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June 10, 2014
11:16 EDTELTPElite Pharmaceuticals in $5M settlemet agreement with Novel Laboratories
Elite Pharmaceuticals entered into a settlement agreement with Novel Laboratories, Veerappan S. Subramanian, VGS Pharma and other related parties pursuant to which the 2006 Strategic Alliance Agreement and Stockholders Agreement with Subramanian and VGS were terminated and all parties executed mutual releases. In addition, the VGS Parties paid Elite $5M in exchange for 9,800 shares of Novel Class A common stock owned by Elite. This resolves all disputes and claims between Elite and the VGS Parties, including those alleged in the action commenced by Elite against the VGS Parties on April 28, 2014, and ends Elite's ownership in Novel.
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April 21, 2015
10:03 EDTELTPElite Pharmaceuticals announces launch of generic Hydroxyzine tablets
Elite Pharmaceuticals announced the launch of generic Hydroxyzine HCI 10 mg, 25 mg and 50 mg tablets through Epic Pharma LLC, a private pharmaceutical company located in Laurelton, NY. Hydroxyzine is indicated for symptomatic relief of anxiety and tension associated with certain disease states and management of pruritus due to certain allergic conditions. Annual U.S. sales for immediate release Hydroxyzine HCI 10 mg and 25 mg and 50 mg tablets are approximately $40M for the twelve months ending June 30, 2014 according to IMS Health Data. Epic will manufacture, package and distribute the product under the Manufacturing and License Agreement previously signed between Epic and Elite. Elite also announced that dosing was completed for two studies to support ELI-200 product labeling - the fed study and the withdrawal effects study. The first study is a Phase I, open-label, randomized, single-dose, three-way crossover study to compare the bioavailability of ELI-200 to the reference product under fed conditions in healthy volunteers. The second study, a safety study, is a randomized, double-blind, multiple-dose, parallel group study to evaluate the potential withdrawal effects following administration of ELI-200 versus the reference product in methadone-maintained opioid-dependent subjects. Final study results are not yet available. A Phase III efficacy study is scheduled to begin dosing this quarter.

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