As discussed earlier, Eli Lilly and Co.’s (LLY) 4Q15 segment-wise performance was positive for both its Human Pharmaceuticals and Animal Health segments. The major developments for Eli Lilly during 4Q15 are illustrated in the chart below:
Eli Lilly launched Portrazza in combination with gemcitabine and cisplatin in the US markets for the first-line treatment of squamous non-small cell lung cancer.
Following are the regulatory developments for Eli Lilly in 4Q15:
- The company submitted for FDA approval, a once-daily baricitinib for the treatment of active rheumatoid arthritis, in collaboration with Incyte Corporation.
- The company received FDA approval for Basaglar, the insulin glargine product, in collaboration with Boehringer Ingelheim
- Eli Lilly submitted 80-unit Basaglar pen for FDA review.
- Lilly submitted a fixed dose combination tablet with empagliflozin and linagliptin for approvals to the European regulatory authorities.
- The company received FDA approval for Humulin R U-500 KwikPen.
- Eli Lilly received positive CHMP recommendations for Cyramza for the second-line treatment of both non-small cell lung cancer and metastatic colorectal cancer.
Other developments for Eli Lilly include:
- an agreement with Roche Diagnostics related to an ongoing development of the cerebral spinal fluid assay for amyloid-beta 1-42 by Roche
- an agreement with Merck (MRK) to evaluate Alimta in combination with Keytruda extended, for the study of usage in first-line non-small cell lung cancer
- a collaboration with Merck (MRK) announced to evaluate the CDK 4 and 6 inhibitor known as abemaciclib as a combination drug with Keytruda for multiple tumor types
- a repurchase of ~$250 million stock during 4Q15, with $2.95 billion in repurchases remaining according to the $5 billion repurchase plan
Apart from these developments, Eli Lilly (LLY) also announced plans to close its Animal Health manufacturing facilities in Sligo, Ireland.
Investors can consider the Healthcare Select Sector SPDR ETF (XLV), which holds ~3.0% of its total assets in Eli Lilly, ~7.3% of its total assets in Pfizer (PFE), ~5.4% of its total assets in Merck and Company (MRK), and ~0.8% of its total assets in Zoetis (ZTS). The iShares Core S&P 500 ETF (IVV) holds ~0.5% of its total assets in Eli Lilly.