Stock Market News Today 2018/09/09
Novartis AG >>> Kymriah became the first in a new type of treatments known as CAR-T to win approval in the U.S. a year ago. The therapies involve extracting immune cells from the body and genetically engineering them to hunt and kill cancer cells after they’re put back into the patient.
CAR-T treatments are considered an important new option for leukemia and lymphoma that doesn’t respond to standard drugs, although they’ve been less successful when used against solid tumors. NHS England, which serves about 54 million people, said the recommendation of Kymriah was one of the fastest funding decisions in its 70-year history and quickly followed the approval of the therapy in Europe late last month.
The NHS, which negotiates drug prices, will get Kymriah for less than the $475,000 Novartis charges in the U.S. The first three NHS hospitals to start the process of providing the therapy for children are in London, Manchester and Newcastle, according to the statement.
Gilead’s Yescarta costs $373,000 per treatment, and treats a form of lymphoma. The U.K.’s National Institute for Health and Care Excellence recommended against the use of the Gilead therapy last week, concluding that its effects were comparable to those of standard treatment in some patients and needed more study. The agency invited additional commentary and data regarding the drug.
Based on its experience in the U.S., Novartis said it decided to take a gradual approach to its European launch, and the price for Kymriah will vary by country.
The drugmaker said it’s working “across Europe to set a fair price that is sustainable for national health-care systems, while recognizing the value Kymriah provides.”
Novartis receives European Commission approval of its CAR-T cell therapy,
The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL and r/r DLBCL
Novartis is the only company with an approved CAR-T cell therapy for pediatric r/r B-cell ALL and the first to receive approval in two distinct indications, both in the EU and the US. Novartis continues its strategy to expand manufacturing facilities with agreements with external collaborators, such as CELLforCURE in France.
This approval was based on the review of the only two global registration CAR-T clinical trials, JULIET and ELIANA, which included patients from eight European countries. In these trials, Kymriah demonstrated strong and durable response rates and a consistent safety profile in two difficult-to-treat patient populations. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers. This collaboration between industry and academia was the first-of-its-kind in CAR-T research and development.
“When the University of Pennsylvania and Novartis agreed to work together to develop CAR-T therapy, our main goal was clear and ambitious to address unmet needs for patients and to extend, improve and save lives,” said Carl June, MD, the Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at Penn and Director of the Center for Cellular Immunotherapies in the Abramson Cancer Center. “We are proud that our efforts in CAR-T now offer the European blood cancer community a breakthrough that brings new hope.”
Kymriah was designated as an orphan medicinal product and is one of the first PRIME-designated therapies to receive EU approval. PRIME (PRIority MEdicines) is a program launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need and help patients benefit as early as possible from therapies that may significantly improve their quality of life.