Eli Lilly & Co. develops and commercializes medicines across cardiometabolic disease, oncology, immunology, neuroscience and genetic medicine. Company news commonly covers product and pipeline developments for medicines such as Mounjaro, Zepbound, Foundayo, Omvoh, Verzenio, Jaypirca and Taltz, including clinical data, regulatory approvals and treatment-indication updates.
Lilly updates also include operating results, financial guidance, dividends, business development agreements and manufacturing expansion. Recent company communications highlight investment in active pharmaceutical ingredient capacity and genetic medicine production, alongside recurring disclosures about demand for diabetes, obesity, immune-disease and cancer therapies.
Eli Lilly's tirzepatide showed superior performance in glycemic control compared to insulin degludec in a sub-study of the SURPASS-3 clinical trial. The results presented at the EASD meeting indicate participants on tirzepatide 15 mg spent 91.2% of the time within a target glucose range (71-180 mg/dL) over 52 weeks. Additionally, they spent significantly less time in hypoglycemia and exhibited reduced glycemic variability. Overall, tirzepatide's efficacy aligns with its profile as a novel treatment for type 2 diabetes, pending regulatory approvals.
Eli Lilly and Company (NYSE: LLY) has partnered with Susan G. Komen to tackle breast cancer health disparities among Black women in the U.S. This multiyear initiative aims to expand resources and support, providing culturally competent patient navigators, psychosocial support, and educational resources. The program will initially focus on Chicago, St. Louis, and Indianapolis, addressing barriers to early diagnosis and treatment. Black women are 40% more likely to succumb to breast cancer than their white counterparts due to systemic inequities. The collaboration highlights a commitment to health equity in breast cancer care.
Eli Lilly announced FDA approval for ERBITUX (cetuximab) in combination with BRAFTOVI (encorafenib) for treating adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. This new indication is based on the BEACON CRC trial, showing improved overall survival (8.4 months vs. 5.4 months) and a notable objective response rate of 20%. ERBITUX, now with seven FDA approvals for CRC, represents a significant advancement for patients with worse prognoses. However, it does come with common adverse reactions, including fatigue and nausea.
Eli Lilly will reduce the list price of Insulin Lispro Injection by 40% starting January 1, 2022, bringing it to $82.41 for vials and $159.12 for a pack of five pens. This new pricing aligns with 2008 levels and aims to lower out-of-pocket costs for those uninsured or underinsured. The average monthly out-of-pocket cost for Lilly insulin has dropped to $28.05, a 27% decrease since 2017. Lilly encourages individuals to utilize its affordability programs to help manage costs as insulin accessibility becomes a growing health concern.
Eli Lilly and Company (NYSE: LLY) announced that new data from its monarchE study will be presented at the European Society for Medical Oncology (ESMO) Virtual Plenary on October 14, 2021. The study focuses on the investigational use of Verzenio (abemaciclib) combined with endocrine therapy for patients with HR+, HER2- high-risk early breast cancer. In total, 5,637 patients were randomized to receive either Verzenio with standard endocrine therapy or standard endocrine therapy alone, aiming to evaluate invasive disease-free survival and other key outcomes.
Eli Lilly (NYSE: LLY) is recalling lot D239382D of its Glucagon Emergency Kit due to a complaint that the vial contained liquid instead of the intended powder form. This issue may lead to decreased effectiveness in treating severe hypoglycemia, posing serious health risks including seizures. The recall was initiated after a patient experienced a lack of drug effect and subsequent seizures. Distribution of the affected lot has been ceased, and return and replacement measures are underway for consumers and wholesalers.
Eli Lilly announced the pricing terms for its cash tender offer for specific outstanding debt securities, totaling up to $1.5 billion. The offer allows holders of eligible notes to receive a total consideration based on a reference yield plus a fixed spread, including an early tender premium of $30 per $1,000 of principal. The offer expires on October 4, 2021. Notably, the previously set maximum purchase limits for the 3.950% and 4.150% notes have been removed, enhancing liquidity. The anticipated settlement date is September 22, 2021.
Eli Lilly (NYSE: LLY) announced a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of bamlanivimab and etesevimab for COVID-19 treatment in patients aged 12 and older. This agreement enables EU countries to purchase these treatments directly, enhancing access before formal marketing authorization. Bamlanivimab and etesevimab have shown efficacy against COVID-19 variants like Delta. Although some countries have already ordered doses, this agreement allows for additional supplies as needed. Lilly does not anticipate a change to its 2021 financial guidance.
Eli Lilly and Company (NYSE: LLY) announced the early tender results of its cash tender offer for up to $1.5 billion in outstanding debt securities. The result showed that $2,016,575,000 in notes were validly tendered before the early tender date of September 20, 2021. Notably, Lilly removed the previously announced caps on its 4.150% Notes due 2059 and 3.950% Notes due 2049, allowing for larger acceptance amounts. The settlement date for accepted notes is set for September 22, 2021, and the tender offer is expected to expire on October 4, 2021.
The FDA has expanded the Emergency Use Authorization (EUA) for Eli Lilly's bamlanivimab and etesevimab to include post-exposure prophylaxis for COVID-19. This authorization targets high-risk individuals aged 12 and older who are either unvaccinated or might not respond adequately to vaccination. Data from the BLAZE-2 study indicated that bamlanivimab significantly reduced symptomatic COVID-19 risk in nursing home residents. Since the pandemic's onset, over 535,000 treatment courses have been provided, helping avert thousands of hospitalizations and deaths.