Lonza wins two biologic contracts

Swiss fine chemicals firm Lonza has secured two new contracts for its contract manufacturing division for monoclonal antibodies to treat systemic lupus erythematosus (SLE) and anthrax.

Lonza has steadily been building up its biologics production capacity in recent years, and is developing a strong position in the outsourcing market. New plants in Singapore, Canada, and the US have allowed it to double the number of biologic contracts between 2006 and 2009.

In its two latest contracts, Lonza has been named the commercial-scale manufacturing partner Benlysta (belimumab), Human Genome Sciences' SLE treatment, and says it will also carry out scale-up and commercial manufacturing of Elusys Therapeutics' anthrax treatment Anthrim.

Benlysta is currently under regulatory review in both Europe and the US, and has been developed by HGS in collaboration with GlaxoSmithKline. GSK filed for approval of the antibody in Europe in June, with HGS submitting it in the US in the same month.

HGS already has a commercial-scale manufacturing facility that will make Benlysta, but expects this can meet capacity only for the first two or three years after launch, according to Randy Maddux, the company's vice president of manufacturing operations.

"We believe that we will eventually require additional capacity," he said, noting that - if approved - demand for the drug is likely to be high as there has been no new drug approved for the treatment of SLE for over 50 years.

Meanwhile, Elusys has not gone down the path of building its own commercial-scale manufacturing capability, and the latest agreement with Lonza is an extension of earlier deal, signed last year, for process development and preliminary production of Anthim using Lonza's GS gene expression system.

The privately-held US biotech was awarded $143 million in funding from the US Department of Health and Human Services late last year to complete the final development, commercial manufacturing and licensing of Anthim.

The funding comes under the auspices of the US government's biodefense strategy Project Bioshield and is among the largest amount ever awarded for advanced product development.

If approved the federal authorities will buy Anthim for the USA's bioterrorism countermeasures stockpile.

Phil Taylor