Alexza Reports European Launch of ADASUVE; Abbott Announces New Data on High-Sensitive Troponin Test Print E-mail
By Staff and Wire Reports   
Tuesday, 30 July 2013 18:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 30, 2013.

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.

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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.


Also Tuesday:


Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD), announced today the appointment of Jonathan Rubin, MD, MBA, as the Company's Chief Medical Officer, effective August 26, 2013.

ARCA biopharma, Inc. (Nasdaq: ABIO)
, a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that Raymond L. Woosley, M.D., Ph.D, has been appointed to the Company’s Board of Directors.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, announced today that the U.S. Patent and Trademark Office ("USPTO") has issued BIOLASE® a new patent for delivering sterile water.

CAS Medical Systems, Inc. (Nasdaq:CASM)
a leader in medical devices for non-invasive patient monitoring, today announced it will report financial results for the second quarter of 2013 on Wednesday, August 7, 2013 prior to the market's opening.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
, a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, today announced the closing of its previously announced initial public offering of 3,846,000 shares of common stock at a price to the public of $12.00 per share.

CollabRx, Inc. (Nasdaq:CLRX)
, a data analytics company focused on informing clinical decision making in molecular medicine, announces that Thomas R. Mika, Chief Executive Officer, will present at the 2013 Southern California Investor Conference (SCIC) at 10:30 a.m. (PT), on August 8, 2013, Track 2.

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY)
today announced its unaudited consolidated financial results for the quarter ended June 30, 2013 under International Financial Reporting Standards (IFRS).

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, today announced financial results for the three and six months ended June 30, 2013.

Genesis Biopharma, Inc. (OTCBB: GNBP)
today announced the appointment of Sanford J. Hillsberg and Jay Venkatesan, MD, to its board of directors. Genesis also announced that Paul Kessler and David Voyticky have tendered their resignations as directors.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
, a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease, today announced that a conference call will be held on Thursday, August 1, 2013 at 8:30 a.m. EDT to discuss results for the second quarter ended June 30, 2013 and a business outlook for the remainder of 2013.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
, a provider of peripheral vascular devices and implants, today reported Q2 2013 financial results. The Company posted record sales of $16.0mm and operating income of $1.4mm.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)
, a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three and six months ended June 30, 2013.

Life Technologies Corporation (NASDAQ: LIFE)
today announced that it has signed a five-year agreement with the Food and Drug Administration (FDA) to accelerate and advance food safety testing of E. coli and Salmonella, two foodborne contaminants commonly associated with outbreaks and/or recalls.

Medifocus, Inc. (TSX VENTURE:MFS) (OTCQX:MDFZF)
has filed its financial statements for the year ended March 31, 2013. Included in the financial statements is a correction of a prior period error that reflects the expensing of $3,904,313 of product development costs relating to the APA technology.

Nuvilex, Inc. (OTCQB: NVLX)
became a much more valuable company in July when it closed a deal it was fully prepared to pay a great deal more money for, but while it spent far fewer dollars, the assets it purchased could prove to fetch a price tag exponentially greater than the $1.5 million the company paid.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the Company's second quarter 2013 financial results will be released on Thursday, August 8, 2013, and that the Company will host a conference call and live webcast at 4:30 p.m. ET that afternoon.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP)
, a developer of oral drug delivery systems, announced today that it submitted a pre-Investigational New Drug (pre-IND) meeting request to the U.S. Food and Drug Administration (FDA) for a US-based trial on its orally ingestible exenatide capsule, ORMD-0901.

POZEN Inc. (NASDAQ: POZN)
, a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it plans to release second quarter 2013 results on August 6, 2013, before the market opens.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced positive results from a pre-clinical study with RHB-104 for the treatment of rheumatoid arthritis (RA), one of the most common chronic inflammatory diseases.

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH), announced today that the Company has acquired the exclusive, worldwide license to patented technology for the development of human immunotherapies against Clostridium difficile infection ("C. diff") from the University of Guelph (Ontario, Canada) ("Guelph").

StemCells, Inc. (Nasdaq:STEM)
today announced that it has formally launched its Alzheimer's disease program, which is being supported by the California Institute for Regenerative Medicine (CIRM).

Symmetry Medical Inc. (NYSE:SMA)
, a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that it has appointed Ajey Atre to the position of President of its subsidiary, Symmetry Surgical, Inc., effective August 12, 2013.

Targacept Inc. (NASDAQ: TRGT)
, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced that it will report financial results for the second quarter of 2013 on Tuesday, August 6, 2013, before the U.S. financial markets open.

Thermo Fisher Scientific Inc. (NYSE: TMO)
, the world leader in serving science, today showcased its comprehensive offering of specialty diagnostics products and analytical instruments designed to improve accuracy and productivity in clinical applications.

Trinity Biotech plc (Nasdaq:TRIB)
, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced results for the quarter ended June 30, 2013 and the acquisition of Immco Diagnostics Inc.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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