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Thanks Birdrockboy, You are right and I think that once on the board, they will work to get the old team gone. I want this to be over so badly. Do you think Denner will be able to work with the existing board or move quickly to remove this board?
PS I already voted Blue Card. I just wanted to make sure I was right in doing so.
Really!!! Ram
I don't need nasty, I need truths. So really what is Denner going to do for us, what is his plan. Does he want to sell the company? How much do you think he will get us?? Does he want to grow the sales before a buy?? Does he think putting seven of his people on the board, he will achieve agreement on going forward? What is Sarissa's plans?
PS: I have already voted Blue Card, just wanted some affirmation on my choice.
To All, Help me decide
It has been a long time since I have posted here, but have owned Amarin since 2013, going through all the ups and downs as you, both financially and mentally. I am so disgusted with Amarin's management, since Joe Z and want this madness to end. I just got off the phone with Amarin's solicitor and as the call progressed. so did I. I told how I lost over 700,000 and my brother lost a little more than that. (I get that it was my decision to hold, but many of you might remember we were dealing with my dying sister-in-law in a nursing home during the Covid lockdown. by the time I looked at my account ( a couple days after Du's bs), I had lost a big chunk of change and was in shock, but dumbly hopeful.) I told her of our little group here on I-hub and EPADI, and that collectively we own millions of shares, but yet we have been ignored through all of this for years, all while the BOD gets free shares and cashing in almost immediately. That they do not even believe in Amarin, they are just getting free shares for attending a zoom call every three months. She responded she understood, yah yah yah, she couldn't be over 25-30 years old. she does not understand losing your retirement to crooks. Having to go back to work at 65. Bullshit, I was pissed. She had heard many similar complaints, yet she never heard from any EPADI. She stated. her job was also to collect data (concerns) from the shareholders and report that to Amarin, again bs. I told her how many times numerous people here tried to contact Amarin over the years, with mediocre response or none at all.
Yet, I am just not convinced to go Sarissa. On one hand I feel Sarissa is doing a hostile take-over and we Amarians will find us in another legal battle, as Denner threatens to sue if he doesn't get his way. I have long believed Amarin has to many BODs and to add another seven is ridiculous. I have looked into some of the candidates and fail to see added value. If we split the board on path of Amarin's future, we shareholders will suffer further delays and stagnate share price. And so what companies have benefited from Sarissa's involvement, besides The Medicine Company and maybe one other? Do you think the new Amarin board is getting their s together and that we will share sales reaching a billion in 2023?? I feel they are both lying and spinning truths for their narratives, don't we see enough of this in our government?? I just don't feel good about either party and need some of my fellow shareholders to share their perspectives.
Laura
Please vote your proxy. By using the power of unity, we can send a message to management that we are not happy and will not be ignored. No more diluting our shares!!!!
Marjac,
You truly are a hero in my book. My sister-in-law was in a nursing home during Covid. Ironically, the last time we got to visit her, was the day before the Judge du decision. We were devastated and heartbroken when she called crying we weren't there. Her last four months were isolated from human contact. Thankfully, when she went to hospice, we got to see her everyday til she died. It is heartbreaking when you think of what our loved ones endured. Go get those bast'ds.
Marjac,
First, I want to sincerely thank you from the bottom of my heart.
I am figuring the day before it closed at 12.38, and the next day to 4.00. If I am remotely correct on those numbers, both my brother and I lost in the 6 digits, We would be very grateful to be included in your fight, We had shares (25k and 23k ).
It is late and to be honest, still processing this BS. I can't formulate my words, I am dishearten to say the least.
My e-mail is laura.abner@yahoo.com
Laura
Capt,
Thank you so very much for all your efforts. What an incredible and amazing article. There is so much knowledge, talent and courage on this board and I thank you all.
Laura
CaptBeer
Can't this be fixed by Amarin? And if so, why haven't they??
