r-

and"more likely" it was rescheduledthese.

Best,
G

D-

Thx.

Best,
G

330566

Best,
G

ps.: Unfortunately I uploaded a new file (All in 1 ... inc. Doc 407) instead of replace the previous one ... sorry.

D-

Please replace the "expired" sticky [#298827, (Relevant) Events] with the #330566, MOTION TO INTERVENE & MOTION TO VACATE JUDGMENT.

Best,
G

MOTION TO INTERVENE & MOTION TO VACATE JUDGMENT (18 Documents, see below) UPDATED: SEE BELOW

MOTION TO INTERVENE & MOTION TO VACATE JUDGMENT (All in 1; Updated version)

401: INTERVENOR EPADI II’S MOTION TO INTERVENE PURSUANT TO FED. R. CIV. P. 24
ORAL ARGUMENT REQUESTED TELEPHONICALLY OR VIA ZOOM

401-1: INDEX OF EXHIBITS

401-2: Exhibit A: Email from Avi Silberberg, Esq. to Amarin’s CEO, John Thero, requesting that Amarin seek Rule 60 relief, dated November 9, 2020 (Sender and Reciept’s email addresses have been redacted)

401-3: Exhibit B: Yahoo Finance screenshot showing the collapse of Amarin’s stock price in the immediate aftermath of the Judgment, dated March 31, 2020

401-4: Exhibit C: True Excerpts from the Amicus Brief filed by the Aimed Alliance in support of Amarin’s Petition for Certiorari to the United States Supreme Court, dated March 4,2021

401-5: DECLARATION OF MICHAEL S. KASANOFF IN SUPPORT OF EPADI II’S MOTION TO INZERVENE PURSUANT TO FED. R. CIV. P. 24

401-6: CERTIFICATE OF SERVICE

405: INTERVENOR EPADI II’S MOTION TO VACATE JUDGMENT PURSUANT TO FED. R. CIV. P.
ORAL ARGUMENT REQUESTED TELEPHONICALLY OR VIA ZOOM

405-1: INDEX OF EXHIBITS

405-2: Exhibit A: Expert Report prepared by Dr. Gavin E. Jarvis, dated March 12, 2021

405-3: Exhibit B: Dr. Jarvis’s Curriculum Vitae

405-4: Exhibit C: Curfman, G., Bhatt, D.L. & Pencina, M., Federal Judge Invalidates Icosapent Ethyl Patents But Based on a Common Statistical Mistake, Nat. Biotehcnol 38, 939-941(2020)

405-5: Exhibit D: Abstract of the Paper supporting Curfman, G., Bhatt, D.L. & Pencina, M., Federal Judge Invalidates Icosapent Ethyl Patents But Based on a Common Statistical Mistake, Nat. Biotehcnol 38, 939-941(2020)

405-6: Exhibit E: Paper supporting Curfman, G., Bhatt, D.L. & Pencina, M., Federal Judge Invalidates Icosapent Ethyl Patents But Based on a Common Statistical Mistake, Nat. Biotehcnol 38, 939-941(2020)

405-7: Exhibit F: Kurabayashi et. al., Eicosapentaenoic acid effect on hyperlipedema in menopausal Japanese women. Obster Gynecol, 2000;96(4):521-8

405-8: DECLARATION OF MICHAEL S. KASANOFF IN SUPPORT OF EPADI II’S MOTION TO VACATE JUDGMENT PURSUANT TO FED. R. CIV. P. 24

405-9: CERTIFICATE OF SERVICE

407: VERIFIED PETITION FOR PERMISSION TO PRACTICE IN THIS CASE ONLY BY ATTORNEY NOT ADMITTED TO THE BAR OF THIS COURT AND DESIGNATION OF LOCAL COUNSEL

Best,
G

l-

Send me the docs and I will post the link (tom.).

Best,
G

r-

I did not read the 5 docs but IIRC HN said: gV is in a lower tier because is is cheaper ... (Please note: HN could not use Vascepa Card ...)

