The federal Medicare program has decided, at least for now, not to reimburse health care providers who conduct diagnostic imaging tests using an Eli Lilly and Co. imaging agent that can help identify the presence of Alzheimer’s disease. Medicare will pay for those scans if they are part of a clinical trial of a drug and will consider paying for broader use in the future. But Indianapolis-based Lilly, as well as the Chicago-based Alzheimer’s Association, had been hoping for wider reimbursement now. The Alzheimer’s Association noted that it typically takes seven years for a procedure to move from clinical-trial-only reimbursement to broad reimbursement. The narrower use of Lilly’s agent, which is called Amyvid, is a small hit financially for Lilly. The bigger impact is that Lilly hoped wide use of Amyvid could help it and other companies bring drugs to market to treat Alzheimer’s. Since there are currently no effective treatments for the disease, any drug that did help with treatment would be an instant blockbuster. Lilly’s experimental drug solanezumab could have sales topping $4 billion annually if it proves effective in patients with mild Alzheimer’s disease. The drug failed its clinical trials last year when tested in a mix of mild and moderate Alzheimer’s patients, but it showed encouraging results in patients with only mild Alzheimer’s disease. The only way to identify such patients is by using a special kind of imaging test that will show deposits of a protein called amyloid—which is one of two telltale signs of Alzheimer’s disease. The imaging test is called PET, or positron emission tomography. Before Amyvid, however, the only way to view these plaques was during an autopsy.
Cancer drug Erbitux, which is partly owned by Indianapolis-based Eli Lilly and Co., extended the lives of patients with a form of advanced colon cancer more than seven months longer than those taking Roche Holding AG’s Avastin, according to clinical trial results released Saturday. According to Bloomberg News, the results were presented at a scientific conference in Europe by Germany-based Merck KGaA, which sells the medicine outside North America. Lilly and New York-based Bristol-Myers Squibb Co. market the drug in the United States. Erbitux generated sales for Merck of $1.2 billion last year, while Lilly realized $400 million in revenue from the drug in 2012. According to Bloomberg, the findings suggest that Erbitux, already approved in Europe as a treatment for patients with so-called KRAS wild-type tumors, may have a role in a subgroup of patients with so-called RAS wild-type cancer.
Purdue University chemistry professor Graham Cooks, whose research has played a role in the launch of several Indiana startups, was awarded the 2013 Dreyfus Prize in Chemical Sciences, the highest award possible for a chemist, during a ceremony last week. Cooks won the prize and its $250,000 payment for his innovations in the fields of mass spectrometry and analytical chemistry. Cooks and his team have fine-tuned the tools for molecular imaging for cancer diagnostics and surgery; therapeutic drug monitoring; testing for biomarkers in urine; and the identification of food-borne pathogens, bacteria, pesticides and explosives residues. His research has contributed to the technology developed by Griffin Analytical Technologies Inc., Prosolia, Inc. and InProteo LLC.
In a big disappointment, Indianapolis-based Eli Lilly and Co. reported that its experimental cancer drug ramucirumab proved no better than a placebo as a treatment for breast cancer. According to the Associated Press, the Indianapolis-based firm no longer plans to seek regulatory approval for the drug as a treatment for patients with a form of breast cancer that has spread. However, Lilly will seek approval to use ramucirumab in combination with chemotherapy in stomach cancer patients after ramucirumab performed better in a separate study on those patients. Ramucirumab extended both overall and progression-free survival times for patients with advanced gastric cancer. Lilly will seek approval from regulators for that use. It also is studying ramucirumab in colorectal and lung cancers and expects more late-stage research results next year. Ramucirumab is one of Lilly’s best hopes to produce new revenue to offset the loss of sales it has been suffering since the 2011 patent expirations on its then-best-seller, Zyprexa, and the patent expiration coming at year’s end on its current best seller, Cymbalta.