Amarin - The Science Of Lipid Therapy (Seite 76)
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isaeed Tuesday, 08/25/20 04:37:08 AM
Re: None 0.010
Post # of 292637
Summary of the case and DC Order Errors (if I missed something plz add or correct):
---------------------------------
FACTS:
1. Prior to Vascepa, TG viz-a-viz LDL-C mechanism was known to works differently in different POPs i.e. different in Below 500 and above 500mg/DL not clearly understood. It was not about ART, it was about Mechanism of action of reducing the Very high TGs that always resulted in LDL-C going up
2. All prior art treatment, prior to Vascepa, in >= 500 mg/DL resulted LDL-C going up significantly
3. No prior art exists for treatments >=500 mg/DL that resulted in LDL-C going down
4. The known ART: Mori taught EPA 4g resulted in LDL-C going down for patients with TGs <=500mg/DL that was later confirmed with Epadel, Niacins, Fibrates and Lovaza etc.
5. The known art, Mori, never resulted in POSA pursuing EPA 4g treatment since all prior art MOA showed LDL-C going up above 500mg/DL treatments. E.g. Lovaza
---------------------------------------------------------------
Why we lost the case and Point of argument:
DC decision only focused on MORI and results that MORI taught was that 4gEPA reduced TGs and LDLC. To prove her point she used statements like ‘strongly suggesting that these two Omega-3 fatty acids (DHA and EPA) could have distinct effects on LDL cholesterol levels” and also used statements like ‘Therefore, a skilled artisan would understand from Mori that DHA and EPA work differently’. Moreover ‘Reasonable expectation of success’ legal standard does not require ‘conclusive proof of efficacy. Which infers that a POSA based on Mori could have made a ‘reasonable expectation’ that the same LDL-C reduction would be obtained in Marine population based on the prior art in EPA but really Defendants don’t have to prove this (appx58-59) as reasonable expectation is sufficient. Also DC used the earlier PTO rejections as proof but ignored that the patents were actually awarded after sufficient proof was provided to the USPTO.
All of these ignore the key factor of differentiation: above 500mg/DL TG population that Vascepa was to address as per the patents. Du listened to Toth and all the evidence provided but decided that this boundary has no relevance. Also she considered all prior art 'irrelevant' since they were not 4gEPA.
All of the above was used to render the 6 Marine patents null and void.
(We also lost the case bcos the statistical data (Dr Bhatt article in Nature was not presented by Amarin. Dr Toth was also not a good expert. We should have done better. But all that is now moot).
-----------------------------------------------------------------
Errors/Omissions by DC (Du):
1- Legal Error: The statement: ‘The court first discusses Defendants’ prima facie obviousness case, which the court finds Defendants supported with clear and convincing evidence of obviousness at Trial, and then discusses each of Plaintiffs’ proffered objective indicia of non-obviousness. The court will go on to explain why the court does not find that Plaintiffs’ proffered evidence of secondary considerations saves the Asserted Claims’.
a) What this means is that the court reached the conclusion of Prima Face before considering the Objective Indicia and only then required Amarin to ‘save’ the claim with the Objective Indicia
b) The court devalued the presented Objective Indicia based on already reached conclusion of obviousness
c) The already reached conclusion infected the review of Objective Indicia
2- The main issue is Hindsight. Today it may seems like a great idea for POSA to remove DHA from Lovaza and get the LDL-C down but really 20 years and no one figured it out? So How is that so obvious even though Epadel pure EPA has been on market for 20 yrs? Its so easy now to say this instead of blaming the disease.
3- Thus she failed to:
a. apply each of the Graham factors, including the common sense objective indicia, before declaring an invention obvious
b. follow concepts like ‘motivation to combine’ and ‘reasonable expectation of success’ exist to avoid a hindsight reconstruction of the claims years after the fact, because that which might appear obvious in hindsight often was not obvious at all.
4- Decision that Defendants satisfied the burden of providing ‘clear and convincing evidence’ basing it on Mori even though Mori taught about a different patient population and taught nothing about patients with TG >= 500mg/DL. Is Medicine like Mathematics? Can we Extrapolate medical results like in Mathematics / Stats? It has to be based on factual ‘clear and convincing’ results. No?
5- Toth cited several evidences relationship of LDL-C with TGs but they were all ignored.
6- DC shifted burden on Amarin to prove that the 2 populations were different (prima facie) – here burden shifting should not have been onto Amarin. It should have stayed with Defendants to prove that the 2 populations are similar. (Burden shifting to Plaintiff only occurs for Secondary considerations not prima facie). Toth explained this population difference issue but Du ignored it citing Mori when in reality Mori exactly did that: show it is different population
7- Factual error: The court equalized (conflated) the 2 patient populations and extrapolated that if in patients with TGs <500mg/DL the LDL-C went down, POSA could have extrapolated that that would occur in the patients with TGs >=500mg/DL – THE CRUX OF THE OBVIOUSNESS CASE – she did that based on Toth’s testimony where he was only talking about TGs and not LDL-C. ‘There was no reason to expect differently for LDL-C.’ This was her own opinion based on nothing but air. This is where she is completely wrong and has no evidence to back this.
