SOURCE: Flamel Technologies

December 04, 2013 16:05 ET

Flamel Technologies Announces $15 Million Line of Credit

LYON, FRANCE--(Marketwired - Dec 4, 2013) -  Flamel Technologies (NASDAQ: FLML) today announced that it established a USD $15.0 million secured line of credit with Broadfin Capital, a current Flamel shareholder. The $15.0 million credit facility can be drawn in three tranches of $5.0 million each. The Company will draw $5.0 million initially and can draw up to two additional $5.0 million tranches prior to August 15, 2014, subject to satisfaction of funding conditions. This line of credit financing will allow the Company to continue its investment in R&D projects and the launch of its first-NDA approved product, Bloxiverz™. The interest rate on any outstanding loan is 12.5% and the loan must be repaid on or before November 15, 2015. There is no cost for undrawn capital or any penalty or premium for early repayment. For each tranche of the line of credit drawn by Flamel, Broadfin Capital will also receive a royalty of less than 1.0% (subject to a maximum cumulative royalty of 2.0% if all three tranches are drawn) on net sales of Bloxiverz and the other products resulting from the R&D projects of the former Éclat Pharmaceuticals, subject to required regulatory approvals and sales of these products.

"This flexible line of credit from Broadfin Capital, drawn only as needed, will be used by Flamel to advance our extensive R&D portfolio in both the U.S. and France and our launch of Bloxiverz across the US, especially as we await potential FDA action on the status of unapproved versions of neostigmine that are still on the market. This line of credit also demonstrates Broadfin Capital's confidence in our corporate strategy and focus," said Mike Anderson, Chief Executive Officer of Flamel. 

About Flamel Technologies. Flamel Technologies SA's (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its partnered pipeline includes biological and chemical drugs formulated with its Medusa® and Micropump® (and its applications to the development of liquid formulations, i.e. LiquiTime™ and of abuse-deterrent formulations Trigger Lock™) proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company has developed products and manufactures Micropump-based microparticles under FDA-audited GMP guidelines. Flamel Technologies has collaborations with a number of leading pharmaceutical and biotechnology companies, including GlaxoSmithKline (Coreg CR®, carvedilol phosphate). The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and manufacturing facilities in Pessac, France. Additional information may be found at

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals and projections regarding financial results, product developments and technology platforms. All statements that are not clearly historical in nature are forward-looking, and the words "anticipate," "assume," "believe," "expect," "estimate," "plan," "will," "may," and similar expressions are generally intended to identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that the launch of Bloxiverz will not be as successful as anticipated; our ability to bring other R&D projects of the former Éclat Pharmaceuticals to market may be unsuccessful; FDA may not take action on the status of unapproved versions of neostigmine still on the market; clinical trial results may not be positive or our partners may decide not to move forward; products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements; products in development may not achieve market acceptance; competitive products and pricing may hinder our commercial opportunities; we may not be successful in identifying and pursuing opportunities to develop our own product portfolio using Flamel's technology; and the risks associated with our reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel's Annual Report on Form 20-F for the year ended December 31, 2012 that has been filed with the Securities and Exchange Commission (SEC). All forward-looking statements included in this release are based on information available at the time of the release. We undertake no obligation to update or alter our forward-looking statements as a result of new information, future events or otherwise.