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December 23, 2016

PLx and Dipexium Merge to Commercialize Targeted Aspirin Products

  • PLx Pharma and Dipexium Pharmaceuticals have agreed to an all-stock merger, through which Dipexium is issuing approximately 36 million new shares of its common stock to PLx shareholders. Following closure, PLx shareholders will own some 76.55% of Dipexium shares. The merger is expected to close during Q2 2017, subject to customary conditions.

    The combined entity will retain the PLx Pharma name and focus on completing manufacturing scale-up and label finalization for PLx’s Aspertec™ 325-mg aspirin dosage form, which has been granted conditional approval in the U.S., and the filing of a supplemental NDA for Aspertec 81-mg maintenance dosage form. PLx is exploiting its PLxGuard™ targeted drug delivery system for the development of safer, more effective aspirin products. The firm claims its Aspertec aspirin offers more reliable and predictable antiplatelet activity to high-risk cardiovascular and neurology patients compared with enteric-coated aspirin, while also reducing adverse gastrointestinal side effects. The PLx Pharma clinical pipeline also includes PLx ibuprofen formulations, with PLx diclofenac and indomethacin formulations in preclinical development.

    Commenting on the merger with Dipexium Pharmaceuticals, Natasha Giordano, president and CEO of PLx Pharma, said, "This merger will provide PLx Pharma with the initial resources necessary to advance our contemplated development efforts for Aspertec and begin the critical precommercialization activities necessary to prepare the market for this important cardiovascular product."

    Dipexium Pharmaceuticals has been focused on the development and commercialization of its broad-spectrum topical antibiotic peptide, Locilex® (pexiganan cream 0.8%), for the treatment of mild and moderate skin and skin structure infections. However, in October 2016 the firm reported that Locilex failed to meet the primary clinical endpoint in two Phase III studies in patients with mild diabetic foot ulcer infections, and there was also evidence of a higher incidence of osteomyelitis and cellulitis in the Locilex treatment arms.
     

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