8- Conclusory Error (legal) : Dr Heienckes’ conclusory opinion that a skilled artisan would reasonably expect from Moriet al. that EPA would not raise LDL-C in the severe hypertriglyceridemia population. This was a firkin opinion. Heinecke extended those Mori studies to severe hypertriglyceridemia merely by agreeing with counsel that, in his opinion, a skilled artisan would not “have expected a different result in patients above 500,” and not, for example, by citing to prior art that supported such an expectation. The district court’s analysis was same i.e. conclusory—relying on off-point testimony from Dr. Toth that medications that reduced triglycerides in patients with triglycerides below 500 would likely also reduce triglycerides in patients with severe hypertriglyceridemia and then faulting Amarin for providing “no reason to expect differently for LDL-C” in the key finding copied from Defendants. OMG.
9- Decided without considering all of the evidence collectively including ‘long-felt unmet need’ (not a single person ever thought of combining Mori + Lovaza) and the ‘commercial success’ which could not have happened if the invention did not address an unmet need. If there was no unmet need or commercial success we would not be here fighting to save our awarded patents.
10- Legal error with no precedent: She improperly weighed these two very strong proven objective indicia against those the district court decided Amarin had not proven, as if Amarin’s alleged failures to prove praise or skepticism carried independent evidentiary weight. So much evidence was provided to support praise and skepticism but was also ignored. Weighing of these indica against each other resulted in a ‘weak’ case for Amarin. Hence the burden shifting.
11- Pure EPA’s TG reducing abilities was very well known prior art for 17 yrs and Mori (TGs <500) was known for 13 years but no one invented a treatment to reduce TGs and LDL-C in 500>=mg/DL patients – only hindsight would suggest it was obvious
12- Based on prior art with LDL-C going up for all severe TGs treatments, the reading of Mori by DC was opposite of what is should have been
13- DC referred to Kurabayashi and Hayashi – all for different TGs population – not related to Vascepa’s patient populations
14- In reprinting Table 3 of Kurabayashi’s Apo-B results, the district court’s opinion cut off the inter-group statistical comparison – it was a key indicator showing indifference in the 2 populations in Kura
15- DC completely ignore the skepticism being faced by Dr. Manku at time of conceiving the invention – a clear discounting of a major secondary consideration
16- Factual and Legal error: Another discounting of skepticism was ignoring the group of experts that Amarin hired to get their view on LDL-C reduction who all had opined and showed skepticism that LDLC would go down with 4gEPA in very high TG population stating they were unaware of Mori – she was wrong, they were all aware of Mori
17- There was praise when Marine results came out – but was also discounted by DC ‘more qualified and equivocal’
18- Assumption that Hayashi had at least one patient above 500mg/DL
19- Clear error in ruling that the PTO had not considered Kuraabayashi
20- Using Hayashi and Kurabayashi as references even though completely different population than for which the patents were awarded
21- The entire argument about the secondary consideration ‘unexpected benefits’ was discounted because of Mori ignoring all other prior art like Niacins, Fibrates and Lovaza which actually increased LDL-C.
--------------------------------------------------------
This is how i see the case based on the DC order and the various briefs. Now you decided if we win or lose.
--------------------------------------
Note: I have copied text from Briefs and DC order in some places
Re: None 0.010
Post # of 292637
Summary of the case and DC Order Errors (if I missed something plz add or correct):
---------------------------------
FACTS:
1. Prior to Vascepa, TG viz-a-viz LDL-C mechanism was known to works differently in different POPs i.e. different in Below 500 and above 500mg/DL not clearly understood. It was not about ART, it was about Mechanism of action of reducing the Very high TGs that always resulted in LDL-C going up
2. All prior art treatment, prior to Vascepa, in >= 500 mg/DL resulted LDL-C going up significantly
3. No prior art exists for treatments >=500 mg/DL that resulted in LDL-C going down
4. The known ART: Mori taught EPA 4g resulted in LDL-C going down for patients with TGs <=500mg/DL that was later confirmed with Epadel, Niacins, Fibrates and Lovaza etc.
5. The known art, Mori, never resulted in POSA pursuing EPA 4g treatment since all prior art MOA showed LDL-C going up above 500mg/DL treatments. E.g. Lovaza
---------------------------------------------------------------
Why we lost the case and Point of argument:
DC decision only focused on MORI and results that MORI taught was that 4gEPA reduced TGs and LDLC. To prove her point she used statements like ‘strongly suggesting that these two Omega-3 fatty acids (DHA and EPA) could have distinct effects on LDL cholesterol levels” and also used statements like ‘Therefore, a skilled artisan would understand from Mori that DHA and EPA work differently’. Moreover ‘Reasonable expectation of success’ legal standard does not require ‘conclusive proof of efficacy. Which infers that a POSA based on Mori could have made a ‘reasonable expectation’ that the same LDL-C reduction would be obtained in Marine population based on the prior art in EPA but really Defendants don’t have to prove this (appx58-59) as reasonable expectation is sufficient. Also DC used the earlier PTO rejections as proof but ignored that the patents were actually awarded after sufficient proof was provided to the USPTO.
