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Pharmalink Enters Manufacturing Agreement for Busulipo™
By: PR Newswire
Nov. 12, 2012 04:02 AM
STOCKHOLM, Sweden, November 12, 2012 /PRNewswire/ --
Pharmalink AB, a Swedish specialty pharma company, today announces it has entered into a service 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), often known as bone marrow transplantation. GP Pharm is a Spanish biopharmaceutical company that focuses on injectable oncology products. Besides its proprietary products it also offers services in contract development and contract manufacturing.
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 manufacturing 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.
Pharmalink is a Swedish specialty pharma company developing high value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical development and marketing and the excellence of medical science in Sweden to identify and progress products that address significant unmet medical needs. With a successful history in pharmaceutical sales and marketing, and highly experienced, dynamic management team, Pharmalink is currently focused on the development of valuable, de-risked projects using a repurposing and reformulation strategy. It has two late-stage clinical phase products under development, Nefecon® and Busulipo™, having successfully divested its Xepol® product in 2010. Pharmalink is actively seeking opportunities to acquire or in-licence product opportunities in niche and hospital care indications. Visit http://www.pharmalink.se for further information.
About GP Pharm
GP Pharm, is a Spanish biopharmaceutical company located in Barcelona. Its activities are focused on research, development, production and marketing of injectable products within the urology and oncology fields, some of them based on proprietary drug delivery systems. These technological platforms include microspheres and liposomes. The company works on the complete development of these drugs, from the preclinical studies until the launch to the markets. These specialties are marketed either under own brands or through licenses. The last successful submitted product is Lutrate® 1 month (a DEPOT formulation of leuprolide acetate for prostate cancer treatment) that has been approved in 23 countries of the European Union, including UK, Spain, Germany and Italy. Visit http://www.gp-pharm.com for further information.
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