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$ALXN presented comprehensive dose-ranging data from 2 Phase 1b/2 studies of ALXN1210, investigational long-acting C5 complement inhibitor, in patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a chronic, progressive, debilitating and potentially life-threatening ultra-rare blood disorder characterized by complement-mediated hemolysis.
$ALXN and $HALO announced a collaboration and license agreement that enables $ALXN to use $HALO’s ENHANZE drug-delivery technology in the development of subcutaneous formulations for their portfolio of products. $HALO will receive an initial $40MM with the potential to earn additional payments of up to $160MM for each target developed.
Following its gMG (generalized myasthenia gravis) approval, $ALXN stated that it is not going to undermine the Soliris pricing strategy and will be focusing the launch in Germany, Europe and U.S. $ALXN expects gMG Japan launch will be early next year since the company is still waiting for the approval from the Japanese Patent Office (JPO).
American pharmaceutical company $ALXN reported a 17% fall in profit to $78MM for the quarter ended September 2017. Alexion’s Soliris (eculizumab), which recently got the approval from FDA for treating patients with generalized myasthenia gravis, sees product sales growth of 4% YoY to $756MM in 3Q17. Total sales grew 8% to $859MM.
Biopharmaceutical company $ALXN named Paul Friedman to its board of directors. Friedman had served as President and CEO of Incyte Corp. from 2001 to 2014. He succeeds Douglas Norby, who retired after serving on Alexion's board for 18 years. The company said Alvin Parven has decided not to stand for re-election as director.
$ALXN has charted out a re-alignment plan, with its refocused corporate strategy. The initiative is expected to deliver annual pre-tax savings of about $270MM (GAAP) and $250MM (non-GAAP) by 2019. The restructuring will reduce the company's workforce by 20%. The total pre-tax restructuring expenses are expected to be between $340MM and $440MM.
$ALXN said John Orloff has been appointed Head of Research and Development. Anne-Marie Law has joined the company as Chief Human Resources Officer and Indrani Franchini has joined as Chief Compliance Officer. All appointments are effective June 5, 2017, and the officers will report to CEO, Ludwig Hantson.
Pharma firm $ALXN obtained approval from the European Commission for extension of the indication for Soliris, a medication for ailments affecting the immune system, to include treatment of refractory generalized myasthenia gravis. The approval was granted based on clinical data from a phase-3 REGAIN study and long-term open-label extension study.
$ALXN announced that the United States Patent and Trademark Office (USPTO) has issued three new patents for Soliris. These will expire in 2027. The company is pursuing corresponding patent applications in other regions and countries, including Europe and Japan.
$ALXN and Sema4 announced a strategic partnership to leverage their shared experience in data science and systems biology to accelerate rare disease diagnosis and therapeutic discovery. This new partnership will combine $ALXN's rare disease SmartPanel analytics with Sema4's proven success in next-generation sequencing and genomic interpretation.
$ALXN's sale of its flagship drug Soliris was $814MM in 2Q17, compared to $701MM in the prior-year period, representing a 16% increase. Soliris volume increased 18% YoY. Soliris is primarily used to treat a rare disorder that destroys red blood cells.
$ALXN raised its 2017 forecast for both GAAP and non-GAAP revenue to $3.45-3.525Bil, vs the prior guidance of $3.40-3.50Bil. Non-GAAP EPS projection for this period was also raised to $5.40-5.55, compared to the prior guidance of $5.10-5.30. Meanwhile, the company now sees GAAP EPS in the range of $2.82-3.12.
Global biopharmaceutical company $ALXN reported 21% jump in revenue in 2Q17 to $912MM. The revenue reflected a benefit of about $35MM due to favorable timing of orders compared to its prior forecast. Net income rose to $165MM, or $0.73 per share, from $120MM, or $0.53 per share, a year ago. On an adjusted basis, $ALXN earned $1.56, up 38% YoY.
$ALXN said it received positive opinion from the Committee for Medicinal Products for Human Use to extend the therapeutic indication for Soliris to include the treatment of refractory generalized myasthenia gravis in patients who are ‘anti-acetylcholine receptor antibody-positive’. A final decision from the European Commission is expected in 3Q17.
$ALXN appointed Paul Clancy as CFO effective July 31, 2017. Clancy will succeed Dave Anderson, who will continue to serve as CFO until July 31, 2017. To ensure a smooth transition, Anderson will then become a Senior Advisor to the CEO and will remain with the company until the end of August.
$ALXN announced key additions to its executive leadership team effective June 5, 2017. Reporting to CEO Ludwig Hantson will be: John Orloff, M.D., EVP, Head of Research & Development, Anne-Marie Law, EVP, Chief Human Resources Officer, and Indrani Lall Franchini, J.D., EVP, Chief Compliance Officer.