June 16, 2011 - Provides 10-year Market Exclusivity for the treatment of Cystic Fibrosis - Glasgow biopharmaceutical firm, Lamellar Biomedical Ltd, launched four years ago to develop a new class of therapies for the prevention, treatment and control of severe respiratory disease, announced that their lead clinical candidate LMS-611 for the treatment of patients with cystic fibrosis has received Orphan Drug Designation from the European Commission. The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) earlier this month.“The designation of LMS-611 as an orphan drug by the European Medicines Agency underscores the importance of developing effective treatments for patients with cystic fibrosis,” said Dr Iain McDougall, Chief Business Officer of Lamellar Biomedical Ltd. “To date we have been extremely encouraged by LMS-611’s preclinical results, and we continue to believe we are developing a therapy which will prove to be both safe and effective with the potential to offer a brand new way of treating the disease when we enter clinical trials early next year.”
Drugs for rare diseases are called “orphans” because the small number of patients they would treat means they are often not developed by the pharmaceutical industry. Today’s designation will make it easier for Lamellar Biomedical Ltd to attract both investment and development partners and facilitate LMS-611’s entry into clinical use. Lamellar Biomedical Ltd and its partners will also have ten years to exclusively market the Drug in the European Union.
LMS-611 is developed from Lamellar’s proprietary inhaled LamellasomeTM delivery platform. The LamellasomeTM is based on the biological and biophysical resemblance to the natural lamellar bodies found in healthy lungs, and found to be absent in cystic fibrosis patients. By mimicking this missing body responsible for normal lung function, Lamellar Biomedical Ltd have already established an impressive package of preclinical data demonstrating significant potential as a mucus-altering treatment with the ability to fight and prevent infection... Lamellar Biomedical's Press Release -
