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GL takes away more V market share than gV which is under limited supply so not an immediate threat currently.
Biotech sector is very weak today. That's why I am OK with AMRN being down today.
Can Amarin send a warning letter to GL prescribing doctors who indirectly infringing RI patents for prescribing GL to TG<500 mg/dL patients? Or at least Amarin can send them a reminder letter for the availability of an on-label treatment for TG<500. I don't understand why doctors need to risk writing off-label script if an FDA approved on-label option is available.
I swear that sounds like JT.
north, this one for you:
Vertex gets much-needed win with ‘extraordinary’ first patient results on potential diabetes cure
https://endpts.com/vertex-gets-much-needed-win-with-extraordinary-results-on-potential-diabetes-cure/
FFS, thank you.
study, nothing new on the 9-minute Mason talk. PI2 will succeed/fail on the trial design,implementation and execution not on efficacy of V on covid19.
newman, please post something informative and relevant to Amarin.
"Anchor patents"?
marjac, thanks for all you have done. IMO, the $6.4B question is what you just stated, "as the Court, if functioning properly"?
I have always felt dirty posting on this board and you confirmed it for me.
styles, thanks for posting the details. Also, below is the Merck 8k on the deal:
10. Background of the Offer; Past Contacts or Negotiations with Acceleron
Background of the Offer and the Merger
The following is a description of contacts between representatives of Merck and its affiliates and representatives of Acceleron and other persons that resulted in the execution of the Merger Agreement. For a review of Acceleron’s additional activities, please refer to the Schedule 14D-9 that will be filed by Acceleron with the SEC and mailed to stockholders of Acceleron.
From time to time in the ordinary course of business, Merck and Parent evaluate various business opportunities to enhance shareholder value. These evaluations have included periodic assessments of potential strategic transactions to strengthen Merck’s existing business.
On July 16, 2021, Mr. Sunil Patel, senior vice president and head of corporate development at Merck, contacted Mr. Habib Dable, chief executive officer of Acceleron, via email, asking for a call to discuss opportunities for the two companies to work together. Mr. Dable replied that Acceleron was not seeking to out-license any of its assets at that time and shared the contact information of Acceleron’s senior vice president of business development in the event that Merck was looking to out-license its own pulmonary disease assets. Mr. Patel later reiterated his request for a call directly with Mr. Dable.
On July 19, 2021, Messrs. Patel and Dable along with Dr. Dean Li, executive vice president of Merck and president of Merck Research Laboratories, and Kevin McLaughlin, senior vice president and chief financial officer of Acceleron, participated in a call during which Mr. Patel previewed for Messrs. Dable and McLaughlin the contents of a letter Merck would deliver proposing an acquisition of Acceleron at a price of $160 per Share.
On July 20, 2021, Merck submitted to Acceleron a non-binding indication of interest to acquire all of the outstanding shares of Acceleron for $160 per Share in cash (the “July 20 Proposal”). The July 20 Proposal valued Acceleron’s equity at approximately $10.2 billion in total, and as compared to Acceleron’s closing stock price on July 15, 2021 of $115.36, represented a 39% premium and a total equity value premium of approximately $2.9 billion. The July 20 Proposal was subject to the negotiation of a definitive acquisition agreement and satisfactory completion of due diligence, including several items identified in the indication of interest as critical to Merck’s valuation and willingness to proceed, one of which was a review of an unredacted version of Acceleron’s license and collaboration agreement for sotatercept with Celgene Corporation (the “Celgene License”). The July 20 Proposal did not specify any financing condition and indicated that Merck could be in a position to announce a transaction within two weeks following the commencement of due diligence.
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On July 28, 2021, Merck and Acceleron executed a confidentiality agreement, which was limited in application to the unredacted copy of the Celgene License and did not contain a standstill provision. Shortly after execution of the confidentiality agreement, Acceleron shared with Merck an unredacted version of the Celgene License.
On August 5, 2021, Acceleron’s financial advisors provided answers and shared additional information in response to several of Merck’s questions arising from its review.
