Shares in Basilea have risen after a tribunal awarded the Swiss biotech around $130 million, to be paid by ex-partner Johnson & Johnson for lost payments related to superbug antibiotic ceftobiprole.
The Netherlands Arbitration Institute has found J&J in breach of its licence agreement for ceftobiprole, after the US healthcare giant’s failed attempts to get approvals. At the beginning of the year, the US Food and Drug Administration rejected the antibiotic, known as Zevtera, because data from two studies was found to be “unreliable or unverifiable”.
A month later, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a negative opinion on the drug, having originally backed approval. Then J&J withdrew ceftobiprole from markets where it had already been approved, notably Switzerland, Canada and Russia
J&J’s handing of the submissions led Basilea to put in a claim against its partner and the Dutch award, which is immediately enforceable, includes lost milestones, other damages and interest. Anthony Man, chief executive of the Basel-based group said the award “has validated our grounds for arbitration”.
He went on to claim that ceftobiprole is “a very innovative drug [which] has activity against a wide range of bacteria, including MRSA and many Gram-negative pathogens, that no other single antibiotic can currently provide”. Mr Man then spoke of the “very unfortunate situation in which patients have not been able to access this potentially life-saving drug” and “we are pleased that we will gain full control of the development and commercialisation of ceftobiprole”.
The process of returning of all the rights should be completed at the latest by February 2011.