Soooo frustrated
Gussettville
That was my point. Pfizer stands to expand their pipeline in several areas of medicine. Biotech are bought out frequently with only one indication. Imho, Pfizer will be well positioned, plus they made 42 billion in vaccine sales. This is a great opportunity for Pfizer, since the stock stays beaten down. Plus I believe the generics will exit the market due to Pfizer's mass market.
What Pfizer would get in the deal:
Cardiovascular
Ischemic Stroke
Plaque Reduction
Diabetes/w heart complications
Alzheimer/Dementia (veterans clinical trial)
Nash
And now inflammation related to Covid
And just about any disease involving inflammation: dry eyes, eczema, and etc.
They are much better equipped to take Vascepa in to the billions in sales.
Plus FierceBiotech has an article that says they are in the market to purchase,
25b?
Levothyroxine vs Synthroid-test results:
I am a true believer in branded Synthroid, here are my latest tests results.
Name
Standard Range
8/3/16 2/14/18 2/21/18 5/10/18 10/19/18 4/26/19 3/23/20 7/12/21
TSH
20.200 H 16.000 A 7.760 H 56.330 H 22.320 H 3.650 2.700 0.893
My doctor seemed to believe that I was non-compliant, yet when I switched to branded, you see my TSH dropped dramatically (10-18). Just this month, doctor dropped my script dosage to .112 from .137.
The cardiologist, the doctor and I believe my heart problem (leading to an ablation) was due to the high TSH levels. I suffered from ventricular bigeminy. My heart is fine now, with no required follow-up from cardiologist.
This was my personal results, not saying that this is true for all thyroid patients. I suffered from Graves disease and had my thyroid radiated in 2009. For years I would switch doctors and even tried the pig hormone. It took ten years, a severe heart problem, and a doctor that finally listened to me to get branded Synthroid. Which my insurance will not cover, thankfully it only around 40.00 a month.
Laura
Amarin Pharma Led ‘Scheme’ to Suppress Competition for Hyperglyceridemia Treatment Vascepa, Class Action Alleges - June 2021
Sorry if this has been posted before, however I just saw this and thought it needed to be shared. And why this group?
Uniformed Fire Officers Association Family Protection Plan Local 854 et al. v. Amarin Pharma, Inc. et al.
https://www.classaction.org/news/amarin-pharma-led-scheme-to-suppress-competition-for-hyperglyceridemia-treatment-vascepa-class-action-alleges
Hikma's ANDA approval letter, I need help with clarifications
I have searched for days to finds some answers, would appreciate any help.
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209457Orig1s000ltr.pdf
Generics (some) are inferior
Lizaa, when I was on generic Synthroid my blood test (T4) was always fluctuating. After talking with several other thyroid patients experiencing the same on generics, I switched to branded (which I pay 3x more) and my numbers have been consistent for two years. I believe the bioequivalences of a generic should be tighter than 80-120 percent. Are you getting too much or not enough? Would they run a clinical trial with such a range?
Laura
An Excerpt from Pubmed:
Dar53, That pretty much sums up my opinion of the management. Another issue for me was how did Amarin's management allow that cropped table with the so called expert testimony to stand up in court. Any one of the management, or at least one, should have caught that.
And yes, the fact they kept getting free shares and cashing in, while totally ignoring the shareholders and the "value of Vascepa". A sales team that could not increase sales nor educate the doctors or insurance companies on Vascepa.
I hope that JT has learned a lesson (one of many). "DON'T LET YOUR RETAIL INVESTORS, FIGHT YOUR FIGHT" Thank you to Marjac and his team, even if all your tremendous effort fails, I will be forever grateful that you fought for "all of us" and the patients rights to a life-saving drug.
In the end, I only have myself to blame for not getting out at 24.
USPTO announces special Patents for Humanity COVID-19 category.
How could/would this affect Amarin's work into Covid-19? Could Hikma steal more of Amarin's patents?
https://www.uspto.gov/about-us/news-updates/uspto-announces-special-patents-humanity-covid-19-category
Based on previous post-
Why would anyone wait five years for the full effect of a drug, This can't be right?? Thoughts? Should I forward this to Amarin for an answer?
