02.11.2015 05:36:32
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ALXA Gets It Back, REGN's Eylea Keeps Adding New Indications, Smooth Flows PTLA
(RTTNews) - Alexza Pharmaceuticals Inc. (ALXA) is planning to reacquire the U.S. rights for Adasuve inhalation powder from Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA). The transition is expected to be completed by January 1, 2016.
Adasuve (loxapine) inhalation powder was approved in the U.S. and Europe for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults in 2012.
Teva licensed from Alexza the U.S. commercial rights to Adasuve in May 2013.
Alexza is scheduled to report Q3-2015 financial results on Nov.5, 2015.
ALXA closed Friday's trading at $1.07, down 1.83%.
Portola Pharmaceuticals Inc. (PTLA) has completed patient enrollment in its pivotal phase III study of Betrixaban for the prevention of blood clots in acute medically ill patients.
Betrixaban is an investigational oral, once-daily Factor Xa inhibitor anticoagulant for extended-duration prevention of venous thromboembolism, or blood clots, in acute medically ill patients.
The top-line data from the trial, dubbed APEX, are expected at the end of the first quarter of 2016. If the trial is successful, the company expects to submit a New Drug Application to the FDA in the second half of 2016 under Fast Track designation.
PTLA closed Friday's trading at $47.61, up 1.45%.
Regeneron Pharmaceuticals Inc.'s (REGN) blockbuster eye drug, EYLEA, has received European approval for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV). Myopic CNV is an eye disease associated with high degrees of myopia (near-sightedness) and frequently affects people of working age.
In the EU, EYLEA is already approved for the treatment of patients with neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, and visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO).
Regeneron maintains exclusive rights to EYLEA in the United States while Bayer HealthCare commercializes the drug outside the United States.
Looking ahead to full year 2015, the company expects the U.S. net product sales of EYLEA to grow 45% to 50% over $1.74 billion reported in 2014.
REGN closed Friday's trading at $557.39, down 0.37%.
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Regeneron Pharmaceuticals Inc. | 685,00 | -2,25% | |
Teva Pharmaceutical Industries Ltd. (spons. ADRs) | 20,40 | -0,49% |