Halozyme Confirms Complete Response Letter For HyQ BLA; Hemispherx Files Reponse Law Over Ampligen Print E-mail
By Staff and Wire Reports   
Wednesday, 01 August 2012 18:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 1, 2012.

Halozyme Therapeutics, Inc. (NASDAQ: HALO)
announced the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Baxter's HyQ Biologics License Application (BLA). HyQ is an investigational product that includes plasma-derived Immune Globulin (IG) 10% and Halozyme's recombinant human hyaluronidase (rHuPH20) for subcutaneous administration in patients with primary immunodeficiency disease.

The letter requested additional preclinical data to support the BLA. The primary issues raised in the letter focused on non-neutralizing antibodies generated against recombinant human hyaluronidase and the possible effects of these antibodies on reproduction, development and fertility. Elevated anti-rHuPH20 antibody titers were detected in the registration trial, but have not been associated with any adverse events.

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subscriberonly8-2-2012Hemispherx Biopharma, Inc. (NYSE: HEB)
filed with the U.S. FDA its complete response to the FDA's November 25, 2009 Complete Response Letter ("CRL") in support of Ampligen^®'s New Drug Application for Chronic Fatigue Syndrome ("CFS"). As previously reported, at a recent meeting with the Agency, Hemispherx reached agreement on the filing requirements for the Company's complete response (please see the Company's press release and Form 8-K dated July 11, 2012).  

The FDA has indicated that the new submission will be reviewed on a 6 month cycle. The Ampligen^® data were organized and filed with the FDA 53 days after the June 8, 2012 meeting with the Agency. At present, no drug has received FDA approval to treat CFS, a chronic, seriously debilitating disease.

Also Wednesday:

Alseres Pharmaceuticals, Inc. (OTC: ALSE)
today announced that it has entered into an agreement with Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB, "Navidea") to license, [123I]-E-IACFT Injection (CFT), also called Altropane®, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson's disease and movement disorders.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH)
, a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced it will report its unaudited financial results for the second quarter ended June 30, 2012 on Tuesday, August 7, 2012, after the market closes in the United States.

Australian drug delivery technology company Phosphagenics Limited (ASX: POH, OTCQX: PPGNY) has appointed US pharmaceutical consulting company, Neura Group LLC, the consulting unit of the pain specialty company, Neura Therapeutik LLC, to provide strategic commercial and development advice for its TPM/oxycodone patch development program.

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC)
today reported financial results and recent accomplishments for the second quarter of 2012.

Echo Therapeutics, Inc. (Nasdaq: ECTE)
, a company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and its Prelude® SkinPrep System for transdermal drug delivery, today announced positive results from its clinical trial of the Symphony tCGM System in major general surgery and cardiothoracic surgery patients.

Integrated Management Information, Inc. (d.b.a. IMI Global, Inc.) (OTCQB: WFCF) (OTCBB: WFCF), a leading provider of verification and Internet solutions for the agricultural/livestock industry under the Where Food Comes From® brand, today announced record revenue and net income for its second quarter and six-month period ended June 30, 2012.

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced today that new preclinical data evaluating antisense compounds to treat myotonic dystrophy type 1 (DM1) were published in the journal Nature.

Life Technologies Corporation (NASDAQ: LIFE)
today announced that the New York Genome Center (NYGC) has purchased four Ion Proton™ Sequencers for its new Innovation Center.

Life Technologies Corporation (NASDAQ: LIFE)
today announced that its Board of Directors has approved a share repurchase program, authorizing the company to purchase up to $750 million of its common stock.

Life Technologies Corporation (NASDAQ: LIFE)
today announced results for its second quarter ended June 30, 2012.

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP)
announced today that it intends to offer and sell shares of its common stock in an underwritten public offering.  MAP Pharmaceuticals expects to grant the underwriters a 30-day option to purchase an additional 15% of the shares of common stock to be sold in the proposed offering.

NanoLogix (OTC Markets: NNLX)
, a biotechnology innovator in the rapid detection and identification of live-threat bacteria, is featured today in the USA Today Group B Strep (GBS) Awareness Campaign titled Your guide to Group B Strep.

Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
today announced its financial results for the quarter ended June 30, 2012. For the second quarter of 2012, the Company reported a net loss of $0.5 million, or $0.01 loss per share, compared to net income of $2.0 million, or $0.04 per share, for the same period in 2011.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
, a biopharmaceutical company focused on the treatment of obesity, will announce financial results for the second quarter ended June 30, 2012 on Tuesday, August 7, 2012 before the markets open.

Pharmacyclics, Inc. (Nasdaq: PCYC)
announced today that the international Phase III randomized, multicenter, open-label clinical trial, RESONATE™ (PCYC-1112), of ibrutinib versus ofatumumab for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) initiated by Pharmacyclics has enrolled its fifth patient.

Australian drug delivery technology company Phosphagenics Limited (ASX: POH, OTCQX: PPGNY) has appointed US pharmaceutical consulting company, Neura Group LLC, the consulting unit of the pain specialty company, Neura Therapeutik LLC, to provide strategic commercial and development advice for its TPM/oxycodone patch development program.

Quidel Corporation (NASDAQ: QDEL)
, a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today that it will present at the Canaccord Genuity 32nd Annual Growth Conference to be held at the InterContinental Boston hotel in Boston, Massachusetts on Tuesday, August 14, 2012.

Sun Healthcare Group, Inc. (NASDAQ: SUNH)
today announced its operating results for the second quarter ended June 30, 2012.

University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS)
, a diversified, integrated multi-specialty health delivery system, today announced that it has completed the acquisition of diagnostic imaging, physical therapy and sleep clinics in Kingwood, Texas, a suburb of Houston, for a combination of stock, cash, and the acquisition of debt.



"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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