Depomed Shares Edge Higher on Court Banning NUCYNTA’s Generics-Depomed $DEPO edged up on Friday amid increased volume trading in response to the news that a court has put a ban on its potential competitor, Allergan, from selling a generic version of NUCYNTA. Earlier both Actavis (TEVA) and Roxane also failed to nullify patents, which are valid until 2022 to 2028.
RegeneRx JV Commences Second Phase 3Stage Study on Dry Eye Syndrome-ReGenTree, a joint venture between RegeneRx $RGRX and GtreeBNT commenced its second Phase 3 study evaluating RGN-259 for the treatment of dry eye syndrome. The double-masked, placebo enabled trial will randomize about 500 subjects to receive either RGN-259 or placebo eye drops for 28 days. The co-primary endpoints are the improvement in corneal staining as measured by total corneal fluorescein staining score and the improvement in ocular discomfort, both 29 days from baseline. Results from the study are anticipated in H2 2017.
Mylan Ready to Market generic Fortamet in U.S.- Mylan N.V. $MYL began the commercial launch of its generic version of Watson’s Fortamet Extended Release Tablets, 500 mg and 1,000 mg for the adjunctive treatment along with diet and exercise , for adult patients with type 2 diabetes. IMS health estimates the U.S. market to be about $770mn.
Endo Pharma Reports Positive Phase 2 Data from XIAFLEX Study-Endo Pharmaceuticals Inc., a subsidiary of Endo International plc $ENDP reported new data assessing the safety and efficacy of XIAFLEX (collagenase clostridium histolyticum) injection under investigation for the treatment of palmar Dupuytren's disease nodules. In a Phase 2 placebo-controlled, dose-ranging study involving 75 adult study subjects with Dupuytren's disease and at least 1 nodule who received a single injection of CCH 0.40 mg or 0.60 mg, a statistically significant decrease was shown from baseline in the mean nodule surface area, consistency score and hardness score at week 8 compared to subjects receiving placebo.
Ophthotech Plunges on Regeneron Pharma’s Failed Mid-stage Study-Ophthotech $OPHT slumped about 14% on Friday amid heavy volume trading in apparent response to Regeneron Pharmaceuticals' $REGN unsuccessful Phase 2 study of a co-formulated therapy of EYLEA (aflibercept) and rinucumab.Regeneron Pharma $REGN announced that a Phase 2 clinical study, CAPELLA, assessing EYLEA co-formulated with rinucumab, for the treatment of patients with neovascular age-related macular degeneration (wet AMD) fell short of showing a treatment benefit over EYLEA alone.
RepliCel Mid-stage Clinical Trial on RCH-01 Delayed- RepliCel Life Sciences $REPCF has delayed its mid-stage clinical study on lead product candidate RCH-01 for male pattern baldness. As a result, the potential milestone payments and royalties, under its 2013 License and Co-development Agreement with Shiseido Company, are at risks as Shiseido calls it breach of the contract.