Regeneron Pharmaceuticals

GSK's Nucala succeeded in a Phase 3 study for COPD patients with chronic bronchitis/emphysema, significantly reducing exacerbations. This follows a 2018 FDA rejection for lack of data. Nucala targets interleukin-5 and is already approved for severe asthma. GSK will discuss the new data with regulators and present it at a future medical meeting.

GSK announced positive Phase III MATINEE trial results for Nucala, showing a reduction in COPD exacerbations. Nucala, a monoclonal antibody targeting IL-5, is currently approved for severe asthma and other conditions but not COPD. GSK plans to present full trial findings and share results with health authorities. The COPD market is anticipating potential approvals for Sanofi and Regeneron's Dupixent and Verona's Ohtuvayre.

FDA issued a Complete Response Letter for Regeneron's linvoseltamab BLA in R/R MM; issue relates to a third-party fill/finish manufacturer. Regeneron working with manufacturer and FDA to resolve and bring linvoseltamab to R/R MM patients. EMA review ongoing. Linvoseltamab is investigational, not yet approved.

Novo Nordisk launches Wegovy® in Australia for weight loss. Xbrane regains certolizumab biosimilar rights. BMS’ Opdivo® gains new NSCLC indication in Australia. Teva’s Q2 revenue grows 7%. Celltrion’s ustekinumab biosimilar approved in Canada. Zydus’ trastuzumab biosimilar approved in Mexico. PBAC agenda includes denosumab & ustekinumab biosimilars. UPC hears omalizumab patent dispute. Biogen’s Leqembi® shows Alzheimer’s benefits. Samsung Bioepis revokes Janssen’s Stelara® patent in UK. Bio-Thera/Sandoz’s bevacizumab biosimilar approved in EU. Roche’s Vabysmo® approved for RVO in EU. FDA approves J&J’s Darzalex Faspro® for multiple myeloma. Formycon’s pembrolizumab biosimilar enters Phase III. US indicts for counterfeit cancer drugs. Roche’s Vabysmo® approved for RVO in Canada. NICE against trastuzumab deruxtecan for HER2-low breast cancer. Amgen’s Xgeva® PFS approved in Korea. FDA alerts on compounded semaglutide imitations. Regeneron disclaims aflibercept patent after adverse IPR decision.

Novo Nordisk and Eli Lilly dominate the obesity drug market with GLP-1 agonists, achieving multi-billion sales in 2024. Their drugs, including Mounjaro and Wegovy, lead in treating Type 2 diabetes and obesity, with the market expected to grow significantly. Other companies are advancing obesity treatments, indicating a competitive and expanding market.

D.A.A.V. and C.J.W. hold patents on LAG-3, with potential income from licensing. D.A.A.V. has multiple roles in biotech firms and receives funding from BMS and Novasenta. E.J.W. advises and holds stock in several biotech companies. A.H.S. has patents on the PD-1 pathway, receives research funding, and serves on various advisory boards. A.R.C. consults for Abound Bio.

BioNTech announces positive Phase 2 results for mRNA immunotherapy BNT111 in advanced melanoma patients, showing significant improvement in ORR when combined with cemiplimab vs. historical control, with both monotherapies active. BNT111, part of BioNTech's FixVac platform, targets four tumor-associated antigens and has received FDA Fast Track and Orphan Drug designations for melanoma treatment.

The biosimilars market is expanding, with the global market projected to hit $43.8 billion by 2024 and exceed $100 billion in a decade. Recent FDA and EMA approvals include biosimilars for Johnson & Johnson’s Stelara and Bayer’s Eylea, following patent expirations. Notable approvals include Pyzchiva, Ahzantive, Yesafily, Opuviz, Hercessi, Selarsdi, Wyost, Jubbonti, Simlandi, and Uzpruvo, targeting various conditions and expected to launch by 2025.

FDA approved Verona Pharma's Ohtuvayre, a novel inhaled treatment for COPD, marking the first new mechanism in over 20 years. It's a dual PDE3 and PDE4 inhibitor offering bronchodilator and anti-inflammatory effects. Set for Q3 2024 launch, backed by $1 billion, with pricing yet announced. Supported by Phase III trials showing improved lung function and reduced exacerbations.

Phase 3 trial data showed the pozelimab and cemdisiran (poze-cemdi) combination achieved greater control of intravascular hemolysis in PNH patients compared to ravulizumab, with 96% achieving adequate LDH control versus 80% with ravulizumab. Poze-cemdi also demonstrated complete, uninterrupted inhibition of terminal complement, offering potential for less frequent, subcutaneous administration.