9th January 2012: - Recipharm, the international contract pharmaceutical development and manufacturing organisation, express satisfaction at the news that PledPharma’s new mangafodipir clinical trial product which is supplied by Recipharm’s pharmaceutical development group has been approved by the Swedish Medical Products Agency. Earlier this year, patient recruitment on the MANAMI study ceased - due to a lack of clinical trial substance. Following an approach by PledPharma, Recipharm has worked together with PledPharma to ensure an approval from the regulatory body allowing the continuation of the MANAMI study.
The decision is highly significant for myocardial infarction (heart attack) patients, enabling PledPharma to continue its promising MANAMI study into the ability of mangafodipir to improve treatment outcomes during angioplasty.
Maria Lundberg General Manager of Recipharm Pharmaceutical Development AB, commenting on the new approval, said: “We are pleased to contribute to the continuation of this important clinical trial. After being contacted by PledPharma, both companies worked very hard together to get the clinical trial material approved as fast as possible. We are well used to working with tight deadlines and we were very happy with the result that was achieved”.
“The restart of the MANAMI study is very positive and it could not have been achieved without a new supply of mangafodipir - and we are satisfied with the collaboration with Recipharm to ensure this. Already we have seen promising results when mangafodipir has been used in conjunction with angioplasty, as it enables a greater reduction in the size of the infarction, for patients suffering myocardial infarction. Furthermore, we are expecting to have two clinical phase II studies ongoing next year, since we are also in the final stages of preparatory work ahead of our clinical phase IIb study in colorectal cancer patients” commented Jacques Näsström, CEO of PledPharma.
About the MANAMI study
Mangafodipir is given just prior to angioplasty treatment in connection with treatment of acute myocardial infarction. The study will include in total 20 patients, whereof 10 patients will receive active substance and 10 patients will receive placebo. 8 patients are included so far. The mangafodipir effect is assessed through measurement of enzyme levels and magnetic resonance imaging (MRI) analysis. The study is done in the County hospital Ryhov under the supervision of Senior Consultant and PhD Jan-Erik Karlsson. Previous pre-clinical studies have shown that PLED-derivates can reduce the size of the remaining infarction after reperfusion of an acute myocardial infarction.
Recipharm AB is a leading contract development and manufacturing organisation
(CDMO) based in Sweden employing some 1 735 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, beta-lactams, hormones, oral liquids, sprays and dry powder inhalers. For more information, please visit www.recipharm.com
PledPharma is a Swedish specialty pharma company, which develops new treatments of life threatening diseases. PledPharma currently runs two projects in clinical development phase II with the patented drug substance class, PLED-derivatives. The preventive effect of PLED-derivatives on adverse effects of chemotherapy in colon cancer is examined in one trial. Another trial investigates the ability of PLED-derivatives to reduce reperfusion injuries in myocardial infarction patients undergoing percutaneous coronary intervention (PCI). PLED-derivatives protect the body’s normal cells against oxidative stress, which is a condition due to overproduction of free oxygen radicals. PLED-derivatives have in previous pre-clinical trials been shown to protect against oxidative stress. Moreover, the PLED-derivative mangafodipir protected against the side effects of chemotherapy in colorectal cancer. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser.
For more information, please visit www.pledpharma.se