- Key points from AstraZeneca's (AZN -0.5%) conference call this morning to update investors on its late-stage pipeline:
- Product development will focus on three therapy areas (Respiratory, Inflammation & Autoimmunity/Cardiovascular & Metabolic Disease/Oncology) with a shift toward more targeted specialty care programs.
- 2015 key milestones: U.S. approvals of Tagrisso (osimertinib), Iressa (gefitinb) and Brilinta post-MI. Regulatory submissions in the U.S. for lesinurad (gout) and PT003 (COPD), in the EU for cediranib (ovarian cancer), saxa/dapa (type 2 diabetes)(CRL rec'd from FDA) and CAZ AVI (serious infections) and Japan for Brilinta ACS, post-MI.
- FDA clearance of PT003 and ZS-9 expected in H1 as well as Tagrisso approval for lung cancer in the EU and Japan. Expected approvals in H2 in the EU are saxa/dapa, cediranib and CAZ AVI.
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Resp/Inflam/Auto: Key products in late-stage development: Benralizumab, an IL-5 inhibitor, in Phase 3 development for severe asthma and COPD. Regulatory submissions expected in H2 2016. Anifrolumab, a fully human IgG1 K monoclonal antibody, in Phase 3 for systemic lupus erythematosus. Final data expected in 2018, regulatory submissions to follow in 2019.
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Cardio/Meta: New indications for Brilinta (stroke/transient ischemic attack, peripheral arterial disease, diabetes) expected to launch in 2017 and 2018. Key pipeline products: Roxadustat (stokes production of red blood cells), ZS-9 (hyperkalemia).
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Oncology: Key pipeline products: durvalumab (PD-L1+ NSCLC and other cancers), expanded indications for Lynparza (olaparib).
- Slide presentation