This week, Pfizer PFE announced a definitive agreement to buy sickle cell disease ("SCD") drugmaker Global Blood Therapeutics GBT for $5.4 billion in cash. J&J JNJ said it will discontinue selling talc-based baby powder globally from 2023. Sanofi SNY paused recruitment in phase III studies of its BTK inhibitor tolebrutinib for multiple sclerosis. The FDA granted approval to AstraZeneca AZN/Daiichi Sankyo's Enhertu for HER2-low metastatic breast cancer.
Recap of the Week's Most Important Stories
Pfizer to Buy Global Blood Therapeutics: Pfizer announced a definitive agreement to acquire Global Blood Therapeutics for a total enterprise value of approximately $5.4 billion, or $68.50 per share, in cash. The acquisition will strengthen Pfizer's position in rare hematology by adding Global Blood's only marketed drug, Oxbryta, which is approved for treating SCD in the United States, Europe and some other countries. Oxbryta is the first approved therapy that directly inhibits sickle hemoglobin polymerization, a major cause for SCD. The drug has been performing well since its approval and launch.
In addition, Global Blood Therapeutics is developing GBT021601 (GBT601), a next-generation sickle hemoglobin (HbS) polymerization inhibitor, in a phase II/III study in patients with SCD. It also has inclacumab in its pipeline being developed in pivotal phase III studies for the treatment of vaso-occlusive crises (VOC) associated with SCD. The transaction is approved by the board of directors of both the companies.
Pfizer and partner Valneva initiated a phase III study on their Lyme Disease vaccine candidate VLA15. The study will enroll around 6,000 participants five years of age and older. The study, called VALOR, will be conducted in Lyme disease-endemic regions in Europe and the United States.
J&J to Discontinue Global Sales of Talc-Based Baby Powder: J&J said it will discontinue selling its talc-based Johnson's Baby Powder worldwide from 2023. The company will transition to an all cornstarch-based baby powder portfolio, which is already sold in several countries around the world.
J&J faces more than 40,000 lawsuits for its talc-based products, primarily its baby powders which allege that its talc products contain asbestos that causes cancer. There have been verdicts against J&J in its talc lawsuits. J&J has consistently denied allegations and insisted that talc-based products are safe and do not cause cancer. J&J permanently discontinued the sale of its talc-based Johnson's Baby Powder in the United States and Canada in 2020.
Sanofi Pausing Recruitment in Some Tolebrutinib Studies: Sanofi announced that following the recommendation of the independent data monitoring committee (iDMC), it is pausing recruitment globally in all clinical studies on investigational BTK inhibitor, tolebrutinib, which are still undergoing active recruitment. Last month, the FDA had placed a partial clinical hold on the company's phase III studies on tolebrutinib, in multiple sclerosis (MS) and myasthenia gravis (MG) indications.
The partial hold was placed after the FDA identified cases of drug-induced liver injury in some study participants who were administered tolebrutinib. The iDMC's decision followed the FDA's decision of the partial hold. The iDMC recommended pausing recruitment globally in all MS and MG studies on tolebrutinib in order to review previous data and the impact of the protocol changes. However, participants currently receiving tolebrutinib in all studies will continue treatment. Sanofi also announced that two phase III studies on tolebrutinib in relapsing MS, GEMINI I and GEMINI II, are fully enrolled. Sanofi expects to file regulatory applications in the United States in 2024.
FDA Nod to AstraZeneca's Enhertu for HER2-low Metastatic Breast Cancer: The FDA approved AstraZeneca and Daiichi Sankyo's cancer drug, Enhertu for previously treated patients with HER2-low unresectable and/or metastatic breast cancer. Enhertu is the first-ever HER2-directed medicine to be approved for the treatment of patients with HER2-low metastatic breast cancer. The approval was based on data from the pivotal phase III DESTINY-Breast04 study. In the study, Enhertu reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
The NYSE ARCA Pharmaceutical Index declined 0.9% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here's how the eight major stocks performed in the last five trading sessions.
Zacks Investment Research
Image Source: Zacks Investment Research
In the last five trading sessions, Merck rose the most (2.5%) while Pfizer declined the most (3.1%).
In the past six months, Lilly rose the most (28.4%) while Roche declined the most (11.2%).
(See the last pharma stock roundup here: MRK, PFE, SNY Q2 Earnings & Sales Beat, GSK Results Mixed)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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