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You might want to read and understand the amendment filings for the 13D schedule for large holders before you saying something that is this incorrect.
Baker Bros are still over 10% owners. I am sure you could figure out how to do the math on your own if you really want to know.
If Baker Bros had bought the shares ( or changed their position substantially recently) we would have known it by now. Baker Bros did buy a good portion of the ACAD secondary on the same day and they have filed their 13D for the transaction. If they had changed their AMRN position they would have already filed a 13D for AMRN and that has not occurred.
I have to wonder why this speculation continues.
Here is a Dr. Bhatt tweet about it which should help with compromising their firewall -
"Precision Policy" - we need to demand the same evidence for new policies that we (rightly) insist upon for new drugs! Great job with this @rkwadhera and thanks to @NEJM for allowing us to introduce this potentially transformative concept.
The presentation itself does not appear to have a change in timeline , it is still showing 'late 19 approval estimate'.
He did not say that about Medicare. Paraphrasing here - He did say it would not be beneficial to contract with Medicaid because the current fee schedules in place would not make it profitable.
I think it is just a way to burn off some extra energy for a few people. I have seen it on other biotech stocks. There are people here who had $150,000 invested (as an example) but how that it is over $1M they feel they need to keep both eyes on the ball.
Things will settle down as scripts start to rise. A little extra effort, as long as it is not too far out there, could be of some benefit. I see it as a good distraction for some. if they are using their excess energy to promote Vascepa instead of second guessing the CEO that will be a good thing.
Whether the greenshoe is exercised or not will depend on the price action over the rest of the month. I have seen them bought out near the end of the timeframe.
This is the link that I get when I click the ad.
https://www.vascepahcp.com/access-and-savings/?utm_source=4523502&utm_medium=DIS&utm_campaign=21589991&utm_content=428109602_106599273&utm_term=227473503DIS
I understand they sell their own crap. That is what we are up against.
The Inflammation Research Foundation (Dr. Sears) understands EPA/AA. He/they need to get on the Vascepa train.
http://www.inflammationresearchfoundation.org
I went to this link to review the article and there on the right side were Vascepa ads.
https://www.endocrinologyadvisor.com/type-2-diabetes/hypertriglyceridemia-associated-with-high-hba1c-t2d/article/817360/
Anyone want to take on webmd and send them a letter telling them why their article needs to be updated. They are using a source from 2005.
https://www.webmd.com/hypertension-high-blood-pressure/guide/omega-3-fish-oil-supplements-for-high-blood-pressure
The disclaimer is a start and it would tell anyone looking at the website clearly what it is and what it isn't. That is what a disclaimer is suppose to help with.
It will be fine. It will just need a disclaimer with something like this included
"Disclaimer: this is not an official website. It is not owned, operated or authorized by Vascepa's maker:Amarin Pharmaceuticals AMRN, or any other party. While every effort is made to ensure authenticity of the information and testimonials, the site owner can not guarantee the truth of every statement. Please contact your doctor for medical advice.
Maybe it should be called the AHAVI - American Heart Association Vascepa Initiative.
That's good. Every state is going to be different though and even the managed care plans within Medicaid can cause discrepancies.
BCBS Illinois Large group High deductible plan, Express Scripts is the PBA, $277.46. Less coupon paying 190. If Vascepa was included in Express Scripts Preventive Medications List, I would not have to pay down deductible to zero before coverage improves.
Medicaid is done at the state level and every state needs to be visited and details presented. Armed with reduce-it and the cost savings to their programs will be where it is at. . You need to come at the commercial population from all angles - Pharmacy Benefits Administrators, Insurance companies and large employers all need to understand the cost benefits to their programs and the health benefits to their patients. Medicare probably will take lobbyists. The consultants can hire the lobbyist so it is not so direct.
A consulting firm with a one year engagement to help with the managed care contracting would have a huge return on investment and would still keep the drug 100% in the hands of Amarin. IMO, much better insurance coverage needs to come before a large sales force.
