update

Novasep joins Lonza as Mydicar API producer in deal with Celladon

By Gareth Macdonald contact

- Last updated on GMT

Novasep site in Seneffe, Belgium
Novasep site in Seneffe, Belgium
Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.

Novasep was named as a potential supplier of the active pharmaceutical ingredient (API) for Mydicar – a gene therapy for heart failure - this week in an announcement that expands on a scale-up and testing deal signed last month​.

If exercised, the deal would see Novasep supply the API through to 2018 with an option to extend until 2020. Production would be based at Novasep’s facility in Seneffe, Belgium which houses a 2,000 litre bioreactor.

The French contractor joins Swiss counterpart Lonza as a second firm to have been asked by Celladon to develop a scaled-up production process for Mydicar.

In November, Celladon announced the execution of a facility construction and commercial supply agreement with Lonza Biologics.

Under the deal Lonza developed a design for the potential construction of a new commercial viral therapeutics facility in Portsmouth, New Hampshire for the manufacture of MYDICAR drug substance.

In January​ Lonza was the first contractor to scale up Mydicar production, announcing that it helped produce supplies of the drug at its facility in Houston, Texas

Whether one or both of the firms will get the API supply contract long term has not yet been decided as Celladon spokesman Frederik Wiklund told us.

We are still working with Lonza. We are currently committed to dual source manufacturing supply.

He added that: “Both Lonza and Novasep deals are option deals and we will decide on the ultimate path forward after our Mydicar data in late April​.”

Mydicar is being examined in Phase IIb trials in the US and Europe, results from which are expected at the end of next month.

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