Developments in 1Q17
As we discussed earlier, Eli Lilly & Co.’s (LLY) segment-wise performance was positive for its Human Pharmaceuticals and Animal Health segments. The recent developments for Eli Lilly include the following:
Recent commercial developments for Eli Lilly include:
- In 1Q17, Eli Lilly and Boehringer Ingelheim launched Synjardy XR tablets in the US for patients with type 2 diabetes.
- In 1Q17, Eli Lilly launched Olumiant (baricitinib) for the treatment of patients in the European markets with active rheumatoid arthritis.
Following are the recent regulatory developments for Eli Lilly:
- The US Food and Drug Administration (or FDA) issued a response letter for the new drug application of baricitinib, stating that the FDA is unable to approve the drug application in its current form.
- FDA approved the label update for the drug Trulicity during 1Q17. The new label includes the use of Trulicity in combination with basal insulin for patients with type 2 diabetes.
- The European Commission approved a label update for the drug Synjardy. The new label includes a change in the indication statement and reduction of risk of cardiovascular death with the use of Synjardy in patients with cardiovascular diseases and type 2 diabetes. Synjardy is developed in collaboration with Boehringer Ingelheim.
Following are the recent clinical developments for Eli Lilly:
- Eli Lilly announced that the MONARCH 2 and MONARCH 3 studies evaluating Abemacicib met their primary endpoints. Abemacicib is under clinical trials for the evaluation for use in the treatment of HR+, HER2- advanced breast cancer. Eli Lilly expects the regulatory submissions of the data of MONARCH 2 and MONARCH 3 studies in 2Q17 and 3Q17, respectively.
- Eli Lilly also announced that RAINFALL, a study evaluating ramucirumab as the first-line treatment of gastric cancer, met its primary endpoints during 1Q17, showing improvements in the progression-free survival. The study will continue until 2018 to evaluate the improvements in overall survival.
For diversified exposure to the company, investors can consider the PowerShares Dynamic Large Growth ETF (PWB), which holds ~3.7% of its total assets in Eli Lilly. PWB also holds 3.4% of its total assets in UnitedHealth Group (UNH), 3.1% in Celgene (CELG), and 2.8% in Bristol-Myers Squibb (BMY).