June 6, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Chicago-based AbbVie , at its first research and development day, discussed its plans to focus on R&D, in particularly looking to broaden its focus in cancer, immunology, virology and neuroscience. Rick Gonazalez, the company’s chief executive officer, also went out of his way to defend the company’s $5.8 billion investment in Stemcentrx last month.
At his presentation at the Fairmont hotel in Chicago on Friday, Gonzalez projected the company would have double-digit average earnings growth through 2020. “Although we’re still early on in our journey, we are extremely proud of our track record and progress. We won’t cut back on R&D to manage a bottom line,” although some cuts in other areas are expected.
AbbVie is working to expand its product lines in light of future softer sales of Humira, the company’s blockbuster drug for rheumatoid arthritis. In 2015, Humira accounted for 61 percent of sales, but in light of biosimilar competition, is expected to lose market share. In 2015’s fourth-quarter, Humria sales jumped 21 percent, which had $3.72 billion in sales during the quarter and $14 billion for the year.
In an attempt to focus on cancer, AbbVie acquired Pharmacyclics for its blood cancer drug, Imbruvica, and last month Stemcentrx for experimental drugs for solid tumors. As part of the Stemcentrx deal, AbbVie picked up rovalpituzumab tesirine (Rova-T), which was in registration trials for small cell lung cancer (SCLC). Rova-T is a biomarker-specific therapy based on cancer stem cells that targets delta-like protein 3 (DLL3), which appears in 80 percent of SCLC tumors, but not in healthy tissue.
Stemcentrx also has four other drugs in clinical trials for various solid tumors, including triple-negative breast cancer, ovarian cancer, and non-small cell lung cancer. It also has several compounds in preclinical studies, as well as a proprietary technology platform that utilizes stem cells to identify and screen tumor targets.
Many analysts felt that $5.8 billion for a company with no drugs on the market was too high. Data released yesterday at the American Society of Clinical Oncology (ASCO) meeting by Stemcentrx may assuage some of that skepticism.
Granted, the results were for a Phase I trial of Rova-T, which was primarily designed to test safety and efficacy. Sixty patients were evaluated, and 11 saw their tumors shrink. In a subgroup of 26 individuals with high levels of DLL3, about 10 responded to the drug and about a third of the 26 were alive after a year.
“Although these results are preliminary, rovalpituzumab tesirine seems to be the first targeted therapy to show efficacy in small cell lung cancer, and we may have identified DLL3 as the first predictive biomarker in this disease,” said Charles Rudin, an oncologist at Memorial Sloan Kettering, who led the study, in a statement. He also told the press that because it was a small study and the first one performed on humans, that healthy skepticism is appropriate.
Stemcentrx is now enrolling patients for a Phase II trial for Rova-T as a third-line treatment in SCLC. AbbVie has hopes the drug will hit the market by 2018.
Moving past oncology, AbbVie is also developing new drugs for rheumatology, dermatology and gastroenterology. It is also working on next-generation therapeutics for hepatitis C. It also has an early-stage compound for Alzheimer’s disease that targets the tau protein, as well as a treatment that has the potential to repair nerve damage in patients with multiple sclerosis (MS).