All of these ignore the key factor of differentiation: above 500mg/DL TG population that Vascepa was to address as per the patents. Du listened to Toth and all the evidence provided but decided that this boundary has no relevance. Also she considered all prior art 'irrelevant' since they were not 4gEPA.
All of the above was used to render the 6 Marine patents null and void.
(We also lost the case bcos the statistical data (Dr Bhatt article in Nature was not presented by Amarin. Dr Toth was also not a good expert. We should have done better. But all that is now moot).
-----------------------------------------------------------------
Errors/Omissions by DC (Du):
1- Legal Error: The statement: ‘The court first discusses Defendants’ prima facie obviousness case, which the court finds Defendants supported with clear and convincing evidence of obviousness at Trial, and then discusses each of Plaintiffs’ proffered objective indicia of non-obviousness. The court will go on to explain why the court does not find that Plaintiffs’ proffered evidence of secondary considerations saves the Asserted Claims’.
a) What this means is that the court reached the conclusion of Prima Face before considering the Objective Indicia and only then required Amarin to ‘save’ the claim with the Objective Indicia
b) The court devalued the presented Objective Indicia based on already reached conclusion of obviousness
c) The already reached conclusion infected the review of Objective Indicia
2- The main issue is Hindsight. Today it may seems like a great idea for POSA to remove DHA from Lovaza and get the LDL-C down but really 20 years and no one figured it out? So How is that so obvious even though Epadel pure EPA has been on market for 20 yrs? Its so easy now to say this instead of blaming the disease.
3- Thus she failed to:
a. apply each of the Graham factors, including the common sense objective indicia, before declaring an invention obvious
b. follow concepts like ‘motivation to combine’ and ‘reasonable expectation of success’ exist to avoid a hindsight reconstruction of the claims years after the fact, because that which might appear obvious in hindsight often was not obvious at all.
4- Decision that Defendants satisfied the burden of providing ‘clear and convincing evidence’ basing it on Mori even though Mori taught about a different patient population and taught nothing about patients with TG >= 500mg/DL. Is Medicine like Mathematics? Can we Extrapolate medical results like in Mathematics / Stats? It has to be based on factual ‘clear and convincing’ results. No?
5- Toth cited several evidences relationship of LDL-C with TGs but they were all ignored.
6- DC shifted burden on Amarin to prove that the 2 populations were different (prima facie) – here burden shifting should not have been onto Amarin. It should have stayed with Defendants to prove that the 2 populations are similar. (Burden shifting to Plaintiff only occurs for Secondary considerations not prima facie). Toth explained this population difference issue but Du ignored it citing Mori when in reality Mori exactly did that: show it is different population
7- Factual error: The court equalized (conflated) the 2 patient populations and extrapolated that if in patients with TGs <500mg/DL the LDL-C went down, POSA could have extrapolated that that would occur in the patients with TGs >=500mg/DL – THE CRUX OF THE OBVIOUSNESS CASE – she did that based on Toth’s testimony where he was only talking about TGs and not LDL-C. ‘There was no reason to expect differently for LDL-C.’ This was her own opinion based on nothing but air. This is where she is completely wrong and has no evidence to back this.
8- Conclusory Error (legal) : Dr Heienckes’ conclusory opinion that a skilled artisan would reasonably expect from Moriet al. that EPA would not raise LDL-C in the severe hypertriglyceridemia population. This was a firkin opinion. Heinecke extended those Mori studies to severe hypertriglyceridemia merely by agreeing with counsel that, in his opinion, a skilled artisan would not “have expected a different result in patients above 500,” and not, for example, by citing to prior art that supported such an expectation. The district court’s analysis was same i.e. conclusory—relying on off-point testimony from Dr. Toth that medications that reduced triglycerides in patients with triglycerides below 500 would likely also reduce triglycerides in patients with severe hypertriglyceridemia and then faulting Amarin for providing “no reason to expect differently for LDL-C” in the key finding copied from Defendants. OMG.
9- Decided without considering all of the evidence collectively including ‘long-felt unmet need’ (not a single person ever thought of combining Mori + Lovaza) and the ‘commercial success’ which could not have happened if the invention did not address an unmet need. If there was no unmet need or commercial success we would not be here fighting to save our awarded patents.
10- Legal error with no precedent: She improperly weighed these two very strong proven objective indicia against those the district court decided Amarin had not proven, as if Amarin’s alleged failures to prove praise or skepticism carried independent evidentiary weight. So much evidence was provided to support praise and skepticism but was also ignored. Weighing of these indica against each other resulted in a ‘weak’ case for Amarin. Hence the burden shifting.
