ROCKVILLE, Md., April 28, 2016 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx") today announced that it has expanded its license to ReGenTree, LLC for RGN-259 in North American from solely the U.S. to the U.S. and Canada. The license expansion was negotiated pursuant to a term sheet that was previously announced by RegeneRx in its most recent Form 10-K. RegeneRx previously received a payment from ReGenTree of $250,000 under the term sheet, which is the license fee for the expanded territory. The U.S. license between the two companies has been amended to include Canada, and the Canadian territory will be subject to the same royalty structure as currently exists.
ReGenTree has notified the Company that it expects to report data from the recently completed dry eye trial the week of May 2nd.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 and its constituent fragments, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in the U.S. and Canada, China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world. RGN-259, the Company's Tβ4-based ophthalmic drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In September 2015, RegeneRx, through its U.S joint venture, ReGenTree LLC, initiated a Phase 2/3 clinical trial in patients with dry eye syndrome and a Phase 3 clinical trial in patients with NK. The dry eye trial has been completed and the NK trial is estimated to be completed later in 2016 or 2017. RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-352, the Company's Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar traumatic injuries. For additional information about RegeneRx please visit www.regenerx.com.
About ReGenTree, LLC
ReGenTree, LLC is a U.S. joint venture company owned by G-treeBNT Co., Ltd., a bio venture company in Korea and RegeneRx Biopharmaceuticals, Inc., a clinical stage drug development company in the U.S. ReGenTree is developing a novel therapeutic peptide, RGN-259 (designated GBT-201 in Korea), in the U.S. and Canada for ophthalmic indications.
G-treeBNT holds a majority equity stake in ReGenTree and is responsible for conducting and funding all clinical trials and product development. RegeneRx also holds a significant equity stake in the joint venture, in addition to a royalty on future sales of any product developed by the venture, and has contributed all of its related intellectual property and non-clinical and clinical data generated to date. The three-member ReGenTree board of directors includes one member each from the two founding companies and one independent director.
ReGenTree seeks to become a top pharmaceutical company specializing in ophthalmology. It is currently sponsoring a Phase 2/3 and a Phase 3 clinical trial in the U.S. to develop treatments for dry eye syndrome and for neurotrophic keratopathy (a rare disease with orphan designation by the U.S. FDA) with RGN-259/GBT-201. RGN-259/GBT-201 is a sterile, preservative-free eye drop formulation using Blow-Fill-Seal technology and the novel compound, thymosin beta 4 (Tβ4), as its active pharmaceutical ingredient.
Forward-Looking Statements
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Forward-looking statements used in this press release relate to, among other things, future license royalty payments. There can be no assurance that any proposed clinical trial will be completed within the estimated timeframe or that positive results from any clinical trials by the Company or its collaborators, in the U.S. or any other country, will result in subsequent clinical confirmation, regulatory approval in the U.S. or elsewhere, or future value. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2015, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
SOURCE RegeneRx Biopharmaceuticals, Inc.
