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I do not have any idea why anybody give any attention to Case 3:20-cv-00421 (Amarin vs Hikma 500 mg case) ... It is going as I told you: #286202 (before any info from the IR / Co.).
Best,
G
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3.) Q2 10-Q (?)
Best,
G
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(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
August
- Week 32: Q2 2020 (10-Q and CC)
September
- September 2, 10:00 a.m: Oral argument (CAFC)
- September 14-17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- Decision about EU approach (partnership or GIA or hybrid)
October
- October 5: Preliminary Q3 (TBC)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: EU Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)
December
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result
January
- Order (CAFC) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
April
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)
Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company:
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) *clock restart
d.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.:
(i) “shortest” EMA timetable in case of LoOI
- September 14-17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November 9-12: Day 210 Opinion by EMA / recommendation of approval
- January 15: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)
(ii) “longest” EMA timetable
- September 14-17: Day 180 LoOI
- December 7-10: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI,
- March 23*: Response to Day 180 LoOI, September 17
- April 19-22: Day 210 Opinion by EMA / recommendation of approval
- June 28: Commission Decision / formal approval (based on Day 210 Opinion by EMA, April 22)
20-1723 Appeal (& 216-cv-02525-MMD-NJK)
CalMustang: Please replace my previous post, sticky this one. Thx.
(Relevant) UPDATE: below
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
CAFC; 20-1723 Appeal Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
33: ORDER]
34: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
35: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
36: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
37: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
38: ENTRY OF APPEARANCE / Aimed Alliance / Amicus curiae
39: BRIEF OF THE BIOTECHNOLOGY INNOVATION ORGANIZATION AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY
40: CERTIFICATE OF INTEREST / Aimed Alliance
43: BRIEF OF AIMED ALLIANCE AS AMICUS CURIAE IN SUPPORT OF APPELLANTS
44: NOTICE OF NON-COMPLIANCE (AIMED ALLIANCE)
47: CERTIFICATE OF INTEREST (Reddy)
49: BRIEF FOR DEFENDANTS-APPELLEES
50: APPELLANTS’ REPLY BRIEF
51: JOINT CERTIFICATE OF COMPLIANCE WITH FED. CIR. R. 33(a)
52: PLAINTIFFS-APPELLANTS’ STATEMENT OF COMPLIANCE WITH FEDERAL CIRCUIT RULES 11(d) AND 30(h)(1)(B)
53: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Hikma)
54: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Reddy)
55-1: NON-CONFIDENTIAL JOINT APPENDIX VOLUME I (APPX1-APPX1512)
55-2: NON-CONFIDENTIAL JOINT APPENDIX VOLUME II (APPX1567-APPX50688)
55-3: NON-CONFIDENTIAL JOINT APPENDIX VOLUME III (APPX50689-APPX111621)
57: ORDER
58: NOTICE TO ADVISE OF SCHEDULING CONFLICTS OF ARGUING COUNSEL
60: ENTRY OF APPEARANCE (AMRN)
61: ENTRY OF APPEARANCE (AMRN)
63: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (AMRN)
69: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (Appellee)
70: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (Appellee)
71: NOTICE OF TELEPHONIC ORAL ARGUMENT (September 2, 2020 at 10:00 a.m. )
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
20-1723 Appeal (& 216-cv-02525-MMD-NJK)
CalMustang: Please replace my previous post, sticky this one. Thx.
