Recipharm 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.