| |NOVEMBER 20249FDA CLEARS JOURNEY MEDICAL'S EMROSI FOR ROSACEA TREATMENTVENUS REMEDIES GAINS PIC/S GMP APPROVAL FOR ROBOTIC SYRINGE FACILITYThe US FDA has given approval for Journey Medical's Emrosi, a brand name for their 40mg minocycline hydrochloride extended-release capsules, for treating the skin condition rosacea. Created with the help of Dr Reddy's Laboratories, Emrosi (formerly DFD-29) has been backed by favorable results obtained from two 16-week Phase III clinical studies. In July 2023, the findings indicated that DFD-29 met all primary and secondary goals, proving its safety and effectiveness when compared to Oracea, owned by Galderma Laboratories.Journey Medical now intends "to establish Emrosi as a new standard of care in the treatment of rosacea." This is according to CEO Claude Maraoui, who believes the drug "has the potential to become the best-in-class oral medication to treat the condition".Journey has stated that they are currently finishing the production of Emrosi for the US market. It foresees that adult rosacea patients will have access to the initial supply by the first half of 2025.The launch will mark a change in the treatment landscape. GlobalData's 2022 `Rosacea Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape` report stated that Galderma was "the most prominent player in the rosacea space, offering a comprehensive portfolio of solutions". However, it also warned that with "no presence in the late-stage pipeline and with its existing marketed products widely genericised, the company may lose its position in the rosacea market". POVenus Remedies announced that its robotic pre-filled syringe facility at the Baddi unit has been granted approval for good manufacturing practices (GMP) by the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. Venus Remedies announced in a statement that their pre-filled syringe (PFS) facility has received its inaugural Pharmaceutical Inspection Co-operation Scheme (PIC/S) accreditation."Securing the PIC/S GMP accreditation from Malaysia's NPRA is a significant milestone and a testament to our commitment to quality and technological innovation in pharmaceutical manufacturing," Saransh Chaudhary, President, Global Critical Care, Venus Remedies and CEO, Venus Medicine Research Centre, said.Chaudhary further noted that "the major technological upgrades and investments we've made in our PFS facility over recent years have culminated in this recognition, reinforcing our team's dedication and excellence."The high compliance standards and world-class quality control measures at Venus Remedies' Baddi facility were highlighted by the approval process completed within six months of a rigorous audit in April 2024.Aditi Chaudhary, president of International Business at Venus Remedies, said, "the PIC/S GMP accreditation is a testament to the dedication and expertise of our teams across the globe. With this achievement, we are well-positioned to extend our international footprint and bring high-quality, life-saving medicines to more markets, thus ensuring better access to healthcare for all." PO
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