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Blog Coverage Benitec Biopharma Secures Orphan Drug Designation for its Product Treating Patients with Oculopharyngeal Muscular Dystrophy

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LONDON, UK / ACCESSWIRE / January 18, 2017 / Active Wall St. blog coverage looks at the headline from Benitec Biopharma Ltd (NASDAQ: BNTC) as the Company announced on January 17, 2017, that the European Commission, based on a favourable recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted Orphan Drug Designation to the Company's BB-301 product as an orphan medicinal product for the treatment of patients with oculopharyngeal muscular dystrophy (OPMD). Register with us now for your free membership and blog access at:


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What is OPMD?

OPMD is a rare inherited myopathy characterized by dysphagia that is the difficulty in swallowing, loss of muscle strength, and weakness in multiple parts of the body. Patients typically suffer from severe dysphagia, ptosis, tongue atrophy, proximal lower limb weakness, dysphonia (altered and weak voice), limitation in looking upward, as well as facial muscle and proximal upper limb weakness. Progressing throughout that patient's life, OPMD is not typically diagnosed until the individuals reach their 50's or 60's. As the dysphagia becomes more severe, patients become malnourished, lose significant weight, become dehydrated and suffer from repeated incidents of aspiration pneumonia. Currently, therapeutic strategies employ repetitive surgical interventions that have limited efficacy.

Details about BB-301

Benitec's BB-301 is a ddRNAi therapeutic for the treatment of OPMD comprised of a single expression construct for the 'knockdown and replace strategy' of mutant PABPN1, the principle cellular component that leads to the diseased condition in humans. BB-301 is currently in preclinical development and Benitec's plans to initiate IND-enabling studies later in 2017. 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 recognizing 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," stated David Suhy, the Company's Chief Scientific Officer.

How Does the Orphan Drug Designation Benefits Benitec?

Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. Moreover, apart from a 10-year period of marketing exclusivity in the EU after product approval, the orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralised authorization procedure. Benitec stated that having European Orphan Drug Designation will allow the Company to optimize steps to further advance BB-301 towards regulatory approval.

Stock Performance

On Tuesday, January 17, 2017, following the announcement, the stock closed the trading session at $3.00, surging 62.16% from its previous closing price of $1.85. A total volume of 8.86 million shares have exchanged hands, which was higher than the 3-month average volume of 13.65 thousand shares. Benitec Biopharma's stock price surged 109.64% in the last month, 108.33% in the past three months, and 129.01% in the previous six months. Furthermore, on a year-to-date basis, the stock gained 96.08%. The stock currently has a market cap of $439.59 billion.

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