Maybe you think who reads that stuff anyway, but I say we need to combat any falsehoods. Back in the day, I was taking a few different meds and used this site (Drug.com) for answers, surely I am not alone in using this site for answers such as drug interactions etc.
Drug.com-guys have you seen this??
HOW LONG DOES VASCEPA TAKE TO WORK?
Official Answer
by Drugs.com
It takes approximately one year for Vascepa to start reducing cardiovascular risk and up to almost five years for the full effects to be seen. In the REDUCE-IT trial, Vascepa significantly reduced the risk of cardiovascular events, such as cardiovascular death, heart attack, stroke, coronary revascularization, or hospitalization for unstable angina by about 25% after approximately 4.9 years. In those with atherosclerotic cardiovascular disease (ASCVD), the risk of events decreased by 35% after 4.9 years.
Laboratory results showed that the average starting levels of triglycerides and LDL-C were similar between the Vascepa and placebo groups, but after one year of taking Vascepa, there was a significant difference between these values between the two groups. The median change in triglycerides from baseline in the Vascepa group after one year was -39 mg/dL (or a drop of 18%) and 5 mg/dL in the placebo group (an increase of 2%). The median change in LDL-C from baseline after one year was 2 mg/dL (an increase of 3%) in the Vascepa group and 7 mg/dL (an increase of 10%) in the placebo group.
How does Vascepa work?
Vascepa is thought to work by reducing the production of triglycerides by the liver and enhancing their clearance from lipid particles, via several different mechanisms. This decreases triglyceride levels in the body.
If Vascepa is taken alongside a Mediterranean-style, low-carbohydrate diet that reduces body weight by 5% to 10% and contains no trans fats in addition to a regular exercise regimen, then triglyceride levels are expected to reduce by up to 50%.
Vascepa only contains eicosapentaenoic acid (EPA), whereas most other fish oils (including prescription fish oils) contain both EPA and docosahexaenoic acid (DHA). By only containing EPA, Vascepa reduces high triglycerides without raising levels of “bad” cholesterol or LDL-C.
The top 10 takeover targets in biopharma
by Phil Taylor | Oct 19, 2020 3:00am
https://www.fiercebiotech.com/special-report/deal-or-no-deal-top-10-takeover-targets-biopharma
Amarin
Location: Dublin, Republic of Ireland
Ticker: AMRN
Website: amarincorp.com
Amarin’s inclusion on this list stems from one thing: a potential multibillion dollar cholesterol blockbuster drug—fish-oil derivative Vascepa (icosapent ethyl)—that has been shown to lower cardiovascular event rates in large-scale trials.
The Ireland-domiciled company has been selling Vascepa in the U.S. as a treatment for adults with very high levels of triglycerides in the blood, a relatively small population of around 600,000 people that nevertheless drove sales to $430 million last year.
Amarin's attraction as a potential buyout candidate rose dramatically, however, in the wake of Vascepa’s unique approval for cardiovascular risk reduction when used with statin drugs, granted by the FDA last December on the strength of data from the REDUCE-IT study.
RELATED: Amarin sidelines field sales team for Vascepa amid growing COVID-19 pandemic
Amarin has been marketing the new indication hard, but it has inevitably suffered in 2020 from the hit to consultation and prescribing rates caused by coronavirus lockdowns, and there’s another big shadow hanging over the company, too.
A judge recently ruled against patents protecting Vascepa in the U.S. from competition until 2030. While this verdict is now being appealed by the biotech, if the appeal fails, it could result in early entrance of generics from the likes of Hikma and Dr. Reddy’s Laboratories that would dramatically reduce peak sales. The U.S. Court of Appeal recently upheld that earlier verdict, and Amarin says it is now “reviewing its legal options.”
Amarin previously settled patent litigation with Teva and Apotex, with agreements that the generic companies hold off on launching their Vascepa copies until 2029—although those pacts will be nullified if Amarin doesn’t prevail in its appeal. The company says it expects to file a petition for an en banc review of the September panel decision. Meanwhile, analysts are split on whether those deals have any read-through to Amarin’s chances of success.
