Recipharm supplies clinical trial material for FDA approved phase IIb study sponsored by PledPharma

Recipharm and PledPharma announce FDA approval of an IND application for Phase IIb clinical trial with PledOx, PLIANT, in the U.S.

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The material for PLIANT has been manufactured by Recipharm Pharmaceutical Development.

Recipharm Pharamaceutical Development’s General Manager, Maria Lundberg says: “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 market place.”

Jacques Näsström, CEO PledPharma says: "We are very pleased with the positive assessment by the FDA. Since the U.S. 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 offer services from straight forward clinical supply through to more complex product development and formulation. From our pharmaceutical development centre we can work on a variety of technologies, including sterile products. Formulation development, clinical supplies, analytical methods development, stability studies and raw material selection and sourcing are all core activities.

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