Tue, May 31, 1:54 PM
- Micro cap Amarin (AMRN +7%) is up on double normal volume in response to its announcement that the FDA has determined that Vascepa (icosapent ethyl) capsules are eligible for five-year new chemical entity (NCE) marketing exclusivity under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act. The NCE exclusivity will be in effect from the date of FDA approval, July 26, 2012 until July 26, 2017.
- In addition, there is a statutory 30-month stay triggered by patent litigation (the company is automatically notified when a would-be generic competitor files its Abbreviated New Drug Application with the FDA which, in turn, automatically results in patent infringement litigation which triggers the automatic 30-month stay while the patent challenge runs its course) that potentially extends Vascepa's marketing exclusivity to January 26, 2020.
- Vascepa accounted for almost all (99%) of the company's Q1 revenue of $25.5M.
Wed, Mar. 9, 9:15 AM
- Gainers: LINE +27%. ATSG +24%. REXX +21%. DNR +19%. CRC +17%. BUFF +14%. LNCO +14%. BIOC +14%. SXE +14%. CJES +14%. SGY +14%. BETR +11%. AMRN +10%. BTE +9%. DANG +9%. BCEI +8%. GGB +7%. WLL +7%. SDLP +7%. EXPR +7%. CLF 6%. PBR 6%. CHK 6%. PBR.A 5%.
- Losers: SDRL -13%. DSX -9%. BPT -9%. GRPN -5%. PLNT -5%. YELP -5%.
Tue, Mar. 8, 4:39 PM
- Amarin (NASDAQ:AMRN) wins its First Amendment litigation against the FDA [Amarin Pharma, Inc. et al. v. FDA et al., No. 15-3588 (S.D.N.Y. May 7, 2015] concerning off-label promotion of Vascepa (icosapent ethyl) Capsules.
- Under the terms of the settlement, both parties agree to abide by the August 7, 2015 judicial declaration that Amarin may promote the off-label use of Vascepa to healthcare professionals with the proviso that it is done so in a truthful and non-misleading manner. In addition, the FDA agreed to provide the company with an optional preclearance provision through 2020 for new off-label claims. Both parties also agreed to a dispute resolution provision designed to avoid future litigation.
- The dispute arose over Amarin's desire to inform physicians of the data from the ANCHOR clinical trial which showed a statistically significant treatment benefit in patients with high triglycerides (between 200 mg/dL and 500 mg/dL) who received Vascepa. The FDA cried foul citing Vascepa's narrower clearance for patients with triglyceride levels above 500 mg/dL, a much smaller patient population.
- Shares are up 9% after hours on light volume.
- Previously: Court says Amarin can promote Vascepa for off-label uses; shares up 5% (Aug. 7, 2015)
- Previously: Amarin sues FDA to allow it to communicate ANCHOR results to docs (May 7, 2015)
- Update: Judge Paul Engelmayer approved the settlement terms on March 9.
Thu, Feb. 25, 9:12 AM| Thu, Feb. 25, 9:12 AM | 9 Comments
Nov. 9, 2015, 10:05 AM
- A study of ~200 adult Japanese coronary heart disease (CHD) patients , called CHERRY, evaluating the efficacy of statin therapy [Livalo (pitavastatin)] alone and statin therapy in combination with highly-purified EPA showed that the addition of EPA significantly improved coronary plaque volume compared to treatment with statin alone. The data were presented yesterday at the American Heart Association Scientific Sessions in Orlando, Florida.
- After six to eight months, the EPA/statin cohort (n=97) showed statistically significant improvements in coronary plaque volume (p<0.001), lipid volume (p<0.05) and fibrous volume (p<0.05) while the statin-only cohort (n=96) failed to achieve statistical significance on any measure. The prevalence of clinically significant plaque regression, defined as more than a 15% reduction in plaque volume, was significantly greater in the EPA group versus the statin-only group (48% versus 25%; p<0.001).
- CHERRY is the first study to use IB-IVUS (integrated backscatter intravascular ultrasound) to measure the effects of statin plus EPA on plaque regression. It is considered a feasible means to predict future cardiovascular events while the analysis of specific tissue components is considered useful for assessing the risk of a coronary event in patients with atherosclerosis. The study was performed independently by researchers in Japan.
- EPA is the active ingredient in Amarin's (AMRN +6.9%) Vascepa (icosapent ethyl), which is currently being investigated for its potential to reduce the incidence of first major cardiovascular events in high-risk patients in an ~8,000-subject study called REDUCE-IT. The company expects to complete the trial in 2017 and publish results in 2018. Over 7,700 patients have been enrolled to date.
Nov. 9, 2015, 9:14 AM
Sep. 17, 2015, 5:37 PM
Aug. 7, 2015, 10:55 AM
- Citing protection under the First Amendment, U.S. District Court Judge Paul Engelmayer in Manhattan rules that the FDA cannot stop Amarin (AMRN +5.4%) from promoting Vascepa (icosapent ethyl) for off-label uses as long as it does so truthfully.
- Long-suffering shareholders will surely appreciate the positive news. The company has lost over 99% of its value since its glory days.
Jul. 7, 2015, 5:36 PM
May 28, 2015, 5:40 PM
May 28, 2015, 3:48 PM
- Amarin (AMRN +18.2%) jumps on a 6x surge in volume in response to its announcement that the federal district court for the District of Columbia has granted the company's motion for summary judgement in its case against the FDA seeking an order requiring the regulator to recognize five-year marketing exclusivity for Vascepa (icosapent ethyl) as a New Chemical Entity (NCE). The company believes the market exclusivity period should extend through July 25, 2017, five years after the FDA's approval in July 2012.
- The court's ruling also confirms that the FDA cannot accept Abbreviated New Drug Applications (ANDAs) for generic versions of icosapent ethyl until July 2016. The automatic 30-month statutory stay triggered by the submission of an ANDA would push approvals out until January 2020.
- Amarin plans to dismiss current Vascepa patent litigation related to previously submitted ANDAs.
- The company has another lawsuit pending against the FDA seeking authorization to communicate ANCHOR clinical trial data to doctors.
- Previously: Amarin sues FDA to allow it to communicate ANCHOR results to docs (May 7)
Apr. 28, 2015, 9:12 AM
Mar. 31, 2015, 5:36 PM
Mar. 17, 2015, 12:45 PM
Mar. 16, 2015, 9:14 AM
Mar. 16, 2015, 8:41 AM| Mar. 16, 2015, 8:41 AM | 4 Comments
Amarin Corp. Plc is a biopharmaceutical company, which engages in the commercialization and development of therapeutics to improve cardiovascular health. Its product, Vascepa capsules, is use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.... More
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