It is not about having the most sales, it should be about having the most cost effective sales. Sales forces in the US are on the decline because it doesn't pay to have them. Access to physicians is limited. Physicians have limited time and want to talk and learn from other physicians. There are less than 70,000 pharmaceutical sales reps left in the United States and most of those are in specialized care.
The XBI was up 3.5%. AMRN just failed to participate. Not sure what happened, possibly people being impatient and short volume being up for the day.
People need to realize this is not the 1990s and you do not need 2000 sales reps to have the same impact that you did then. You have to use different tactics today because many physicians are part of large groups that do not allow sales reps or severely limit access. Ad spend through Websites, journal ads, DTC, and physician conferences have a much greater impact and are not about the number of sales reps. We have already seen all of these things in the works. Physicians do not need a sales rep to show up at their door anymore to prescribe a drug. Also vascepa should be a very easy drug to prescribe. drug to drug interactions are not significant and you do not have to do any titrating or special pharmacy instruction. Just look at the data available at www.vascepahcp.com
I wish it was bigger, more sites, more patients. I feel like it is wasted time. I checked the federal grant site and this is the only federal grant out there related to icosapent ethyl. It seems to me based on what we know, there should be twenty.
Is plaque in the brain and plaque in the arteries related? It appears Icosapent ethyl crosses the blood brain barrier pretty easily. You know where I am going with this, alzheimers.
OCUL just had an FDA approval this morning, one month ahead of PDUFA date. Just an FYI.
Biotech/Pharma stocks are going to have a good day today. Shorts are going to get squeezed. I don't see any reason that AMRN is not going to participate.
If you do't see go it alone option as viable, you might not want to have all of your money invested here. I am not saying they will or they won't be bought out but holding a position in a stock because you want them to be bought out is not an investment strategy.
Both of these type 2 diabetes drugs have been advertising like this for several years. Like most new diabetes drugs, they have been required to run post approval cardiovascular outcomes trials (CVOTs). Both companies have conducted and completed large CVOTs and were successful in showing reductions in events.
I have to wonder why they went to all this trouble to make this deal unless they thought there was something there for the future.
AMARIN AND MOCHIDA ANNOUNCE COLLABORATION ON FUTURE DEVELOPMENT OF EPA-BASED DRUG PRODUCTS AND INDICATIONS
Jun 12, 2018
BEDMINSTER, N.J. and DUBLIN, Ireland, June 12, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has entered into a multi-faceted collaboration with Mochida Pharmaceutical Co., Ltd. (“Mochida”, TYO:4534), an integrated Japanese pharmaceutical company. The collaboration is focused on the development and commercialization of early-stage drug products and indications based on the omega-3 acid, EPA (eicosapentaenoic acid). Amarin and Mochida are recognized worldwide as the leading, innovation-driven companies committed to the research and development of EPA-based drug products to treat the needs of tens of millions of patients who are at-risk of cardiovascular disease.
Amarin developed and markets Vascepa® (icosapent ethyl) capsules in the United States, the first and only FDA-approved, prescription pure EPA drug product. Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Amarin's clinical development program for Vascepa includes the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011.1 REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (150-499 mg/dL). Amarin expects to announce top-line results of this landmark study before the end of Q3 2018.
Mochida is an integrated Japanese pharmaceutical company that developed and markets a prescription pure EPA drug product, Epadel, as a treatment for hyperlipidemia and arteriosclerosis obliterans in Japan. Mochida sponsored and successfully completed a cardiovascular outcomes trial with Epadel in Japan, JELIS. JELIS was the world’s first large-scale randomized controlled cardiovascular outcomes trial of a prescription pure EPA drug product and showed beneficial effects of the drug in further reducing cardiovascular events in statin-treated, hypercholesterolemic Japanese patients.2, 3, 4
“We are excited to enter into a collaboration with Mochida given our common mission to create preventative healthcare solutions on a worldwide basis, and our mutual commitment to continued innovation in the EPA research and development area,” stated John F. Thero, president and chief executive officer of Amarin. “This collaboration seeks to leverage the decades of successful research and development experience at Amarin and Mochida towards expediting the development of new products and indications.”