11- Pure EPA’s TG reducing abilities was very well known prior art for 17 yrs and Mori (TGs <500) was known for 13 years but no one invented a treatment to reduce TGs and LDL-C in 500>=mg/DL patients – only hindsight would suggest it was obvious
12- Based on prior art with LDL-C going up for all severe TGs treatments, the reading of Mori by DC was opposite of what is should have been
13- DC referred to Kurabayashi and Hayashi – all for different TGs population – not related to Vascepa’s patient populations
14- In reprinting Table 3 of Kurabayashi’s Apo-B results, the district court’s opinion cut off the inter-group statistical comparison – it was a key indicator showing indifference in the 2 populations in Kura
15- DC completely ignore the skepticism being faced by Dr. Manku at time of conceiving the invention – a clear discounting of a major secondary consideration
16- Factual and Legal error: Another discounting of skepticism was ignoring the group of experts that Amarin hired to get their view on LDL-C reduction who all had opined and showed skepticism that LDLC would go down with 4gEPA in very high TG population stating they were unaware of Mori – she was wrong, they were all aware of Mori
17- There was praise when Marine results came out – but was also discounted by DC ‘more qualified and equivocal’
18- Assumption that Hayashi had at least one patient above 500mg/DL
19- Clear error in ruling that the PTO had not considered Kuraabayashi
20- Using Hayashi and Kurabayashi as references even though completely different population than for which the patents were awarded
21- The entire argument about the secondary consideration ‘unexpected benefits’ was discounted because of Mori ignoring all other prior art like Niacins, Fibrates and Lovaza which actually increased LDL-C.
--------------------------------------------------------
This is how i see the case based on the DC order and the various briefs. Now you decided if we win or lose.
--------------------------------------
Note: I have copied text from Briefs and DC order in some places
Kursziel US Dollar 15:
Amarin: Improving HCP Access Should Drive More Vascepa Sales, Says Analyst
TipRanks
•August 6, 2020
Keeping it simple, biotech Amarin (AMRN) has one product. This means the company can focus solely on the progress of its high triglycerides treatment, Vascepa.
However, the drawbacks of having only one item for sale are obvious; Being wholly dependent on its success is a risky business, especially when confronted with a force such as COVID-19. The pandemic put a serious dent in Amarin’s plans for Vascepa in Q2. Nevertheless, the biotech coped well with the disruption.
In the second quarter, Amarin reported revenue of $135 million, up by 34% year-over-year. However, the figure came in $14.16 million shy of the estimate. Vascepa sales reached $133.7 million, indicating a year-over-year increase of 33%. Amarin even managed to turn a profit with EPS of $0.01, beating the consensus estimate by $0.09.
The results are impressive considering the coronavirus headwinds. A 70% drop in patient visits to HCPs (health care personnel) during April was bound to have an effect on sales. Although access has improved since then, HCP visits in July remain roughly 35% below pre-COVID levels.
Following the FDA’s decision to expand Vascepa’s label last December, Amarin was gearing up for a nationwide sales push. The pandemic put a stop to the initiative. However, in June, Amarin picked up the campaign again. Access remains limited in metropolitan areas such as LA and New York, but Northland Securities analyst Carl Byrnes is buoyed by Vascepa’s trajectory.
Byrnes said, “VASCEPA TRx remain strong and has increased. Normalized prescriptions for VASCEPA increased by 44% and 47% in 2Q20 according to IQVIA and Symphony Health, respectively, totaling 2.15 million and 1.97 million in the 1H20 period. Amarin has also initiated DTC campaigns, including TV ads, focusing on the persistent CV risk reduction and the benefit of VASCEPA in reducing heart attack and stroke by 25% when added to a statin regimen. Our 2020 sales estimate of $610 million remains intact, which we believe will prove conservative.”
Accordingly, Byrnes rates Amarin an Outperform (i.e. Buy) along with a $15 price target. What does it mean for investors? Upside potential of a whopping 119%. (To watch Byrnes’ track record, click here)
As for the rest of the Street, opinions on Amarin are mixed, with the bulls in the lead. Based on 4 Buys and Holds each, the biotech has a Moderate Buy consensus rating. Over the next year, the analysts are forecasting hefty upside of 102%, considering the average price target clocks in at $14.17. (See Amarin stock-price forecast on TipRanks)
Amarin: Improving HCP Access Should Drive More Vascepa Sales, Says Analyst
TipRanks
•August 6, 2020
Keeping it simple, biotech Amarin (AMRN) has one product. This means the company can focus solely on the progress of its high triglycerides treatment, Vascepa.
However, the drawbacks of having only one item for sale are obvious; Being wholly dependent on its success is a risky business, especially when confronted with a force such as COVID-19. The pandemic put a serious dent in Amarin’s plans for Vascepa in Q2. Nevertheless, the biotech coped well with the disruption.
