RegeneRx intends to partner strategically with companies with clinical development and commercialization interests in desired pharmaceutical therapeutic fields. We are actively seeking partnerships with suitable infrastructure, expertise and a long-term initiative in our focus disease areas.
In 2004, RegeneRx entered into a partnership with Sigma-Tau Group’s wholly-owned subsidiary, Defiante Farmaceutica L.d.a., for development and marketing of RGN-137, and certain indications relating to RGN-352, in Europe and certain contiguous countries. Sigma-Tau fully funded and managed the dermal phase II trial in the EU for the treatment of venous stasis ulcers.
In 2012, RegeneRx entered into a licensing agreement with Lee’s Pharmaceuticals, Inc. for development and marketing of Tβ4-related products in the countries of China, Macau, Hong Kong and Taiwan. Lee’s will be responsible for product development in the licensed territory and each party will share clinical and other data related to these product candidates. Lee’s submitted its first IND for RGN-259 in China in June 2014 for the treatment of dry eye syndrome.
In 2014, RegeneRx entered into a strategic partnership agreement with G-treeBNT, a Korea biotech company for development and marketing of RGN-259 in 28 Asian countries including Korea, Japan, and Australia. G-treeBNT will also develop RGN-137 in the U.S. for dermal wound healing. G-tree is planning to initially file an IND for a Phase III clinical trial with RGN-259 in South Korea, followed by a similar strategy in Japan and Australia. If successful, this should facilitate the commercialization of RGN-259 in other countries in Asia and the Pacific Rim that are covered by our partnership.
In February 2015, RegeneRx entered into agreements with G-treeBNT Co. Ltd., to develop RGN-259 for dry eye syndrome and neurotrophic keratitis (an orphan indication) in the United States. Under the terms of a joint venture agreement (ReGenTree LLC) between the parties, G-treeBNT is responsible for conducting and funding all clinical trials and product development through approval of a new drug application (NDA). Pursuant to the terms of a license agreement between RegeneRx and the joint venture entity, RegeneRx granted the JV an exclusive, royalty-bearing license to market and sell RGN-259 in the U.S. RegeneRx also contributed all of its non-clinical and clinical data generated to date.
Our ownership interest in ReGenTree is 49% and will be reduced to 42% upon funding, initiation and completion of the Phase 2b trial for Dry Eye Syndrome. Based on when, and if, ReGenTree achieves certain additional development milestones in the U.S. with RGN-259, our equity ownership may be incrementally reduced to between 42% and 25%, with 25% being the final equity ownership upon FDA approval of an NDA for Dry Eye Syndrome in the U.S. In addition to our equity ownership, RegeneRx retains a royalty on net sales that varies between single and low double digits, depending on whether commercial sales are made by ReGenTree or a licensee. In the event the ReGenTree entity is acquired or there is a change of control that occurs following achievement of an NDA, RegeneRx shall be entitled to 40% of all change of control proceeds paid or payable and will forgo any future royalties.
RegeneRx has the right to participate in all key development and commercialization decisions under the agreements, including the right to approve key commercial relationships and transactions, such as product licensing, mergers or acquisitions.
Under the terms of the ReGenTree license agreement, RegeneRx received a total of $1 million in two tranches, and will receive royalties ranging from high single digits to low double digits, depending on medical indications approved and if ReGenTree’s ophthalmic product candidates are commercialized internally or through a third party. RegeneRx is not required to provide any funding for the venture.
To inquire about partnership opportunities with RegeneRx contact:
President and CEO