Key Developments: Halozyme Therapeutics Inc (HALO.O)
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24 May 2013
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Latest Key Developments (Source: Significant Developments)
Halozyme Therapeutics Inc Names David Ramsay As CFO-AP
The Associated Press reported that Halozyme Therapeutics Inc named David Ramsay as Chief Financial Officer, replacing Kurt Gustafson. Gustafson had been an executive at Amgen Inc. before he joined Halozyme in 2009. Halozyme said he was leaving the company to pursue other opportunities. Full Article
Baxter International Inc And Halozyme Therapeutics Inc Announces Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In European Union
Baxter International Inc and Halozyme Therapeutics Inc announced that European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. The application was based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQvia in prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of study was to infuse a 3-or 4-week dose of the therapy in a single subcutaneous site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In tolerability assessment of HyQvia, the frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in European Union later this year. Full Article
Halozyme Therapeutics Inc And Pfizer Inc Enter Into Collaboration To Develop And Commercialize Subcutaneous Biologics Using Recombinant Human Hyaluronidase
Halozyme Therapeutics Inc announced that it has entered into a worldwide Collaboration and License Agreement with Pfizer Inc for the purpose of developing and commercializing products combining Pfizer biologics with Halozyme's Enhanze technology. Enhanze is Halozyme's drug delivery platform and is based on the Company's patented recombinant human hyaluronidase enzyme (rHuPH20). Under the terms of the agreement, Halozyme has granted to Pfizer a worldwide license to develop and commercialize products combining rHuPH20 with Pfizer biologics directed to up to six targets. Targets may be selected on an exclusive or non-exclusive basis. Halozyme will receive an initial payment of $8 million, which includes the upfront fee for exclusive licenses to two specified therapeutic targets in primary care and specialty care indications and the right for Pfizer to elect up to four additional targets upon payment of additional fees. Halozyme is eligible to receive additional payments upon Pfizer's achievement of specified development, regulatory and sales-based milestones, totaling up to $507 million. Halozyme is also entitled to royalty payments based on net sales of any licensed products. Full Article
ViroPharma Inc and Halozyme Therapeutics Inc Announce Initiation of Phase 2b Dose Ranging Combination Study for Subcutaneous Administration of Cinryze With Hyaluronidase
ViroPharma Inc and Halozyme Therapeutics Inc announced that ViroPharma has initiated its Phase 2b double blind, multicenter, dose ranging study to evaluate the safety and efficacy of subcutaneous (SC) administration of Cinryze (C1 esterase inhibitor [human)] in combination with Halozyme's Enhanze technology, drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), in adolescents and adults with hereditary angioedema (HAE) for prevention of HAE attacks. Cinryze is currently approved for intravenous (IV) administration. Full Article
Halozyme Therapeutics Inc Announces Interim Data From Pre-administration of Hylenex in Analog Insulin Pump Therapy Demonstrate Consistent Insulin Action Profile
Halozyme Therapeutics Inc presented results from a Phase 4 study of Hylenex recombinant (hyaluronidase human injection) in sensor augmented insulin analog pump (SAP) therapy in patients living with Type 1 diabetes. Interim data from this study indicate that pre-administration of Hylenex recombinant in the SAP provided a consistent ultrafast insulin action profile over the infusion set life that resulted in improved glucose control. A presenter will be available to discuss the poster on June 10 from 12:00 - 2:00 PM EDT. The outpatient study compared the effects of treatment with and without Hylenex recombinant in SAP therapy in each patient. Every three days, immediately following infusion site change, a dose of 150 Units (1.25 micrograms in 1.0 ml) of Hylenex recombinant or sham injection was administered through the infusion cannula at the time of infusion site insertion. In order to maintain a double-blind study design, the Hylenex recombinant injections were administered by a trained medical professional who was not otherwise involved in the study. Interim data from the study confirm that Hylenex recombinant provided an accelerated and more consistent insulin action profile which resulted in meaningful, statistically significant improved postprandial glucose control. Full Article
Halozyme Therapeutics Inc Announces Positive Data From Two Ultrafast Insulin Clinical Trials With Human Hyaluronidase Enzyme - rHuPH20
