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Eli Lilly and Company (NYSE: LLY), founded in 1876 by Colonel Eli Lilly, is a global leader in the pharmaceutical industry, headquartered in Indianapolis, Indiana. With operations in 18 countries and products sold in approximately 125 countries, Eli Lilly is dedicated to pioneering life-changing discoveries through innovative drug development. The company focuses on several therapeutic areas including neuroscience, cardiometabolic, cancer, and immunology.
Key products in Eli Lilly’s portfolio include Verzenio for cancer treatment; Jardiance, Trulicity, Humalog, Humulin, Mounjaro, and Zepbound for diabetes management; and Taltz and Olumiant for immunology. The company's recent financial performance has been robust, with Q1 2024 revenues increasing by 26% year-over-year to $8.77 billion, driven by strong sales of Mounjaro and Zepbound.
Eli Lilly continues to expand its manufacturing capabilities to meet growing demand, recently investing $5.3 billion in its Lebanon, Indiana site. This commitment supports the production of key therapies, particularly for chronic diseases like obesity and type 2 diabetes. The company’s innovative endeavors include the development of new treatments such as the once-weekly insulin efsitora alfa, which showed promising results in phase 3 trials for type 2 diabetes.
The company is also advancing its pipeline of oncology treatments with presentations of data on products like Verzenio, Retevmo, olomorasib, and imlunestrant at major medical conferences. Furthermore, Eli Lilly announced a major leadership change with Melissa Seymour joining as Executive Vice President of Global Quality, ensuring the sustained excellence of their product offerings.
Eli Lilly’s commitment to addressing significant health challenges is evident in its diverse product pipeline and ongoing clinical trials. The company remains focused on improving patient outcomes globally by harnessing advancements in biotechnology, chemistry, and genetic medicine.
Eli Lilly's recent Phase 3 CENTURION study reveals that REYVOW™ (lasmiditan) significantly improves pain freedom in adults suffering from migraines. Results show participants taking REYVOW at 200 mg experienced 4.6 times greater odds of pain freedom at 2 hours compared to placebo, while those at 100 mg had 3.8 times greater odds. Additionally, REYVOW demonstrated differences in pain relief and sustained freedom from pain up to 48 hours. Safety findings align with earlier studies, confirming a tolerable profile.
Eli Lilly will conduct a webcast on September 21, 2020, at 3:00 PM EDT, to discuss its presentations at the 2020 ESMO Virtual Congress. Investors, media, and the public can access the live webcast via a link on Lilly's website. A replay will be available afterwards. Lilly is committed to discovering and delivering life-changing medicines to improve health outcomes globally.
Eli Lilly and Company (NYSE: LLY) has expanded its Lilly Insulin Value Program, introducing a $35 copay card to help individuals with diabetes manage their insulin costs. This program, effective from January 2021, is aimed at people with commercial insurance and the uninsured, alleviating financial burdens associated with insulin purchases. Lilly also noted the integration of this copay card into their broader affordability solutions, which support approximately 20,000 patients monthly. Lilly's initiatives include partnerships to raise awareness about insulin affordability and options available to patients.
Eli Lilly will present data from 20 oncology studies at the ESMO Virtual Congress from September 19-21, 2020. Notable findings include positive Phase 3 results for Verzenio in treating high-risk HR+, HER2- early breast cancer, marking it as the only CDK4 & 6 inhibitor with significant improvement in invasive disease-free survival. Additionally, Lilly will showcase data on Retevmo for RET fusion-positive cancers and CYRAMZA's efficacy in EGFR-mutated NSCLC. The emphasis is on advancing cancer treatment and enhancing patient outcomes through collaborative efforts.
Eli Lilly and Company (NYSE: LLY) announced leadership changes effective October 1, 2020. Patrik Jonsson has been appointed as senior vice president, president of Lilly USA, and Chief Customer Officer. He succeeds Ilya Yuffa, who is promoted to senior vice president and president of Lilly Bio-Medicines. Both leaders will report to CEO David A. Ricks. Jonsson's extensive experience in managing complex markets and Yuffa's leadership in U.S. Diabetes are expected to benefit the company as it prepares for new medicine launches.
The FDA has approved two new doses of Trulicity (dulaglutide) by Eli Lilly (NYSE: LLY), expanding its offerings to 3.0 mg and 4.5 mg. This decision follows positive results from the phase 3 AWARD-11 trial, which indicated significant reductions in A1C and body weight for patients with type 2 diabetes. The 4.5 mg dose achieved A1C reduction of -1.9% and weight loss of -10.4 pounds, while the 3.0 mg dose showed reductions of -1.7% in A1C and -8.8 pounds in weight. These new doses are expected in U.S. pharmacies by late September.
Full results from the EMPEROR-Reduced phase III trial revealed that Jardiance (empagliflozin) significantly reduced cardiovascular death or hospitalization due to heart failure by 25%. The trial, presented at ESC Congress 2020, included adults with heart failure and was compared to a placebo. Key findings showed a 30% reduction in heart failure hospitalizations and a slower decline in kidney function among those taking Jardiance. The FDA has granted Fast Track designation for Jardiance concerning heart failure and chronic kidney disease, emphasizing the urgency for new treatment options.
Eli Lilly announced that the New England Journal of Medicine published Phase 1/2 study results for Retevmo™ (selpercatinib), the first therapy specifically indicated for metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced RET-altered thyroid cancers. The study showed high overall response rates (ORR) of 85% in treatment-naïve and 64% in previously treated NSCLC patients. In RET-mutant medullary thyroid cancer, the ORR was 73%. The data supports Retevmo as a significant treatment option for these patient populations, contingent on further confirmatory trials.
Eli Lilly and Innovent Biologics have expanded their global alliance for TYVYT® (sintilimab injection), an anti-PD-1 monoclonal antibody, to include markets outside of China. Innovent will receive a $200 million upfront payment and potential milestones totaling $825 million. TYVYT is already approved for relapse or refractory classic Hodgkin's lymphoma in China and is undergoing trials for non-small cell lung cancer (NSCLC). Recent data shows TYVYT alongside Alimta and chemotherapy significantly improves progression-free survival in advanced NSCLC. The deal is pending regulatory clearance.
Eli Lilly and Company (NYSE: LLY) has announced the initiation of BLAZE-2, a Phase 3 trial of LY-CoV555 aimed at preventing SARS-CoV-2 infection in long-term care facilities in the U.S. This study will enroll up to 2,400 participants and assess the antibody's efficacy and safety over eight weeks. LY-CoV555 is a neutralizing antibody developed in collaboration with AbCellera, designed to block viral entry. The trial addresses the urgent need for effective therapies in these vulnerable populations significantly affected by COVID-19.