|Alexza Reports European Launch of ADASUVE; Abbott Announces New Data on High-Sensitive Troponin Test|
|By Staff and Wire Reports|
|Tuesday, 30 July 2013 18:43|
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced the company's commercial partner Grupo Ferrer Internacional, S.A. has initiated sales of ADASUVE^® inhalation powder, pre-dispensed (Staccato^® Loxapine) in the European Union ("EU"). ADASUVE is now available in Germany. The first sale and shipment of product by Ferrer triggers a $1.25 million milestone payment to Alexza, pursuant to the Company's collaboration agreement with Ferrer.
"This launch represents the first commercial sale of ADASUVE in the world, and marks the culmination of many years of dedicated effort and rigorous clinical development. I am incredibly proud of the efforts by the Alexza team and our partner Ferrer in bringing ADASUVE to physicians in the EU for use in their treatment of agitated patients with schizophrenia or bipolar disorder," said Thomas B. King, President and CEO of Alexza. "The initial launch of ADASUVE in Germany, followed by Ferrer's planned commercial roll out across the EU, is a key milestone for Alexza."
Alexza received marketing authorization for ADASUVE from the European Commission in February 2013. ADASUVE is the first inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder authorized to be placed on the market in the EU. The marketing authorization for ADASUVE requires that patients receive regular treatment immediately after administration of the product to control acute agitation symptoms. It also requires that ADASUVE be administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should also be available for treatment of possible severe respiratory side-effects, such as bronchospasm.
"Alexza and Ferrer's effective cooperation has enabled a product launch of ADASUVE in an admirably short time following the EU approval in February 2013," said Antoni Villaro, Chief Operating Officer of Ferrer. "ADASUVE is an important strategic product for Ferrer and we are excited to be introducing ADASUVE to the EU psychiatric and hospital treatment community."
Under the terms of the collaboration agreement between Alexza and Ferrer, which was announced in October 2011, Alexza is the exclusive supplier of ADASUVE, responsible for all aspects of manufacture of the product. Alexza began manufacturing launch quantities of the product for the EU in the second quarter of 2013 at its Mountain View, California facility. The commercial product was shipped to Ferrer in June 2013, and Ferrer completed EU product quality control release and final packaging in preparation for the planned third quarter launch. Ferrer is expected to launch ADASUVE in additional EU countries before year-end and will continue the EU launch into 2014.
Alexza and Ferrer estimate that as many as 8 million adults in the EU alone suffer from schizophrenia or bipolar disorder^1. Agitation is a common symptom for these patients^2, characterized by feelings of distress, anxiety and loss of control.
Abbott (NYSE: ABT) announced promising results from a study evaluating its High Sensitive Troponin-I (hsTnI) assay presented at this year's American Association for Clinical Chemistry (AACC) annual meeting in Houston, Texas. The study, conducted by researchers at Brigham and Women's Hospital, demonstrated that Abbott's hsTnI test (currently for research-use only in the United States) may help doctors predict which patients presenting with symptoms of a heart attack, such as severe chest pain, are at a higher risk for having a heart attack 30 days later.
A concern for patients who present with severe chest pain is that they are more likely to experience another cardiovascular event within a few weeks or months. Researchers at Brigham and Women's Hospital evaluated the performance of a hsTnI assay (Abbott, ARCHITECT) with the performance of a fourth generation troponin T assay (Roche, TnT) among 4,695 patients presenting with severe chest pain and found that the hsTnI assay identified more patients at higher risk of recurrent heart attack, even at very low troponin concentrations.
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