Since 2012, AstraZeneca (AZN) has launched multiple new products in its three main therapeutic areas of diabetes and respiratory diseases, cardiovascular diseases, and oncology. These products are Farxiga, Lynparza, Tagrisso, and Duaklir.
The above diagram shows AstraZeneca’s products that are scheduled to be launched in 2017. Most of these upcoming product launches are expected to become major revenue drivers for AstraZeneca in 2017.
New product launches
On December 9, 2016, the FDA (U.S. Food & Drug Administration) accepted for review AstraZeneca’s application for approval of durvalumab, an investigational PD-L1 inhibitor, as a second-line therapy for patients suffering with urothelial carcinoma, a type of bladder cancer. The FDA granted priority review status for this application and is expected to announce its decision through the PDUFA (Prescription Drug User Fee Act) in 2Q17.
Data from AURA3, a Phase 3 trial, has demonstrated the superiority of Tagrisso over chemotherapy as a second-line therapy for NSCLC (non-small cell lung cancer) patients with an EGFR (epidermal growth factor receptor) T790M mutation. The FDA has already granted priority review status to Tagrisso for this indication. It’s expected to be approved in the first half of 2017. AstraZeneca also wants to secure regulatory approval for Tagrisso as a first-line therapy for NSCLC patients in 2018.
In the first half of 2017, AstraZeneca is waiting for regulatory approval for Faslodex as a first-line breast cancer therapy. To know more about Faslodex, please refer to AstraZeneca’s Faslodex Expected to Benefit from FALCON Trial Data.
Multiple new product launches in the oncology space are expected to help AstraZeneca pose stiff competition to other cancer players such as Pfizer (PFE), Merck & Co. (MRK), and Bristol-Myers Squibb (BMY).
If AstraZeneca’s new product launches manage to offset its losses due to the patent expirations of mature brands such as Crestor and Nexium, there could be a positive impact on AZN stock as well as the First Trust Value Line Dividend ETF (FVD). AstraZeneca makes up about 0.54% of FVD’s total portfolio holdings.
In the next part of this series, we’ll look at emerging market trends for AstraZeneca in 2017.