Best,
G

i-

(i) all off-label use ... which could be substantial but that does not matter because on-label use is relevant also for contributory infringement determination.

indicatian A: not labeled, not patented ... does not matter
indicatian B: labeled, not patented ... it should be substantial to avoid contributory infringement of indicatian C
indicatian C: not labeled (for generic), but patented ... could be a subject of inducement claim.

MARINE indication fits to this. Meanwhile the MARINE volume is less than 10% of the total, this 10% is not any of the above.

Best,
G

r-

It is not about this ... it is about "why?"

Best,
G

i-

Yes, definitely.
a.) Agree, raf said differently ... as volume is necessary ("The only positive from this is that if gV were a tiny fracture of V sales, Amarin couldn't claim infringement in court")

b.) If "substantial non-infringing use" does not exist ... otherwise no infringement (any type top of direct)

Best,
G

r-

Yes, I disagree. Volume / market% does not matter in any form of infringement (especially in induced). The substantial, non-infringing use matters in case of contributory infringement but it is not determined based on volume/market share%.

a.) A generic has a tiny (<1%) market share but it has "some language / data" on the label and actively, loudly promote AB rating and everything else ... In this case, do you agree with yourself? (with a quote from you above)

b.) A generic has a 50% market share but it does not have anything on the label, did not promote AB rating or anything in any form ... What is the basis of the infringement claim?

Best,
G

K-

Did you sell all? (As adviced).

Best,
G

r-

??? I said: quantity does not matter. 1 script / year could be a basis or 1.000.000 / week could not be ... induced infringement does not depend on volume.

Best,
G

Outbidding 14 others and then themselves: How Amgen spent $2 billion on a biotech that had been on the brink

Jason Mast
Editor

In the summer of 2020, you could get a share of Five Prime Therapeutics for less than a latte, but the company’s leadership knew that could soon change.

Five Prime was nearing a readout on their Phase II trial for gastric cancer. If it proved successful, it could return them to the perch they had lost in 2017, when a Bristol Myers Squibb-partnered drug flopped and tanked their shares. So they met with the board twice in June and twice in August to decide what would come next.

The company’s fate hung in the air. There was also the strong possibility the new trial could fail like the previous one, and the stock entered black coffee price territory. And their SEC filings indicated that while they were not running out of money, they were not swimming in it either.

Word came on November 8: The trial was a success. Patients in control saw their tumors progress 2.1 months sooner than patients on the drug arm. The drug will still have to prove itself in Phase III, but the readout has already proved a lucrative swing for Five Prime and its shareholders, after Amgen put down $2 billion this month to purchase a company that months prior had been staring at an uncertain future.

Despite press release quotes about “tremendous complementarity,” the Amgen-Five Prime buyout didn’t come out of a deep ongoing relationship between the two biotechs or Amgen’s unique ability to commercialize the drug. The two companies had spoken about a collaboration as far back as 2019, but after the Phase II news came in, Five Prime wasn’t particularly picky: Starting on Nov. 23, they gave presentations to 15 different potential partners in less than a month. The board then sent letters soliciting bids to 13 of them.

Of those, five different companies emerged as leading contenders. Amgen wasn’t the first to try to acquire the biotech, instead, another company, Party C, submitted a bid on Jan. 27 to acquire Five Prime for $25 per share, or around $1.2 billion. Amgen put in their first offer to collaborate two days later.

The board reviewed the two bids, along with partnership proposals from two other companies,  and decided to reach out to everyone who might be interested — including those who had already dropped out of the process — to say that they had received a buyout offer and were looking for other bids.

Amgen, Party C and a third Party D emerged as the leading contenders, getting ushered through presentations and data rooms. Party D, though, dropped out on February 18, the same day Amgen sent an offer to buy out the company at $32 per share. Party C called the next day, saying they could go in the high $20s or low $30 but wouldn’t be submitting a formal bid.

Five Prime told them a few hours later that they’d need to put down more. They told Amgen the race was competitive and to bring their final offer.

