Lonza wins second high-tech trial supply contract in a week

The drug in question - Mydicar - consists of an adeno-associated viral vector attached to a gene encoding the enzyme sarcoplasmic reticulum Ca(2+) ATPase (SERCA2a), the activity of which drops in late-stage heart failure. 

At present, Mydicar is under clinical investigation in a 200 patient Phase 2b clinical trial in NYHA Class III/IV heart failure patients.

The new deal – which covers tech transfer and manufacture of the drug for clinical trials – also gives Lonza the option to negotiate for the commercial-scale production contract if the product goes on to achieve regulatory approval.

The development and production work will be carried out at the recently opened good manufacturing practices (GMP) clean room at Lonza’s facility in Houston, Texas in the US, according to company head of viral-based therapeutics David Enloe.

“This is an exciting project for Lonza in that we will be producing materials for Celladon beginning at the 1,000 liter scale and likely expanding to 2,000 liters, which our recently completed and validated GMP suite was specifically designed to support​."

Celladon CEO Krisztina Zsebo was similarly upbeat about the agreement, commenting that: "Lonza's large scale viral manufacturing expertise will greatly complement and support our future development and commercialization efforts​."

The Celladon agreement is the second trial supply contract Lonza has announced this week behind its deal with Intellect NeuroSciences​.

Lonza has increasingly focused its contract manufacturing business on high-tech and high value products, both to fight off lower-cost competition and - in Europe - as a way of offsetting the negative impact of the strong Swiss franc.

As with the Intellect deal the impact of the Celladon accord on Lonza’s business is hard to estimate as further details were not disclosed.

However, a commercial scale manufacturing contract for what is likely to be a high value enzyme-replacement therapy product with a huge potential market would surely be good news for Lonza.