Major product developments
As discussed earlier, Pfizer’s (PFE) innovative pharmaceutical business is offsetting sales declines in its established products business. To strengthen its innovative pharmaceutical business, the company is focused on the development of new drugs as well as expanding the market reach of its existing products.
The company’s key product developments during 3Q15 are as follows:
- The European Medicines Agency validated for review the marketing authorization application for Ibrance in combination with other therapy for treatment of metastatic breast cancer.
- The company launched global phase three clinical trials for the palbociclib compound for the treatment of early-stage breast cancer in collaboration with the Alliance Foundation Trials and the Austrian Breast & Colorectal Cancer Study Group. This study, called the Palbociclib Collaborative Adjuvant Study (or PALLAS), was announced in August 2015.
- The company announced positive top-line results for two phase three studies of Trumenba, a meningitis B vaccine.
- The company received a response letter from the US FDA for its supplement new drug application for Xeljanz in the treatment of chronic plaque psoriasis.
- Pfizer announced positive top-line results for two phase three studies of Xeljanz for the treatment of adults with moderate-to-severe ulcerative colitis. Two more phase three studies are underway.
- The FDA accepted a new drug application for Xeljanz 11 mg once-daily modified release tablets for the treatment of rheumatoid arthritis. The anticipated Prescription Drug User Fee Act action date is February 2016.
- CHMP of the European Medicines Agency adopted a positive opinion recommending the extension of current Xalkori indications to include first-line treatment of ALK-positive advanced non-small cell lung cancer. This recommendation will be reviewed by the European Commission, which approves medicines for the European Union.
- Pfizer, in alliance with Bristol-Myers Squibb (BMY), presented new data for Eliquis at the ESC Congress in August and September 2015. The data pertains to the evaluation of Eliquis in both non-valvular atrial fibrillation and venous thromboembolism patient populations.
- The company announced the phase four clinical trial to evaluate the safety of Eliquis in September 2015.
Pfizer competes with Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), and GlaxoSmithKline (GSK). Investors can consider ETFs like the VanEck Vectors Pharmaceutical ETF (PPH) in order to divest company-specific risk.