Warren, NJ and Portage, Ind. (March 12, 2008) – MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, announced today it has received an additional $2.5 million in private debt financing from White Oak Global Advisors. The financing was triggered by the Company’s achievement of certain milestones outlined in the $12.5 million private Loan and Security Agreement signed with White Oak Global Advisors in April of 2008.
A. Mark Schobel, chief executive officer of MonoSol Rx, commented, “We are pleased to announce that our milestone achievements over the past several months have triggered an additional $2.5 million of available financing from White Oak Global Advisors. Our thin film products offer significant advantages over existing dosage forms, including improved compliance, convenient dosing, superior stability and durability, quicker absorption, low dose content uniformity, and the potential to deliver therapeutic efficacy at reduced doses. This funding provides additional capital and financial strength thereby allowing us to continue to develop and deliver to the global prescription market the most advanced, effective and safest thin film pharmaceutical products.”
Keith J. Kendall, chief financial officer of MonoSol Rx, commented, “We are pleased to secure the additional $2.5 million financing under our agreement with White Oak. This is an indication of our ability as a growing business to commit to and deliver on our business targets. We set objectives with White Oak on how the business would perform and have exceeded those commitments, resulting in additional financing availability to further fuel the company’s growth.”
During 2008 and into 2009, MonoSol Rx entered into three new collaborations focused on the development and commercialization of thin film drugs, and made significant progress towards securing the first ever potential U.S. marketing approval of a thin film prescription drug:
- Licensed exclusive rights to Hikma Pharmaceutical PLC (”Hikma”) (LSE: HIK) (DIFX:HIK) for distribution of three thin film pharmaceutical products in the Middle East, exclusively supplied by MonoSol Rx
- Completed bioequivalence (BE) studies for a thin film formulation of ondansetron, an anti-emetic therapy, triggering a milestone payment to MonoSol Rx from Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX). Under terms of the agreement between the companies, Strativa licensed exclusive U.S. commercialization rights to thin film ondansetron, with MonoSol Rx eligible to receive up to $23.5 million in pre-commercial and sales-based milestone payments, in addition to product supply purchase payments and net sales royalties.
- Entered into a partnership with Midatech Group Ltd, a world leader in the production and application of synthetically produced nanoparticles, to jointly research, develop and commercialize new drug candidates designed to deliver therapeutic nanoparticles in thin film.
- Closed $20 million private equity financing round, including conversion of $10 million of bridge loan debt, led by the Ed Bass Group with participation from The Halifax Group and CNF Investments, a subsidiary of Clark Enterprises
- Granted two new U.S. patents from the United States Patent and Trademark Office (USPTO): 1) U.S. patent No. 7,425,292, the first of its kind related to proprietary thin film manufacturing and its ability to ensure controlled uniformity of drug content in each strip; and 2) U.S. patent No. 7,357,891 related to proprietary mixing system technology and controlled film drying processes.
- Completed pilot product development for a thin film formulation of escitalopram oxalate, a selective serotonin reuptake inhibitor (SSRI) marketed under the brand name Lexapro® for the treatment of depression and generalized anxiety disorder.
- Closed $12.5 million private debt financing with White Oak Global Advisors
MonoSol Rx is using proceeds from its debt and equity financings for general corporate purposes, capital equipment investments and research and development programs targeting prescription, generic and over-the-counter (OTC) thin film pharmaceutical products based on PharmFilm® technology.
Cowen and Company served as the sole arranger in the loan financing with White Oak Global Advisors, a leading restructuring and financial advisory firm serving middle market companies, as well as financial and lending institutions throughout the US.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in quick dissolving films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in thin film drug delivery is supported by strong intellectual property, a portfolio of commercialized over-the-counter (OTC) drug products, and a development pipeline of prescription formulations based on PharmFilm® technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that fund prescription product development programs that will generate long-term value.
The Company’s commercialization strategy for all PharmFilm® products is to partner with the innovator, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm® formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).
About White Oak Group
White Oak Group is a leading restructuring and financial advisory firm serving middle market companies and their owners, as well as financial and lending institutions throughout the US.
About Cowen and Company
Cowen and Company provides investment banking services, equity research, sales trading and mergers and acquisition advice, to emerging growth companies in sectors including healthcare, technology, media and telecommunications, aerospace and defense, consumer and alternative energy.