PFIZER INC.

Pfizer CEO Albert Bourla has withstood an ousting attempt by activist investor Starboard Value, despite Pfizer's declining share price. Starboard, with a $1 billion stake, blamed Bourla for the decline and claimed support from former executives. However, Bourla remains in control, attributed to Starboard's flawed analysis and Pfizer's potential hidden value in recent deals. Pfizer's Q3 2024 revenues rose 30%, further supporting Bourla's position.

Pfizer's Ibrance showed efficacy in HR+, HER2+ metastatic breast cancer, extending median progression-free survival by 50% in Phase III PATINA trial. This marks the first benefit shown by a CDK4/6 inhibitor in this patient group, representing about 10% of breast cancers. Ibrance, first approved in 2015, generated $4.75 billion in 2023, while Novartis' Kisqali brought in $2.08 billion.

The PATINA trial results show palbociclib (IBRANCE®) plus standard-of-care maintenance therapy significantly improves progression-free survival in HR+, HER2+ metastatic breast cancer patients, extending median PFS by over 15 months. The study, sponsored by Alliance Foundation Trials, is the first large phase III to demonstrate CDK4/6 inhibition benefits in this patient group. Pfizer plans to discuss these results with regulatory authorities.

The Clinical Trials Market is projected to grow from US$483B in 2023 to US$886.5B by 2032, driven by personalized medicine, tech advancements, and chronic disease prevalence. North America leads, while Asia-Pacific grows rapidly. Key trends include AI, decentralized trials, and regulatory support for inclusivity and efficiency.

ICER's review found 5 of the 10 highest-priced U.S. drugs lacked new clinical evidence to justify price increases, costing payers $815M in 2023. ICER uses the GRADE approach to assess evidence quality, focusing on new, moderate- to high-quality evidence. Some drugs, like Keytruda, Imfinzi, and Opdivo, had price increases supported by new evidence from randomized control trials.

COVID-19 treatment companies focus on vaccines, antivirals, monoclonal antibodies, and supportive care. Vaccines like Pfizer-BioNTech and Moderna reduce severe cases, while antivirals like Remdesivir and Paxlovid limit viral replication. Monoclonal antibodies like Bamlanivimab offer early intervention. Supportive care remains crucial. Market growth is driven by COVID-19 spread, new variants, and increased demand for effective therapies. Government investments and rapid vaccine advancements accelerate treatment availability. The global pulmonary drug delivery systems market is projected to reach USD 97.8 billion by 2033.

The oral proteins and peptides market is projected to grow to $2.86 billion by 2028 at a CAGR of 22.4%, driven by factors like rising chronic diseases, biotechnology investments, and non-invasive treatments. Key advancements include novel oral peptides, AI in drug discovery, and oral insulin formulations.

At ASH 2024, physicians discussed advancements in hemophilia care, including Roche's Hemlibra and curative AAV gene therapies like CSL Behring's Hemgenix, Biomarin's Roctavian, and Pfizer's Beqvez and Hympavzi. Despite progress, unmet needs remain, with concerns over long-term risks of gene therapies and limited access. Pfizer presented Phase III AFFINE trial data for giroctocogene fitelparvovec, showing comparable efficacy to Roctavian with better safety. Sanofi's fitusiran, a siRNA, demonstrated efficacy similar to clotting factor replacement therapy. Staidson's bemiltenase alfa, a fusion protein, showed favorable bleed clearance rates. Challenges persist, but advancements in curative, prophylaxis, and on-demand treatments offer more options for patients.

FDA detected severe side effects in Moderna's mRNA-1345 and mRNA-1365 RSV vaccine candidates for infants, with blunted responses to prophylactic antibody Beyfortus. VRBPAC will discuss safety findings, implications for pediatric development, and potential interactions between RSV prophylactic antibodies and vaccines. mRNA-1345 is approved for adults aged 60+ and continues in high-risk adults and pediatric populations. mRNA-1365, a combination vaccine for RSV and human metapneumovirus, is in Phase I. Moderna paused mRNA-1365 study due to severe RSV LRTI cases.

Sanofi's two combination vaccine candidates, NCT06695117 and NCT06695130, received Fast Track designation from the FDA for preventing influenza and COVID-19 in people aged 50+. These candidates combine Sanofi's Fluzone High-Dose or Flublok with Novavax's NVXC19 vaccine. Sanofi and Novavax have a deal for co-marketing NVXC19 from 2025, with Sanofi having sole rights to develop and market the combination with its influenza vaccines. Novavax's NVXC19 shows better tolerability and high efficacy. Sanofi's Vaccines unit has strong sales growth, expecting over €10 billion in annual net sales by 2030.