In the second quarter, Amarin reported revenue of $135 million, up by 34% year-over-year. However, the figure came in $14.16 million shy of the estimate. Vascepa sales reached $133.7 million, indicating a year-over-year increase of 33%. Amarin even managed to turn a profit with EPS of $0.01, beating the consensus estimate by $0.09.
The results are impressive considering the coronavirus headwinds. A 70% drop in patient visits to HCPs (health care personnel) during April was bound to have an effect on sales. Although access has improved since then, HCP visits in July remain roughly 35% below pre-COVID levels.
Following the FDA’s decision to expand Vascepa’s label last December, Amarin was gearing up for a nationwide sales push. The pandemic put a stop to the initiative. However, in June, Amarin picked up the campaign again. Access remains limited in metropolitan areas such as LA and New York, but Northland Securities analyst Carl Byrnes is buoyed by Vascepa’s trajectory.
Byrnes said, “VASCEPA TRx remain strong and has increased. Normalized prescriptions for VASCEPA increased by 44% and 47% in 2Q20 according to IQVIA and Symphony Health, respectively, totaling 2.15 million and 1.97 million in the 1H20 period. Amarin has also initiated DTC campaigns, including TV ads, focusing on the persistent CV risk reduction and the benefit of VASCEPA in reducing heart attack and stroke by 25% when added to a statin regimen. Our 2020 sales estimate of $610 million remains intact, which we believe will prove conservative.”
Accordingly, Byrnes rates Amarin an Outperform (i.e. Buy) along with a $15 price target. What does it mean for investors? Upside potential of a whopping 119%. (To watch Byrnes’ track record, click here)
As for the rest of the Street, opinions on Amarin are mixed, with the bulls in the lead. Based on 4 Buys and Holds each, the biotech has a Moderate Buy consensus rating. Over the next year, the analysts are forecasting hefty upside of 102%, considering the average price target clocks in at $14.17. (See Amarin stock-price forecast on TipRanks)
Amarin Reports Second Quarter 2020 Financial Results and Provides Update on Operations
August 4, 2020
Total Revenue Increased 34% in Second Quarter 2020 Compared to Second Quarter 2019 Despite COVID-19 Headwinds
Multiple Upcoming Milestones Regarding VASCEPA® Opportunity in United States and Internationally
Management to Host Conference Call Today at 7:30 a.m. ET
DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced
financial results for the three and six months ended June 30, 2020, and provided an update on company operations.
Key Amarin achievements since its last quarterly report include:
Maintaining favorable revenue progress amid COVID-19 challenges: Reported $135.3 million in net total revenue in Q2
2020, an increase of 34% over Q2 2019, resulting in H1 2020 net total revenue of $290.3 million, an increase of 67% over
H1 2019.
Progressing VASCEPA® development in Europe towards expected approval in early 2021: Continued to support review of
VASCEPA by the European Medicines Agency in anticipation of expected approval of VASCEPA for commercial sale in
Europe in early 2021 while advancing commercial plans for VASCEPA reimbursement and related commercial launch in
Europe.
Decision made on commercialization in Europe: As announced separately today, Amarin plans to maximize the blockbuster
potential of VASCEPA in Europe through its own dedicated European commercial organization. Amarin’s plan retains for
shareholders substantially all of the economic upside to participate in the multi-billion-dollar cardiovascular risk reduction
market in Europe while preserving strategic optionality and enabling later partnering of VASCEPA in smaller countries in
Europe. To help execute on this European strategy Amarin appointed industry veteran, Mr. Karim Mikhail, as senior vice
president, commercial head Europe. As detailed in today’s separate press release, Mr. Mikhail has extensive
cardiovascular and international experience and a track-record of success to rely on in building multi-billion-dollar brands.
Results of VASCEPA clinical trial in China nearing reporting: VASCEPA clinical trial results on-track to be reported by
Amarin’s partner in China before end of 2020.
Patent appeal progressing: Substantive briefing completed with two supporting amicus briefs submitted and September 2,
2020 hearing date scheduled in Amarin’s appeal to the U.S. Court of Appeals for the Federal Circuit of the March 30, 2020
adverse district court decision on patents covering the first FDA-approved indication for VASCEPA.
Strong cash and investments balance: As of June 30, 2020, Amarin reported total cash and investments of $611.3 million
with its only debt remaining to be paid being a maximum of $23.0 million on its royalty-like instrument
August 4, 2020
Total Revenue Increased 34% in Second Quarter 2020 Compared to Second Quarter 2019 Despite COVID-19 Headwinds
Multiple Upcoming Milestones Regarding VASCEPA® Opportunity in United States and Internationally
Management to Host Conference Call Today at 7:30 a.m. ET
DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced
financial results for the three and six months ended June 30, 2020, and provided an update on company operations.