On August 6, 2021, Mr. Patel from Merck confirmed to Acceleron’s financial advisors that Merck had completed its review of the Celgene License and was satisfied with the results of that review.
On August 9, 2021, following a meeting of the Acceleron Board, Acceleron’s financial advisors contacted Mr. Patel and informed him that Merck’s July 20 Proposal offered insufficient value to Acceleron’s stockholders to justify further engagement by Acceleron.
On August 12, 2021, Merck submitted to Acceleron a revised non-binding indication of interest, which increased the per Share price from $160 per Share to $175 per Share in cash (the “August 12 Proposal”). The revised indication of interest valued Acceleron’s equity at approximately $11.2 billion in total, an increase of $1.0 billion in total from Merck’s previous proposal, and as compared to Acceleron’s closing stock price on July 15, 2021 of $115.36, represented a 51.7% premium and a total equity value premium of approximately $3.9 billion. The August 12 Proposal indicated that Merck’s executive committee had been actively involved in evaluating the potential transaction and continued to be supportive of a transaction, subject to completion of due diligence and approval by Merck’s board of directors.
On August 17, 2021, Acceleron and Merck executed a revised confidentiality agreement, which amended and restated the confidentiality agreement previously entered into by the parties on July 28, 2021 and which contained a standstill provision that would terminate upon the public announcement of the execution of a definitive agreement for a change in control transaction. Thereafter, beginning on August 23, 2021 and continuing through September 7, 2021, members of Merck’s team attended a series of technical presentations and due diligence meetings held by members of Acceleron’s management team, at which representatives from Merck asked questions regarding Acceleron’s business, and members of Acceleron’s management team responded. Acceleron also made available to Merck a virtual data room (the “Data Room”) to facilitate Merck’s technical due diligence investigation.
Following the completion of Merck’s technical due diligence on September 7, 2021, Acceleron’s financial advisors informed Merck that it should submit its “best and final” proposal by September 13, 2021.
On September 13, 2021, Merck submitted its “best and final” proposal to acquire Acceleron for $180 per Share in cash. The proposal valued Acceleron’s equity at approximately $11.5 billion in total, and as compared to Acceleron’s closing stock price on July 15, 2021 of $115.36, represented a 56% premium and a total equity value premium of approximately $4.2 billion to Acceleron’s closing stock price on July 15, 2021. On a call with Mr. Dable in advance of submitting the written proposal, Mr. Robert M. Davis, chief executive officer and president of Merck, noted to Mr. Dable that $180 per Share was Merck’s best and final price. Merck confirmed the proposal in writing the following day.
Beginning on September 14, 2021, and continuing through September 29, 2021, members of Merck’s team participated in a series of confirmatory due diligence meetings held by members of Acceleron’s management team, at which representatives from Merck asked questions regarding Acceleron’s business, and members of Acceleron’s management team responded. Acceleron also expanded Merck’s access to the Data Room to facilitate Merck’s confirmatory due diligence investigation.
On September 14, 2021, Ropes & Gray LLP (“Ropes & Gray”), legal advisor to Acceleron sent to Covington & Burling LLP (“Covington”), legal advisor to Merck, an initial draft of the merger agreement. The draft merger
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agreement provided for, among other things: (i) a tender offer, followed by a back-end merger if the tender offer is successful; (ii) a “no-shop” provision with a fiduciary out; (iii) Merck’s commitment to take all actions necessary to obtain any approvals required under applicable antitrust laws, including divesting any of Merck’s or its subsidiaries’ assets; (iv) a “company material adverse effect” standard for Merck’s obligation to close the transaction with various exclusions from the events that could constitute a “material adverse effect”; and (v) a termination fee in an amount equal to 2.0% of Acceleron’s enterprise value payable by Acceleron to Merck in the event that Acceleron were to terminate the merger agreement to accept a superior proposal and in certain other circumstances.
