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LONDON, UK / ACCESSWIRE / January 10, 2017 / Active Wall St. blog coverage looks at the headline from Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) as the Company announced on January 09, 2017, that it has submitted marketing applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to extend the indication for Soliris® (eculizumab) as a treatment for patients with refractory generalized myasthenia gravis (gMG). Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of Alexion Pharma's competitors within the Biotechnology space, Jazz Pharmaceuticals PLC (NASDAQ: JAZZ), is estimated to report earnings on February 28, 2017. AWS will be initiating a research report on Jazz Pharma following its earnings release in the coming weeks.

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Alexion Pharma stated that the European submission has been validated by the EMA, thus beginning the review process in Europe for this potential new indication for Soliris. Both the US and EU submissions are supported by the comprehensive data from the Phase-3 REGAIN study.

The Company stated that if approved, Soliris would address a significant unmet need for patients with refractory gMG who have largely exhausted conventional therapy. Refractory gMG patients who are anti-AChR antibody-positive are an ultra-rare segment of MG, a debilitating, complement-mediated neuromuscular disease in which patients suffer muscle weakness throughout the body, resulting in slurred speech, impaired swallowing and choking, double vision, disabling fatigue, shortness of breath due to respiratory muscle weakness, frequent hospital and ICU visits with prolonged stays, and episodes of respiratory failure.

"Today there is an urgent need among patients suffering with refractory gMG, as there are no effective therapies for this ultra-rare and devastating disease population, causing patients to face disabling limitations in their daily lives, including difficulty walking, talking, swallowing, and breathing normally," said Martin Mackay, Ph.D., Executive Vice President and Global Head of R&D at Alexion, "The US and EU regulatory submissions put us one step closer to accomplishing our goal of transforming the lives of patients suffering with refractory gMG with anti-AChR antibodies. We look forward to working with regulatory authorities as they review our applications."

Soliris has received Orphan Drug Designation (ODD) for the treatment of patients with MG in the US and EU.

FDA Orphan Designation

On January 06, 2017, Alexion Pharma announced that the US FDA has granted ODD to ALXN1210, a longer-acting anti-C5 antibody that inhibits terminal complement, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare, life-threatening blood disorder.

Alexion Pharma is currently enrolling patients in Phase-3 trials of ALXN1210 in patients with PNH as well as in patients with atypical hemolytic uremic syndrome (aHUS), another ultra-rare and life-threatening disease caused by chronic uncontrolled complement activation. In June 2016, ALXN1210 was granted ODD by the European Commission for the treatment of patients with PNH. The Company has also secured a composition of matter patent for ALXN1210 in the US and Europe through 2035.

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan status to drugs and biologic products that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. ODD provides a drug developer with certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication.

Stock Performance

On Monday, the stock closed the trading session at $144.77, slightly up 0.81% from its previous closing price of $143.61. A total volume of 2.61 million shares have exchanged hands. Alexion Pharma's stock price advanced 15.24% in the last month, 15.77% in the past three months, and 15.54% in the previous six months. Furthermore, on a year-to-date basis, the stock surged 18.32%. Shares of the company have a PE ratio of 87.90 and currently have a market cap of $32.45 billion.

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SOURCE: Active Wall Street