01.11.24
Cereno Scientific, a company that develops treatments for common and rare cardiovascular disease, entered into an agreement with CordenPharma, a contract development and manufacturing organization (CDMO), to manufacture drug candidate CS1 in larger quantities that are needed to ensure supply to conduct the next clinical trial and later when approved for market launch.
A request for extended access (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.
“I am very pleased that we have agreed with CordenPharma to initiate the scale-up manufacturing of CS1,” said Sten Sörensen, CEO at Cereno Scientific. “This is a key milestone for Cereno marking a starting step of our pivotal clinical trial program, which we anticipate being 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.”
Sorensen added: “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.”
A request for extended access (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.
“I am very pleased that we have agreed with CordenPharma to initiate the scale-up manufacturing of CS1,” said Sten Sörensen, CEO at Cereno Scientific. “This is a key milestone for Cereno marking a starting step of our pivotal clinical trial program, which we anticipate being 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.”
Sorensen added: “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.”