Thu, May 7, 4:52 PM
- In a regulatory filing, Amarin (NASDAQ:AMRN) disclosed that it, along with four independent physicians, filed a lawsuit against the FDA to allow it to communicate the efficacy data from the ANCHOR clinical trial that assessed Vascepa (icosapent ethyl) for the treatment of patients with high triglycerides (between 200 mg/dL and 500 mg/dL) who were also on statin therapy. The trial met its primary and secondary endpoints but the FDA did not approve the expanded label because it withdrew the company's Special Protocol Assessment (SPA). Per current FDA regulations, company representatives may only promote approved indications for their products. No "off-label" communications are allowed.
- Amarin seeks a judicial declaration that the FDA's regulations forbidding off-label promotion of truthful and non-misleading information are unconstitutional based on the First Amendment guaranteeing free speech and the Fifth Amendment guaranteeing due process. The lawsuit is captioned: Amarin Pharma, Inc., et al. v. Food & Drug Administration, et al. (Case No. 1:14-cv-00324).
- It also seeks the freedom to communicate the health claim of supportive, but not conclusive, research that shows the consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease as well as the data from peer-reviewed publications that show the potential effect of EPA on the reduction of the risk of coronary heart disease.
- Amarin is not alone in using the free speech angle to justify promoting off-label use. The pharmaceutical industry is pressuring the agency to soften its restrictions in light of a 2012 appeals court ruling exonerating a drug sales rep from promoting off-label in a truthful and non-misleading manner based on First Amendment protection. A bill currently working its way through Congress, The 21st Century Cures Act, contains language that relaxes the guidelines. The FDA will hold a public hearing on the issue this summer.
- Previously: FDA to hold public meeting on off-label drug promotion (May 7)
Tue, Apr. 28, 10:16 AM
- It took more than a year, but the FDA finally sends a Complete Response Letter (CRL) to Amarin (AMRN -5.1%) to address its supplemental New Drug Application (sNDA) for an expanded label for Vascepa (icosapent ethyl) to include use as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with mixed dyslipidemia (one or more lipid disorders) and triglyceride levels from 200 to 499 mg/dL (ANCHOR population). Vascepa is currently cleared as an adjunct to diet to reduce TG levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia. Vaccepa's current labeling remains unchanged.
- The original PDUFA date for the sNDA was December 20, 2013. In October, the FDA rescinded the Special Protocol Assessment after its advisory committee voted 9-2 against the expanded indication citing the need for "more clinically relevant measures of efficacy."
- In the CRL, the FDA acknowledged that Vascepa demonstrated a treatment effect compared to placebo in reducing TG levels in the ANCHOR study but stated that there are insufficient data at present that support a drug-induced change in TGs as a surrogate for reducing CV risk, the rationale for the use of Vascepa in the ANCHOR population. The FDA did not determine that the effects of Vascepa, which go beyond lowering TGs, would not actually reduce CV risk. Despite Amarin proposing alternative indications and disclaimers, the agency has decided not to approve the expanded indication.
- The company, with the support of the FDA, intends to complete the 8,000 patient REDUCE-IT CV outcomes study, which is currently 93% enrolled. The independent Data Monitoring Committee is expected conduct an interim review of the data in 2016. The study is projected to be completed in 2017 with final results available and published in 2018.
Tue, Apr. 28, 9:12 AM
Wed, Apr. 8, 1:05 PM
- The following companies are extended at least 30% above their 50-day moving averages, trade at least 500K shares per day, have market caps less than $500M and have poor fundamentals:
- (CAPN -7.6%)(AMRN +4.1%)(NYMX +3.6%)(CRMD -1.2%)(CNDO +6.8%)(ADXS +13.1%)(AXN +3.6%)(DRRX +4.9%)(CYTX -1.9%)(AVEO +2.6%)(RIGL +1.8%)(NVGN +10.5%)
- The list is not meant to provide Buy/Sell recommendations. It is a group of stocks that may warrant further research by individual investors.
Tue, Mar. 31, 5:36 PM
Tue, Mar. 17, 12:45 PM
Mon, Mar. 16, 9:14 AM
Mon, Mar. 16, 8:41 AM| Mon, Mar. 16, 8:41 AM | 4 Comments
Fri, Mar. 13, 12:45 PM
Thu, Mar. 12, 12:45 PM
Thu, Mar. 12, 9:14 AM
Thu, Mar. 12, 8:27 AM
- Amarin (NASDAQ:AMRN) is up 16% premarket on increased volume. H.C. Wainwright analyst Andrew Fein upgraded the stock to "Buy" with a $10 price target. The consensus analyst rating on the stock is "Hold" with a $6 target.
- Maybe Mr. Fein sees something that others don't. According to TipRanks.com, he is a top 100 analyst with an average return of 36.5% and a 69.2% success rate.
- In Q4, Amarin posted a 64% increase in revenue. Vascepa revenue was $16.5M. Consensus view for Q1 is a loss per share of ($0.12) on revenues of $18.7M.
Wed, Mar. 11, 5:36 PM
Fri, Mar. 6, 7:16 AM
- Amarin (NASDAQ:AMRN) enters into a definitive securities subscription agreement with institutional investors, both existing and new, for the private placement of up to a maximum of $52.8M of restricted American Depositary Shares at $0.15, each representing one share of the company's non-voting Series A Convertible Preference Shares.
- Each ten Series A Convertible Preference Shares may be consolidated and redesignated as one ordinary share up to a maximum aggregate of 35,215,079 ordinary shares.
- Net proceeds of ~$52.2M will fund the commercialization of Vascepa, advance the REDUCE-IT cardiovascular outcomes trial and general corporate purposes.
Wed, Mar. 4, 9:13 AM
- Gainers: IFON +44%. NVGN +44%. EFUT +36%. CNDO +27%. W +22%. ATOS +16%. PHMD +20%. ATHM +13%. NURO +12%. SWHC +10%. AMRN +9%. AEO +8%. AMBA +8%. CRMD +8%. SOL +7%. OREX +7%. TIVO +6%. EXAS +5%.
- Losers: CYCC -22%. BOBE -19%. TNET -16%. BV -16%. VEEV -15%. CYTX -8%. ANF -8%. ONCY -6%. ACHN -5%. FAST -5%.
Tue, Mar. 3, 4:26 PM
- Amarin (NASDAQ:AMRN) Q4 results ($M): Revenues: 16.5 (+63.5%); Operating Expenses: 30.8 (-20.8%); Net Loss: (19.7) (-27.6%); Loss Per Share: (0.11) (+59.3%); Quick Assets: 119.5 (-37.6%).
- Vascepa revenue of $16.5M represented a sequential increase of 17.0% versus Q3. Prescriptions were up 11% sequentially and 55% compared to a year ago.
- Patient enrollment in the REDUCE-IT cardiovascular outcomes trial should be completed this year (8,000 subjects). The study will continue until the attainment of 100% of the 1,612 primary endpoint events which is estimated to happen in 2017 with results ready for publishing in 2018.
- The company does not expect a favorable decision from the FDA regarding its ANCHOR supplemental New Drug Application (sNDA) which had a PDUFA date of December 20, 2013. In September 2014, the agency denied the company's appeal of its decision to rescind the ANCHOR trial Special Protocol Assessment (SPA) and management decided not to appeal further.
- Shares are up 3% after hours on moderate volume.
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