RELATED: Amarin loses make-or-break Vascepa patent appeal
If Amarin eventually wins, that would likely create situation in which a takeout would be more plausible for a buyer looking to augment its position in cardiovascular/primary care, and the company’s valuation could approach or exceed the $9.7 billion that The Medicines Company fetched late last year when it was bought by Novartis.
If, however, Amarin fails, the company has said it will reduce its marketing and commercial spend in the U.S. and consider launching its own generic.
Amarin meanwhile still has a decade of exclusivity in the EU, which it sees as a big market for Vascepa. The company says it has spurned several offers of help from a larger partner to market Vascepa in Europe, where it is due to launch next year, saying it feels going it alone is the best move.
I like the commercial
It's catchy- I will have that song in my head all day
Dear Irishman,
My heart sinks for you. I lost my grandson, Tyler to SCIDS (Severe Combined Immune Syndrome) 13 years ago. He was 21-months old. I too am Catholic and conservative, my son was an atheist and liberal, all of which means nothing
when a loved one is sick, as we all prayed for God grace. As I remember Tyler this morning, I will pray for a positive outcome for Mario and your family.
As many have stated here, Mario's age is a positive. Hold on to that.
Prayers
Laura
Bill B
Fed. Circ. Urged To End 'Unrealistic' Obviousness Test
Please if anyone has access to Law 360 please post this article.
Fed. Circ. Urged To End 'Unrealistic' Obviousness Test
Can someone with access post this article
https://www.law360.com/ip/articles/1275318/fed-circ-urged-to-end-unrealistic-obviousness-test
Hikma and the FDA Quid Pro Quo
DRUG FIRM OWNERS POCKET £33MILLION ON BACK OF COVID (Vascepa)
https://www.msn.com/en-za/news/other/drug-firm-owners-pocket-33million-on-back-of-covid/ar-BB14lyxR
On Tuesday – the day before the family trust sold shares – Hikma announced it had launched its new anaesthetic drug in the US after receiving approval from regulators. Propofol Injectable Emulsion can be used for patients in intensive care who require intubation and mechanical ventilation.
The company said the drug was currently on the US Food and Drug Administration’s shortage list ‘following a surge in demand due to the increase in hospitalised, ventilated patients resulting from the Covid-19 pandemic’.
Hikma shares have also been boosted by the US courts, which ruled that its generic version of the heart drug Vascepa did not infringe on a rival’s patents.
Amrn does not want to negotiate period
Amarin has a history fighting for their rights, ie First Amendment, SPA.
And now Amarin will take on another challenge, PATENT LAW AND REFORM
Y'all may think I am simple in thought, but why in the hell should American's Innovation be stolen by patent trolls. Why should Amarin's success be pirated or shared. American is based on capitalism not socialism. Every innovator and medical research company should get involved and take a stand.
Many here on the board have opined that Reddy, nor Himka is really interested in selling a generic or may have even taken the action on behalf of BP, I agree. This practice must be stopped. A district judge, with no medical or statistical knowledge should not have the ability to override the experts of the USPO and the FDA. Absolutely ridiculous and blatant thief of Amarin's investment of time, research and monies. Judge DU stole billions from Amarin and limited medical care to millions, she should be sanctioned. And, I will remind the courts that generics do not advertise and as a result a medical breakthrough drug that hoped to save millions will never get to half of the people that would benefit. It's murder.
Did JT mention timeline on DTC ads, have the ads been submitted and we are waiting on the FDA to act??
Great Job Captbeer,
Very concise and to the point, I should of had you write my letter.
Let's us know if you get a response.
Many thanks, Laura
Re: Letter to Senate Reform
I need the boards help. As stated before the base of the letter was meant to entice further reading of the addendums. I feel the letter is okay but somewhat repetitive, some factual error and long. Thankfully, Johnsking has helped me get this far. We need someone with expertise to form those addendum, please volunteer to our cause. Can you pm me with suggestions, additions, expertise and constructive criticism. Once we achieve the final, maybe we can use google doc to collaborate So, here is what JK and I have written so far.