That offer came on March 1, at $38 per share. Amgen CEO Bob Bradway would herald the deal, but he had bid against himself. Party C had called the day before to say they were dropping out, unable to offer more than high $20s, low $30s.

r-

No idea (I saw yours and replied), nevermind.

Do you (or anybody) remember who is the oculist / ophthalmologist on the board? (I could not recall ... )

TIA,
G

r-

Pls check your spam folder.

Best,
G

G-

Novartis is not the only one who is on the wrong end of the muzzle ...

It is a a new risk for all approvals (top of the "usual").
- It is not for ex-US facilities only
- FDA has a backlog of 1,000 site inspection (SI) ... just from 2020
- They had a 6-month period in 2020, when they did 3 (again three) ex-US SI and the US was minimal also.
- I am not privy to the details, but a cooperation agreement exists between the FDA and the EMA ... the EC approved Leqvio in Dec 2020. I assume the EMA inspected the facility.
- Contrary the "lucky" ones (below), the application should be filed again .. and in best case scenario it will get a Class 1 (2 months) review, but Class 2 (6 months) or standard (10 months) are more likely.

The "lucky" ones have a delayed PDUFA ... without new date. They do not have to resubmit, could be approved by "any" day.

Do not be surprised if some drug shortage will exist soon, since the FDA does not do the necessary reinspection (every/within 5 year), so the y stop a lot of transport (from not (re)inspected) facility) at the border.

Best,
G

H- (& Number sleven)

N- saw it correctly: gV is not covered as of 03/01/2021 by Aetna.

It is a good thing ... however there is a "difference between:

a.) gV was not covered anytime in 2021
and
b.) gV was covered as of 01/01/2021 (as N- said/claimed*/**) but was dropped recently

* I could not find Aetna Standard formulary as of 1/1/2021 to check it. I found other Aetna formulary that covered gV as of 01/01/2021 ... but it covers as of 03/01/2021 also.

** Number sleven

Please link / upload the document as of 1/1/2021 for Aetna Standard Plan

Best,
G

r-

LOL ... C'mon man ... You said - - - - -<> (Emphasis mine)

Best,
G

N-

Yep.

You said:: and posted the doc for 03/01/2021.

Later you said (Empasis mine) But you did not post the the doc for January 2021. ... Let us see also ...

Best,
G

N-

I mean the one that is 1/1/2021 and includes gV (that you saw).
How could it (gV) be on the list if it is updated quarterly? (01/01 - 04/01 ... so on)

Best,
G

N-

Are you sure? It looks like (for me) Aetna changes the Stanard Plan quarterly:Plan guide changes

Could you post a link or upload the file?

Please note: I am not sure. I do not reach everything from here.

Best,
G

Does you have a responsibility to tell the patient that if they select gV for a REDUCE IT Indication that they may be liable for patent infringement ?

r-

First tough w/o knowing the details: much better to fight as T2 than as T3. Depends on what is the OoP price in case of T2 and T3.

e.g.:
(i) T3
V: 120 - coupon = 9 (Amarin cost: 111)
gV: 120 - 0 = 120
Amarin cheaper by 111

(ii)
V: 80 - coupon = 9 (Amarin cost: 71)
gV: 80 - 0 = 80

Amarin is still cheaper by 71 - patient more likely will choose V - but Amarin collect more by 40. Are you sure? Meanwhile, generic drug companies rarely offer coupons it is available across (e.g.) RxSaver. Is not it?

Best,
G

W-

US: launched March 2020
EU (Germany): Nov 2020 ??? Best,
G

r-

But the expected completion of the CLEAR study (an event-driven*, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries) is 2022 H2.

* occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered “statin averse.”

Best,
G

K-

Thx.

