GOTHENBURG, SWEDEN 7 March 2005 The drug development company Arexis AB announced today that it has entered into a collaboration agreement with the Danish company CMC Biopharmaceuticals on the production of recombinant human BSSL for the upcoming cystic fibrosis and preterm infant clinical trials.
The collaboration represents an important step in the preparations for the BSSL (bile salt-stimulated lipase) clinical trials in cystic fibrosis patients with fat malabsorption and preterm infants. Under the collaboration agreement, Copenhagen-based CMC Biopharmaceuticals, a contract development and manufacturing organization specialized in GMP manufacturing (good manufacturing practice, required for substances in clinical development), will provide Arexis with all recombinant human BSSL for the trials.
With its impressive qualities in GMP manufacturing, CMC represents an ideal partner for the timely and reliable delivery of high-quality BSSL for our clinical trials,” says Lennart Hansson, CEO of Arexis.
Recombinant BSSL is an exciting new biopharmaceutical, and we look forward to starting production in a close and fruitful collaboration with Arexis,” says Mads Laustsen, CEO of CMC Biopharmaceuticals.
The key function of BSSL is to degrade a large spectrum of lipids in food. Arexis’ BSSL program consists of two projects where its patented human recombinant enzyme is used to target fat malabsorption in cystic fibrosis patients and preterm infants. Following the recent successful cystic fibrosis phase II clinical trials which proved the concept, Arexis now plans a dose-finding study followed by a clinical phase III trial. Arexis also plans clinical phase II preterm infant efficacy studies. As a future therapeutic option, BSSL is perhaps the most promising new entry of options to improve fat malabsorption currently in development.
The cystic fibrosis project recently received orphan drug status in the EU. The preterm infant studies will be part of the EARNEST EU-funded program, and orphan drug designations will be applied for in the EU and US.
CMC Biopharmaceuticals will produce BSSL in a mammalian cell bioreactor, with the first batch reserved for the dose-finding cystic fibrosis study and the initial preterm infant clinical phase II studies, and the second batch to be used in the clinical phase III cystic fibrosis trial. Mammalian cell culture production systems are very well established for producing recombinant therapeutic proteins. CMC Biopharmaceuticals will base its production on one of Arexis’ proprietary cell lines.