Year Established: 1876
Revenues: $22,871 (+8%)
LOSS: $204 (n/a)
R&D: $5,282 (+1%)
TOP SELLING DRUGS
|Trulicity||type 2 diabetes||$2,029||119%|
|Erbitux||head and neck cancer||$646||-6%|
In 2017 Eli Lilly and Co. reported an 8% growth in revenue to $23 billion from $21 billion the year before. Sales in Endocrinology increased 25 percent primarily driven by growth of Trulicity, Basaglar, Forteo, Jardiance, and Trajenta. Oncology grew 2 percent primarily due to higher volumes for Lartruvo and Cyramza, partially offset by lower volumes for Alimta, and Immunology grew due to higher volumes for Taltz. Revenue in Neuroscience decreased 20 percent driven by lower volumes for Strattera, Cymbalta, and Zyprexa due to loss of patent protection, and Cardiovascular decreased 11 percent driven by lower volumes for Cialis and Effient.
In new products approvals, at the end of September 2017 the FDA approved Lilly’s Verzenio (abemaciclib) to treat breast cancer. Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy. Breast cancer is the most common form of cancer in the U.S. and Verzenio has the potential to be an important treatment option for patients.
Expanding the pipeline through acquisition
In 2017 Lilly acquired CoLucid for approximately $960 million, enhancing its portfolio in pain management for migraine with a potential near-term launch. CoLucid is developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine and has completed the first of two Phase III trials, and pending results, submission of lasmiditan for U.S. regulatory approval are scheduled for 2018.
If approved, Lasmiditan would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies.
Lasmiditan was originally discovered at Lilly and was out-licensed to CoLucid in 2005. CoLucid has taken important steps to decrease the risk related to development and commercialization of lasmiditan. Lilly has since reorganized its R&D efforts to focus on migraine as part of its emerging therapeutic area of pain.
In more recent acquisition news, Lilly entered an agreement in May 2018 to acquire ARMO BioSciences for approximately $1.6 billion, expanding its portfolio of immuno-oncology therapies. ARMO, based in Redwood City, CA is developing cancer treatments that harness the body’s immune system to fight tumors. Its lead candidate, AM0010 is being investigated in a pivotal Phase III trial in pancreatic cancer. According to Armo, AM0010 has demonstrated clinical benefit on its own, but can also be combined with chemotherapy and checkpoint inhibitor therapies across several tumor types.
AM0010, a long-acting form of recombinant human interleukin 10 (IL-10) linked to polyethylene glycol (PEG), is also being investigated in Phase II studies in combination with Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo in patients with metastatic non-small-cell lung cancer.
Armo’s immune-oncology pipeline also includes several preclinical candidates—AM0001, an anti-PD-1 monoclonal antibody; AM0003, an anti-LAG-3 checkpoint inhibitor; AM0015, a form of recombinant human interleukin-15 (IL-15); and AM0012, a form of recombinant human interleukin-12 (IL-12).
Development deals and supply pacts
Lilly and Purdue University entered a strategic five-year agreement, under which Lilly will provide as much as $52 million to develop improved delivery of injectable medicines to reduce pain, number of injections, and improve patient compliance. The collaboration will also focus on developing predictive models for clinical trials that reduce risks associated with investing in drug development and more effectively predict the outcome of new therapies in humans. The collaboration aims to expand to other areas to further leverage the range of expertise at the two institutions.
Also, Rimidi and Lilly are partnering to develop provider-focused tools that will integrate personalized solutions for people who use insulin to manage their diabetes. Under the partnership, Rimidi will integrate its diabetes management software platform with Lilly’s integrated insulin management system in development.
The non-exclusive agreement aims to make diabetes management easier for the approximately 30 million Americans by helping people use insulin more effectively while optimizing diabetes management within the normal clinical workflow.
Rimidi’s platform helps clinicians personalize care by leveraging the individual characteristics and clinical histories of people with diabetes to identify individuals who may benefit from specific management approaches. Lilly’s insulin management system combines a connected insulin pen with glucose-sensing technologies (e.g., glucose meter, CGM) and software applications to deliver personalized insulin dose recommendations. Data from these devices and apps will flow back to physicians.
With Evonik Industries, Lilly renewed a long-term supply agreement for active pharmaceutical ingredients (APIs) and intermediates for use in key Lilly human and veterinary drug products. Evonik acquired Lilly’s Tippecanoe site in Lafayette, IN, in January 2010. Since then, the facility has been operating as a contract development and manufacturing organization (CDMO) for the pharma industry, serving more than 20 Evonik customers. The facility has 170 cubic meters of high potency APIs (HPAPIs) capacity and a total of 860 cubic meters of cGMP manufacturing.