Lamellar Biomedical Secures its First Orphan Drug Licence
Thursday, June 16, 2011
|Glasgow, Scotland, June 16, 2011
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, today 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 Lamellasome™ delivery platform. The Lamellasome™ 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.
About European Orphan Drug Designation
European Orphan Drug designation by the European Medicines Agency (EMA) is granted to medicines intended for treatment of life-threatening or chronically debilitating pathologies that affect no more than 5 in 10,000 people in the European Community. An orphan designation by the European Medicines Agency (EMA) confers a range of benefits to sponsor companies including scientific advice and regulatory assistance on clinical development, direct access to centralised marketing authorisation, and certain financial incentives including eligibility for grant support from European agencies. The designation also provides 10 years of marketing exclusivity subsequent to product approval.
About Cystic Fibrosis
Cystic Fibrosis (CF) is the most common, life threatening disease in the Caucasian population. It is estimated that there are between 70,0000 and 100,000 people with CF worldwide. There are around 30,000 people with CF in the USA, over 9,000 in the UK and approximately 30,000 in European Union. Cystic Fibrosis affects the internal organs, especially the lungs and digestive system, by clogging them with thick sticky mucus, which makes it very difficult to breathe and digest food. Rigorous daily treatment is required to keep people healthy including hours of physiotherapy, inhaled and intravenous drugs to fight and prevent infection, and taking enzyme pills to digest food. Only half of those living with Cystic Fibrosis are likely to live past their late 30s.
About Lamellar Biomedical
Lamellar Biomedical Ltd is Scottish based preclinical biopharmaceutical company developing a new class of inhaled medicines to treat, prevent and control serious respiratory disease. The Company’s proprietary compounds are derived from it’s own Lamellasome™ delivery technology and have been shown to be effective in altering mucus, dispersing biofilms, and fighting infection. For additional information about the Company, please visit http://www.lamellar.com/.
About the Lamellasome™
By mimicking nature to disrupt mucus, fight infection, and make breathing easier, Lamellar Biomedical have successfully developed the Lamellasome™, a synthetic “biomimic” of the missing body responsible for normal lung function.
Lamellasome™ therapies have broad potential to treat and prevent a wide range of respiratory disease conditions, including cystic fibrosis, brochiectasis, severe asthma and COPD. Lamellasome™ therapies act on contact to disrupt the thick, sticky mucus which clogs the airways. For sufferers, the clearing of mucus will be easier, the need for physical therapy reduced, and overall breathing function improved. Lamellasome™ therapies also disrupt bacterial colonies, overcome infectious biofilm buildup and improve the efficacy of certain antibiotics up to 16-fold. The use of antibiotics is reduced, airways protected, and sufferers less susceptible to recurring infection.
Further details and interview opportunities, please contact:
Dr Iain McDougall
Glasgow, ML4 3NJ
PHONE: +44 741 295 9057
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