Amarin Corp Plc (AMRN)

[Biobillionair]

GSK will aquire Amarin. They have been setting this up for over a year with the shut down of their website. They've now rebooted it with the TRUTH, increase LDL and A.fib warnings. This helps sheild them from Antitrust suits....oh I know what your thinking....here goes Williams with Antitrust BS again, but here's my angle:
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May 31, 2006

Antitrust Case Against Abbott Moves Forward: Were TriCor Formulation Changes Illegal?

In an opinion released last Friday, Judge Kent A. Jordan of the U.S. District Court for the District of Delaware denied Abbott's motion to dismiss numerous antitrust claims in Abbott Labs et al. v. Teva Pharms. et al., No. 02-1512.

The antitrust claims were originally brought by Teva and Impax as counterclaims in patent infringement litigation concerning Abbott's TriCor (fenofibrate) drug product, a treatment for high cholesterol and triglycerides. Later, various pharmacies and third-party payors filed related antitrust claims against Abbott, and those cases were consolidated with the patent infringement cases. The antitrust plaintiffs are seeking treble damages from Abbott.

Teva and the other antitrust plaintiffs allege that Abbott responded to the threat of generic entry by changing the formulation of TriCor, not to improve the product but simply to prevent generic formulations from becoming AB-rated for substitution with TriCor. Pharmacists may substitute a generic equivalent for a branded drug only if the generic drug has been AB-rated by the FDA, which means not only that the generic drug is bioequivalent to the branded drug, but also that the generic has the same form, dosage, and strength.

If true, Teva's allegations reveal how Abbott employed some very creative "life-cycle management" strategies for TriCor:

1998: Abbott receives FDA approval for TriCor capsules;
1999: Teva files ANDA for TriCor capsules, with Paragraph IV certification to U.S. Pat. No. 4,895,726, covering the TriCor capsule formulation;
2000: Abbott sues Teva for patent infringement, initiating a 30-month stay;
early 2001: Abbott files a new NDA for 54 mg and 160 mg TriCor tablets, submitting capsule safety and efficacy data as support;
Sep. 2001: FDA approves Abbott's TriCor tablets NDA; Abbot withdraws capsules from market and changes the code for TriCor capsules in the National Drug Data File ("NDDF") to "obsolete," meaning pharmacies can no longer fill TriCor prescriptions with a generic capsule formulation;
Mar. 2002: N.D. Ill. grants summary judgment of non-infringement to Teva in the capsule litigation;
Apr. 2002: FDA approves Teva's ANDA for TriCor capsules;
Jun. 2002: Teva files ANDA for 54 mg and 160 mg TriCor tablets, with Paragraph IV certification;
Oct. 2002: Abbott sues Teva for infringing its patents on TriCor 54 mg and 160 mg tablets, initiating another 30-month stay; Teva files counterclaims for antitrust violations;
Mar. 2003: Fed. Cir. affirms summary judgment in capsule litigation;
2003-2005: Abbott files a new NDA, for 48 mg and 145 mg TriCor tablets, seeking a label change stating that the new tablets need not be taken with food (the "no food effect label");
May 2005: D. Del. grants partial summary judgment of non-infringement to Teva in the tablets litigation; FDA then grants final approval to Teva's ANDA for 54 mg and 160 mg TriCor tablets; Abbott voluntarily dismisses remaining patent infringement claims.
Teva is pursuing ten separate antitrust claims against Abbott, including Sherman Action monopolization and sham litigation violations, Walker Process violations, and state law tortious interference with valid business expectations. In opposition to Teva's motion to dismiss, Abbott unsuccessfully argued that changing its TriCor formulation did not violate federal antitrust law; that any actions taken in its patent infringement litigation are immune under the Noerr-Pennington doctrine because Teva did not adequately plead the litigation was a sham; and that the state law allegations failed to state a claim.

While acknowledging that "[o]ne of the benefits of competition is the introduction of new, improved products," the court relied on the Microsoft case, 253 F.3d 34 (D.C. Cir. 2001) and the "nature of the pharmaceutical drug market," to determine that Teva's antitrust counterclaims should proceed and be analyzed under the "rule of reason." According to Judge Jordan's opinion, "The per se standard proposed by Defendants presupposes an open market where the merits of any new product can be tested by unfettered consumer choice. But here, consumers were not presented with a choice between fenofibrate formulations. Instead, [Abbott] allegedly prevented such a choice by removing the old formulations from the market while introducing new formulations.

As the antitrust case moves forward, "Plaintiffs [will] not [be] required to prove that the new formulations were absolutely no better than the prior version or that the only purpose of the innovation was to eliminate the complementary product of a rival. Rather, as in Microsoft, if Plaintiffs show anticompetitive harm from the formulation changes, that harm will be weighed against any benefits presented by Defendants."

http://www.orangebookblog.com/2006/05/antitrust_case_.html
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GSK by shutting down Lovaza website in the Fall of 2012, then rebooting it in the Summer of 2013 with LDL and Afib warnings galore have clearly indicated superior clinical and safety profiles driving them to withdraw Lovaza and replace it with Vascepa.

This is definitely going down...When, How much, and with what other BP ire the questions....

AZN didn't get invited to the Omega party, did Merck, Pfizer, Abbott, TEVA....get invited?

After Anchor Vascepa target population is 50 million patients in the US, 200 million world wide. This is a World wide drug, REDUCE-IT is in many European, Asia, and North American countries.

REDUCEIT success doubles the above to: 100,000,000 target in US and 600,000,000 World.

Japan has Epadel OTC, one of the first Pharmaceuticals in Japan to change from prescription to OTO.

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Lovaza will be withdrawn, generics Omega prescriptions will never happen, Omthera might get it done...but they will have no patents and have a clinically inferior drug, GSK leads a consortium of BP's that aquire Amarin for more than any have predicted....$15 Billion plus.

BP's have purchased Hep C bios with no products, Amarin has a drug that will out sell Lipitor records by multiples.

Good luck

Williams/Biobillion