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April 15, 2014
10:22 EDTELTPElite Pharmaceuticals enters stock purchase agreement with Lincoln Park
Elite Pharmaceuticals announced yesterday that it has entered into a common stock purchase agreement with Lincoln Park Capital Fund for up to $40M. Proceeds from the transaction will be used to develop the company's pipeline of products, including the abuse resistant opioids, and for general corporate purposes. The company has agreed to file a registration statement with the SEC covering the shares that may be issued to Lincoln Park Capital under the terms of the common stock purchase agreement. After the SEC has declared the registration statement related to the transaction effective, Elite has the right over a period of three years to sell up to an aggregate of $40M of its common stock to Lincoln Park under the terms and amounts as set forth in the agreement. Under the terms of the agreement, there are no upper limits to the price that Lincoln may pay to purchase Elite's common stock.
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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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