Fight disease with disease. That’s the logic behind a new drug from Amgen Inc., and it could pave the way for other treatments in the future. Imlygic, or T-Vec, is a genetically modified herpes virus used to treat recurring melanoma, the most dangerous form of skin cancer. On Oct. 27, the Food and Drug Administration approved the first-of-its-kind Imlygic therapy, produced by the Thousand Oaks biotech. The drug is injected directly into tumors, where the virus replicates and produces an immune-stimulating protein known as GM-CSF. This treatment causes the tumor to burst and die, which, in turn, releases tumor-derived antigens and GM-CSF that might induce an anti-tumor immunity in the patient. The new drug costs $65,000 for a series of treatments and became available earlier this month. Analysts believe Imlygic will have a limited effect on Amgen’s stock price and bottom line, because the new treatment is only appropriate for a fragment of patients with skin cancer. Since the drug was approved, shares have traded in a narrow band between $158 and $162. Amgen’s stock price closed Nov. 11 at $156.86. “We view Imlygic as a very modest drug for Amgen,” said Eric Schmidt, an analyst at Cowen Group Inc. in New York. “We don’t think it will move the needle on the company’s stock price.” Schmidt didn’t even bother to calculate the sales potential from Imlygic, since it would pale in comparison with Amgen’s total revenue last year of more than $20 billion. Medically, Imlygic has not been proved to increase overall survival rates or affect cancer that has spread to vital organs. Some of its common side effects include fever, fatigue, nausea and pain at the injection site. However, according to the FDA, 16.3 percent of the participants in the clinical study saw a reduction in tumors for at least six months. As the first viral treatment for cancer, the drug could set a precedent for similar treatments in the future. Dr. Brad Thompson, chief executive of Oncolytics Biotech Inc. in Alberta, Canada, is thrilled with the addition of this new type of medicine. “I have been working on viral therapy for 15 years, and a key question I get asked is, Will the FDA ever approve a viral therapy for the treatment of advanced-stage cancer?” Thompson said. “That uncertainty about whether these agents are approvable or not is now gone. That is a big advantage when talking to people about investing in these products.” Dr. Jill O’Donnell-Tormey, chief executive at the Cancer Research Institute in New York, emphasized that there is still uncertainty surrounding how this drug will be used in conjunction with other cancer treatments. “Imlygic can best be thought of as another arrow in a doctor’s therapeutic quiver,” she said. “The best sequence to try existing drugs, including Imlygic, has not been determined yet, and doctors will therefore need to exercise clinical judgment.” Amgen executives were unavailable for an interview.