Halozyme Therapeutics Inc announced the presentation of two posters at the 72nd Scientific Sessions of the American Diabetes Association (ADA) highlighting its research on improved treatment options for both the multiple daily injection therapy and continuous subcutaneous insulin infusion markets. This 30-week randomized, double-blind, two-way cross-over, Phase 2 study compared two rapid acting insulin analog products (lispro or aspart), formulated with the Company's recombinant human hyaluronidase (rHuPH20) enzyme (lispro-PH20 and aspart-PH20, each an Analog-PH20), to an active comparator (lispro alone) in patients with Type 2 diabetes. The study met the primary endpoint of showing that the Analog-PH20 formulations were non-inferior for A1C compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.12, +.05). Patient groups in all treatment arms of this study achieved excellent blood glucose control, with endpoint A1C values <6.7%. Data from the study showed that in the patient groups treated with Analog-PH20, there was a 61% increase in the proportion of patients who consistently achieved (for at least two-thirds of their meals) the American Association of Clinical Endocrinologists (AACE) recommended postprandial glucose target of <140 mg/dL, compared with the patient group treated with lispro alone (45.2% vs. 28.0%, p=.0007). Full Article
Baxter International Inc. And Halozyme Therapeutics, Inc. Provide Update On HyQ Biologics License Application
Baxter International Inc. and Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) is requesting additional information to complete its review of the HyQ Biologics License Application (BLA). Baxter and Halozyme will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. The companies now expect to participate in a meeting of the FDA's Blood Products Advisory Committee concerning the agency's request for additional data. The companies expect these requests to require additional time to complete and to delay the companies' anticipated regulatory review and approval timeline. HyQ is an investigational, combination product that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant Human Hyaluronidase, which are packaged as a kit. IG provides the therapeutic effect of HyQ and the Recombinant Human Hyaluronidase facilitates the dispersion and absorption of the IG. The IG is a 10% solution that is prepared from human plasma and contains a broad spectrum of antibodies. Full Article
ViroPharma Incorporated And Halozyme Therapeutics Inc Announce Positive Data Of Subcutaneous Cinryze
ViroPharma Incorporated and Halozyme Therapeutics Inc announced the presentation of positive data from ViroPharma's Phase 2 subcutaneous trial of Cinryze (C1 esterase inhibitor [human]) in combination with Halozyme's Enhanze technology, a drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), in patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal genetic disease. The presentation occurred as part of the late-breaker session at the 2012 annual meeting of the American Academy of Allergy Asthma & Immunology (AAAAI), held March 2 to 6, 2012 in Orlando, Fla. According to the presenters, these data demonstrate that subcutaneous co-administration of Cinryze with rHuPH20 was easy to administer, well tolerated and resulted in sustained physiologically relevant C1 INH functional concentrations. The presenters concluded that this combination administered subcutaneously as a single injection will be further evaluated for the prevention of HAE attacks. Halozyme's Enhanze technology, a drug delivery platform using recombinant human hyaluronidase enzyme (rHuPH20) facilitates the absorption and dispersion of drugs or fluids that are injected under the skin. Recombinant HuPH20 transiently generates channels in subcutaneous tissues to increase the absorption and spread of injected drugs. Full Article
Halozyme Therapeutics Inc Announces Exercise In Full of Over-Allotment Option And Completion of Public Offering Of Stock
Halozyme Therapeutics, Inc. announced the completion of an underwritten public offering of 7,820,000 shares of its common stock, including 1,020,000 shares sold pursuant to the full exercise of an over-allotment option previously granted to the underwriter. All of the shares were offered by Halozyme at a price to the public of $10.61 per share. The proceeds to Halozyme from this offering were approximately $81.8 million, after deducting the underwriting discounts and commissions but before expenses. The Company anticipates using the net proceeds from the offering to build commercial inventory for anticipated product launches, fund research and development of proprietary programs, and for general corporate purposes. Barclays Capital Inc. acted as the sole book-running manager for the offering. Full Article
Halozyme Therapeutics Inc Announces Pricing of Public Offering of Common Stock
Halozyme Therapeutics, Inc. announced the pricing of an underwritten public offering of 6,800,000 shares of its common stock at a price to the public of $10.61 per share. The offering is expected to settle and close on February 15, 2012, subject to customary closing conditions. Barclays Capital Inc. is the sole book-running manager of the offering, and Halozyme has granted them a 30 day option to purchase up to 1,020,000 shares of common stock. Halozyme intends to use the net proceeds from the offering to build commercial inventory for anticipated product launches, fund research and development of proprietary programs, and for general corporate purposes. Full Article
BRIEF-Halozyme Therapeutics shares up 27 pct in heavy volume
NEW YORK, March 22 - Halozyme Therapeutics Inc : * Shares extend advance in heavy volume, up 27 percent
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