On September 18, 2021, Covington sent to Ropes & Gray a proposed revised draft of the Merger Agreement, which, among other things: (i) removed the requirement for Merck to take all actions necessary to obtain any approvals required under applicable antitrust laws, and instead provided that Merck would not be obligated to take certain affirmative actions in respect of obtaining regulatory approvals; (ii) proposed a termination fee in an amount equal to 3.5% of equity value; and (iii) limited the proposed exclusions from the definition of “company material adverse effect.” Also on September 18, 2021, Ropes & Gray sent to Covington an initial draft of the disclosure letter that would accompany a merger agreement.
Between September 18, 2021 and September 29, 2021, Ropes & Gray and Covington, on behalf of and with the involvement of their respective clients, further negotiated the terms of the Merger Agreement and the contents of the corresponding disclosure letter.
On September 24, 2021, Bloomberg published an article reporting that Acceleron was in discussions to be acquired for $180 per Share, representing $11.5 billion in total equity value. On September 27, 2021, The Wall Street Journal published an article confirming the Bloomberg report and further reporting that Merck was the party in discussions with Acceleron.
On the evening of September 28, 2021, Mr. Dable contacted Mr. Davis regarding the market reaction to rumors regarding the proposed transaction and requested that Merck increase its offer, and Mr. Davis declined to do so.
On the morning of September 29, 2021, Ropes & Gray and Covington finalized negotiation of the Merger Agreement containing the terms described in Section 11—“The Merger Agreement; Other Agreements—The Offer.”
On September 29, 2021, Parent, Purchaser and Acceleron executed and delivered the Merger Agreement.
On the morning of September 30, 2021, prior to the opening of trading of shares of Acceleron’s common stock on Nasdaq, Merck and Acceleron issued a joint press release announcing the execution of the Merger Agreement.
On October 12, 2021, Purchaser commenced the Offer.
https://www.sec.gov/Archives/edgar/data/64978/000119312521296484/d202184dex99a1a.htm#toc202184_13
Inside the deal: As leaked details goosed its stock, Acceleron's CEO pumped Merck for more cash:
https://endpts.com/inside-the-deal-as-leaked-details-goosed-its-stock-accelerons-ceo-pumped-merck-for-more-cash/
Revance Therapeutics shares down 20% after FDA releases inspection document
https://www.fda.gov/media/153014/download
"$32m charge"? Must be false memory!
Capt, according to S&P Capital IQ:
Earnings
Next earnings release: Nov 4 before market, unconfirmed.
S&P Capital IQ EPS consensus: -0.03
S&P Capital IQ Rev consensus: 162.75 mln
No, I am waiting for any offer, $10, $11, $12...
If no offer comes, just wait for KM to execute. The stock should see $10 within 2 years. 100% return in two years is not a bad return.
The problem is twofold. Can you treat a disease when it's silent until it hits you? When it hits you, why are you still not treated with Vascepa? I think the answer lies in the cheapness of health insurers and the laziness of most doctors and patients.
could, IMO, JT sold V right to HLS, before R-I trial results, because of personal relationships among AMRN board members, JT and Orbimed Advisor
What would PFE do if JT did not sell Canadian Vascepa right on the cheap?
"Pfizer approached HLS", kudos to poster lizzy who told us that a month ago.
Two biotech mergers (Monday) with CVR:
https://www.streetinsider.com/Corporate+News/Supernus+Pharma+%28SUPN%29+Acquires+Adamas+Pharmaceuticals+%28ADMS%29+for+%248.10sh/19044248.html?classic=1
and
https://www.streetinsider.com/Corporate+News/Pacira+BioSciences+%28PCRX%29+Confirms+Deal+to+Acquire+Flexion+Therapeutics+%28FLXN%29/19044443.html
Our time will come.
Price is king = Rich is great.
I am talking about sales/revenue so no need to subtract COGS or SGA.
Kiwi, why 400? I thought it's 120 cap per bottle.
"Someday, I hope BP will sell Vascepa in the US. That may be the best way to optimize the uptake of the drug in the US."
Sounds familiar. Who posted that before?
raf, the doctor did try to prescribe gV:
"They deny me, a board certified internal medicine physician to prescribe generic Vascepa for a patient with all the FDA indications because I am not a cardiologist, endocrinologist or “lipid specialist.”
