February 12, 2013 -- Recipharm and PledPharma announce FDA approval of an IND application for Phase IIb clinical trial with PledOx, PLIANT, in the U.S. 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.
Recipharm AB is a leading contract development and manufacturing organization (CDMO) based in Sweden employing some 1700 employees. The Company operates development and manufacturing facilities in Sweden, France, the UK, Germany and Spain and is headquartered near Stockholm. Recipharm supplies the global pharmaceuticals market with hundreds of different products in multiple dosage forms that include solid dose, granulates and powders, sterile liquids and lyophilisates, semi solids, oral liquids, sprays and dry powder inhalers. For more information visit: www.recipharm.com.
PledPharma is a Swedish specialty pharma company that develops a new medicine, PledOx®, for prevention of the severe side effects that patients develop as a consequence of chemotherapy treatment of cancer. Many times the treatment cannot be carried out as planned due to very difficult side effects. The current market for supportive cancer care is some SEK 72 billion. PledOx is a medicine within the patent protected substance class PLED, which protects the body’s normal cells against oxidative stress. Oxidative stress is a condition where an overabundance of harmful oxygen molecules (free oxygen radicals) has been formed. We are also evaluating opportunities with PLED substances for other diseases. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser. For further information, please visit www.pledpharma.se.
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