Headquarters: Indianapolis, IN
Year Established: 1876
Revenues: $21,222 (+6%)
Net Income: $2,738 (+14%)
R&D: $5,244 (+9%)
TOP SELLING DRUGS
|Erbitux||head and neck cancer||$687||42%|
While Lilly dropped a spot to number 13 this year revenues were up from $19.9 billion to $21.2 billion in 2016. U.S. sales were $11.5 billion while outside the U.S. sales were $9.7 billion. The Indianapolis, IN-based company reported revenue growth across its three largest therapeutic areas. The Endocrinology segment increased 15% to $8 billion primarily driven by growth of Trulicity, Forteo, Jardiance, Trajenta, and Basaglar. Oncology grew 6% to $3.7 billion due to higher volumes for Cyramza and Erbitux, and Cardiovascular grew 5% to $3.2 billion, mostly due to higher realized price for Cialis. Revenue in Neuroscience decreased 7% to $2.7 billion as a result of lower volumes for Zyprexa and Cymbalta following patent expirations.
On the drug development front, the company reported two new molecular entities (NMEs) were approved by regulatory authorities in 2016, Ixekizumab (Taltz), a neutralizing monoclonal antibody to interleukin-17A for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis, and Olaratumab (Lartruvo), a human lgG1 monoclonal antibody for the treatment of advanced soft tissue sarcoma.
During the year, Lilly continued its successful Alzheimer’s disease collaboration with AstraZeneca. It received Fast Track designation from the FDA for the AZD3293 development program, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III trials. The FDA’s Fast Track program is designed to expedite the development and review of new therapies to treat serious conditions and tackle key unmet medical needs.
AZD3293 has been shown in Phase I studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s and healthy volunteers. The progression of Alzheimer’s disease is characterized by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of amyloid beta and inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.
AstraZeneca received a $100 million milestone payment from Lilly now that AZD3293 has moved into Phase III testing in the Amaranth study.
The two companies also announced the planned initiation of a new Phase III trial for AZD3293, named Daybreak,which will study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia.
The alliance between the two companies was formed in 2014 for the development and commercialization of AZD3293/LY3314814. Lilly leads clinical development, working with researchers from AstraZeneca’s neuroscience research and development team, while AstraZeneca is responsible for manufacturing. The companies have joint responsibility for commercialization of the molecule and will share all future costs equally for development and commercialization, as well as net global revenues post-launch.
In another Alzheimer’s alliance, Lilly and AstraZeneca are co-developing MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is in Phase I development. AstraZeneca received a $30 million upfront payment from Lilly.
In another clinical trial collaboration, Lilly and Boehringer Ingelheim teamed up to battle metastatic breast cancer. The collaboration will evaluate the safety and tolerability of abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with BI 836845, Boehringer’s insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody, in patients diagnosed with HR+, HER2- mBC. Based on the Phase Ib trial results, the collaboration has the potential to expand to Phase II trials in patients with HR+, HER2- mBC and other solid tumors.
Lilly’s abemaciclib is designed to block the growth of cancer cells by specifically inhibiting CDK 4 and CDK 6. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signaling from CDK 4 and CDK 6. Boehringer’s BI 836845 is an IGF ligand-neutralizing antibody that binds to both IGF-1 and IGF-2 preventing activation of the respective receptor, resulting in decreased growth-promoting signaling, which may decrease tumor growth. In a Phase Ib/II trial, BI 836845 has shown promising preliminary efficacy and good clinical safety in combination with everolimus and exemestane in patients with HR+ mBC.
The rationale for the collaboration is based upon the hypothesis that these two agents, in combination, could offer a more complete pathway interference and could potentially prolong cell cycle arrest. For HR+, HER2- mBC patients, this could translate to a reversal of resistance to hormone therapy.
Lastly, Regen BioPharma entered into an agreement with Lilly to receive compounds for drug discovery purposes and allows Regen to share structural information on compounds of mutual interest. Regen will examine 21,000 Lilly compounds in its NR2F6 high-throughput screening program to identify activators and inhibitors of this protein. NR2F6 is a molecular switch known as an “orphan nuclear receptor,” which controls genes associated with the immune response as well as genes associated with the ability of cancer stem cells to propagate. Lilly has an option to negotiate a compound purchase agreement, a license agreement, or a research collaboration agreement for further research and development of material of mutual interest.