SUN PHARMACEUTICAL INDUSTRIES LIMITED

U.S. District Court of New Jersey granted preliminary injunction delaying Sun Pharma's LEQSELVI launch due to patent infringement lawsuit by Incyte Corporation; Sun Pharma plans to appeal.

Sun Pharmaceutical Industries faces a US court-imposed delay on launching its drug LEQSELVITM (deuruxolitinib) for severe alopecia areata, with plans to appeal. Despite this, the company reported a 27.94% YoY increase in net profit for Q2 2024, reaching ₹3,040 crore, with US formulation sales up 20% to $517 million.

Sun Pharmaceuticals Ltd. announced the US District Court of New Jersey granted a preliminary injunction preventing the launch of Leqselvi until further legal developments or patent expiry. Sun Pharma intends to appeal the decision.

US drug shortages decreased to 277 in Sept 2024, with 50% lasting 2+ years. Key shortages include ADHD meds, pain treatments, chemotherapy drugs, insulin, and diabetes/weight loss meds. IV fluids added due to Hurricane Helene impacting Baxter's production.

Sun Pharma's specialty drug Leqselvi faces launch delays due to a patent dispute, potentially affecting $200 million in projected sales. Despite this, Q2 earnings showed a 28% net profit increase to Rs 3,040 crore, driven by strong seasonality and robust growth in the specialty segment.

Sun Pharma presented open label extension data for deuruxolitinib (Leqselvi) in severe alopecia areata at the Fall Clinical Dermatology Conference, showing long-term efficacy and safety. 48.8% achieved a SALT score of 20 or lower by week 68, and 99.6% of initial responders maintained their response, indicating sustained hair regrowth.

Keytruda, a cancer drug, achieved $25 billion in global sales, treating 40 cancers in the US and 17 in India. Its mechanism activates the immune system to fight cancer cells, categorized as immunotherapy. Despite high costs, it has shown remarkable results in some cases, prompting Indian drugmakers to develop affordable biosimilars as patents expire.

JAK inhibitors are key drugs for treating inflammatory diseases and cancer, with billions in revenue. They target JAK enzymes, crucial for cytokine signaling, reducing inflammation and symptoms. Approved for atopic dermatitis, ulcerative colitis, rheumatoid arthritis, psoriasis, and alopecia areata, they offer significant benefits. For cancer, they treat myelofibrosis and are being explored in combinations with immune checkpoint inhibitors. Safety concerns led to FDA and EMA restrictions, but market growth is expected due to rising autoimmune disease prevalence.

AL Ideathon 2024 at Novotel, Hyderabad, showcased AI, ML, NLP, and automation applications in pharma, receiving 544+ global submissions. Industry leaders discussed digital transformation, AI in manufacturing, and R&D impact. Top innovators were recognized, with Anurag Gokhale winning the Golden Innovation Award for voice search-enabled systems.

CDSCO identified over 50 drugs as 'Not of Standard Quality,' differentiating them from counterfeit and spurious drugs. Consumers advised to buy from trusted retailers and verify packaging details. Regulatory bodies and pharmaceutical companies collaborate to combat counterfeit drugs, with recent amendments enhancing drug safety standards.