(Relevant) UPDATE: below
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
CAFC; 20-1723 Appeal Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
33: ORDER]
34: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
35: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
36: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
37: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
38: ENTRY OF APPEARANCE / Aimed Alliance / Amicus curiae
39: BRIEF OF THE BIOTECHNOLOGY INNOVATION ORGANIZATION AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY
40: CERTIFICATE OF INTEREST / Aimed Alliance
43: BRIEF OF AIMED ALLIANCE AS AMICUS CURIAE IN SUPPORT OF APPELLANTS
44: NOTICE OF NON-COMPLIANCE (AIMED ALLIANCE)
47: CERTIFICATE OF INTEREST (Reddy)
49: BRIEF FOR DEFENDANTS-APPELLEES
50: APPELLANTS’ REPLY BRIEF
51: JOINT CERTIFICATE OF COMPLIANCE WITH FED. CIR. R. 33(a)
52: PLAINTIFFS-APPELLANTS’ STATEMENT OF COMPLIANCE WITH FEDERAL CIRCUIT RULES 11(d) AND 30(h)(1)(B)
53: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Hikma)
54: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Reddy)
55-1: NON-CONFIDENTIAL JOINT APPENDIX VOLUME I (APPX1-APPX1512)
55-2: NON-CONFIDENTIAL JOINT APPENDIX VOLUME II (APPX1567-APPX50688)
55-3: NON-CONFIDENTIAL JOINT APPENDIX VOLUME III (APPX50689-APPX111621)
57: ORDER
58: NOTICE TO ADVISE OF SCHEDULING CONFLICTS OF ARGUING COUNSEL
60: ENTRY OF APPEARANCE (AMRN)
61: ENTRY OF APPEARANCE (AMRN)
63: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (AMRN)
69: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (Appellee)
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
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(Relevant) Events:
Dancing in the dark: If you think, please replace my previous post (sticky) with this one. Thx.
August
- Week 32: Q2 2020 (10-Q and CC)
September
- Week 36 (August 31- September 4): Oral argument (CAFC) … September is the earliest but could be later
- September 14-17: Day 180 Opinion / recommendation of approval by EMA (if no more issue) or List of Outstanding Issues (LoOI)
- Decision about EU approach (partnership or GIA or hybrid)
October
- October 5: Preliminary Q3 (TBC)
November
- Week 45: Q3 2020 (10-Q and CC)
- November 23: EU Commission Decision / formal approval (based on Day 180 Opinion by EMA, September 17)
December
- December 23*: Response to Day 180 LoOI, September 17 (Amarin will have three months to answer the LoOI.)
- Chinese MARINE trial completion / result
January
- Order (CAFC) (average time is 4 months after oral argument)
- January 28: Day 210 Opinion by EMA / recommendation of approval
April
- April 5: EU Commission Decision / formal approval (based on Day 210 Opinion by EMA, January 28)
Note:
a.) dates are (i) all “on or before” (ii) lot of them TBA or TBC
b.) EMA approval calculated by the “longest” (3-months reply) timeframe due to changed communication by the company:
“Our expectation is that VASCEPA will be approved near the end of this year for launch in Europe” vs. “recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year” (latest).
Amarin “speed” (reply) will depends (IMO) on the appeal procedure: expedited or normal
c.) *clock restart
d.) if something will be sometime during the relevant quarter it is listed for the last month of the quarter
Best,
G
ps.:
(i) “shortest” EMA timetable in case of LoOI
- September 14-17: Day 180 List of Outstanding Issues (LoOI)
- October 13*: Response to Day 180 LoOI, September 17
- November 9-12: Day 210 Opinion by EMA / recommendation of approval
- January 15: Commission Decision / formal approval (based on Day 210 Opinion by EMA, November 12)
(ii) “longest” EMA timetable
- September 14-17: Day 180 LoOI
- December 7-10: CHMP meeting, Request extension of time (+3-months) for response to Day 180 LoOI,
- March 23*: Response to Day 180 LoOI, September 17
- April 19-22: Day 210 Opinion by EMA / recommendation of approval
- June 28: Commission Decision / formal approval (based on Day 210 Opinion by EMA, April 22)
a-
Nothing special. Response to Day 120 letter was received by the EMA, the clock running again (since July 16).
Icosapent will be on the September agenda (this phase takes 60 days) as List of Outstanding Question (LoOI) or Opinion (recommendation for approval). In case of the later: approval late November.
see: sticky above
Best,
G
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r-
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20-1723 Appeal (& 216-cv-02525-MMD-NJK)
CalMustang: Please replace my previous post, sticky this one. Thx.
