this very good company.
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That's for the HAHAHAHA person who doesn't understand how to spell you're correctly. No wonder why they were let go.
 






anonymous said:
It's so funny to see bitter former employees who were fired because they are worthless come on the internet and attempt to troll. You literally write the same thing in the same font and the same color on every post. What a tool.

For everyone else, the company is in good shape, no one is getting laid off and we will appeal. Don't listen to the losers who couldn't hang on to their job at this very good company.
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Thanks for calming down my anxiety. Real stressful evening and day. Any chance JT is at the bargaining table with other Pharma companies to buy us? Or we really will fight this out for the long hall. Our manager said that they are 100% committed to our careers here. I want to give it 100% but at the end of the day, I need a steady paycheck or need to start to be proactive and find another job.
 






anonymous said:
It's so funny to see bitter former employees who were fired because they are worthless come on the internet and attempt to troll. You literally write the same thing in the same font and the same color on every post. What a tool.

For everyone else, the company is in good shape, no one is getting laid off and we will appeal. Don't listen to the losers who couldn't hang on to their job at this very good company.
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Did you really end your rant with very good company???? A one “drug/fish oil supplement” that just lost its exclusivity and has nothing else in the pipeline??

are you high?
 






anonymous said:
Thanks for calming down my anxiety. Real stressful evening and day. Any chance JT is at the bargaining table with other Pharma companies to buy us? Or we really will fight this out for the long hall. Our manager said that they are 100% committed to our careers here. I want to give it 100% but at the end of the day, I need a steady paycheck or need to start to be proactive and find another job.
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What!? This has to be written by home office. Who will buy a company who's patent is under imminent threat? A liquidation of assets is likely, including cutting back on all expenditures (which includes advertising and overhead ) but long term career growth and prosperity is gone as of yesterday. Use your own noggin, not your managers. The reason the stock dropped 70% is because the situation is severe. You need to treat it as such.
 






It's almost like none of you even know what happened. Amarin didnt lose its reduce it patents, it lost its marine patents. You know, the one that indicates high trigs. Generics cannot sell a generic that indicates cvd reduction. In fact the generics wanted to ban the reduce it study from the trial all together. The issue is now the generics can come in and sell the exact same drug and hope the docs prescribe it off label for cvd instead of amrn. The high trig market is already saturated. Also the rest of the world is still under Amarins patents so this doesnt effect any one but the US. You guys need to do more research for Pete's sake. It isnt over. Amrn does have 3 options. 1. Sell the company. And yes they can because they still have exclusivity to the rest of the world. And they also can still sell in the US just like Lipitor does after patent expiration. 2. They can appeal. 3. They can try to settle with the generics. You cant guage the severity off a stock market over reaction, you need to use that brain God gave you.
 






anonymous said:
It's almost like none of you even know what happened. Amarin didnt lose its reduce it patents, it lost its marine patents. You know, the one that indicates high trigs. Generics cannot sell a generic that indicates cvd reduction. In fact the generics wanted to ban the reduce it study from the trial all together. The issue is now the generics can come in and sell the exact same drug and hope the docs prescribe it off label for cvd instead of amrn. The high trig market is already saturated. Also the rest of the world is still under Amarins patents so this doesnt effect any one but the US. You guys need to do more research for Pete's sake. It isnt over. Amrn does have 3 options. 1. Sell the company. And yes they can because they still have exclusivity to the rest of the world. And they also can still sell in the US just like Lipitor does after patent expiration. 2. They can appeal. 3. They can try to settle with the generics. You cant guage the severity off a stock market over reaction, you need to use that brain God gave you.
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What are branded Lipitor sales compared to generic atorvastatin sales? Haha, laughable. Non existent. You are also comparing years of marketing of the best selling drug of all time. You compare apples to oranges.

Vascepa sales took off when reduce it was announced, before the indication was granted. Payers choose to be restrictive or not restrictive. My point is that generic competition may not have a CV indication, but insurance companies can apply a molecule to molecule comparison and demand a generic substitute. After all, it's not Vascepa itself that is special, that's just a name. It's pure epa that is benefitial. Generic may not have CV data in its label, but players will exude confidence in substituting a generic given it's pure epa and will loosen restrictions of a generics off label use. It's all about cost.

Too many people posting as if they know with certainty what the future looks like. At least make good use of this forum and offer different perspectives. That's better use of your brain.
 






anonymous said:
It's almost like none of you even know what happened. Amarin didnt lose its reduce it patents, it lost its marine patents. You know, the one that indicates high trigs. Generics cannot sell a generic that indicates cvd reduction. In fact the generics wanted to ban the reduce it study from the trial all together. The issue is now the generics can come in and sell the exact same drug and hope the docs prescribe it off label for cvd instead of amrn. The high trig market is already saturated. Also the rest of the world is still under Amarins patents so this doesnt effect any one but the US. You guys need to do more research for Pete's sake. It isnt over. Amrn does have 3 options. 1. Sell the company. And yes they can because they still have exclusivity to the rest of the world. And they also can still sell in the US just like Lipitor does after patent expiration. 2. They can appeal. 3. They can try to settle with the generics. You cant guage the severity off a stock market over reaction, you need to use that brain God gave you.
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How about you use the brain God gave you. Docs will write generics off label for CV risk reduction instead of Vascepa. Therefore, Amarin still doesn’t need 800 sales reps. Bye bye
 






anonymous said:
It's almost like none of you even know what happened. Amarin didnt lose its reduce it patents, it lost its marine patents. You know, the one that indicates high trigs. Generics cannot sell a generic that indicates cvd reduction. In fact the generics wanted to ban the reduce it study from the trial all together. The issue is now the generics can come in and sell the exact same drug and hope the docs prescribe it off label for cvd instead of amrn. The high trig market is already saturated. Also the rest of the world is still under Amarins patents so this doesnt effect any one but the US. You guys need to do more research for Pete's sake. It isnt over. Amrn does have 3 options. 1. Sell the company. And yes they can because they still have exclusivity to the rest of the world. And they also can still sell in the US just like Lipitor does after patent expiration. 2. They can appeal. 3. They can try to settle with the generics. You cant guage the severity off a stock market over reaction, you need to use that brain God gave you.
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#1 Sell the company? We have to go through the appeal process for 12-24 months. After that’s settled, then they can sell. Amarin can’t sell since they started the appeal process. They don’t “own” exclusivity here anymore. Dr. Reddy already is seeking approval from the FDA.
 


















anonymous said:
#1 Sell the company? We have to go through the appeal process for 12-24 months. After that’s settled, then they can sell. Amarin can’t sell since they started the appeal process. They don’t “own” exclusivity here anymore. Dr. Reddy already is seeking approval from the FDA.
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I didnt see a press release that they filed an appeal today. Even if they did they can still negotiate settlement and then disregard the appeal...if they were going to settle.
 






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