Key Amarin achievements since its last quarterly report include:
Maintaining favorable revenue progress amid COVID-19 challenges: Reported $135.3 million in net total revenue in Q2
2020, an increase of 34% over Q2 2019, resulting in H1 2020 net total revenue of $290.3 million, an increase of 67% over
H1 2019.
Progressing VASCEPA® development in Europe towards expected approval in early 2021: Continued to support review of
VASCEPA by the European Medicines Agency in anticipation of expected approval of VASCEPA for commercial sale in
Europe in early 2021 while advancing commercial plans for VASCEPA reimbursement and related commercial launch in
Europe.
Decision made on commercialization in Europe: As announced separately today, Amarin plans to maximize the blockbuster
potential of VASCEPA in Europe through its own dedicated European commercial organization. Amarin’s plan retains for
shareholders substantially all of the economic upside to participate in the multi-billion-dollar cardiovascular risk reduction
market in Europe while preserving strategic optionality and enabling later partnering of VASCEPA in smaller countries in
Europe. To help execute on this European strategy Amarin appointed industry veteran, Mr. Karim Mikhail, as senior vice
president, commercial head Europe. As detailed in today’s separate press release, Mr. Mikhail has extensive
cardiovascular and international experience and a track-record of success to rely on in building multi-billion-dollar brands.
Results of VASCEPA clinical trial in China nearing reporting: VASCEPA clinical trial results on-track to be reported by
Amarin’s partner in China before end of 2020.
Patent appeal progressing: Substantive briefing completed with two supporting amicus briefs submitted and September 2,
2020 hearing date scheduled in Amarin’s appeal to the U.S. Court of Appeals for the Federal Circuit of the March 30, 2020
adverse district court decision on patents covering the first FDA-approved indication for VASCEPA.
Strong cash and investments balance: As of June 30, 2020, Amarin reported total cash and investments of $611.3 million
with its only debt remaining to be paid being a maximum of $23.0 million on its royalty-like instrument
Gute Zusammenfassunf für unseren Gerichtsfall, bei dem Mr. Singer, the best attorney money can buy, hoffentlich Schlitzauge Mirinda Du, zeigt wo der Hammer hängt:
Why an Appeals Court May Hold Key to Amarin Stock Future
Carla Baranauckas
3 months ago
Amarin Corp. PLC (NASDAQ: AMRN) plans to mount a vigorous and speedy appeal of a U.S. District Court ruling that blocked its patents on the medication Vascepa, the company’s chief executive says.
In a conference call last week about first-quarter earnings, president and CEO John Thero said Amarin had filed a notice of appeal. It will submit legal briefs next week.
Vascepa is a synthetic formulation of fish oil. It is prescribed to help reduce the risk of heart attack and stroke in patients with cardiovascular disease or diabetes. When used in conjunction with a low-fat, low-cholesterol diet, it can help reduce high triglyceride levels, Amarin says.
Amarin holds six patents on Vascepa, which delivers high doses of omega-3 fatty acids. The company has put most of its muscle behind this one drug and it appeared to have limited competition. Acasti Pharma Inc. (NASDAQ: ACST) and AstraZeneca PLC (NYSE: AZN) invested millions of dollars trying to develop drugs that could take market share from Amarin. Neither was successful.
‘Invalid as Obvious’
Generic competitors Dr. Reddy’s Laboratories Inc. (NYSE: RDY) and Hikma Pharmaceuticals notified the Food and Drug Administration of their intent to develop generic alternatives. Amarin then filed suit in U.S. District Court in Nevada claiming patent infringement.
Chief Judge Miranda Du ruled on March 30 that the drugmakers would be infringing on Amarin’s claims in its patents if they brought generic drugs to market but that those claims were “invalid as obvious” and should not have been granted by the U.S. Patent Office.
“We are convinced that the invention of Vascepa was not obvious,” Thero insisted on April 30. He said that Amarin’s competitors were benefiting from hindsight.
“It remains astonishing that the invention of Vascepa can now be seen as obvious by everyone,” Thero said. “During our more than 10 years of developing and testing Vascepa, this was not obvious to our competitors or others in the industry. I appreciate that the elegance of our solution seems obvious after the fact. However, this is often due to the nature of innovation.”
Amarin and the defendants have agreed to expedite the appeal, Thero said. Arguments may be heard as early as the first week of September or October.
The company is bolstering its legal team by bringing in high-power attorney Jonathan Singer of Fish & Richardson as lead counsel. Singer heads the life sciences practice for the law firm, which is a leader in patent infringement litigation.
He successfully argued an appeal for Cephalon Inc. to protect its patent on Amrix, a muscle relaxant. A lower court had deemed it “obvious.” Cephalon is now part of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA).
Potential Major Impact for Drug Industry
Thero said the Vascepa case had the potential to have a major impact on the pharmaceutical industry.
If the district court’s decision in the appeal process is not overturned, undermining the local Vascepa patent will prevent companies from taking the risk of developing future innovative therapies to meet unmet medical needs.
