FDA approves Yescarta from Gilead’s Kite
FOSTER CITY, Calif. — The Food and Drug Administration has approved the first chimeric antigen receptor T cell, or CAR T, therapy for patients with certain types of lymphoma. Yescarta, from Gilead’s recently acquired company Kite, was approved to treat relapsed or refractory large B-cell lymphoma following two or more lines of systemic therapy.
“The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” Kite founder Dr. Arie Belldegrun said. “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR T therapies.”
Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma, representing 1-in-3 of the roughly 72,000 new cases diagnosed every year in the United States. Each dose of Yescarta is customized based on a patient’s immune system to help fight the immune system. A patient’s T-cells are collected and genetically modified to include a new gene that targets and kill lymphoma cells. The list price of Yescarta, according to Gilead, is $373,000.
The approval comes as the FDA is set to offer more guidance to manufacturers on the development of gene therapies similar to Yescarta.
"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer," FDA commissioner Dr. Scott Gottlieb said. "This approval demonstrates the continued momentum of this promising new area of medicine and we're committed to supporting and helping expedite the development of these products. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies.”
National digestive brands see mixed sales results
The upper gastrointestinal proton pump inhibitors segment saw a 9% decrease — national brands only — in sales in multi-outlets for the latest 12 months compared with the previous year, with losses primarily driven down by large decreases at Procter & Gamble’s Prilosec OTC (-13%) and for GSK Consumer Heathcare’s Prevacid (-15%). Among the H2 segment — which was up 2% versus the previous year, national brands only — McNeil’s Pepcid brand showed strong growth versus the prior year with a 6% increase, while Chattem’s Zantac decreased 1% (Figure 1).
For leading manufacturers in the PPI segment, Pfizer’s Nexium 24HR saw the highest percentage of sales on promotion at 40%. Bayer’s Zegerid saw the lowest percentage of sales on promotion at just 13%. In the H2 segment, both Chattem and McNeil saw similar per-
centages of sales on promotion at 20% and 21% respectively (Figure 2).
Average PPI retailer margins were consistently the highest in the mass, food and drug channels for Bayer, while GSK Consumer Healthcare saw the lowest average margins. In the H2 segment, McNeil saw the highest margins across all channels while Chattem saw the lowest (Figure 3).
For upper GI PPI segment, P&G saw the largest amount of ad support across all three channels. For the H2 segment, Chattem saw the largest number of print circular ads for both food and drug channels, while mass focused primarily on price only (Figure 4).
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Specialty drugs up share of per-capita spend as sales growth slows
Even after the boom that the specialty pharmacy sector saw in 2014 with the introduction of new treatments for hepatitis C, the drug class continues to see its share of per-capita spending grow as manufacturers continue to develop more targeted therapies. The changes that the specialty space is seeing have been documented by the Quintiles IMS Institute, both in its report on the use of medicines in 2016 and its issue briefs on the drivers of drug expenditure and the oncology space.
Between 2014 and 2016, the growth rate of specialty revenue growth has been in decline — from close to 25% in 2014 to around 7% in 2016, which is still higher than it was before the hepatitis C treatment boom in 2014. As specialty growth looks set to plateau, the drug class continues to see its share of per-capita spending increase, with a decline in spending on traditional medicines creating space for more specialty share.
The share of net spend that went to specialty rose from 21.8% in 2007 to 39.6% in 2016. In real-number terms, this means that in 2016 for every $895 in real net manufacturer revenue per capita, $384 of it was for specialty, with the other $511 coming from traditional medicines. Among specialty medications, biologic drugs saw 13% growth in 2016, compared with 10% per year for the previous five years. And though 2016 was the year that biologics saw the most competition from biosimilars, biologics with biosimilars competition only accounted for $3.2 billion of the total $102.3 billion that biologics brought in last year, with biosimilars only accounting for $300 million of that figure.
Also increasing is the share of approved new active substances in the specialty space. Though 2016 saw fewer than half the number of new launches that 2015 and 2014 saw, it reflected the larger trend of new active substances largely being for specialty medicines, with many receiving Orphan Drug designation from the Food and Drug Administration. Two-thirds of the drugs with an Orphan Drug designation last year were for cancer, with the rest looking to treat such rare diseases as hemophilia B and cystic fibrosis. QuintilesIMS projects that between 2017 and 2021, the FDA will approve 40 to 45 new active substances.
In terms of continued revenue growth, the QuintilesIMS institute projects new brand spending growth — largely driven by specialty — to grow by $15 billion and $17 billion every year between 2018 and 2021, with new treatments focusing on oncology, immunology and autoimmune disorders.
The oncology space is among the most active disease states within specialty, with more than 68 different agents launching between 2011 and 2016 for more than 22 indications. And the late-stage research and development pipeline features 631 oncology new treatments, or about a quarter of the 2,346-drug pipeline, with a quarter of the cancer drugs seeking to address blood cancers.
“The pace of development in cancer treatments is accelerating, not just because of the number of new medicines in research, but [because] the combination regimens that may have greater effects than the individual drugs, and because of the continuous development of biomarkers and the potential to more appropriately target the right drug to the right patient with minimal waste and risk of non-response,” QuintilesIMS wrote in its Global Oncology report.