- Novartis has made an offer to acquire CellforCure, a French contract manufacturer that the Swiss pharma already works with on clinical production of its cancer cell therapy Kymriah.
- If the drugmaker's bid is accepted by LFB, the owner of CellforCure, the CDMO's manufacturing facility in Les Ulis, France would be folded into Novartis' global manufacturing network alongside cell and gene therapy plants in Morris Plains, New Jersey and Stein, Switzerland.
- The Swiss pharma has sought to expand its production capabilities for Kymriah, even as manufacturing difficulties have hampered rollout of the cell therapy. Its initial collaboration with CellforCure was followed by an agreement with Cellular Biomedicines in China to supply the CAR-T therapy there.
Working with CellforCure for six months was apparently enough to convince Novartis that buying the CDMO outright would be worth the expense.
Novartis and CellforCure recently completed the technology transfer which will permit clinical supply production of Kymriah (tisagenlecleucel) to begin at CellforCure's Les Ulis site by mid-2019.
At Les Ulis — which is located south of Paris — CellforCure has more than 38,000 square feet of space, including nearly 24,000 square feet of Good Manufacturing Practice area. The site has two GMP certificates from the French drugs regulator, Novartis said.
If Novartis' bid is accepted by LFB, Novartis would acquire the site directly along with related adjacent land. While it's not clear when LFB might decide, Novartis said the transaction could close in the first half of 2019.
The Swiss pharma plans to fund the transaction with cash on hand. No proposed price was disclosed.
Currently, Novartis manufactures Kymriah for commercial use out of its site in Morris Plains, New Jersey. It's building a facility in Stein and has inked a partnership with the Fraunhofer Institute in Germany as well to help support production of the complex treatment.
Rollout of Kymriah hasn't been completely smooth, however. Novartis has had difficulties manufacturing Kymriah up to specifications, resulting in some product that — while deliverable to patients — can't be billed.
In the three months from July to September, Novartis recorded $20 million in sales of Kymriah, which costs hundreds of thousands of dollars per patient.