If You Can't Make Your Drug a Blockbuster, Sue Your Competitor

Amarin's (NASDAQ: AMRN  ) lawyers sure are keeping busy.

The company is appealing the Food and Drug Administration's decision to rescind the Special Protocol Assessment, or SPA, for its fish oil pill Vascepa. The SPA would allow the biotech to gain expanded approval to treat patients with moderately high triglyceride levels while waiting for an outcomes study in that population. The FDA pulled the SPA because it now wants to see the results of the outcomes study to confirm Vascepa is not only lowering triglyceride levels, but also reducing heart attacks and strokes.

Amarin is also suing the FDA over the agency's decision to only give Vascepa three years of exclusivity rather than designating it as a New Chemical Entity, which would entitle the drug to five years of exclusivity. Vascepa is a purified fish oil, but the FDA apparently decided that it wasn't different enough from GlaxoSmithKline's (NYSE: GSK  ) Lovaza to justify designating it as a New Chemical Entity.

Source: Amarin

And today the company announced it's suing AstraZeneca (NYSE: AZN  ) over its fish oil pill Epanova. The pharma giant acquired the drug when it purchased Omthera Pharmaceuticals last year. Amarin claims that its patent covers "lowering triglycerides by administering a pharmaceutical composition that includes amounts of EPA [eicosapentaenoic acid] as free acid, and no more than about 30% DHA [docosahexaenoic acid]."

EPA and DHA are two types of omega3 fatty acids found in fish oils. Amarin developed Vascepa as purified EPA because there's a hypothesis that DHA may actually increase bad LDL cholesterol. DHA makes up about 45% of the omega3 fatty acids in GlaxoSmithKline's Lovaza, and the drug increased LDL cholesterol by 44% in the pivotal study used to approve the drug. Vascepa on the other hand, lowered LDL cholesterol by 5%.

As best I can tell -- there's less info on Epanova because it's not approved yet -- AstraZeneca's drug fits the definition that Amarin claims to have covered. The bigger question is whether the patent is valid. In general, method of use patents like this one are a lot harder to defend than composition of matter patents.

Even if the chance for a positive outcome of each lawsuit/appeal is relatively low, it's probably worth whatever Amarin is paying the lawyers. Of course, the return on investment depends on sales of Vascepa and Epanova. Amarin has struggled to gain traction with Vascepa, selling just $10 million worth of the drug in the fourth quarter. If AstraZeneca has similar problems marketing Epanova, blocking or trying to gain a royalty on the drug won't be worth much to Amarin.

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Read/Post Comments (8) | Recommend This Article (4)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On March 04, 2014, at 6:33 PM, BioBillorg wrote:

    Brian, what's your pHD in?...basket weaving ...

    You are a bigger tool than Adam!

    When someone sh!t's in your sand box you kick em out

  • Report this Comment On March 04, 2014, at 7:30 PM, dontworrycmurray wrote:

    Brian, In case you dont understand. Its called patent infrigment. Since Amarin spend mult millions of dollars protecting their drug. Do you think they are going to sit back and let someone else infringe on their patents? But then again you probably wouldnt understand that..

  • Report this Comment On March 05, 2014, at 8:59 PM, bohdan wrote:

    Your title is misleading.

    And your story is so very shallow.

    There is a lot more at play than your few paragraphs capture.

    Get a clue man...............

  • Report this Comment On March 06, 2014, at 3:14 AM, RHMASS wrote:

    It is very unfortunate you has always held such a negative bias in any of your writing on AMRN, I think you have gone out of your way to do so and as such, you actually lost your credibility as a journalist or commentator on such matter. The real question is why? Just look at the title of your article this time, reader will know how biased you are.

  • Report this Comment On March 08, 2014, at 7:45 PM, dontworrycmurray wrote:

    Brian, By the response you get after writing your worthless articles I dont think you will be with the Fool to much longer. You see Brian readers want honest research from the M Fool not headlines. Thats the reason no one is commenting. I bet the pink slip is comming soon.

  • Report this Comment On March 10, 2014, at 3:51 PM, porgy wrote:

    Vascepa could be a hidden blockbuster if used off label. There have been several clinical trials using EPA-ethyl esters to treat depression. See the review article

    "Eicosapentaenoic acid appears to be the key omega-3 fatty acid

    component associated with efficacy in major depressive disorder:

    a critique of Bloch and Hannestad and updated meta-analysis" in Molecular Psychiatry (2012) 17, 1144 -1149, When you look at the tables, notice that the compound that had the greatest affect was pure EPA-ethyl ester.

    The nutraceutical companies know this and are selling same-dose Vascepa (1,000) as a dietary supplement without filing for ANDA. See http://www.renewlife.com/norwegian-gold-epa-1000-omega.html and

    http://www.advancednaturals.com/products/pure-epa-1000/ both clearly violating the Dietary Supplement Health Act of 1994.

    Porgy

  • Report this Comment On March 13, 2014, at 10:33 AM, jabel5 wrote:

    This story would have been more interesting if more details of the controversy were covered. What does it do to the risk of future drug development when the FDA commits itself to a SPA and then backs out of it? Will this action inhibit future expensive clinical trials by biotechs, knowing that even if the trial gets the result that the FDA says is a success in a SPA, the FDA might change its mind and call the trial a failure?

    What if the Amarin trial that is aimed to show cardiac benefits (REDUCE-IT) succeeds, as many of us expect from the existing scientific evidence? Amarin must protect their patents now, because to wait for that trial result would be much too late. Thus, your title is contrary to the facts and prejudicial. I would like to use more blunt language, but I am trying my best to honor the Fool's request to "Please be respectful with your comments".

  • Report this Comment On October 19, 2014, at 4:27 PM, johnford706 wrote:

    worthless article. MF writers are POS.

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