US Senate Judicial Committee
Patent Reform
To Members on Patent Reform:
Vascepa, a cost-effective, life saving drug will never be able to save the millions of lives they hoped for. We would like to introduce a recent patent challenge case, Amarin Pharmaceutical v Hikma Pharmaceutical and Dr. Reddy Labs, heard by Judge Du, Ninth District Court of Nevada. The case represents several issues that are anticipated to be corrected by the Stronger Patents Act of 2019 and/or patent reform acts in the Legislative committees.
The rule of obviousness and secondary considerations (under U.S.A 25-103) and how those rules are interpreted by the different agencies and courts are the issues we feel addresses the struggles of patent reform that your committee is working to correct.
Amarin was granted patents from the USPO based on the agency interpretation of the rules. The FDA used their interpretation of the rules, but in the end, added the patents to the Orange Book. Judge DU used a different view which differs from the Federal District rules on how to handle appeal cases in regards to the obviousness and secondary consideration. Many post analysis of her decision to invalidate the patents claims opine she erred by applying the wrong standards, a rookie mistake. (her ruling and post analysis listed a addendum.)
The Damages:
A 2019 ICER ( the Institute of Clinical and Economic Review) report deemed Amarin’s Vascepa drug was a cost-effective life saving drug that will save millions of lives and reduce expensive hospital stays and costs related to cardiac events and stroke. The American Lipid Association and Diabetes Association added Vascepa to their recommended Standards of Care Policy. In addition, Amarin’s Reduce-it Study is still producing valuable insights on how the drug’s method of action is adding value in the care of cardiac and diabetes patients. (Addendum below)
The Judge, by invalidating those patents, opened the market to generics. By losing those patents only four months after FDA approval, Amarin will have no choice but to rethink how to market Vascepa. Generic companies do not advertise their drugs, so how are those millions of Americans to learn of this life saving drug? How are new life-saving drugs and other innovations to come to market with patent thief. Why would any company spend hundreds of millions and years bringing innovation. Our government agencies work against one another in a show of power and/or fee grabbing and it hampers America’s future. It needs to stop. Our laws need to change to protect America’s growth, such as other countries protect their intellectual property.
Amarin has filed an appeal to the Federal District Court, but that may take a year. Amarin and their investors cannot financially continue if the generics are allowed to market. Financially, the stock peaked at 25.00 a share at approval in December, after the lawsuit was announce the stock started downward to 13.50, and after the Judge invalidated the patents; trades at around 5.00. (appeal attached below)
We need your help:
America’s innovators and the people they help, need your help. Please look at the addendums provided below that will give you more insight as to the struggle to get this drug (Vacepa) to market and how only four months after FDA approval, Amarin’s research and financial contribution was stolen by a patent troll.
Summary of parties:
Amarin has been working to bring the drug Vascepa, an Icosapent Ethyl acid compound, to market for almost 10 years. Vascepa has been on the market since 2012, as an adjunct to statins, labeled to address the lowering of triglycerides of >500. Amarin wished to have Vascepa listed as a cardiac drug and was required by the FDA to do a 5-yr and 8000 subject outcome study. The Reduce-It study was completed and in September 2018, the results were above expectation in that Vascepa lowered cardiac risks by 25% and strokes by 28%, when added to statin therapy. The National Lipid Association and the Diabetes Association both adopted the therapy as a Standard of Care, even before FDA Approval. Vascepa was finally approved December 2019. A 10-year and close to a billion dollar journey between innovation and approval. Imagine, a drug that could save millions of lives and billions in yearly health care costs has been around over ten years, did everything our regulatory agencies asked of them to achieve market approval, gone due to Judge Du’s inept knowledge of patent law and the generic company that took advantage of the flaws in the patent sytem. (Complete story on Amarin’s journey through the USPO and FDA listed below)
Hikma Pharmaceutical, based in London, is a global generic drug company. Their mantra is seeking success by challenging patents. A recent Yahoo article transcribing Hikma 2019 year-end results, states that Hikma bragged they were listed in over 600 of the current 3000 lawsuits going through the court system. They have acquired several smaller companies over the years; one is Hubie Haosun Pharmaceutical in Wuhan Province, China. Hikma has acquired so many drugs, they have been ordered by the courts to sell off certain drugs to avoid being a monopoly, (addendums attach)
Reddy Labs are more OTC drugs that challenge patents to create supplements that through their infomercial comes closes to claiming the same pharmaceutical benefits as the branded counterparts.
