MILAN, 29 Mar (APM) - Italy’s plan to develop its own CAR-T therapies has too little funding and risks falling foul of patent litigation, according to a health economist writing in the online publication Quotidiano Sanità on Tuesday.
In a comment piece, Fabrizio Gianfrate noted that the health ministry has set up a working group of medical centres to conduct the research with MolMed providing the manufacturing expertise (APMHE 62327
The health economist noted that the first two approved CAR-T therapies, Novartis’ Kymriah and Gilead’s Yescarta, are only currently reimbursed in some countries, such as the UK, but not yet in Italy.
The health economist described them as exceptionally innovative because they provide a ‘one-shot’ treatment for long-term benefit. But he questioned how health systems will pay for them.
Gianfrate believes it might be done in instalments over several years, linking payment to confirmation of continuing effectiveness of the treatment. He also speculated about financial institutions such as banks taking over CAR-T debts by securitising them, or perhaps companies being paid with multi-year bonds.
The costs are so high because developing the CAR-T therapies is a long and complex process, the health economist pointed out. Gianfrate doubts whether Italy’s public funding will be enough.
“Given the need for specific technological and logistical equipment and the need for products and components of the highest quality, I have to say, with the utmost respect, that the €5 million made available by the tax decree is not going to achieve very much,” he wrote.
Gianfrate also said it is conceivable that there could be litigation if Italy’s therapies infringe on the patents covering those developed by industry.
GSK opens new €42 million quality control unit at Siena vaccines site
GlaxoSmithKline has opened a new €42 million quality control unit at its global vaccines centre at Rosia, near Siena, according to Friday’s Il Sole 24 Ore.
Around 47 million doses of vaccine were manufactured at the plant for 52 different markets in 2018, the paper said. The new unit will control the quality of all products from their clinical development to production and distribution.
According to Il Sole 24 Ore, the laboratories at Rosia will be among the most advanced in the world, confirming the strategic role in GSK’s global vaccines production network.
'Mediterranean anaemia' targeted with Celgene’s luspatercept
New cell therapies are being developed which can be used to treat beta-thalassemia which is also known as Mediterranean anaemia because of the higher number of cases in the Mediterranean area, Il Giornale reported on Wednesday.
One of these is Celgene’s luspatercept, a special protein which reduces the severity of the disease, the paper said. Patients, who have to have continuous blood transfusions, are hoping that they will soon be able to be treated with it.
The results obtained from trials are described as positive and very promising. It is estimated that in 81% of patients treated with luspatercept, the number of transfusions has been reduced by 20%. In 10% of the patients the number of transfusions has been halved.
Another possibility has emerged from research at the haemoglobin treatment centre of the Vanvitelli University Hospital, into gene auto-transplantation. The treatment allows a "healthy gene" to be transferred into the patient's cells, Il Giornale said.
Farmindustria chief urges parliament to approve clinical testing law
The head of the industry body Farmindustria has told parliament that legislation to introduce new clinical testing rule needs to be approved quickly, Il Sole 24 Ore reported on Tuesday.
Massimo Scaccabarozzi was addressing the social affairs committee in the chamber of deputies. He said the reforms introduced through the law are needed so that Italy can become more competitive in R&D and the number of clinical trials can be increased significantly.
“In the absence of favourable conditions, investment will be directed towards countries that have more agile procedures and which respect the times foreseen by the European clinical testing regulation which has to be implemented by the end of 2020,” he told the committee.
Farmindustria has called on the health ministry to introduce the necessary procedures quickly and to work with the medicines agency AIFA so new rules can be drafted, the paper said.
Snapchat interested in starting drugs advertising
Snapchat is looking to introduce medicines advertising onto its platform, About Pharma reported on Monday.
It is following Facebook, which has built an important slice of the business, the specialist publication said. Snapchat, which tends to appeal to younger age groups, sees makers of vaccines and contraceptives as the companies most likely to invest in this sort of advertising.
About Pharma cited a report from eMarketer last year which showed that, based on U.S. data, digital medicines advertising amounted to $2.52 billion in 2017 and has forecast it could reach $3 billion by the end of 2019. However, it still only accounts for 2.7% of the market as a whole.