Lonza has signed two new agreements for the supply of monoclonal antibody-based drugs that provide an early fillip for its contract manufacturing business, which was adversely affected by overcapacity in 2003.
In the first agreement, Lonza will supply clinical-grade monoclonal antibody drugs, all the way to market supply, for NovImmune. The latter company develops fully human MAbs, and Lonza gains access to the whole pipeline of NovImmune, including those products that may be licensed to third parties.
"The agreement will initially lead to the production of two antibodies and provision of GMP (Good Manufacturing Practice-grade) material for clinical trials," said Markus Gemuend, Lonza's outgoing chief executive who is due to stand down shortly.
Initially, the contract will focus on the supply of antibodies for clinical trials. NovImmune, based in Geneva, Switzerland, currently has 10 different monoclonal programmes at various stages of discovery and development, all focused in the field of immune-related disorders and inflammation. The first two MAbs should enter clinical trials before the end of the year, and are fully human versions of humanised antibodies that are already validated in Phase II trials as effective treatments for psoriasis and diabetes.
Erbitux relationship extended
In the second deal, Lonza has won a contract to make ImClone System's Erbitux (cetuximab), a new antibody-based drug for advanced colorectal cancer that has just been approved for marketing by the US Food and Drug Administration (FDA). The drug, which will also be marketed in the US by Bristol-Myers Squibb, is tipped to make sales well in excess of $1 billion (€795m).
Lonza Biologics was involved in making clinical material for the trials of Erbitux, but will also handle the initial commercial supply. ImClone had set up its own manufacturing plant - BB36 - to handle the production of the drug, but has decided to hold off on making the drug at the plant following an FDA request for validation data for the facility.
This request could have impacted the commercial supply of the drug, so Lonza has stepped forward to meet the initial demand. BB36 will still be used to supply material for trials and for some commercial supply in Europe, where it is marketed by Merck KGaA and manufactured by Boehringer Ingelheim.
Biotechnology - and particularly drugs made in mammalian cell culture at Lonza Biologics - has been one of Lonza's big investment projects over the last few years, perhaps unsurprisingly as Gemuend was made CEO after doing a good job at this division. But in 2003 a lack of demand hit hard at Lonza's smaller-scale (2,000L and 5,000L) reactors, which tend to be used in the early stages of a product's life cycle while sales are building. The two new agreements will go some way towards solving the capacity issue.