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news.UK-based biotechnology company, NovaBiotics' Lynovex has been granted orphan drug designation (ODD) in Europe (EU) by the Committee on Orphan Medicinal Products of the European Medicines Agency (EMA).
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Lynovex is the company’s novel dual mucolytic-antibacterial drug for the treatment of cystic fibrosis (CF).
According to the company, Lynovex (Cysteamine) is the first drug candidate with a novel dual mode of action which addresses the overproduction of mucous in airways and disrupts bacterial biofilms by attacking the bacteria that cause the recurrent infections associated with CF.
The orphan drug status is believed to provide marketing exclusivity in the EU for 10 years after approval and affords a fast-track route to clinic and patient access.
NovaBiotics founder and CEO Deborah O’Neil said Lynovex already has a well-established history of safety as scores and edge over currently marketed products in its mucolytic action.
"This novel drug candidate is expected to be tested in patients in 2012," Deborah O’Neil added.