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Halozyme Therapeutics (HALO)

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Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases.

The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets. In addition, the company has received FDA approval for two products: Cumulase® and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.

Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.


Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.

The foundation of our capabilities is our recombinant human hyaluronidase enzyme, rHuPH20, which temporarily degrades hyaluronan, a structural protein in the interstitial space. This temporary alteration provides an opportunistic window that allows the delivery of injectable biologics such as monoclonal antibodies, as well as small molecules and fluids. With our enzyme, many pharmaceuticals that would normally be injected intravenously (IV) can be administered subcutaneously (SC). This change in route of delivery may improve patient convenience, enhance pharmacokinetics, boost efficacy, extend the product lifecycle, and reduce cost, in addition to other attributes.

Four key internal programs comprise our current proprietary product development portfolio. The endocrinology franchise consists of Insulin-PH20, which applies our PH20 enzyme to currently approved and marketed insulin products. The oncology franchise consists of PEGPH20, a new molecular entity administered intravenously that targets the external environment of tumor cells, and Chemophase, which utilizes the PH20 enzyme for local administration in bladder cancer. Our lead enzyme in the dermatology franchise, HTI-501, is a new molecular entity which digests collagen and may have applications in both medical and aesthetic dermatology such as cellulite.

Our product development pipeline also includes three distinct partnered programs with two companies; Roche and Baxter BioScience for Enhanze technology, and a partnership with Baxter Medication Delivery for Hylenex, our FDA-approved drug. These partnered programs validate our technology and may generate clinical and commercial milestone revenue based on the achievement of pre-specified events along with sales royalties when products reach the commercial stage. We utilize the cash milestone payments generated from the partnered programs as a source of development funding for our proprietary pipeline projects.


Our endocrinology development activity focuses on insulin, a mainstay of treatment for people with diabetes. This program combines our PH20 hyaluronidase enzyme with insulin, a frequently prescribed, commercially successful pharmaceutical already approved and on the market.

Insulin – Developing a best-in-class profile

We believe that the combination of our PH20 enzyme with existing, meal time insulin products such as regular insulin or a fast acting analog could lead to a best-in-class product that more closely mimics the release of natural insulin in the body. The results of a Phase 1 study, where we combined PH20 with Humulin® R (regular human insulin) and with Humalog® (insulin lispro), demonstrated significantly faster and higher insulin plasma concentrations compared to either insulin alone. Faster acting insulin could provide patient benefits such as reduced hypoglycemia, lower intra-subject variability, and less weight gain. These potential benefits would be significant but must first be demonstrated and proven in clinical development.

Our first Phase 2 clinical trial with insulin began in October 2008 and enrolled Type 1 diabetic patients. Data presented from our Phase 1 trial showed that the administration of regular insulin and an insulin analog with our PH20 enzyme led to faster insulin absorption and more rapid effects than either insulin alone. Our Phase 2 trial is designed to demonstrate similar results in Type 1 diabetic patients. We hope to present preliminary Phase 2 results at the American Diabetes Association meeting in June. Additional clinical trials are planned in 2009.


Hyaluronan (HA) is a component of the extracellular matrix that frequently accumulates in human cancers. The quantity of HA produced by the tumor cells directly correlates with increased tumor growth and metastasis and it has been linked with tumor progression and poor prognosis. Previous clinical trials of bovine hyaluronidase showed promise in enhancing chemotherapy regimens using adjunctive systemic hyaluronidase in chemo-refractory patients. In animal studies the removal of HA from tumors with hyaluronidase has demonstrated improved survival, suppression of tumor growth, and enhanced efficacy of certain anti-cancer drugs. Chemotherapeutic agents may be able to better penetrate the tumor once the HA has been removed.

We have also observed significant reduction of tumor interstitial fluid pressure (IFP) following the administration of rHuPH20 in solid tumors grown in mice. Tumor interstitial pressure is widely believed to be an important factor limiting the access of cytostatic regimens to solid tumors. By digesting the HA gel, rHuPH20 may reduce IFP in the tumor and promote more effective delivery of chemotherapy throughout the tumor. This could potentially lead to better patient outcomes and increased survival.