The development of new drugs is expensive and takes many years. Developers must be able to rely on properly granted patents from the United States Patent Office. A precedent in which patents are revoked in circumstances such as ours will keep developers from taking such risks for fear that they will not be able to cover their costs or benefit from their risks.
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Amarin has made a significant investment in Vascepa and has doubled its sales force to 800, Thero said. It is also investigating whether the drug can reduce the cardiovascular risks associated with COVID-19.
The litigation has been a drag on Amarin’s share price. The stock fell to a 52-week low of $3.95 on March 31, the day after the district court ruling. It’s 52-week high had been near $25 anticipating FDA approval of Vascepa, which came in December. In today’s trading, Amarin was up about 3% at midday at $7.76.
Why an Appeals Court May Hold Key to Amarin Stock Future
Carla Baranauckas
3 months ago
Amarin Corp. PLC (NASDAQ: AMRN) plans to mount a vigorous and speedy appeal of a U.S. District Court ruling that blocked its patents on the medication Vascepa, the company’s chief executive says.
In a conference call last week about first-quarter earnings, president and CEO John Thero said Amarin had filed a notice of appeal. It will submit legal briefs next week.
Vascepa is a synthetic formulation of fish oil. It is prescribed to help reduce the risk of heart attack and stroke in patients with cardiovascular disease or diabetes. When used in conjunction with a low-fat, low-cholesterol diet, it can help reduce high triglyceride levels, Amarin says.
Amarin holds six patents on Vascepa, which delivers high doses of omega-3 fatty acids. The company has put most of its muscle behind this one drug and it appeared to have limited competition. Acasti Pharma Inc. (NASDAQ: ACST) and AstraZeneca PLC (NYSE: AZN) invested millions of dollars trying to develop drugs that could take market share from Amarin. Neither was successful.
‘Invalid as Obvious’
Generic competitors Dr. Reddy’s Laboratories Inc. (NYSE: RDY) and Hikma Pharmaceuticals notified the Food and Drug Administration of their intent to develop generic alternatives. Amarin then filed suit in U.S. District Court in Nevada claiming patent infringement.
Chief Judge Miranda Du ruled on March 30 that the drugmakers would be infringing on Amarin’s claims in its patents if they brought generic drugs to market but that those claims were “invalid as obvious” and should not have been granted by the U.S. Patent Office.
“We are convinced that the invention of Vascepa was not obvious,” Thero insisted on April 30. He said that Amarin’s competitors were benefiting from hindsight.
“It remains astonishing that the invention of Vascepa can now be seen as obvious by everyone,” Thero said. “During our more than 10 years of developing and testing Vascepa, this was not obvious to our competitors or others in the industry. I appreciate that the elegance of our solution seems obvious after the fact. However, this is often due to the nature of innovation.”
Amarin and the defendants have agreed to expedite the appeal, Thero said. Arguments may be heard as early as the first week of September or October.
The company is bolstering its legal team by bringing in high-power attorney Jonathan Singer of Fish & Richardson as lead counsel. Singer heads the life sciences practice for the law firm, which is a leader in patent infringement litigation.
He successfully argued an appeal for Cephalon Inc. to protect its patent on Amrix, a muscle relaxant. A lower court had deemed it “obvious.” Cephalon is now part of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA).
Potential Major Impact for Drug Industry
Thero said the Vascepa case had the potential to have a major impact on the pharmaceutical industry.
If the district court’s decision in the appeal process is not overturned, undermining the local Vascepa patent will prevent companies from taking the risk of developing future innovative therapies to meet unmet medical needs.
The development of new drugs is expensive and takes many years. Developers must be able to rely on properly granted patents from the United States Patent Office. A precedent in which patents are revoked in circumstances such as ours will keep developers from taking such risks for fear that they will not be able to cover their costs or benefit from their risks.
ALSO READ: Why Partial Reopenings Are Set to Boost Disney Stock
Amarin has made a significant investment in Vascepa and has doubled its sales force to 800, Thero said. It is also investigating whether the drug can reduce the cardiovascular risks associated with COVID-19.
The litigation has been a drag on Amarin’s share price. The stock fell to a 52-week low of $3.95 on March 31, the day after the district court ruling. It’s 52-week high had been near $25 anticipating FDA approval of Vascepa, which came in December. In today’s trading, Amarin was up about 3% at midday at $7.76.
