Dipexium Pharmaceuticals, Inc., a late-stage pharmaceutical company, and PLx Pharma Inc. (PLx Pharma), a privately held late-stage specialty pharmaceutical company, have entered into a definitive agreement under which PLx Pharma will merge with a wholly-owned subsidiary of Dipexium in an all-stock transaction.
Following closing, Dipexium will be renamed PLx Pharma Inc., and will operate under the leadership of the PLx management team with Michael Valentino serving as executive chairman of the company's board of directors and Natasha Giordano serving as president and chief executive officer.
The combined company will initially be focused on completion of manufacturing scale-up and label finalization for the previously conditionally approved Aspertec 325 mg aspirin dosage form thereby satisfying the open conditional items, and filing of a supplemental new drug application (sNDA) for Aspertec 81 mg maintenance dose form. Aspertec is being developed to provide high-risk cardiovascular and neurology patients with more reliable and predictable antiplatelet efficacy as compared to enteric coated aspirin while also reducing the adverse gastric events common in an acute setting.
Natasha Giordano, president and chief executive officer 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 pre-commercialization activities necessary to prepare the market for this important cardiovascular product."
PLx stockholders will receive newly issued shares of common stock of Dipexium in connection with the merger contemplated by the merger agreement. Dipexium will issue approximately 36 million new shares of its common stock to PLx stockholders under the exchange ratio formula defined in the merger agreement. Upon the closing of the merger, existing PLx stockholders are expected to own 76.75% of Dipexium common shares outstanding and existing Dipexium stockholders are expected to own 23.25% of Dipexium common shares outstanding. The exchange ratio is defined in the merger agreement and is subject to potential adjustment.
"This transaction with PLx Pharma reflects the continued commitment of Dipexium's board of directors and management team to deliver value to Dipexium stockholders," said David Luci, President and Chief Executive Officer of Dipexium. "The merger brings with it the PLx Pharma management team, comprised of highly accomplished and seasoned executives who have launched and successfully commercialized many market leading over-the-counter products, among them Mike Valentino as executive chairman of PLx Pharma, who previously launched multiple major Rx-to-OTC switches including Benadryl, Motrin Jr., Rogaine Extra Strength, Lamisil, Nasalcrom, Voltaren, and most recently, as CEO of Adams Respiratory Therapeutics, Inc., Mucinex."
The boards of directors of both Dipexium and PLx Pharma have unanimously approved the proposed transaction, which is subject to customary closing conditions, including approval by the stockholders of each of Dipexium and PLx Pharma. The merger is expected to close during the second quarter of 2017, subject to customary closing conditions.
Raymond James & Associates is acting as financial advisor to Dipexium and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as its legal counsel. Janney Montgomery Scott LLC is acting as financial advisor to PLx and Jackson Walker LLP is acting as its legal counsel.
Dipexium Pharmaceuticals, Inc. is a late-stage pharmaceutical company focused on the development and commercialization of Locilex (pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide, which recently announced that Locilex failed to meet the primary and secondary endpoints in its OneStep-1 and OneStep-2 Phase 3 clinical trials.
PLx Pharma Inc. is a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard delivery system to provide safer and more effective aspirin products.