Our PEGPH20 program utilizes pegylated hyaluronidase that allows for intravenous administration to degrade the HA that surrounds tumor cells. The Chemophase program applies the hyaluronidase enzyme along with mitomycin C directly into the bladder where the enzyme can hydrolyze the HA produced by the cancerous bladder cells. Unlike tumor cells, normal cells do not produce HA in this manner and appear not to be adversely affected by the enzyme.

PEGPH20 for Solid Tumors

We are investigating pegylated-rHuPH20, or PEGPH20, a new molecular entity, as a candidate for the systemic treatment of tumors rich in hyaluronan, or HA. Pegylation refers to the attachment of polyethylene glycol to our rHuPH20 enzyme, which extends its half life from less than 30 seconds to more than 24 hours. Numerous solid tumors, including prostate, breast, pancreas, colon and non-small cell lung, accumulate HA that forms a halo like coating over the surface of the tumor cell.

In preclinical studies, PEGPH20 has been shown to remove the HA coating surrounding several tumor cell lines. Treatment of PC3 (a prostate cancer cell line that produces HA) tumor bearing mice with PEGPH20 as a single agent demonstrated approximately 70% tumor growth inhibition relative to controls. Repeat dosing with PEGPH20 produced a sustained depletion of HA in the tumor microenvironment. For tumor models that do not produce HA, the presence of PEGPH20 has no effect. An estimated 20% to 40% of certain solid tumors may produce HA.

Administration of the combination of PEGPH20 with docetaxel or with liposomal doxorubicin in HA producing animal tumor models produced a significant survival advantage for the combination relative to either chemotherapeutic agent alone. Therefore, based on these animal studies and other tests conducted by Halozyme, PEGPH20 may represent a potentially innovative treatment approach against tumors that produce HA.

PEGPH20 recently started its first Phase 1 clinical trial which will evaluate the agent over a range of doses. The study will enroll up to 46 advanced cancer patients who will receive treatment cycles of intravenous PEGPH20 as a single agent twice weekly for three weeks followed by one week without dosing. Patients may continue subsequent cycles at their assigned dose as long as there is no tumor progression and no unacceptable toxicity. Groups of four to eight patients will be in each dosage cohort. The primary outcome measures of the study will be to evaluate safety and tolerability of PEGPH20 and to determine the recommended single agent Phase 2 dose. Secondary objectives will be to determine pharmacokinetics, obtain dose limiting toxicities, and observe patients for any evidence of anti-tumor activity.


Chemophase is a chemoadjuvant we have investigated for possible use in the treatment of patients with superficial bladder cancer, which represents a smaller potential market than our other proprietary pipeline opportunities. The Chemophase program combines our PH20 enzyme with mitomycin C, a cytotoxic drug, for direct administration into the bladder immediately after transurethral resection of bladder tumors (TURBT), a standard surgical treatment for the disease. Many bladder tumor cells produce high quantities of HA and thus treatment to remove the HA coating could increase their exposure to mitomycin C. This may lead to a lower recurrence of the cancer and a better prognosis for patients.

In June 2008, we announced the interim results of a Phase I/IIa clinical trial in which the Chemophase combination treatment of mitomycin C plus rHuPH20 enzyme was well tolerated and appears safe. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme. An ongoing safety trial involves the immediate post operative (IPOP) administration of PH20 and mitomycin directly into the bladder of patients after a TURBT procedure. 


The foundation of our dermatology program is HTI-501, a human lysosomal proteinase that degrades collagen. It may be useful in the treatment of both medical and aesthetic dermatologic conditions such as cellulite, Dupuytren’s contracture and Peyronie’s disease. This pH sensitive enzyme demonstrates activity under mildly acidic conditions but shows no activity at normal physiologic pH. This attribute may be harnessed to exert control over the duration and location of the enzyme’s therapeutic activity.

