Thu, May 28, 5:40 PM
Thu, May 28, 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)
Fri, May 8, 9:11 AM| Comment!
Fri, May 8, 6:02 AM
Thu, May 7, 5:30 PM
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
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Mon, Mar. 16, 8:41 AM| 4 Comments
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