Citius Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the company has entered into a non-binding letter of intent to acquire all of the outstanding shares of Leonard Meron Biosciences, Inc. (LMB), a private, late-stage specialty pharmaceutical company. LMB's lead drug candidate, Mino-Lok, is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections, or CRBSIs.
Mino-Lok is a patent-protected, novel solution containing minocycline, edetate (disodium EDTA), and ethyl alcohol, which act to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. Mino-Lok is entering phase 3 trials after demonstrating safety in its phase 2b trial conducted at the MD Anderson Cancer Center in Houston. Recently, the US Food and Drug Administration (FDA) granted a Qualified Infectious Disease Product (QIDP) designation for Mino-Lok. Receiving QIDP designation means that Mino-Lok is now eligible for Fast Track designation, Priority Review for development, and a five-year extension of market exclusivity. The company believes that the commercial target for Mino-Lok represents a significant opportunity in the multi-billion, critical care market.
"We are excited with this merger which we believe will provide us immediate access to Mino-Lok, a phase 3 ready programme in a billion-dollar industry," said Leonard Mazur, chairman and chief executive officer of Citius Pharmaceuticals, Inc.
"We are especially pleased with the expansion of our management team to include industry veteran, Myron Holubiak, who will manage and direct all of our development programmes including our prescription hemorrhoid treatment. Holubiak has an extensive background in pharmaceutical general management, having been president of Roche Labs Inc., and health economics, an increasingly important discipline in healthcare today. After the merger, we will be prepared to seek additional opportunities to expand our product pipeline in critical care and associated treatment areas while conforming to our growth philosophy of developing and introducing drug products that address unmet medical needs and provide cost-effective solutions in today's healthcare world. We are at the forefront of an exciting time for Citius".
Closing of the acquisition is subject to due diligence, definitive merger documentation, and closing of additional financing and other customary formalities. Citius is expected to issue shares of its stock in exchange for shares of LMB in which, after the completion of the transaction, all prior common shareholders of LMB will retain approximately 49 per cent of the common stock in Citius. Additionally, no preferred shares or notes convertible into common stock will be outstanding in the newly combined company. Citius will reserve shares for any non-extinguished obligations of LMB at the closing, in the form of warrants and options, and will also assume certain liabilities created in the ordinary course of business. Leonard Mazur, Citius' Chief executive officer is the chairman and principal stockholder of LMB. Myron Holubiak, a director of Citius is currently the president and CEO of LMB and is a significant stockholder of LMB. Myron Holubiak, CEO of LMB, will assume the role of CEO for the combined company, and Leonard Mazur will assume the role of chairman of the Board. All key employees of LMB will also join the combined company in their respective roles.