Novartis announced an offer to acquire CellforCure from LFB. CellforCure, a French company, is one of the first and largest contract development and manufacturing organizations (CDMO) producing cell and gene therapies in Europe.
Under the proposed agreement, Novartis would acquire the share capital of CellforCure from LFB including the cell and gene manufacturing facility located in Les Ulis and the related adjacent land. If the offer is accepted, CellforCure would become a wholly owned Novartis manufacturing site, joining the network of cell and gene therapy sites including Morris Plains, New Jersey, USA and Stein, Switzerland, where construction continues to progress as planned.
In July 2018, Novartis announced that it had signed an agreement with CellforCure to produce CAR-T cell therapies including Kymriah®(tisagenlecleucel), the first CAR-T cell therapy approved by the United States Food and Drug Administration (FDA) and indicated for two distinct, difficult-to-treat cancers in the United States, European Union, Switzerland, Canada and Australia. Novartis and CellforCure have successfully completed technology transfer and Kymriah clinical supply production is expected to begin by mid-2019. The proposed acquisition of CellforCure is another example of continued commitment by Novartis to investing in cell and gene therapies as well as in France.
Novartis has made several steps recently to strengthen and expand its cell and gene manufacturing, including 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.
Novartis Global Head of Technical Operations Steffen Lang said, “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. If completed, this acquisition also would potentially increase manufacturing capacity for other cell and gene therapies in the Novartis pipeline. We are excited about the possibility of adding the significant experience of CellforCure to our existing leadership in pioneering research, development and supply of cell and gene therapies.”
The transaction is subject to usual and customary closing conditions, including employee consultation process and necessary regulatory approvals. If approved, the transaction is expected to be funded through available cash and close in the first half of 2019.
CellforCure is an LFB group company specializing in innovative therapy drugs. CellforCure`s industrial platform located in Les Ulis, near Paris is one of the first and largest in Europe for the production of cell and gene therapy drugs. Established as a pharmaceutical company since 2013, CellforCure operates a Contract Development and Manufacturing Organization. The company obtained two Good Manufacturing Practice (GMP) certificates from the French Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in 2016 for the production of innovative experimental and commercial therapy drugs.