Elbit Systems announced, further to the company's announcement of January 5, 2021, that it was awarded a contract valued at approximately $1.65B for the establishment and operation of the International Flight Training Center of the Hellenic Air Force, as part of an agreement between the Israeli Ministry of Defense and the Hellenic Ministry of National Defense. The contract will be performed over a period of approximately 20 years and will include price indexation. Under the contract, Elbit Systems will supply new M-346 training aircraft and will maintain the entire training fleet, comprised of dozens of M-346 and T-6 training aircraft for a period of approximately 20 years. In addition, the company will provide its latest advanced Embedded Virtual Avionics onboard the training aircraft, deliver networked flight simulators and an array of Ground-Based Training Stations as well as a command and control systems to enable efficient management of the flight training operation.

Amarin announced that further analyses from the Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: EVAPORATE Trial were presented as Late-Breaking Science at European Society of Cardiology Preventive Cardiology 2021, the Annual Congress of the European Association of Preventive Cardiology, on April 17. As previously reported and published in the European Heart Journal, VASCEPA demonstrated significant, 17% regression of low attenuation plaque volume on multidetector computed tomography compared with placebo over 18 months. The Effect of Icosapent Ethyl on Changes in Coronary Plaque Morphology: EVAPORATE analyses presented at ESC Preventive Cardiology 2021 demonstrated that with administration of 4 g/day of VASCEPA on top of statin therapy, there was an observed change in plaque stability occurring at 9 months and sustained through 18 months. Of the 80 patients that were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial, 55 patients had images that were able to be utilized for the histology-validated software. The EVAPORATE plaque morphology study used ElucidVivo, the first FDA-cleared analysis for specific tissue characterization using histopathologic correlates to assess plaque morphology characteristics, including Lipid Rich Necrotic Core, fibrous cap thickness, and intraplaque hemorrhage. Whereas with placebo LRNC increased and cap thickness decreased, both indicative of moving to a less stable phenotype, with icosapent ethyl there was a measured LRNC decrease and cap thickness increase, indicative of moving to a more stable phenotype. The primary limitation of this single coronary plaque study as identified by its investigators is its small sample size. More study is needed to more fully understand the effects of VASCEPA on coronary plaque to determine the relationship, if any, of such plaque effects on cardiovascular risk reduction.

Avadel Pharmaceuticals announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act target date of October 15, 2021. FT218 demonstrated significant consolidation of sleep on polysomnography for the 6 g dose at Week 3, the 7.5 g dose at Week 8, and 9 g dose at Week 13 compared to placebo. Data from the randomized, double-blind, placebo-controlled, multicenter, parallel-group study showed that the mean difference between FT218 and placebo for disturbed nocturnal sleep was statistically significant at all doses tested. FT218 was generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions. Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients with Narcolepsy: Additionally, FT218 demonstrated significant improvement in the Epworth Sleepiness Scale versus placebo at all doses tested. FT218 showed a statistically significant improvement compared to placebo at all doses tested for sleep quality and refreshing nature of sleep on a visual analogue scale, and for sleep paralysis on a sleep symptom diary. FT218 did not demonstrate significant improvement for hypnagogic compared to placebo. Adverse events were similar to the known sodium oxybate safety profile.