Tests with HTI-501 in several animal models have produced encouraging results and our pre-clinical investigations of the enzyme will continue throughout 2009.


Enhanze™ Technology, a proprietary drug delivery platform using Halozyme’s first approved enzyme, rHuPH20, is our broader technology opportunity that can potentially lead to partnerships with other pharmaceutical companies. When co-formulated with other injectable drugs, Enhanze Technology may facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin.  

Molecules as large as 200 nanometers may pass freely through the extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin. The principal focus of our Enhanze Technology platform is the use of rHuPH20 to facilitate subcutaneous or intramuscular routes of administration for large molecule biological therapeutics. We are seeking partnerships with pharmaceutical companies that market drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology. In December 2006, we signed our first Enhanze Technology partnership with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche, Inc. In September 2007, we signed our second Enhanze Technology partnership with Baxter Healthcare Corporation and Baxter Healthcare S.A.


Full prescribing information is available below or at

Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We filed a New Drug Application (NDA) in March 2005 and we received approval of our Hylenex NDA in December 2005.

Enzymatically- Augmented Subcutaneous Infusion (EASI):

Hylenex may facilitate subcutaneous delivery of fluids up to one liter without the need for intravenous access, a procedure known as EASI. Importantly, EASI for fluid replacement in terminal patients may be achieved with limited or no need for nursing assistance. Over 1.1 million subcutaneous fluid infusions are performed per year with hospice patients alone (Source: Company estimates based on National Hospice and Palliative Care Organization data, 2001). In addition, over 500 million infusion bags are utilized annually in the United States, some of which could potentially convert to EASI using Hylenex, giving rise to additional market potential (Source: B. Braun, 2003).


During January 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer’s clinical trial, or INFUSE-LR study, which was designed to determine the subcutaneous (Sub-Q) infusion flow rate of Lactated Ringer’s solution with and without Hylenex, determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24 gauge catheters.

INFUSE-Morphine Study:

During October 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, which was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 12 evaluable patients who received Sub-Q infusions.

For full prescribing information, visit or


Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes (eggs) prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte. The FDA considers hyaluronidase IVF products to be medical devices subject to 510(k) approval and we filed our 510(k) application during September 2004.

We received FDA clearance in April 2005. We launched Cumulase in the European Union and in the United States in June 2005. We believe the total ICSI market consisted of an estimated 500,000 intracytoplasmic sperm injection cycles worldwide in 2005 (Source: CDC, 2001; ESHRE, 2002).

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Informative Links
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(Clinical Trials)

Clinicals & Partners
Halozyme and Roche enter agreement for the application of Enhanze, a novel technology to improve drug delivery
(Halozyme and Roche presents “Developing and Managing Strategic Alliances” at the SCRIP conference
May 15-16, 2007  Berlin, Germany)
Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously (Enhanze 3-16-08)
Halozyme and Baxter Expand Global HYLENEX Collaboration (Feb. 12, 2008 Slide Show Presentation)
Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences

Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference

Halozyme Therapeutics Presents Pre-Clinical Studies on Dermal Remodeling With HTI-501, a Lysosomal Proteinase
Phase I/II data showed that Enhanze Technology™ enabled subcutaneous administration of a monthly dose of GAMMAGARD LIQUID in patients with Primary Immunodeficiency Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability

Cheetah full ADA presentation

Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models

Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial

Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabetic Patients

Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target

Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
Halozyme Deprioritizes Bisphosphonate Program to Reallocate Resources to More Commercially Attractive Internal Programs

Phase III Trial Begins for GAMMAGARD LIQUID Plus rHuPH20 in Primary Immunodeficiency Patients

Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial With Second Biologic

Halozyme Therapeutics Presents Positive Pre-Clinical Single Agent Data for PEGPH20                                                                                                                              

AACR presentations show that PEGPH20 produces anti-cancer activity in models of breast, prostate, and brain metastases that produce hyaluronan

Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations
-- Insulin-PH20 Combinations Demonstrated Significantly Faster Glucose Metabolism --

 Accelerated Insulin Pharmacokinetics and Improved Glycemic Control in T1DM Patients by
Coadministration of Prandial Insulin with Recombinant Human Hyaluronidase

Halozyme Announces Roche Selects Fifth Exclusive Biologic Target

Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme


 First patient dosed in trial with third Roche biologic formulated with Halozyme’s recombinant human hyaluronidase enzyme

Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration
Data from the First Pediatric Rehydration Study, INFUSE-PEDS 1, Published Today in Pediatrics

Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial with Subcutaneous Herceptin(R)



Earnings Transcripts
Halozyme Therapeutics Q4 2007 Earnings Call Transcript
Halozyme Therapeutics Inc. Q1 2008 Earnings Call Transcript
Halozyme Therapeutics Inc. Q2 2008 Earnings Call Transcript
Halozyme Therapeutics, Inc. Q3 2008 Earnings Call Transcript
Halozyme Therapeutics, Inc. Q4 2008 Earnings Call Transcript
Halozyme Therapeutics, Inc. Q3 2009 Earnings Call Transcript

Links to understanding Clinical results

Shares Outstanding: 91,095,288
Float: 73.21M
(O-T How the market is manipulated and companies destroyed)

Halozyme Therapeutics Inc.
11588 Sorrento Valley Road
Suite 17
San Diego, CA 92121
United States
Phone: 858-794-8889

Halozyme Contact
Robert H. Uhl
Senior Director Investor Relations

(Disclaimer) Do your own DD and confirm anything said on this board.

