FDA clears Lonza for Orencia production

By Gregory Roumeliotis

- Last updated on GMT

Related tags Lonza Rheumatoid arthritis

Lonza has been authorised by the US Food and Drug Administration
(FDA) to produce Bristol-Myers Squibb's arthritis drug Orencia
(abatacept), in what is shaping up to be a major manufacturing deal
for the Swiss company.

Biologic drugs like Orencia, that suppress inflammation-causing immune system cells, or cytokines, are new to the treatment of rheumatoid arthritis, a disease that afflicts almost 3m Americans and has created a global market for innovative drugs projected to reach $10bn (€8.4bn) by 2008.

Orencia therefore has potential to be a huge earner for both BMS and Lonza, since it is indicated for patients who do not respond to tumour necrosis factor (TNF) antagonists, and so faces direct competition only from Rituxan (rituximab), a cancer drug made by Genentech, which was approved in February to treat rheumatoid arthritis.

Many in the industry feel that uncertainty regarding dosing and risks of injection reaction may make Rituxan less competitive than Orencia, but ironically, Lonza is also involved in the production of Rituxan, making around 50 per cent of Genetech's requirements for the drug.

Yet Genetech is becoming increasingly self-reliant, dampening Lonza's spirits by announcing plans last year to dramatically increase in-house production capacity in the wake of its $408m acquisition of Biogen-Idec's Oceanside facility.

Nevertheless, Lonza will take heart from its manufacturing agreement with BMS, whose plant in Syracuse, New York, is not producing enough to meet demand.

Apart from contracting Lonza, BMS also announced last month it will splash out $200m to expand its Puerto Rico biologics facility, while in March it approved a plan to build a $660m plant to make biologic products in the US.

Unfortunately for Lonza, BMS said earlier this year that it will only share the manufacturing of Orencia until that new US biologics plant is ready.

Still, it will take five years to complete the building and meet regulatory requirements for production, so for now Lonza appears upbeat and ready to start to production at its Portsmouth site in New Hampshire.

"Scaling up a biologic drug like Orencia is part of the value that we bring to the market and to our partners,"​ Lonza spokeswoman Margot Connor told In-PharmaTechnologist.com​.

"We are able to scale up effectively, with repeatability in operations, a capability which differentiates us in the market."

Orencia, approved by the FDA in December 2005 and launched in the market last February, is the first in a new class of drugs called selective T-cell co-stimulation modulators.

It acts by blocking the activation of T-cells that play a role in the body's immune response.

The biopharmaceutical sector is proving lucrative for pharma companies, with approximately one-fourth of new drugs coming on the market being biopharmaceuticals and annual sales projected to surpass $52bn by 2010.

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