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Where can I find information on the results of the EVAPORATE trial being presented at the European Society of Cardiology (ESC) Congress 2020- The Digital Experience on Saturday, August 29, 2020? Final results of the EVAPORATE study are not yet public but have been selected by the European Society of Cardiology (ESC) as a late breaker scientific presentation at the ESC Congress 2020 - The Digital Experience on August 29, 2020 is preliminarily scheduled from 11:10 – 11:40 am Central European Summer Time (CEST), 5:10-5:40 am Eastern Standard Time (EST). Registration for the ESC conference is free.To listen to this presentation please visit the Late-Breaking Science in Lipids at https://programme.escardio.org/ESC2020/Channels-by-Topic?s=$channels[0]=1871&_ga=2.43661548.879190233.1595957224-627377798.1563819807Amarin cannot provide any additional information on the results or the substance of the schedulepresentation per ESC embargo policies.EVAPORATE is a randomized, double-blind trial of VASCEPA® (icosapent ethyl) 4 g/day compared to placebo in which plaque in patients’ arteries was evaluated by coronary computed tomographic angiography (CCTA) scans. Patients underwent a scan at the start of the study, had an interim scan at 9 months, halfway through the study, and were followed for 9 more months with a final CCTA scan at the end of the study. The trial design and interim results were published; these results and other information regarding the trial can be found via this link: publication. More information on the EVAPORATE trial can also be found at https://clinicaltrials.gov/. Dated: July 30, 2020 Notice to Investors Regarding Forward-Looking Statements: Recipients of this message who are investors or potential investors in Amarin Corporation plc. (Nasdaq: AMRN) are reminded that any forward-looking statements included in this message is subject to risks, uncertainties and other factors which may cause our actual results to materially differ from any future results expressed or implied by such forward-looking statements. Investors are cautioned to not place undue reliance on such statements and to review the discussions of forward-looking statements and Risk Factors in our annual report as filed with the U.S. Securities and Exchange Commission.
Where can I find information on the results of the EVAPORATE trial being presented at the European Society of Cardiology (ESC) Congress 2020- The Digital Experience on Saturday, August 29, 2020? Final results of the EVAPORATE study are not yet public but have been selected by the European Society of Cardiology (ESC) as a late breaker scientific presentation at the ESC Congress 2020 - The Digital Experience on August 29, 2020 is preliminarily scheduled from 11:10 – 11:40 am Central European Summer Time (CEST), 5:10-5:40 am Eastern Standard Time (EST). Registration for the ESC conference is free.To listen to this presentation please visit the Late-Breaking Science in Lipids at https://programme.escardio.org/ESC2020/Channels-by-Topic?s=$channels[0]=1871&_ga=2.43661548.879190233.1595957224-627377798.1563819807Amarin cannot provide any additional information on the results or the substance of the schedulepresentation per ESC embargo policies.EVAPORATE is a randomized, double-blind trial of VASCEPA® (icosapent ethyl) 4 g/day compared to placebo in which plaque in patients’ arteries was evaluated by coronary computed tomographic angiography (CCTA) scans. Patients underwent a scan at the start of the study, had an interim scan at 9 months, halfway through the study, and were followed for 9 more months with a final CCTA scan at the end of the study. The trial design and interim results were published; these results and other information regarding the trial can be found via this link: publication. More information on the EVAPORATE trial can also be found at https://clinicaltrials.gov/. Dated: July 30, 2020 Notice to Investors Regarding Forward-Looking Statements: Recipients of this message who are investors or potential investors in Amarin Corporation plc. (Nasdaq: AMRN) are reminded that any forward-looking statements included in this message is subject to risks, uncertainties and other factors which may cause our actual results to materially differ from any future results expressed or implied by such forward-looking statements. Investors are cautioned to not place undue reliance on such statements and to review the discussions of forward-looking statements and Risk Factors in our annual report as filed with the U.S. Securities and Exchange Commission.
Antwort auf Beitrag Nr.: 64.582.965 von Magnetfeldfredy am 29.07.20 15:50:04Ich glaub einfach, dass eine gewisse Unsicherheit bezüglich des Ansatzes in Europa herrscht: GIA oder partnership könnten bei Verlust des US-Patents den Wert für und Aktionäre stark vermindern...
Entscheidung war ja für Q3 angekündigt... Ich hoffe aber, dass sie sich bis zur Appeal-Entscheidung Zeit lassen: bei einer Niederlage macht es keinen Sinn Europa zu verpartnern, nur ein Verkauf...
Entscheidung war ja für Q3 angekündigt... Ich hoffe aber, dass sie sich bis zur Appeal-Entscheidung Zeit lassen: bei einer Niederlage macht es keinen Sinn Europa zu verpartnern, nur ein Verkauf...
Hier wird von Wallstreet Gangster manipuliert was das Zeug hält, bei Appeal win US Dollar 20!
bei Verlust aber mit EU-Zulassung US Dollar 10!
bei Verlust aber mit EU-Zulassung US Dollar 10!
Sehr schönes Chance-Risiko-Verhältnis hier auf diesem Level... denke, dass selbst bei Scheitern im appeal case und dem endgültigen Verlust des US-Marktes die Rechte für Europa und Rest der Welt einem potentiellen Käufer in Europa wie Novartis oder AstraZeneca sicher min. $12 wert sein werden...
Antwort auf Beitrag Nr.: 64.561.626 von dpdwvz am 27.07.20 21:18:40Wären gut für Dein Hirn, wenn Du eins hättest!🤣
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