Adventrx To Develop ANX-188; FDA Grants QIDP and Fast Track Designations for Cubist Print E-mail
By Staff and Wire Reports   
Thursday, 28 February 2013 19:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 28, 2013.

ADVENTRX Pharmaceuticals (NYSE: ANX)
announced its plans to develop ANX-188 in complications of arterial disease, initially as an adjunct to thrombolytics in acute limb ischemia (ALI), a complication of peripheral arterial disease. Peripheral arterial disease affects an estimated 8 to 12 million people in the United States.

Arterial disease resulting from atherosclerotic and thromboembolic processes is a common circulatory problem in which plaque-obstructed arteries reduce the flow of blood to tissues. Peripheral arterial disease refers to disease affecting arteries outside the brain and heart and often refers to blockage of arteries in the lower extremities. Ischemic cerebrovascular infarction, or stroke, results from blockage of arteries to the brain, while myocardial infarction, or heart attack, results from blockage of arteries to the heart. Thrombolytic agents, such as tPA (tissue plasminogen activator), commonly referred to as "clot busting" drugs, are used to treat acute complications of peripheral arterial disease, heart attack and stroke.

R. Martin Emanuele, Senior Vice President, Development, said: "Data from experimental models demonstrate the potential for ANX-188, when used alone or in combination with thrombolytics, to improve outcomes for patients with thrombotic arterial disease, whether manifesting as acute limb ischemia, stroke or some other variant. Studies in animals and humans suggest that ANX-188 can shorten time-to-thrombolysis, improve blood flow, delay re-occlusion and reduce reperfusion injury, each of which may improve the effectiveness of existing thrombolytic agents."

Santosh Vetticaden, Chief Medical Officer, said: "We plan to evaluate the potential of ANX-188 in arterial disease initially by evaluating it in acute limb ischemia. Near-term goals include seeking orphan drug designation for ANX-188 in ALI, meeting with FDA to discuss our development plan in ALI and, assuming FDA agrees with the plan, initiating a phase 2, clinical proof-of-concept study in late 2013 or early 2014. Currently, we estimate that third-party costs to conduct this study will be approximately $2 million and that it will take approximately 15 to 18 months to enroll. Ultimately, we plan to leverage the data in ALI to find a partner to develop ANX-188 in larger indications within arterial disease, such as stroke."

Conference Call Information The Company will hold a conference call tomorrow, Friday, March 1, 2013, at 8:30 a.m. (ET), 5:30 a.m. (PT) to discuss its development plans in acute limb ischemia. Interested parties may access the conference call by dialing (800) 860-2442 from the U.S. and (412) 858-4600 from outside the U.S. and should request the ADVENTRX Pharmaceuticals Update Call. The webcast will be available live via the Internet by accessing the Events & Presentations page of Investors section of ADVENTRX's website at http://www.adventrx.com/investors/events/. Replays of the webcast will be available on the Company's website for 30 days and a phone replay will be available through March 6, 2013 by dialing (877) 344-7529 from the U.S. and (412) 317-0088 from outside the U.S. and entering conference reference number 10025903.


======


Cubist Pharmaceuticals (NASDAQ: CBST)
announced that the U.S. Food and Drug Administration (FDA) has designated the company's late-stage antibiotic candidate, ceftolozane/tazobactam, as a Qualified Infectious Disease Product (QIDP) for the indications of Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI).

Additionally, the company received from the FDA notification that Cubist's antibiotic candidates, ceftolozane/tazobactam and surotomycin, have been granted Fast Track status in their previously granted QIDP indications, Complicated Intra-Abdominal Infections (cIAI) and Clostridium difficile-Associated Diarrhea (CDAD) respectively.

“We are excited to receive the QIDP and Fast Track designations for ceftolozane/tazobactam and surotomycin, which further reinforce the importance the FDA places on helping to advance critically needed antibiotics,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “In a very short period of time, the GAIN Act has shown its value in helping to incentivize antibiotic development.”

The QIDP designation for ceftolozane/tazobactam will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for Fast Track status, and if ceftolozane/tazobactam is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which received strong bipartisan support in Congress and was signed into law by President Obama in July 2012 as part of the FDA Safety and Innovation Act (FDASIA), the fifth authorization of the Prescription Drug User Fee Act.

Ceftolozane/tazobactam is currently being studied in pivotal Phase 3 trials as a potential first-line intravenous therapy for the treatment of cIAI and cUTI caused by Gram-negative pathogens, including those caused by multi-drug resistant Pseudomonas aeruginosa. Cubist expects to initiate a Phase 3 VABP program for ceftolozane/tazobactam by mid-year. Surotomycin, a rapidly bactericidal lipopeptide, is currently in Phase 3 being studied as a potential treatment for patients with a severe and sometimes life-threatening diarrhea caused by CDAD.



