Cereno Scientific Signs CordenPharma To Manufacture CS1

Cereno Scientific have announced that an agreement has been signed with CordenPharma. CordenPharma is contracted to manufacture drug candidate CS1 in larger quantities, so-called scale-up manufacturing, needed to ensure supply to conduct the next clinical trial and later when approved for market launch.

A request for Extended Access (also called “compassionate use”) for the use of CS1 is currently under consideration by the FDA, which, if accepted, will require a supply of CS1 to PAH patients for whom there may be a request to continue treatment long-term with CS1 after the initial Phase II study.

Scale-up of manufacturing can be described as the process of increasing the production of a drug to commercial-scale, instead of the laboratory-scale batches being produced for early clinical trials.

“I am very pleased that we have agreed with CordenPharma to initiate the scale-up manufacturing of CS1. This is a key milestone for Cereno marking a starting step of our pivotal clinical trial program, which we anticipate to be pursued after our currently ongoing Phase II study in PAH. With often long lead times in drug development, we are with this agreement ensuring that there will be a supply of CS1 when we are ready to initiate the next clinical trial with CS1. With this contract, we are also securing long-term availability of CS1 supply for the Extended Access that was requested from the FDA last week. Now we can be assured that there is a continuous supply of CS1 available for the patients who are to continue treatment after the Phase II study. We are deeply committed to patients with the rare disease PAH and we hope, in the future, to be able to support many more patients to fight this deadly disease. This is a key step on that journey,” said Sten R. Sörensen, CEO at Cereno Scientific.