The Irish biotech company's stock has continued its upward march this month, with shares gaining We can attribute Amarin stock's incredible September performance to the company's release on Sept. Armed with this strong trial result, Amarin "should now have little trouble getting Vascepa's label expansion approved in the United States," according to George. That would surely be a particularly welcome boon for the company and its investors, as the stock has been struggling for a long time.
Here's the year stock picture:. Amarin plans to release additional details from the study at the Scientific Sessions of the American Heart Association on Nov. Investing Best Accounts. Stock Market Basics.
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Amarin Corporation plc (AMRN)
New Ventures. Search Search:. Oct 9, at AM. Image source: Getty Images. Stock Advisor launched in February of Join Stock Advisor. Related Articles.The company's sole product, Vascepa, is a drug derived from fish oil. It was approved by the U. Food and Drug Administration FDA as an add-on with statin therapy to lower the risk of heart attack, stroke, and cardiovascular disease and to bring down high levels of triglycerides in adult patients.
The stock plummeted in late March after the company lost a patent trial it had brought against two generic drug manufacturers, Hikma Pharmaceuticals and Dr. Reddy's Laboratorieswhich were seeking to sell an equivalent version of Vascepa. The decision weakened Amarin's protection against potential generic competition, and the company filed an appeal with a federal circuit court earlier this month.
The outcome of that decision will be key for Amarin's revenue in the U. As mentioned, Amarin's first quarter was a success, with increased revenue and gross margins from sales of Vascepa in the U. The company reported positive net cash flow from operations and expanded its sales force to representatives and managers. Combined with improved managed care coverage for Vascepa in the U. The expansion of sales representatives provides a unique opportunity for Amarin to educate healthcare professionals about the benefits of Vascepa in cardiovascular risk reduction, which should help bolster the number of prescribers.
That said, this success may not continue. Social distancing measures have created challenges for the sales team, including the suspension of in-person meetings. Nonetheless, management says the sales team has identified new methods to receive feedback from healthcare providers.
They expect a decline in continued growth from current prescribers in the second quarter, noting a decrease in prescriptions in the month of April. Investors should be excited to learn that growth lies ahead in international markets. Canada -- where about 2. China may also offer an exciting commercial opportunity once Amarin's partner there, Eddingpharm, nears completion of a clinical trial later this year barring any COVIDrelated delay.
Success in China -- where management believes about It is currently under registration in other countries in the MENA region. A decision is anticipated near the end of Cardiovascular disease is the leading cause of death for both men and women in many parts of the EU, and an approval of Vascepa in the region may provide future top-line growth and long-term shareholder value by increasing sales, earnings, and free cash flow.
It is expected to make a decision by Q3 In the original patent infringement case, Amarin Pharmaceuticals the plaintiff was seeking to prevent Hikma Pharmaceuticals and Dr. Reddy's Laboratories the defendants from launching generic competitors to Vascepa.
The most recent decision in the case held that Amarin's patents did not meet the criteria of "non-obviousness," making them invalid. Amarin's decision to appeal the court's ruling and file a preliminary injunction prevents rivals from launching generic competitors to Vascepa -- even if they receive FDA approval of an Abbreviated New Drug Application ANDA for generic drugs -- until the court's final decision is reached.Sure, there was a little intrigue along the way.
The drug, first approved in for lowering triglyceride levels, is now also approved to reduce cardiovascular risk. Amarin's shares soared on last week's FDA decision. Sales of Vascepa are sure to soar very soon. Plenty of observers including yours truly anticipate that Amarin could become an acquisition target. But don't think that Amarin is totally out of the woods. The biotech still faces three key risks after its huge FDA win for Vascepa. The biggest risk for Amarin, by far, is that the company could fail to meet the lofty expectations for Vascepa.
But that's just the beginning. There are also plenty of analysts with sales projections somewhere in between those levels. I don't think that's an unrealistic prospect. However, there are quite a few scenarios that could unfold where Amarin misses those expectations. Many of the highest sales projections for Vascepa assume that the drug will have the market all to itself.
That could prove to be an invalid assumption. Acasti Pharma expects to announce results from its late-stage Trilogy 1 clinical study evaluating triglyceride-lowering drug CaPre this month.
Results from a second late-stage study, Trilogy 2, should be announced in late January Matinas BioPharma could present a bigger threat. The biotech plans to report results from a head-to-head pivotal study comparing its drug MAT against Vascepa in the fourth quarter of next year.
But while Acasti and Matinas are initially focusing on besting Vascepa at lowering triglycerides, AstraZeneca seeks to win the big prize -- reducing cardiovascular risk. The drugmaker should wrap up its cardiovascular outcomes study for Epanova in August Epanova was approved by the FDA in for lowering triglyceride levels. Most of the key patents for Vascepa don't expire until or later. So is Amarin safe for at least the next decade?
Not necessarily. The company faces patent challenges for Vascepa from Hikma Pharmaceuticals and Dr. Reddy's Laboratories. Such patent challenges are often settled. Amarin and Teva Pharmaceuticals struck a deal where Teva will be able to sell a generic version of Vascepa in the U. However, there's no guarantee that either Hikma or Dr. Reddy's will go for a similar settlement agreement. There's also no guarantee that Amarin will win in its litigation over the challenges to its patents for Vascepa.
All three of these are valid risks for Amarin and shouldn't be ignored. However, they should be viewed in perspective. Most biotech stocks face similar risks.
