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Halozyme Therapeutics, Inc. (HALO) Presents Positive Data from Two Ultrafast Insulin Clinical Trials with Human Hyaluronidase Enzyme - rHuPH20 - at American Diabetes Association2012


6/11/2012 11:29:29 AM

PHILADELPHIA, June 9, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today 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.

(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

Presenters will be available to discuss the posters at the following times:

  • "Human Hyaluronidase Plus Rapid Analog Insulin (RAI) Improves Postprandial Glycemic Control in Type 2 Diabetes (T2DM) Compared to Insulin Lispro Alone," Saturday, June 9 from 12:30 1:30 PM EDT during an audio guided tour and on Sunday, June 10 from 12:00 - 2:00 PM EDT.
  • "Human Hyaluronidase (rHuPH20) Provides Consistent Ultrafast Insulin Absorption and Action Over Three Days of Continuous Subcutaneous Infusion," Sunday, June 10 from 12:00 - 2:00 PM EDT.

"With diabetes reaching epidemic proportions globally, the need for improved therapies that can help people better manage the all too common rollercoaster ride of glucose swings is critical," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. "Pairing Halozyme's lead enzyme, rHuPH20, with mealtime analog insulins accelerates the absorption and action of prandial insulins, helps moderate glucose fluctuations and enables patients to achieve tighter control of this chronic disease."

882-P: Human Hyaluronidase Plus Rapid Analog Insulin (RAI) Improves Postprandial Glycemic Control in Type 2 Diabetes (T2DM) Compared to Insulin Lispro Alone
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 percent 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). The secondary outcomes of hypoglycemia rates (7.92 for Analog-PH20 episodes per subject-month vs. 7.65 for lispro, p=.41), and change in body weight (+3.35 lbs for Analog-PH20 vs +3.44 lbs for lispro), were comparable between the patient groups treated with Analog-PH20 and the patient group treated with lispro alone. A trend for reduction in total insulin dose was seen in the patient groups treated with Analog-PH20 (123+67 U vs. 127+69 U, p=.031), compared with the patient group treated with lispro alone. Adverse events were comparable between treatments, with no difference in adverse events, immunogenicity or injection site pain and Analog-PH20 was well tolerated.

Study Design
This safety and efficacy study compared subcutaneously injected Analog-PH20 versus lispro alone in patients with Type 2 diabetes who were an average age of 59+9 years and had been treated with insulin for > 12 months and prandial insulin (at least 2 meals per day) for > 2 months. The study enrolled 121 patients with an average Body Mass Index (BMI) of 35.2+4.0, and A1C of 7.8+.5 percent. After a four to six week run-in period using prandial glulisine plus twice-daily glargine, patients were randomized to lispro-PH20 or aspart-PH20 versus lispro alone for two, 12-week intensive management periods. Prandial therapy was administered immediately before meals. The primary endpoint of the study was A1C non-inferiority. Secondary outcomes included rates of hypoglycemia, insulin dose, change in body weight, along with blood glucose measures.

905-P: Human Hyaluronidase (rHuPH20) Provides Consistent Ultrafast Insulin Absorption and Action Over Three Days of Continuous Subcutaneous Infusion
Rapid analog insulins (RAIs) demonstrate systematic variation in insulin absorption and action as insulin pump infusion sites age. This Phase 2 study was conducted to test the effect of rHuPH20 administered both as a coformulation and as a single injection prior to the start of three days of insulin aspart pump infusion therapy (referred to as pre-administration).The data showed that pre-administration of 150 units (1.25 micrograms) of rHuPH20 at the time of infusion set change led to a more consistent, ultrafast profile for insulin aspart infused over the three days of the infusion site use, eliminating the variability in insulin absorption and action associated with infusion site aging.

Euglycemic clamps were performed after bolus infusion of insulin aspart (0.15 U/kg), administered as either a coformulation or single injection pre-administration prior to infusion set insertion, in two cohorts of generally healthy adult patients with Type 1 diabetes. With RAI alone, the absorption and onset action of insulin varied considerably with infusion site age, with insulin exposure during the first hour following a bolus infusion being only 15 percent of the total, and doubling to 27 percent after three days of infusion site use. Similarly, the onset and duration of insulin action varied by up to 30 minutes as the infusion site aged.

The coformulated aspart-PH20 therapy accelerated insulin absorption and action over the duration of the infusion, compared to insulin aspart alone. In addition to increased absorption and action, pre-administration of rHuPH20 provided a consistent ultrafast profile over the three days of the infusion site life, compared to insulin aspart alone. (See Table 1 below.)

Table 1

Cohort*

Infusion Site Age

Insulin Aspart Alone

With rHuPH20

Early Exposure

(% total)

Onset of Action

(min)

Duration of Action

(min)

Early Exposure

(% total)

Onset of Action

(min)

Duration of Action

(min)

Coform

1/2 days

21

47

164

35

35

147

Coform

2 1/2 days

33

35

147

51

40

133

Pre-Rx

< 2hr

15

60

180

31

34

139

Pre-Rx

1 days

22

34

164

37

32

134

Pre-Rx

3 days

27

30

156

32

31

146

*Coform = Aspart (100 U/mL)+ rHuPH20 (600U/mL); Pre-Rx = rHuPH20 pretreatment (150 U bolus)

Study Design
This randomized, double-blind, interventional study was to determine if rHuPH20 would change the exposure and action of an approved insulin analog when given either by continuous subcutaneous infusion of a coformulation of insulin aspart with rHuPH20, or as a pretreatment of the infusion site with an injection of rHuPH20 alone followed by continuous infusion of insulin aspart in patients with Type 1 diabetes. The study enrolled subjects who were in generally good health and used a continuous subcutaneous insulin infusion pump as the primary route of insulin administration. Patients, who had an A1C of <10%, received, in random sequence, insulin aspart or the coformulation of aspart+rHuPH20 (Stage 1 cohort, n=16) or rHuPH20 pretreatment versus sham injection (Stage 2 cohort, n=16) followed by three days of insulin aspart infusion. The primary endpoint of the study was pharmacokinetic percent of area under the curve (PK% AUC) based on serum level insulin concentrations collected at specified time points. Secondary outcomes included glucodynamic and mixed meal glycemic responses.

About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible benefits and attributes of our ultrafast insulin formulations) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including clinical trial enrollment and results, regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 7, 2012.

Media/Investor Contact:
Anne Erickson
Executive Director
Halozyme Therapeutics
858-699-9166
aerickson@halozyme.com

SOURCE Halozyme Therapeutics, Inc.


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