Judge Du, is the Chief Judge in the Ninth District Court of Nevada. Her nomination was offered by Harry Reid to the Obama Administration in 2012. J Du received her law degree in 1994 and mainly practiced labor law. The case was Judge DU’s first bench trial for a patent challenge and it appears that procedural and other errors were made potentially due to her lack of experience in the complicated issues of patent challenges and laws regulating such procedures.
Submitted for your consideration by the Amarin I-Hub Group, a collection of doctors, clinicians, statisticians, lawyers and other experts in various related fields.
.
To All, Letter draft
I have completed my first draft and pm to a few individuals that have offered to help me finalize the letter. Hopefully will be completed by next week.
My intended target groups and individuals (which can be expanded}:
US Senate Committee on Patent Reform
"stronger Patent Act of 2019"
Senator Stivers of Ohio {writer of the bill)
Representative Massie of Kentucky, an inventor and the largest patent holder in political Washington
The Biotechnology Innovation Organization
Meeting on Patent Reform Oct 2020
Yahoo members, I need your help
There is an article on Yahoo regarding a transcript of Hikma year-end results of 2019. I cannot open the full article for some reason. But in the highlights it implies Hikma brags about being named in over 600 of the current 3000 lawsuits.
As part of my letter to the Judicial Committee, I would like to show the arrogance and "fee fii fo fom" attitude this company displays. Google Hikma v and see how many companies they have gone after and they also have Hikma Venture Inc that is going after smaller companies in other fields. Hikma is out for a monopoly on our drugs and in another lawsuit they were forced to give up 5 drugs to another company (due to creating a monopoly).
And even though based in London, they own haosun pharmaceutical in epi-center of the Coronavirus. Haosun supplies several drugs to the US
Look what the FDA did to Hikma
Hikma Pharmaceuticals and Vectura hit by US regulatory setback
https://www.proactiveinvestors.co.uk/companies/news/192974/hikma-pharmaceuticals-and-vectura-hit-by-us-regulatory-setback-192974.html
A number of questions were raised by the FDA in what’s called a complete response letter and while the majority were addressed working with the drugs watchdog, one couldn’t be resolved.
The issue was whether Hikma should carry out a clinical endpoint study. The UK company argued it shouldn’t have to, so the matter was taken through the FDA’s dispute resolution process, which upheld the original finding, namely the additional study should be commissioned.
Other cases
Hikma wins dismissal of Takeda patent lawsuit over gout drug
Hikma Pharmaceuticals PLC, In the Matter of
https://www.ftc.gov/enforcement/cases-proceedings/151-0198/hikma-pharmaceuticals-plc-matter
States say Alvogen lawsuit is part of a 'guerilla' war ...
https://www.fiercepharma.com/pharma/states-say...
Aug 10, 2018 · Meanwhile, Hikma has joined the fight on Alvogen’s side. The company manufactures fentanyl that Nevada has identified as one of three components to …
Takeda loses again to Hikma in gout drug patent battle ...
https://www.fiercepharma.com/pharma/takeda-loses...
May 24, 2016 · A federal court backed Hikma's right to sell a med with the same active ingredient as Takeda’s Colcrys because it's approved for an off-patent indication. Takeda suffered a …
Mutual, Hikma Settle Suit Over Unapproved Gout Drug - Law360
https://www.law360.com/articles/203044/mutual...
By Jocelyn Allison Law360 (October 20, 2010, 7:28 PM EDT) -- U.K.-based Hikma Pharmaceuticals PLC 's U.S. unit has settled a lawsuit with Mutual Pharmaceutical Co. Inc. over the gout treatment...