“Mochida is delighted to partner with Amarin,” stated Mr. Naoyuki Mochida, president of Mochida. “Both Mochida and Amarin have demonstrated strong capabilities in developing and commercializing EPA-based products and we believe that together we can achieve much more to improve patient care in the years to come.”
Among other terms in the agreement, Amarin obtained an exclusive license to certain Mochida intellectual property to advance Amarin’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for Amarin’s commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are in relatively early stages of development.
Amarin is only one European or Central American partnership away from having all the money they need. Inventory and sales are already ramping up prior to even filing for approval. Instead of putting a thousand reps out it is much cheaper to advertise though medical journals and direct to physicians at conferences. The NEJM article will just be the first of many. The vascepa.hcp website has all of the reduce it information available. It is not like this drug is difficult to prescribe. Getting better managed care coverage will start with the NEJM. It will be hard for managed care to argue with reduce-it results. A small team of competent managed care folks is what Amarin needs.
Although a PR is not necessary for a deal, an 8-k for a material agreement is required to be filed.
Under what circumstances must a Form 8-K be filed?
Form 8-K identifies events that require the filing of a Form 8-K and provides detailed instructions for filing. The following is a list of the events that trigger a filing, along with the corresponding Section and Item references from Form 8-K:
Section 1 ? Registrant’s Business and Operations Item 1.01 Entry into a Material Definitive Agreement.
? “Material” agreements are those that give rise to obligations that are material to and enforceable against the company, or rights that are material to the company and enforceable by the company against one or more parties to the agreement.
? Many agreements requiring board or shareholder approval would be filed under this Item.
? This includes “definitive” agreements but not non-binding term sheets or letters of intent.
? Filing the agreement itself as an exhibit is encouraged but not required. If the agreement is not filed as an exhibit to the Form 8-K, it will be required to be filed with the company’s next periodic report (e.g., its Form 10-Q or Form 10-K, whichever comes first).
? Material employment agreements are usually reported under Item 5.02.
This has been going on for some time with Diabetes medicines. Although not approved for weight loss... You can check out Novo Nordisk's Victoza commercials to see another example.
This has been going on for some time with Diabetes medicines. Although not approved for weight loss... You can check out Novo Nordisk's Victoza commercials to see another example.
I hope it works out for you. I think because I am in a high deductible plan that I have this issue. Hopefully Amarin can get it added to the preventive care list. It looks like it is at least on some of UHC's preventive care lists.
Anyone else have express scripts?
Blue cross blue Shield Illinois is my provider. They use Express Scripts. I pay a large out of pocket because I have not met my deductible for the year.
I just called Express Scripts. I asked that they add Vascepa to their Preventative Medication list. I mentioned the reduction in stroke and heart attack. I told them I can't imagine anything more Preventative than that. I gave them the name of the trial reduce-it. They noted the comments in their system and said they would push the comments up to their supervisor.
In a high-deductible health plan, federal rules permit certain preventive drugs to be paid without being subject to the plan’s deductible.
Physicians here who have a vested interest in this could spend some extra time with their patients and Amarin reps giving real world examples that will need to be shared with the managed care people at Amarin.
Whether it is high tier coverage or prior authorization issues they need to be fully vetted and fixed by Amarin. Thero acts like the coverage is good but I think we all know there are issues for various payers. How an insurance company can now require someone to take Generic Lovaza and fenofibrate and confirm issues with them before being allowed to take vascepa now seems totally wrong. Vascepa is clearly superior and differentiated and needs to be tiered and priced accordingly.
I am not saying scripts will not rise even with these issues but when physicians get frustrated because of lack of coverage it needs to be fixed.