Also Thursday:



Adamis Pharmaceuticals Corporation (OTCQB: ADMP)
, a biopharmaceutical company engaged in the development and commercialization of specialty pharmaceutical and biotechnology products in the therapeutic areas of respiratory disease, allergy, oncology and immunology, announced that a court entered an order of dismissal with prejudice of a complaint filed against Adamis regarding a dispute over one of its license agreements, resolving the case in Adamis' favor.

A.P. Pharma, Inc. (OTCBB: APPA)
today announced the appointment of Jesse Hollingsworth as vice president of sales.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, today announced that its Board of Directors has declared a one-half percent stock dividend payable on March 29, 2013, to stockholders of record on March 15, 2013.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, announced today that following promising pre-clinical data, EDP-14, for the treatment of severe and persistent asthma, has been added to the Company's main therapeutic pipeline.

Celgene Corporation (NASDAQ: CELG)
plans to present at two upcoming investor conferences. The conferences will be webcast live and will be available in the Investor Relations section of the Company’s Web site at www.celgene.com.

CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical research and development company specializing in oncology, announced that enrollment of 140 evaluable patients has been completed in the Company’s global Phase 2b clinical trial with its oral retinoid compound tamibarotene in combination with chemotherapeutic agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC).

Esterline Corporation (NYSE: ESL)
, a leading specialty manufacturer serving global aerospace/defense markets, today reported that its Montreal-based CMC Electronics subsidiary has been awarded a contract by Korea Aerospace Industries (KAI) to supply the integrated glass cockpit for 20 Peruvian Air Force turboprop trainer aircraft designated as KT-1P.

Esterline Corporation (NYSE: ESL)
, a leading specialty manufacturer serving the global aerospace/defense markets, today reported fiscal 2013 first quarter (ended January 25) net income of $25.1 million, or $0.80 per diluted share, on sales of $458.0 million.

FluoroPharma Medical, Inc. (OTCBB: FPMI)
, a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today released images from the Phase II clinical trial for CardioPET™ (FCPHA) to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients.

MDxHealth SA (EURONEXT BRUSSELS: MDXH)
, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced results for the fourth quarter and the fiscal year ended December 31, 2012.

MediSwipe Inc. (OTCQB: MWIP)
, a patient security solutions and financial products company for the medicinal marijuana and health care industry, today announced plans to open the first of two patient certification centers within the state of Michigan.

NewLink Genetics Corporation (NASDAQ: NLNK)
, a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today reported consolidated 2012 financial results and reviewed key 2012 accomplishments.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
announced today that the Company's fourth quarter 2012 financial results will be released on Thursday, March 7, 2013, and that the Company will host a conference call and live webcast at 4:30 p.m. ET that afternoon.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
today announced that management will present a company overview at the Cowen & Co. Annual Health Care Conference in Boston. The presentation is scheduled for Monday, March 4, 2013 at 3:30 p.m. Eastern Time.

OvaScienceSM, (OTC: OVSC)
, a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today announced that Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience, will present at the Cowen and Company 33rd Annual Health Care Conference on Wednesday, March 6 at 10:00 a.m. at the Boston Marriott Copley Place in Boston.

PAREXEL International Corporation (NASDAQ: PRXL)
announced today that it will be presenting at the Raymond James Investors Conference in Orlando, FL.

PDI, Inc. (Nasdaq: PDII)
today announced that it will release its fourth quarter and full year 2012 financial results on Wednesday, March 6, 2013 after the market close and host a conference call on Thursday, March 7, at 8:30 am Eastern time to discuss the results.

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY)
announced today that the Company resubmitted its MOXDUO®New Drug Application (NDA).

Rapid Fire Marketing (OTC Pink: RFMK)
(http://www.bioniccigs.com), a leading maker of vaporizers as well as the only publicly-traded company for vaporizers, announced today that the Company has updated shareholders on the corporate side of the business on the Company's website at http://rapid-fire-marketing.com/update-to-shareholders-regarding-rapid-fire-marketings-business.

Shire plc (LSE: SHP, NASDAQ: SHPG)
today announced its support of Rare Disease Day, joining patients, healthcare providers, and patient organizations around the world to support a day that focuses attention on rare diseases as a public health issue, and highlights the need for more understanding and awareness about these diseases.

Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA)
, a clinical stage biopharmaceutical company developing therapeutic products for rare diseases, joins the National Organization for Rare Disorders (NORD), the European Organisation for Rare Diseases (EURORDIS), The Global Genes Project, and others around the world in observing Rare Disease Day.

VMware, Inc. (NYSE: VMW)
, the global leader in virtualization and cloud infrastructure, today introduced the VMware vCloud® for Healthcare solution supporting the IT care environment -- from point-of-care to the most critical patient-care systems.



"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'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 

Newsletter