Novartis offers to buy Kymriah manufacturer

Under the proposed agreement, Novartis would acquire the share capital of the French company – one of the first and largest contract development and manufacturing organisations (CDMO) producing cell and gene therapies in Europe – including the manufacturing facility located in Les Ulis.

If the offer is accepted, CellforCure would become a wholly owned Novartis manufacturing site, joining the existing network of cell and gene therapy sites including Morris Plains, New Jersey, USA and Stein, Switzerland.

Novartis previously signed an agreement with CellforCure in July to produce CAR-T cell therapies including Kymriah (tisagenlecleucel) – which was the first CAR-T cell therapy approved by the FDA and became one of the fastest funding approvals in the NHS’ 70-year history. Novartis and CellforCure have successfully completed technology transfer and Kymriah clinical supply production is expected to begin by mid-2019.

But the launch of the drug has not been without setbacks. Marketing has proved difficult in the US, where many hospitals do not have the expertise or capacity to administer it.

Yesterday the company also announced that its oncology CEO, Liz Barrett, who had been heading the launch of Kymriah, would be leaving after less than a year after deciding not to relocate to Basel.

Barrett told pharmaphorum in November that the company is looking to move manufacturing facilities closer to the clinics where patients are treated in order to make the time-consuming CAR-T treatment process – which involves harvesting a patient’s own T-cells, genetically modifying them to attack cancer, and then re-injecting them back into the patient – more efficient.

At the moment the company relies on larger hubs to manufacture the cells, transporting them to and from various clinics in the countries where the treatment is available.

Other steps Novartis has been taking to strengthen its cell and gene manufacturing include signing a strategic licensing, collaboration and share purchase agreement with Cellular Biomedicine Group (CBMG) to manufacture and supply Kymriah in China; expanding an alliance with the Fraunhofer Institute in Germany to support manufacturing for clinical trials and post approval manufacturing; and a contract manufacturing collaboration in Japan.

"The proposed acquisition of CellforCure is another strategic step in our pursuit of additional manufacturing capacity to make our transformational CAR-T cell therapy Kymriah available to more patients in need around the world," said Steffen Lang, Novartis’ global head of technical operations. "If completed, this acquisition also would potentially increase manufacturing capacity for other cell and gene therapies in the Novartis pipeline."

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