Hikma Pharmaceuticals PLC (LSE:HIK) : Articles :: Law360
https://www.law360.com/companies/hikma-pharmaceuticals-plc
Stay ahead of the curve. In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries.
Newsroom | Hikma
Edited Transcript of HIK.L earnings conference call or ...
https://finance.yahoo.com/news/edited-transcript-hik-l-earnings-212959617.html
Mar 23, 2020 · Full Year 2019 Hikma Pharmaceuticals PLC Earnings Call. ... But to defend on over -- we have mentioned, in over 600 lawsuits out of over 3,000, like
Did not find the whole article but really, they brag their name is list on over 600 lawsuits, We someone access this article on Yahoo,it won't open for me.
AND THEN I see Hikma Venture Group and now I hate the arrogance of this company.
In the Matter of Hikma Pharmaceuticals PLC and C.H. Boehringersohn AG & Co. KG
https://www.ftc.gov/enforcement/cases-proceedings/151-0044/bedford-laboratorieshikma-pharmaceuticals
Case Summary
Generic drug marketer Hikma Pharmaceuticals PLC agreed to divest its rights and interests in five generic injectable pharmaceuticals to settle charges that its $5 million acquisition of the rights to various drug products and related assets from Ben Venue Laboratories, Inc. would likely be anticompetitive. According to the complaint, without a remedy, Hikma’s purchase of certain generic injectables would likely harm future competition in the U.S. markets for (1) Acyclovir sodium injection: an antiviral drug used to treat chicken pox, herpes, and other related infections, (2) Diltiazem hydrochloride injection: a calcium channel blocker and antihypertensive used to treat hypertension, angina, and arrhythmias, (3) Famotidine injection: a treatment for ulcers and gastroesophageal reflux disease, (4) Prochlorperazine edisylate injection: an antipsychotic drug used to treat schizophrenia and nausea, and (5) Valproate sodium injection: a treatment for epilepsy, seizures, bipolar disorder, anxiety, and migraine headaches. Hikma is required to divest the five generic injectable drug assets to Amphastar Pharmaceuticals, Inc., a California-based specialty pharmaceutical company that sells generic injectable and inhalation products.
Here's what will happen to Vascepa
2011
http://www.pharmatimes.com/news/hikma_takes_stake_in_chinas_haosun_980734
Jordanian drugmaker Hikma Pharmaceuticals, which is listed on the London Stock Exchange, has acquired a "significant minority interest" in China’s Hubei Haosun Pharmaceutical Co.
Under the terms of the deal, Hikma has bought a stake in the privately-held firm through the subscription of new equity for $5 million in cash. As part of the partnership, it gets access to Haosun's state-of-the-art US Food and Drug Administration and European Union-approved facility in Wuhan province.
2020
https://uk.reuters.com/article/uk-hikma-pharma-results/hikma-sees-2020-sales-growth-after-profit-beats-view-on-newer-drugs-idUKKCN20L0UR
Overall core sales grew 6% to $2.20 billion, while core operating profit rose 10% for the year ended Dec. 31, Hikma said. The company reported a 5% rise in U.S. sales and strong growth across its segments. U.S. sales made up 61% of total core revenue.
Hikma also said it currently does not anticipate any material impact to its business from the coronavirus outbreak as it does not have extensive operations or manufacturing in China. It said it was monitoring the “complex situation”.
The firm's only unit here in China, Hubei Haosun Pharmaceutical, is in the Hubei province, the Chinese district at the centre of the coronavirus outbreak.
Coronavirus 2020
https://www.linkedin.com/pulse/hubei-vs-covid-19-in-depth-focus-expected-supply-chain-schurder/
Hubei vs. Covid-19: An In-Depth Focus on Expected Pharmaceutical Supply Chain Disruptions & Drug Shortages
Check out the amount of drugs coming from China.
Now I know why the aspirin shelf are empty. Now to find out what is happening with the toilet paper.
Jesse,
Do you mind if I use some of these points in my letter.
