CDMO Supplies Clinical Trial Material for FDA Approved Phase IIb Study

Recipharm and PledPharma have announced FDA approval of an IND application for a Phase IIb clinical trial with PledOx, PLIANT, in the US. The material for PLIANT has been manufactured by Recipharm Pharmaceutical Development.

Recipharm Pharamaceutical Development’s General Manager Maria Lundberg said: “We are delighted to contribute to the development of a new product that may reduce serious side-effects of the chemotherapy in patients treated for advanced colorectal cancer. Furthermore, manufacturing material for an FDA-approved clinical study reflects the highest standards of service quality and capabilities that Recipharm provides to its customers, meeting the expectations and demands of today’s competitive marketplace.”

Jacques Näsström, CEO of PledPharma, said: “We are very pleased with the positive assessment by the FDA. Since the US is perhaps the single most important market, it is particularly encouraging that we received approval for our study there.”

Recipharm’s Pharmaceutical Development Services group offers formulation development, clinical supplies, analytical methods development, stability studies and raw material selection and sourcing.

Recipharm AB, +46 8 602 52 00, info@recipharm.com, www.recipharm.com.