July 25, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Indianapolis-based Eli Lilly and Co reported an increase of 8 percent in quarterly revenue, but the real shake-up is what the company plans to do with its pipeline.
The company reported second-quarter revenue of $5.8 billion, up from $5.4 billion in the same quarter last year. David Ricks, Lilly’s chairman, president and chief executive officer, said in a statement, “Lilly delivered strong revenue growth in the second quarter, building on the momentum of Trulicity, Taltz and the other new products in our portfolio. To deliver on our mission and maximize our opportunity, we have four key priorities—launching with excellence, replenishing the pipeline, driving productivity, and building talent and capability in our core areas of focus.”
Lilly has developed a new framework for decision-making. In a statement, the company said, “Lilly will pursue new standard-of-care changing therapies that target tumor dependencies in molecularly enriched populations, build rational combinations that overcome resistance and develop next-generation immunotherapies.”
As a result, while the company is prioritizing the development of seven drug candidates, one already being reviewed by the U.S. Food and Drug Administration (FDA), it is looking to rid itself of seven Phase II candidates and hoping to partner for another 10 of its mid-stage cancer drugs.
The company indicates it plans to unload the following compounds:
• Galunesertib, an inhibitor of TGF beta R1 kinase
• Ralimetinib, a p38 MAP kinase inhibitor
• Emibetuzumab, a MET antibody
• A notch Inhibitor
• A FGFR inhibitor
• A CXCR4 peptide antagonist
• A FGFR-3 antibody-drug conjugate
In April, the FDA rejected Lilly and Incyte Corporation ’s New Drug Application (NDA) for baricitinib for rheumatoid arthritis. The FDA requested additional materials, and Lilly and Incyte indicated today that the resubmission will be delayed by at least 18 months while they evaluate their options. The FDA issued a Complete Response Letter and asked for additional clinical data around the most appropriate dose, as well as more information about safety concerns.
“We are disappointed that resubmission will not occur this year,” said Christi Shaw, president of Lilly Bio-Medicines, in a statement, “but are committed to bringing baricitinib to people with RA and we will work with the FDA on the path forward.”
In a note to investors, Jeffrey Holford, an analyst with Jefferies, wrote, “Management’s announcement today that the new studies required will take a minimum of 18 months to conduct is more in line with our refiling timeline of 2019, though even that may be too optimistic. In addition, the association with the potential risk of increased thromboembolic events may impair the future commercial value of the product, whilst favoring new entrants, such as AbbVie ’s upadacitinib.”
On the more positive front, the FDA granted Lilly’s abemaciclib Priority Review for two indications—abemaciclib monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease, and abemaciclib in combination with fulvestrant in patients with HR+, HER2- advanced breast cancer who had disease progression after endocrine therapy. The FDA also granted Fast Track status for tanezumab for chronic patient in patients with osteoarthritis and chronic low back pain. And Japan’s Ministry of Health, Labor and Welfare granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg for rheumatoid arthritis.