Laura
My letter-focus areas
This is by no means a final -just starting on an outline and focus areas. Since the letter will be sent to the Judiciary committees I need to grab their attention and not go into much detail on initial correspondence
I believe Marksman's reasoning and the Jefferies call, added to what The Judicial Court has been trying to do on reform, will make Amarin's case of interest in finally pushing for Patent Reform.
Focus areas, final to be more concise and provide case studies
If a District court does not have faith or lacks clarity in the authority and practice knowledge concluded by both the FDA and USPTO in granting patent and exclusion, (authority given to them by our government) to the point of reversing their costly prior approvals, how are companies or their investors to invest millions to go through their processes.
Furthermore, when you have 2 branches of the Judicial system (District v Federal) that are at odds on procedure (aside from personal opinions of the judges that conflicts to their sworn duty), how is innovation in medical research and intellectual property to advance the power of the United States.
Patent trolls have plagued the states for years, corruption has stifled growth of small companies, valuable advances in healthcare will never reach our people, China will hold us hostage for medical drugs to keep our nation alive. Millions of our US Citizens will die while we do nothing. Our elected officials are helplessly drowning in the swamp of big business, politics, judicial branches and China's greed, thus stifling US growth
Generic drugs are not the answer, Pharma big and small, will cease bringing us the advances in medicine because after spending millions and years to bring a drug to market they will now know how easily it can be stolen. Generics are not the same as brand in several cases and I believe this is the case here based on several failed trials of similar compounds.
Generic drug bare no burden of research and development, clinical trial, patents, nor can they be held liable for injury to patients. These are all costs of our US pharmaceutical companies and many small biotechs. We have now seen where a judge though a procedural error, can reverse patents, only four months after FDA approval, thus crushing the hopes of patients to have a life saving drug and investors who have in invest millions to bring to market only to give it to China or other global markets.
Is this America first? Is this supporting innovation in medical and technical fields? Is this giving away American's ingenuity to the same country that recently threatened to withhold lifesaving drugs.
Please fix this corruption of the US system. I believe Amarin's can set precedent on new reform.
Hey other,
This is very valuable information. I believe Marksman's reasoning and the Jefferies call, added to what The Judicial Court has been trying to do on reform, will make Amarin's case of interest in finally pushing for Patent Reform.
If a District court does not have faith or lacks clarity in the authority and practice knowledge concluded by both the FDA and USPTO in granting patent and exclusion, (authority given to them by our government) to the point of reversing their costly grantings, how are companies or their investors to invest millions to go through their processes. Furthermore, when you have 2 branches of the Judicial system (District v Federal) that are at odds on procedure (aside from personal opinions of the judges that conflicts to their sworn duty), how is innovation in medical research and intellectual property to advance the power of the United States. Patent trolls have plagued the states for years, corruption has stifled growth of small companies, valuable advances in healthcare will never reach our people, China will hold us hostage for medical drugs to keep our nation alive. Millions of our US Citizens will die while we do nothing. Our elected officials are helplessly drowning in the swamp of big business, politics, judicial branches and China's greed.
Generic drugs are not the answer, Pharma big and small, will cease bringing us the advances in medicine because after spending millions and years to bring a drug to market. Generics are not the same as brand in several cases and I believe this is the case here. Generic drug bare no burden of research and development, clinical trial, patents, nor can they be held liable for injury to patients. These are all costs of our US pharmaceutical companies and many small biotech. We now seen where a judge though a procedural error, can reverse patents, only four months after FDA approval and give it to China or other global markets.
Is this America first? Is this supporting innovation in medical and technical fields? Is this giving away American's ingenuity to the same country that recently threatened to withhold lifesaving drugs.
Please fix this corruption of the US system. I believe Amarin's can set precedent on new reform.
ILT
As an avid Fox watcher, I am all to familiar with these guys. Problem is I think they have a lot on their plate right now. I thought starting with the judicial committee, familiar with these patent issue, would get some attention. With that being said, it certainly would not hurt. Once I get the letter written, it would just as easy to send to all.