The U.S. Court of Appeals for the Federal Circuit left a question hanging over the marketing of Pfizer Inc.’s Ruxience, a biosimilar to Genentech Inc.’s Rituxan (rituximab). Saying that Pfizer didn’t have standing when it appealed in January 2019, the appellate court dismissed the New York company’s appeal of two inter partes review decisions in which the Patent Trial and Appeal Board (PTAB) upheld several claims in two Chugai Pharmaceutical Co. Ltd.’s patents. In accordance with a settlement agreement with Genentech, a wholly owned subsidiary of Roche Holding AG, Pfizer launched its biosimilar in January 2020. Although Roche is the majority owner of Chugai, the Tokyo-based company wasn’t a party to the Genentech settlement. In its appeal, Pfizer said Chugai was likely to accuse its biosimilar of infringing the patents because the biosimilar uses protein A chromatography and the patents “concern methods of purifying proteins involving the use of protein A chromatography.” While that may be, the Federal Circuit said Pfizer was not in danger of an infringement suit when it filed the appeal, as the FDA didn’t approve Ruxience until six months later. To have standing to appeal a PTAB ruling, a party must be able to show that it “was suffering a cognizable injury at all stages” of the appeal, the Federal Circuit said.
Although Vertex Pharmaceuticals Inc.’s Trikafta (elexacaftor/tezacaftor/ivacaftor) is a “remarkable advance” in treating cystic fibrosis (CF) and could alter the course of the disease for most patients, its price is out of proportion to its benefits, said David Rind, chief medical officer for the Institute for Clinical and Economic Review (ICER). Trikafta earned ICER’s highest “A” evidence rating for its indicated populations and is likely to be at least as good as Vertex’s Symdeko (tezacaftor/ivacaftor) in treating patients who are heterozygous for the F508del mutation and a residual function mutation, even though it has yet to be treated in that subpopulation, ICER said in an evidence report released Monday. The report also evaluated new data for other Vertex CF drugs and found that Kalydeco (ivacaftor) provides a substantial net health benefit, Orkambi (lumacaftor/ivacaftor) provides a small net health benefit and Symdeko provides at least a small net health benefit with the potential for a substantial benefit. ICER’s recommended health-benefit price benchmark for Trikafta, which has a broader label than the other three drugs, is $67,900-$85,500 per year. That would require at least a 73% discount off the drug’s current list price, according to the evidence report. While all four Vertex drugs are “transformative therapies, the prices set by the manufacturer – costing many millions of dollars over the lifetime of an average patient – are out of proportion to their substantial benefits,” Rind said. He noted that Vertex, of Boston, has a monopoly on the CF treatments. Due to the COVID-19 pandemic, ICER is indefinitely postponing its public meeting on the CF evidence report.
The EMA Tuesday updated its March guidance on managing clinical trials during the COVID-19 pandemic. The updates include recommendations on distributing study drugs to participants, taking into consideration social distancing measures and possible resource limitations at the trial site or hospital. Another update discusses remote source data verification. The guidance also clarifies how and when sponsors should notify authorities when urgent action is needed to protect trial participants against an immediate hazard or when other trial changes, which could affect patient safety or the robustness of data, might become necessary to mitigate disruptions during the public health crisis.
The FDA is beginning to reschedule some of the meetings it had to postpone because of the COVID-19 pandemic. The agency’s public meeting on modernizing its data strategy is now set for June 30 at the FDA campus in White Oak, Md. The meeting will focus on agency level approaches to data quality, data stewardship, data exchange and data analytics. The comment period has been extended to July 30, 2020, and comments should be submitted to Docket No. FDA-2019-N-5799.
The U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) is seeking comments regarding best practices for sequestering evidence during research misconduct proceedings. ORI is particularly interested in challenges and solutions in sequestering digital evidence, such as data stored in cloud environments and on personal electronic equipment or storage devices, according to a notice scheduled for publication in Wednesday’s Federal Register. The information will be used to draft guidelines to support institutions carrying out research misconduct proceedings. Comments should be emailed to OASH-ORI-Public-Comments@hhs.gov by June 13, 2020, with “sequestration RFI” in the subject line.
Fresenius Kabi AG’s April 20 recall of multiple lots of pain drug ketorolac, due to particulate matter found in the reserve sample vials, is having a bit of a domino effect. Quva Pharma Inc., of Sugar Land, Texas, said Tuesday that it’s working with the FDA to voluntarily recall lots of its RECK (ropivacaine, epinephrine, clonidine, ketorolac) 50 ml in sodium chloride-60 ml BD syringe that were prepared using Fresenius’ recalled ketorolac.