The good news is that in the EU they will have new chemical entity status when they do file with a bigger indication right from the start.
8-k related to secondary
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): November 26, 2018
Amarin Corporation plc
(Exact name of registrant as specified in its charter)
England and Wales 0-21392 Not applicable
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
2 Pembroke House, Upper Pembroke Street 28-32, Dublin 2,
Ireland
Not applicable
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: +353 1 6699 020
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
?
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
?
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
?
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
?
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ?
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ?
Item 1.01.
Entry into a Material Definitive Agreement
On November 26, 2018, Amarin Corporation plc (the “Company,” “we,” “us” and “our”) entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC and Cantor Fitzgerald & Co. (the “Underwriters”), pursuant to which the Company (i) agreed to issue and sell 11,111,112 American Depositary Shares (“ADSs”) to the Underwriters at a price of $17.575 per share, which price includes what might be deemed an underwriting fee, and (ii) granted the Underwriters an option for 30 days to purchase up to an additional 1,666,666 ADSs that may be sold upon the exercise of such option by the Underwriters at the same share price, with each ADS representing one of the Company’s ordinary shares, par value £0.50 per share, in an underwritten public offering pursuant to a Registration Statement on Form S-3ASR (File No. 333-216385) and a related prospectus and prospectus supplement, in each case filed with the Securities and Exchange Commission (the “Offering”).
The Company estimates that the net proceeds from the sale of the 11,111,112 ADSs in the Offering will be approximately $194.9 million, or approximately $224.2 million if the Underwriters exercise in full their option to purchase 1,666,666 additional ASDs, after deducting the estimated offering expenses payable by the Company. The Offering closed on November 29, 2018. The Company currently intends to use the net proceeds from the Offering (1) to support the ongoing commercialization of Vascepa following REDUCE-IT results, including (i) seeking regulatory approval to expand the approved label for Vascepa based on the cardioprotective effect of Vascepa demonstrated in the REDUCE-IT study, beginning with submission of an sNDA to the FDA in early 2019, (ii) expansion of its sales force, and (iii) support of expanded commercial operations; (2) to increase commercial supply of Vascepa from third-party drug product suppliers; and (3) for general corporate purposes.
In the Underwriting Agreement, the Company makes customary representations, warranties and covenants and also agrees to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the Underwriters may be required to make because of such liabilities. The Underwriting Agreement has been filed with this report to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The foregoing is only a brief description of the material terms of the Underwriting Agreement and does not purport to be a complete description of the rights and obligations of the parties thereunder. The Underwriting Agreement is filed as Exhibit 1.1 to this report, and the description of the terms of the Underwriting Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of K&L Gates LLP relating to the legality of the issuance and sale of the ADSs in the Offering is attached as Exhibit 5.1 hereto.
Item 8.01.
Other Events
On November 26, 2018, the Company issued a press release announcing the commencement of the Offering. A copy of this press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
On November 26, 2018, the Company issued a press release announcing that it had priced the Offering. A copy of this press release is attached as Exhibit 99.2 hereto and is incorporated herein by reference.
Item 9.01.
Financial Statements and Exhibits.
Exhibits
Pursuant to the rules and regulations of the Securities and Exchange Commission, the attached exhibits are deemed to have been filed with the Securities and Exchange Commission:
Exhibit
No.
Description
1.1 Underwriting Agreement, dated as of November 26, 2018
5.1 Opinion of K&L Gates LLP
23.1 Consent of K&L Gates LLP (included in Exhibit 5.1)
99.1 Press Release, dated November 26, 2018
99.2 Press Release, dated November 26, 2018
* * *
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 29, 2018 AMARIN CORPORATION PLC
By:
/s/ John Thero
John Thero
President and Chief Executive Officer
When it comes to Medicare you need to ask the question more specifically. A Medicare patient will have a Medicare Part D provider to provide outpatient pharmacy drugs. Who is their Part D provider, what state are they in and what formulary do they use.