|Human Genome Announces Multiple Abstracts Related to BENLYSTA® ; Synergy Reports Partial Exercise of Over-Allotment Option|
|By Staff and Wire Reports|
|Tuesday, 05 June 2012 19:40|
Human Genome Sciences, Inc. (NASDAQ:HGSI) announced several abstracts related to BENLYSTA® (belimumab) and systemic lupus erythematosus (SLE) will be presented at the EULAR Annual European Congress of Rheumatology, being held in Berlin, Germany from June 6 to June 9, 2012. A total of seven abstracts all posters have been accepted for presentation, five clinical trial data abstracts and two health economics and outcomes research (HEOR) abstracts.
Belimumab is the first in a drug class known as BLyS-specific inhibitors. Belimumab was approved by the U.S. Food and Drug Administration (FDA) on March 9, 2011 for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. Limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Belimumab has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is not recommended in these situations. Belimumab is currently administered as a one-hour intravenous infusion given at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
In Europe, belimumab was approved by the European Commission on July 13, 2011. It is indicated as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g., positive anti-dsDNA and low complement), despite standard therapy. The summary of product characteristics (SmPC) lists patient groups which have not been studied with belimumab, including severe active CNS lupus and severe active lupus nephritis. Use of belimumab is therefore not recommended to treat these conditions. Caution should be exercised if belimumab is co-administered with other B-cell targeted therapy or intravenous cyclophosphamide, as it has not been studied in combination with these agents.
The clinical abstracts examine the impact of BENLYSTA on patients with SLE, including its efficacy and safety, its early clinical improvement and its impact in patients also being treated with mycophenolate mofetil and/or corticosteroids. In addition, predictors of moderate-to-severe SLE flares were evaluated from the placebo groups in the phase 3 BLISS trials. The HEOR analyses explore the prevalence of SLE in Europe as well as the impact of lupus on healthcare utilization following early diagnosis versus late diagnosis.
Synergy Pharmaceuticals Inc. (Nasdaq: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced the partial exercise of the over-allotment option granted to the underwriters with respect to the purchase of 750,000 shares of common stock at a public offering price of $4.50 per share, in connection with its previously announced underwritten public offering of 10,000,000 shares of common stock, bringing total gross proceeds from the offering to $48,375,000.
AeroGrow International, Inc. (PINKSHEETS: AERO) ("AeroGrow" or the "Company"), makers of the AeroGarden® line of indoor gardening products, announced that it successfully completed a $1.59 million capital raise on May 31, 2012.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that Phase 1 trial results for the Company's oral anticancer compound, perifosine, in multiple myeloma, have been published in the online May 2012 issue of the British Journal of Haematology.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Vikas Sinha, Chief Financial Officer of Alexion Pharmaceuticals, will present at the William Blair & Company 32nd Annual Growth Stock Conference in Chicago at 8:50 a.m. Central time (9:50 a.m. Eastern time) on Tuesday, June 12, 2012.
Biogen Idec Inc. (NASDAQ: BIIB) announced today that its 2012 Analyst Day will be webcast live on Tuesday, June 12, 2012 at 10:00 a.m. ET.
BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that two Notices of Allowance have been issued by the United States Patent and Trademark Office (USPTO) for BL-1021, an orally available small molecule for treating neuropathic pain.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will host a live webcast in conjunction with its Investor Day on Monday, June 11, 2012 at 8:30 a.m. EDT at NASDAQ.
Delcath Systems, Inc. (NASDAQ-DCTH) announced that an exploratory analysis of the Company's Phase 3 trial was presented at the American Society of Clinical Oncology (ASCO) held in Chicago, IL this week.
Dyax Corp. (NASDAQ: DYAX) has granted exclusive distribution rights to taiba ME (taiba) for the use of Kalbitor in the treatment of hereditary angioedema (HAE) within the Middle East, including Saudi Arabia, United Arab Emirates, Oman, Bahrain, Qatar, Kuwait, Libya and Iran.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the completion of the first commercial implants of the Maestro® Rechargeable (RC) System, delivering VBLOC® vagal blocking therapy.
Enterologics, Inc., (OTCBB: ELGO.OB) a biotechnology company, is dedicated to the development of live biotherapeutic products for gastrointestinal (GI) disorders that it believes are poorly addressed by current therapies.
Exelixis, Inc. (NASDAQ:EXEL) today reported positive updated interim data from an ongoing phase 2 trial of cabozantinib in men with metastatic castration-resistant prostate cancer (CRPC) and bone metastases.
Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that new immune response data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine undertaken by Generex wholly-owned subsidiary Antigen Express, Inc. was presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (http://chicago2012.asco.org) on June 2, 2012 in Chicago, IL.
IGI Laboratories, Inc. (NYSE Amex: IG), a New Jersey based formulation and manufacturing company, today announced that it has submitted an additional abbreviated new drug application (ANDA) to the US FDA, bringing the company’s total number of submissions to six.
IsoRay Inc. (NYSE Amex: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced another milestone in the treatment of brain tumors using its groundbreaking Cesium-131 (Cs-131) seed sutured mesh for internal radiation therapy.
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), announced that at the special meeting of ISTA stockholders held today, ISTA's stockholders voted to approve the adoption of the previously announced Agreement and Plan of Merger, dated March 26, 2012, as amended on May 24, 2012, by and among Bausch + Lomb Incorporated, Inga Acquisition Corporation, a wholly-owned subsidiary of Bausch & Lomb Incorporated, and ISTA.
ITT Exelis (NYSE: XLS) and Altapure, LLC are launching a new model of their state-of-the-art disinfection system at the Association for Professionals in Infection Control and Epidemiology annual conference this week in San Antonio, Texas.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for ridaforolimus.
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (NASDAQ: ONCY) announced today that it has entered into an agreement whereby the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, will sponsor and conduct a randomized Phase II study of REOLYSIN® in patients with advanced or metastatic non-small cell lung cancer ("NSCLC").
OPKO Health, Inc. (NYSE: OPK) has entered into a definitive agreement to acquire a forty-five percent stake in a private Israeli company that produces a third-generation hepatitis B vaccine (“Sci-B-Vac”) in its state of the art biologics manufacturing facility in Rehovot.
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced new data that demonstrate opioid-related adverse drug events (ORADEs) following laparoscopic or open gastrointestinal (GI) surgeries increased total hospitalization costs by up to $12,724 and as much as doubled the length of hospital stay (LOS), depending on the type of surgical procedure performed.
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saúde, Infarmed) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the establishment of a strategic alliance with med fusion LLC in Lewisville, Texas, that designates the company as a Roche Molecular Center of Excellence (MCOE) for the next five years.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced promising clinical data in five poster presentations for ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, as well as a poster presentation and one e-abstract publication for belinostat, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois, from June 1-5, 2012.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will host a live audio webcast at the Jefferies 2012 Global Healthcare Conference in New York. Jon Congleton, Senior Vice President, Global Brand Strategic Marketing, will present on Wednesday, June 6, 2012.
Transgenomic, Inc. (OTCBB: TBIO) today announced the commercial launch of its ICE COLD-PCR mutation detection technology, a breakthrough technology enabling unmatched sensitivity and complete DNA mutation detection using the standard sequencing equipment already installed in laboratories around the world.
Walgreens (NYSE: WAG) (NASDAQ: WAG) had May sales of $5.98 billion, a decrease of 1.6 percent from $6.08 billion for the same month in fiscal 2011.