Constipation in chronic kidney disease (a quick, high-level DD)

Highlight:
- The problem of constipation in CKD has long been underrecognized and its management strategies have scarcely been documented.
- Constipation is highly prevalent in patients with chronic kidney disease (CKD) and is primarily characterized by decreased intestinal motility.
- The pathogenesis of constipation in CKD patients is multifactorial: decreased physical activity, comorbidities affecting bowel movement, such as diabetes mellitus, cerebrovascular disease, and hyperparathyroidism, a restricted dietary intake of plant-based fiber-rich foods, and multiple medications, including phosphate binders and potassium-binding resins, have all been implicated.
- Since constipation is often intractable, particularly in CKD patients, every available means needs to be employed in its treatment.
- The chronic symptoms of constipation negatively affect patients’ quality of life and impose a considerable social and economic burden.
- Recent epidemiological studies have revealed that constipation is independently associated with adverse clinical outcomes, such as end-stage renal disease (ESRD), cardiovascular (CV) disease, and mortality, potentially mediated by the alteration of gut microbiota and the increased production of fecal metabolites..

Constipation in chronic kidney disease: it is time to reconsider

Constipation in CKD

So, it could be 2-in-1 solution

Best,
G

I-

Nope. All reported (Bloomberg) script collected by the same company, from the same locations, with the same frequency and analyzed/extrapolated with the same method in case of every drug.

The big "beta" - more likely - is the result of the small(er) script number (The method has a higher CI in case of low(er) number.)

Best,
G

c-

I guess BP has internet access (and other tool/avenue) to check it.Best,
G

g- (Invest83838)

- - - - - Meanwhile the EMA Opinion is not binding for the EC* the surety of EU/EC decision is 99.999999999999%. The recommendation from the EMA’s CHMP still has to be approved by the European Commission, but CHMP opinions are routinely adopted.

I am aware one case only - Cell Therapies Research & Services, Orphacol (cholic acid), a drug intended for the treatment of inborn errors in primary bile acid synthesis - where the EC's decision to refuse approval to Orphacol came despite a recommendation from the EMA. But the European Court of Justice has instructed the EC to approve it.

I do not aware of any case for the opposite (negative EMA opinion but approved).

* Whether positive or negative, the CHMP opinion is communicated to the applicant and to the EC to issue a binding decision. The EC, before releasing the final decision, forwards a draft decision to a regulatory committee called the Standing Committee on Medicinal Products for Human Use where representatives of the MS have 30 days to raise objections. If important objections are raised, the CHMP is asked to formulate a reply, and a new Standing Committee procedure is started based on the CHMP answer.

Best,
G

c-

Why do you think the official approval (by EU/EC !!! not EMA) will change anything? What is the difference between "now" (EMA opinion) and "then" (EU/EC implementing Decision)?

Best,
G

K-

Thx.
If you think - much easier - keep in touch by email.

Best,
G

K-

More later, but

Sell all ASAP, you could buy back later Best,
G

K-

Thx. I got it / understood. I will make more DD re. diarrhea and stool form and frequency changes for my final conclusion.

e.g.: AMPLIFY study

Best,
G

ps.: What is your view about
(i) FGEN (Roxadustat / anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients) and
(ii) CARA (KORSUVA (CR845/difelikefalin) injection / Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus)

K-

Was from 5.24 to 6.74 ... and in again @4.77 (last week) ... till tomorrow morning (PM)

Best,
G

ps.: I posted on a wrong board about Tenapanor (see my reply here )

K-

Thx for the reply / DD. I will check, DD the stool "issue".

I was not detailed. It is not on the market, PDUFA: April 29.

Check the Corp. presentation.

I see it as better than the current SOC (check the completed study section in the presi) ... the market leader had $1bn revenue in last year.

I am interested in your wife opinion.

Best,
G

K-

Please check this one

Best,
G

K-

Check this one (AGRX).

What is your wife's view / opinion?

Tenapanor: First-in-class product candidate for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. (Three successful statistically significant Phase 3 studies).

Best,
G

F-

Yes. Hungary, Budapest, II. district

Best,
G

F-

Yep ...f***k GDPR ...

Best,
G