SUN PHARMACEUTICAL INDUSTRIES LIMITED

Sun Pharma and Philogen have agreed on a global exclusive commercialization, license, and supply agreement for Fibromun (L19TNF), an anti-cancer immunotherapy. Philogen will handle trials, approval, and manufacturing, while Sun Pharma will lead global commercialization. Post-commercialization profits will be split 55:45 in favor of Sun Pharma. Fibromun has shown promise in treating soft-tissue sarcomas and glioblastoma, transforming 'cold' tumors into 'hot' for enhanced immune recognition.

Trevi Therapeutics appoints James V. Cassella, Ph.D., as Chief Development Officer to lead Haduvio™ development for chronic cough in IPF and RCC, leveraging his extensive CNS drug development experience.

Sun Pharma presented 3 updates on deuruxolitinib at the 33rd EADV Congress, including improved hair satisfaction, reduced anxiety and depression, and optimized dosing. Deuruxolitinib, a JAK 1/2 inhibitor, was approved by the FDA in 2024 for severe alopecia areata based on THRIVE-AA1 and THRIVE-AA2 trials. The 8 mg twice-daily dose showed superior efficacy and safety.

Pancreatic cancer, a leading cause of cancer deaths worldwide, affects older adults more frequently and has a poor prognosis. 2024 guidelines recommend tailored FOLFIRINOX and gemcitabine-based therapies. Over 2,000 trials since 2019, led by North America, Asia-Pacific, and Europe, are advancing treatments. Novotech, a global CRO, supports oncology trials, highlighting progress in chemotherapy, RAS-targeted therapies, and personalized medicine.

The FDA granted fast track designation to MM-II, a non-opioid product for osteoarthritis knee pain, following a phase 2b trial showing significant pain relief for up to 26 weeks. This designation aims to expedite the development and review of MM-II, potentially offering a new treatment option for OA patients.

Pembrolizumab (Keytruda) showed sustained survival benefits over ipilimumab (Yervoy) in unresectable stage III or IV melanoma patients, with 10-year follow-up data from the KEYNOTE-006 study presented at the 2024 ESMO Congress. Pembrolizumab had a median overall survival (OS) of 32.7 months vs 15.9 months for ipilimumab, with 8- and 10-year OS rates of 36.9% and 34.0% vs 24.8% and 23.6%, respectively. The study also highlighted the safety profile and long-term efficacy of pembrolizumab, supporting its standard of care status in advanced melanoma.

Indian pharma giants focus on quality over quantity, with complex product filings increasing. US generics sales show slight growth, and regulatory challenges ease. Nomura recommends Lupin for its upcoming launches and stable market shares, while noting setbacks. Sun Pharma's specialty segment growth slows, and Dr Reddy's faces market share declines. Cipla and Zydus Lifesciences show growth but face inspection and competition challenges.

Early switch to atezolizumab after vemurafenib plus cobimetinib in BRAF V600-positive melanoma showed improved OS at 4 and 5 years in the ImmunoCobiVem trial, but not statistically significant. Rapid progression after switch to immune checkpoint inhibition was observed in some patients.

Pembrolizumab (Keytruda) showed improved survival over ipilimumab (Yervoy) in stage III/IV melanoma patients, with 10-year OS rates of 34% vs 23.6% and MSS rates of 45.2% vs 31.3%. Pembrolizumab's median OS was 32.7 months vs 15.9 months for ipilimumab, and median modified PFS was 9.4 months vs 3.8 months. Patients who responded well to initial pembrolizumab treatment had significant long-term benefits, with 80% OS rate after 94 weeks of treatment. These results support pembrolizumab as a standard care for advanced melanoma.