Benitec Biopharma (NASDAQ: BNTC; BNTCW) is trading 71% higher on news that the company’s BB-301 for the treatment of patients with oculopharyngeal muscular dystrophy (OPMD) has been granted Orphan Drug Designation by the European Commission. The designation, which provides regulatory and financial incentives including a 10-year period of marketing exclusivity in the EU after product approval and protocol assistance from the European Medicines Agency (EMA) during the product development phase, was based on favorable recommendation from the EMA Committee for Orphan Medicinal Products (COMP). Entry into the clinic with a phase I/II study in OPMD patients is anticipated in 2018, subject to toxicity results and future regulatory review. “We are very excited that BB-301 has received Orphan Drug Designation in Europe from the EMA COMP. This is a key program in our pipeline and we are happy to see the EMA recognising the urgent and unmet medical need for a safe and effective treatment for OPMD patients. We believe that our innovative approach may offer new treatment options for patients who might not otherwise be able to receive benefit in treating their disease. Having European Orphan Drug Designation will allow us to optimise steps to further advance BB-301 towards regulatory approval,” Chief Scientific Officer David Suhy stated in the news release.
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About Benitec Biopharma Limited:
Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is a biotechnology company developing innovative therapeutics based on its patented gene-silencing technology called ddRNAi or ‘expressed RNAi’. Based in Sydney, Australia with laboratories in Hayward, California (USA), and collaborators and licensees around the world, the company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including hepatitis B, wet age-related macular degeneration and OPMD. Benitec has also licensed ddRNAi to other biopharmaceutical companies for applications including HIV/AIDS, Huntington’s Disease, chronic neuropathic pain, cancer immunotherapy and retinitis pigmentosa. To learn more visit www.benitec.com
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