(Relevant) UPDATE: below
Appellant: Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited (AMRN)
Appellee:
- West-Ward Pharmaceuticals International Limited (n/k/a Hikma Pharmaceuticals International Limited) and Hikma Pharmaceuticals USA Inc. (Hikma)
-Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (Reddy)
CAFC; 20-1723 Appeal Available documents #:
4: DOCKETING STATEMENT (AMRN)
8: UNOPPOSED MOTION TO EXPEDITE BRIEFING AND ORAL ARGUMENT
13: DOCKETING STATEMENT (Hikma)
23: DOCKETING STATEMENT (Reddy)
30: APPELLANTS’ OPENING BRIEF
31: NOTICE OF CORRECTION OF APPELLANTS’ OPENING BRIEF
32: APPELLANTS’ CORRECTED OPENING BRIEF
33: ORDER]
34: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
35: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
36: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
37: ENTRY OF APPEARANCE / BIOTECHNOLOGY INNOVATION ORGANIZATION / Amicus curiae
38: ENTRY OF APPEARANCE / Aimed Alliance / Amicus curiae
39: BRIEF OF THE BIOTECHNOLOGY INNOVATION ORGANIZATION AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY
40: CERTIFICATE OF INTEREST / Aimed Alliance
43: BRIEF OF AIMED ALLIANCE AS AMICUS CURIAE IN SUPPORT OF APPELLANTS
44: NOTICE OF NON-COMPLIANCE (AIMED ALLIANCE)
47: CERTIFICATE OF INTEREST (Reddy)
49: BRIEF FOR DEFENDANTS-APPELLEES
50: APPELLANTS’ REPLY BRIEF
51: JOINT CERTIFICATE OF COMPLIANCE WITH FED. CIR. R. 33(a)
52: PLAINTIFFS-APPELLANTS’ STATEMENT OF COMPLIANCE WITH FEDERAL CIRCUIT RULES 11(d) AND 30(h)(1)(B)
53: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Hikma)
54: CERTIFICATE OF COMPLIANCE WITH CONFIDENTIALITY RULES (Reddy)
55-1: NON-CONFIDENTIAL JOINT APPENDIX VOLUME I (APPX1-APPX1512)
55-2: NON-CONFIDENTIAL JOINT APPENDIX VOLUME II (APPX1567-APPX50688)
55-3: NON-CONFIDENTIAL JOINT APPENDIX VOLUME III (APPX50689-APPX111621)
57: ORDER
58: NOTICE TO ADVISE OF SCHEDULING CONFLICTS OF ARGUING COUNSEL
60: ENTRY OF APPEARANCE (AMRN)
61: ENTRY OF APPEARANCE (AMRN)
63: RESPONSE TO NOTICE TO ADVISE OF SCHEDULING CONFLICTS (AMRN)
DC; 216-cv-02525-MMD-NJK Available documents
Best,
G
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New poll (new complaint: Case 3:20-cv-00421; Document 1; Filed 07/13/20; 27 & 29)
1.) "Nor does an ANDA applicant establish any new conditions of use for the proposed drug product. Instead, an ANDA applicant may seek approval only for conditions of use that previously have been approved in connection with an approved NDA. 21 U.S.C. § 355(j)(2)(A)(i)."
It is from:
A.) Case 3:20-cv-00421 Document 1 Filed 07/13/20 (27)
B.) Case 2:16-cv-02525 Document 1 Filed 10/31/16 (22)
C.) From both (the two documents are identical regarding this)
2.) "VASCEPA® is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. A true, correct, and complete copy of the Prescribing Information for VASCEPA® approved in NDA No. 202057 is attached as Exhibit A."
(Case 2:16-cv-02525 Document 1 Filed 10/31/16 [24])
vs
"VASCEPA® is currently indicated, inter alia, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. VASCEPA® is also indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. A true, correct, and complete copy of the FDA-approved Prescribing Information for VASCEPA®, covering both the 1 g and 0.5 g strengths, is attached as Exhibit A."
(Case 3:20-cv-00421 Document 1 Filed 07/13/20 [29])
The difference has any significance, it is relevant:
A.) No. It is a description of Vacepa indication(s) only at the time of the document
B.) Yes ... if you live in Wonderland ...
Best,
G
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C'on man...
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Difference in "Nature of the Action".
Case No.: 2:16-cv-02525 (CAFC 20-1723)