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HALO News: Halozyme Therapeutics To Present At The Bank Of America Merrill Lynch 2016 Global Health Care Conference 09/08/2016 04:30:00 PM
HALO News: Statement of Changes in Beneficial Ownership (4) 09/02/2016 04:18:17 PM
HALO News: Initial Statement of Beneficial Ownership (3) 09/02/2016 04:12:41 PM
HALO News: Current Report Filing (8-k) 09/01/2016 05:09:32 PM
HALO News: Halozyme Names Mark J. Gergen As Chief Operating Officer 09/01/2016 09:00:00 AM
#4658  Sticky Note Interesting historical chart on HALO royalty stream Fred Kadiddlehopper 08/09/16 10:55:28 AM
#4752   Goodbye, September, hello Q4! Helen has promised some Fred Kadiddlehopper 10/01/16 11:20:27 AM
#4751   Nice to see a prominent doctor state that maumar 09/30/16 03:41:56 PM
#4750   Dr. Tempero on the HALO 301 Trial for rod5247 09/30/16 03:26:30 PM
#4748   Recruiting Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and rod5247 09/30/16 02:23:37 PM
#4747   Ha Ha, I keep trying! Fred Kadiddlehopper 09/27/16 03:20:05 PM
#4746   Nice reverse jinx there Fred.. XenaLives 09/27/16 02:27:26 PM
#4745   Agreed. Fundamentals rule. In the meantime I wouldn't Fred Kadiddlehopper 09/26/16 08:18:46 PM
#4744   Now need some good news to start rolling rod5247 09/26/16 06:21:30 PM
#4743   Well, for what it's worth the 50 DMA Fred Kadiddlehopper 09/26/16 05:09:48 PM
#4742   That is a first but it is the rod5247 09/24/16 02:42:57 PM
#4741   Musings on Humira biosimilars (from 1-year ago): #msg-118781959. DewDiligence 09/23/16 07:31:18 PM
#4740   FDA approves Amgen's biosimilar to Humira. maumar 09/23/16 06:25:32 PM
#4739   So, this is a new trial but the maumar 09/23/16 06:23:10 PM
#4738   41 Not yet recruiting PEGPH20 Plus Gemcitabine rod5247 09/22/16 11:25:45 AM
#4737   Going to be another high volume day: already Fred Kadiddlehopper 09/20/16 10:45:31 AM
#4736   Well...look at the two year chart and see Fred Kadiddlehopper 09/20/16 12:40:02 AM
#4735   Slowly creeping up every day... When do XenaLives 09/19/16 04:59:33 PM
#4734   She also suggested that Halo's Enhanze partners will maumar 09/16/16 08:08:20 PM
#4733   Yes, she said that Keytruda was an underestimated Fred Kadiddlehopper 09/16/16 07:34:53 PM
#4732   Good point. Thanks. I realized that maumar 09/16/16 06:38:32 PM
#4731   An interesting end to the week. Fred Kadiddlehopper 09/16/16 04:54:48 PM
#4730   Her explanations in the London talk were particularly Fred Kadiddlehopper 09/16/16 01:42:10 PM
#4729   I think Helen converted a lot of nonbelievers maumar 09/16/16 01:22:11 PM
#4728   During Q&A Helen pointed to current Keytruda study Fred Kadiddlehopper 09/16/16 12:08:36 PM
#4727   Herceptin SC is now at 47%, MAB is Fred Kadiddlehopper 09/16/16 12:01:29 PM
#4726   Dew, it's a new one as far as Fred Kadiddlehopper 09/16/16 11:40:45 AM
#4725   When did they start using that tagline? DewDiligence 09/16/16 11:31:38 AM
#4724   HALO now billing itself as a "Diversified Oncology Fred Kadiddlehopper 09/16/16 11:28:07 AM
#4723   Here is corroboration of Piper's (Charlie Duncan) raise Fred Kadiddlehopper 09/16/16 10:23:06 AM
#4722   Helen must have impressed the Brits yesterday. Fred Kadiddlehopper 09/16/16 10:06:38 AM
#4720   "Hizentra®, the first and only ready-to-use 20% solution rod5247 09/14/16 02:33:04 PM
#4719   Will this be in direct competition with Hyqvia? maumar 09/14/16 11:33:05 AM
#4718   You are correct, Dew: Fred Kadiddlehopper 09/14/16 10:45:42 AM
#4717   I presumed that Cuvitru came to SHPG in DewDiligence 09/14/16 10:38:51 AM
#4716   Since Shire bought BXLT is it likely then Fred Kadiddlehopper 09/14/16 10:35:46 AM
#4715   FDA approves SHPG’s IVIG product: #msg-125147750. DewDiligence 09/14/16 10:18:02 AM
#4714   PEGPH20 as a Potential Breakthrough in Pancreatic Adenocarcinoma rod5247 09/11/16 10:06:46 AM
#4713   Thanks for the heads up on Baird. I Fred Kadiddlehopper 09/10/16 10:30:45 AM
#4712   That was the best T/A lineup in a rod5247 09/10/16 09:31:19 AM
#4711   Whenever I get all technical on you, you Fred Kadiddlehopper 09/09/16 05:21:59 PM
#4710   Fritz, that didn't last long. Kiss of rod5247 09/09/16 02:37:58 PM
#4709   Closed above the 200 dma for the first Fred Kadiddlehopper 09/08/16 05:44:04 PM
#4708   Wells Fargo reiterates "buy" rating today, one day Fred Kadiddlehopper 09/08/16 01:30:38 PM
#4707   Interesting discussion after the 15:00 mark about the Fred Kadiddlehopper 09/08/16 10:38:41 AM
#4706   Another tidbit that had heretofore escaped my attention: Fred Kadiddlehopper 09/08/16 10:24:44 AM
#4705   Helen did repeat the story about Roche filing Fred Kadiddlehopper 09/08/16 10:15:53 AM
#4704   Anything new in Helen's presentation yesterday? Fred Kadiddlehopper 09/08/16 10:05:59 AM
#4703   Whatever happened to the previous incumbent? jamtomorrow2 09/05/16 03:53:49 PM
#4702   New job posting for halozyme. Pay attention to biotechinvestor1 09/03/16 01:46:33 PM
#4701   They all say that. Fred Kadiddlehopper 09/01/16 05:34:31 PM