Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based biotechnology firm Therabron Therapeutics has received orphan drug designation from the European Medicines Agency (EMA) for its lead product candidate, CG100, for the prevention of bronchopulmonary dysplasia (BPD).
Subscribe to our email newsletter
CG100 is a potentially transformative biologic drug that consists of a recombinant human club cell 10kD protein (rhCC10), a secretory protein.
rhCC10 is believed to play a major protective role in the lung via maintenance of airway epithelia and through immunomodulatory mechanisms.
Therabron president and chief operating officer Thomas Miller said: "Orphan designations granted by regulatory bodies like the FDA and EMA are important because it encourages research and product development for underserved patient populations that can benefit from innovative solutions to otherwise overlooked healthcare conditions.
"The orphan designations granted by both the US and EU give significant meaning to the current CG100 phase II clinical trial currently underway as our experience to date suggests this product candidate has the potential to be a viable therapeutic option to prevent chronic respiratory morbidities that are common in preterm infants."
The EMA orphan drug status allows products receiving a marketing authorization to have up to ten years of market exclusivity in the European Union (EU).
Earlier, the company had secured an orphan designation for the prevention of BPD from the US Food and Drug Administration (FDA).
Last year, the company had started a Phase II trial to evaluate CG100 for the prevention of chronic respiratory morbidities in premature infants and it is supported by a $1.6m grant from the FDA’s Office of Orphan Product Development.