Research and development prospects
According to Pfizer’s 37th Annual J.P. Morgan Healthcare Conference transcript, the company expects 15 of these products to emerge as blockbuster therapies. The company has a robust and diversified R&D pipeline across a variety of therapeutic areas, including oncology, immunology, inflammation, infectious diseases, rare diseases, internal medicine, and vaccines. Pfizer expects three product approvals with potential blockbuster potential in 2019.
Anticipated near-term milestones
On January 14, 2019, Pfizer issued a press release announcing the FDA’s acceptance of its application seeking regulatory approval for tafamidis for the treatment of the rare disease transthyretin amyloid cardiomyopathy (or ATTR-CM). According to the press release, the application had secured a priority review from the FDA based on the robust results of its Phase 3 ATTR-ACT trial. The Prescription Drug User Fee Act date has been set for July 2019.
According to the company’s third-quarter earnings conference call, Pfizer expects to launch four new oncology drugs with combined blockbuster potential by the end of 2019.
On September 11, 2018, Pfizer issued a press release announcing positive top line results from its Phase 3 JAVELIN Renal 101 study. In this study, the company compared the combination regimen of immunotherapy Bavencio and tyrosine kinase inhibitor Inlyta with Sutent in an advanced renal cell carcinoma indication.
According to Pfizer’s 37th Annual J.P. Morgan Healthcare Conference transcript, the company expects to file to secure a breakthrough therapy designation for the Bavencio-Inlyta combination regimen in 2019. Pfizer also expects to file applications for four major biosimilars in 2019.
In the next article, we’ll highlight Pfizer’s expense trends in greater detail.