I don't think that Amarin is more vulnerable than the average biotech would be. I remain quite bullish about Amarin's prospects. I also still think that Amarin is a great acquisition target.Yahoo Finance. Sign in. Sign in to view your mail. Finance Home.
Currency in USD. Add to watchlist. Market open. Summary Company Outlook. Top Reactions. According to the Investor Relations update, patent appeal ruling can be expected anywhere between 6 months to 9 months. That sure is such a long time.
The Stock price have been crucified for the past couple of months and it is unfortunate that it would continue to do so for another months. AMRN management has to put more effort to prop up the product, and constantly provide updates on sales, covid 19 situation, trials taking in collaboration with others for Covid 19 Treatment, etc I mean constantly release something positive rather than just letting this go idle.“นิก” ปัดข้อเรียกร้อง “พชร์” หลังศาลนัดไกล่เกลี่ยคดีหมิ่นประมาท - Apop Today
Ideally, settlement with Reddys and Hikma would be the best. I know some of you guys had mentioned that a ruling must take place regardless. Is it just me?
I keep on asking for more effort from management. I had emailed Investor relations several times, but getting some cookie cutter responses.
What do you guys think? Reply Replies 2.A marin shares fell sharply Monday evening after a federal judge ruled that key patents covering its heart drug Vascepa were invalid. The decision is a victory for two drug makers, Hikma Pharmaceuticals and Dr. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.
And for those of us that own AMRN, it was painful. The judge supported her ruling with a 70 page opinion. Given the facts and law, her ruling was not ridiculous. However, the battle is not over. I provide biopharma investors insight into the significance of this ruling and the future of this lawsuit e. By Jonathan Saltzman — Boston Globe.
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About the Author Reprints. Tags biotechnology. They were not obvious to the FDA. My Covid symptoms have lasted more than days,….The spark behind this eye-catching move northward was the release of the U. Food and Drug Administration's FDA briefing materials for the company's upcoming advisory-committee meeting set for this Thursday. Come Thursday, Amarin and the FDA's panel of experts will mull over the putative cardioprotective benefits of the company's prescription omega-3 treatment known as Vascepa.
The big deal is that Vascepa's addressable market would expand to upwards of around 9. Future price hikes, combined with the continued growth of this target market as a whole, though, could push Vascepa's sales into truly rarefied air. For those new to the world of biopharma, Lipitor and Humira are the two bestselling pharmaceutical products of all time.
That's just how big of a deal Vascepa's proposed cardioprotective indication is from a commercial standpoint. With this background in mind, it's arguably the perfect time to consider if Amarin's stock can climb even higher in the days and weeks ahead. Here's a look at Amarin's potential risks and rewards in light of yesterday's market-moving event.
Amarin's stock sports two clear-cut risk factors: the regulatory risk associated with Vascepa's proposed label expansion and the company's real world ability to fully capitalize on this ginormous commercial opportunity, post-approval. Now, the risk emanating from the upcoming label-expansion decision appears to be minimal in the wake of yesterday's briefing-document release. The most critical issue heading into this advisory-committee meeting was the potentially confounding effect of the mineral oil placebo on the magnitude of Vascepa's observed cardioprotective benefit in the Reduce-It trial.
However, the FDA's own reviewers admitted that they couldn't explain away Vascepa's cardioprotective benefit simply as a function of a non-inert placebo.
So, unless something truly extraordinary happens at Thursday's meeting, the FDA will more than likely approve Vascepa's label expansion. Amarin's key risk thus boils down to the company's ability to maximize Vascepa's commercial potential. Although Amarin is planning on significantly beefing up its sales force once the FDA formally approves this label expansion, the reality of the situation is that the company simply cannot tackle this vast market by itself.
Amarin doesn't have the commercial infrastructure or the marketing clout to cover all the bases, so to speak. There's an inherent structure reason, after all, why all the bestselling drugs in the world are either marketed directly by a pharma titan or at least partnered with one of the industry's biggest names.
There is a wildcard at play here, however.
Amarin's management hasn't even attempted to build out a broader clinical pipeline to complement Vascepa, and that's a big tell in regards to the company's value-creation strategy. Cutting to the chase, Amarin has probably already fielded a few tender offers in the event the FDA greenlights Vascepa's Reduce-It indication. Making this situation even more intriguing is that both Amgen and Pfizer have been been gobbling up high-value assets of late in order to finally move beyond the patent cliff.
Vascepa, for its part, could turn into a crown jewel of the pharma industry under the umbrella of either Amgen or Pfizer, making it a highly desirable asset for these titans of the industry.
How much could Amarin fetch in a buyout? When would a buyout most likely occur? Big pharma has a tendency to announce needle-moving business development moves early in the year -- frequently in January around the time of the J.
Morgan Healthcare Conference. The reason is that these early-year announcements help to set the stage for investors' expectations for the full year. The big picture is that investors shouldn't be surprised if Amarin indeed gets this all-important label expansion for Vascepa before the end of the year, and this regulatory win, in turn, leads to a buyout at a healthy premium within the first quarter of Investing Best Accounts.The pharma stock collapsed on the threat of generic competition for a drug that launched in Decemberbut the move may have been a bit of an overreaction.
Amarin's sole revenue generator was stripped of its patent protection in the U. The mid-cap drugmaker's poor start to the year could be an outstanding buying opportunity for long-term investors. An FDA briefing could improve the chances of approval for an important new indication for Vascepa.
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Amarin Corporation plc (AMRN)
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3 Risks Amarin Still Faces After Its Huge FDA Win for Vascepa
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