Pharmalink enters manufacturing agreement for Busulipoâ„˘
Pharmalink AB, a Swedish specialty pharma company, today announces it has entered into a contract with GP Pharm for the manufacturing of Pharmalink’s Busulipo™, which is under development to provide a best-in-class conditioning agent for use prior to hematopoietic stem cell transplantation (HSCT), also often known as bone marrow transplantation.
The agreement covers the manufacturing of Busulipo™ from clinical to commercial quantities and is an important step in progressing the product towards the market. No commercial terms were disclosed.
Johan Häggblad, Managing Director of Pharmalink, said: “Busulipo™ is an immediate release liposome formulation that improves the safety and stability of the chemotherapy agent busulfan that is currently the gold standard for use in conditioning prior to HSCT. Busulipo™ allows the elimination of the toxic solvent DMA and has been designed to have a two year shelf life and increased stability after reconstitution. GP Pharm has an excellent track record in the manufacture of complex injectables and specifically with liposomes. We look forward to working with GP Pharm as Busulipo™ enters the next phase of clinical development.”
HSCT has become a treatment of choice for many diseases in adults and children and myeloablation as a conditioning regimen is an important part of a successful outcome. There are more than 50,000 HSCTs carried out per year. The concept behind Busulipo was originally developed at Karolinska Institute (Sweden) and was acquired by Pharmalink in 2006.
Busulipo™ has successfully undergone clinical trials with more than 90 patients treated. Extensive data on efficacy, safety and pharmacokinetics have been collected and these compare positively with historical controls. Pharmalink is currently preparing the late stage clinical trials needed for registration and introduction of Busulipo™ into key global markets in discussion with regulatory authorities.