Dr. Corral is just refering to the following publication:
https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehab643/6380417
SPY down .7% and IBB down .85%.
CTW, thanks for your contribution. One brick at a time for "a few patients have been started on Vascepa". Give KM time and I am confident he can do it.
zip, your research said "From the magistrate’s report, the district judge will then hand down a decision on a case". Is that what happen in AMRN's case?
I guess we were wrong in assuming Judge Andrew would review Judge Hall's ruling without holding another motion to dismiss hearing.
From ltro at ivil:
The effect of omega-3 fatty acid supplementation on clinical and biochemical parameters of critically ill patients with COVID-19
This study was a double-blind, randomized clinical trial study carried out from May to July 2020 in critically ill patients infected with COVID-19 in Razi Hospital, Rasht, Iran. The inclusion criteria were the age between 35 and 85 years, diagnosis of COVID-19 confirmed by a positive RT-PCR nasopharyngeal swab, as well as symptoms such as severe pneumonia, fever, fatigue, dry cough, respiratory distress, and indicated for enteral nutrition. One hundred thirty five patients were assessed for eligibility and 128 patients met the inclusion criteria. Sample size was calculated using a=0.95, ß=20%, ratio of unexposed to exposed of 2:1, and power of 0.8. An unequal randomization ratio (2:1) was used because of a fixed and limited budget for this research project. Therefore, more participants were randomized to the cheaper arm in order to facilitate greater overall recruitment in the face of a possibly high drop-out rate.
This study was done in form of a double-blind trial. Though no placebo was used, the patients were not aware of their feeding contents, and the patients and researchers were not aware of the arms of the study. Finally, the results were analyzed by a person outside of the treatment team. The allocation to the groups was done through web-based randomization using https:// www.randomizer.org. Sealed non-transparent envelopes with randomized sequences were used to hide the allocation. All participants received high protein formula as 30 kcal/kg/d through enteral feeding. The intervention group received one capsule of 1000 mg omega-3 daily (Vita Pharmed, Switzerland) containing 400 mg EPAs and 200 mg DHAs for 14 days through adding the supplement to their enteral formula. Omega-3 fatty acids fortified formula was administered to the case group by a nurse, who was not a member of the research team, for 2 weeks after the first 24 h of hospitalization in ICU. The omega-3 capsules were pierced with a syringe, then its contents were squeezed out into a prepared enteral formula, with thorough mixing. The control group received nutritional support including the isocaloric-isovolemic formula using the same route, except for the intervention.
The intervention group had significantly higher 1-month survival rate compared with the control group (21% vs 3%, P=0.003). About 21% (n=6) of the participants in the intervention group and only about 3% (n=2) of the participants in the control group survived at least for 1 month after the beginning of the study.
To our knowledge, this is the first randomized clinical trial assessing the effect of omega-3 fatty acid supplementation in ICU patients with COVID-19. We found that administration of omega-3 PUFA significantly improved arterial PH, HCO3, and Be. This trial also supports our hypothesis that omega-3 supplementation can improve the level of indicators of kidney function including BUN, Cr, K, and urine volume. The results have indicated that omega-3 supplementation may increase the lymphocyte count and GCS. However, these increases were not statistically significant.
/uploads/87669/files/Omega-3-supplementation-in-covid-icu-patients.pdf
Old news dated last August.
215K EU V patients * $240 per 120 caps * 12 months = $619M
720K US patients if you include GL as V doesn't compete with GL in the EU.
Amarin just need 215K EU Vascepa patients to double its current annual revenue, that's 0.5% of statin taking patients in EU.
Thanks raf for the numbers. I am confident in KM's new strategy.
Countries in the EU by population (2021):
https://www.worldometers.info/population/countries-in-the-eu-by-population/
Plus UK has a population of 68M.
If IBB and the market continue to be weak next week, there is no reason to expect AMRN to be able to hold the $5 level unless it announce some good news next week.