Amgen Spotlight On Advertising, Study Results

Amgen Inc., Merck & Co., Eli Lilly Co. and the Association of National Advertisers filed a lawsuit to stop a new federal regulation requiring the disclosure of the list price for prescription drugs in television advertisements, according to a Reuters report on June 17. The lawsuit was filed in federal court in Washington, D.C. against the Trump administration, which introduced a new regulation through the U.S. Department of Health and Human Services that would require pharmaceutical companies to disclose a drug’s list price in advertisements. The regulation, set to take effect in July, is part of the government’s efforts to bring down drug costs for consumers. Companies such as Thousand Oaks-based Amgen oppose the regulation because it excludes rebates and discounts that drug makers may offer. “Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments and patients themselves, by requiring disclosure of list price,” Amgen said in a statement. “Most importantly, it does not answer the fundamental question patients are asking: ‘What will I have to pay for my medicine?’” The lawsuit asks the court to vacate the rule. The biotech giant has had its ups and downs with recent studies and approvals in the past month – nearly half of patients involved in a study for Amgen Inc.’s BiTE drug, an experimental cancer treatment, experiencing adverse effects, according to data released June 5 from its phase 1 study for myeloma. Nineteen of 43 patients in the study showed a negative reaction to the drug – 16 of those patients required hospitalization. Two patients died during the study, but the deaths are not considered to be treatment-related, the Thousand Oaks biotech said. “Our BiTE immuno-oncology platform offers unique versatility, with the potential to treat various tumors through targeting tumor-associated antigens,” said Dr. David Reese, vice president of research and development at Amgen, in a statement. In a positive turn, a cancer drug developed through a collaboration between Amgen Inc. and Allergan Plc. has been approved by the U.S. Food and Drug Administration, according to a statement from the companies. Kanjinti is a biosimilar to Herceptin, a drug made by the Roche Group, a Swiss company, which is already on the market for certain types of breast and stomach cancer. “The FDA approval of Kanjinti is an important milestone for our biosimilars portfolio, providing an additional treatment option for patients across three types of cancer,” Reese said in a statement. “Kanjinti is the third biosimilar from our portfolio to receive FDA approval, highlighting our long-term commitment to providing patients with serious illnesses access to high-quality biological therapies.” To expand its patient pool for clinical research into oncology and other drug development areas, Amgen launched an initiative to introduce more people to the R&D side of the industry. The Thousand Oaks company has teamed up with leading community oncology networks to form Amgen Community Oncology Research Collaborators. Collaborations will allow Amgen to expand its clinical research footprint to more than 200 patient care sites across the U.S.