- Data Support Intravenous to Subcutaneous Conversion -
SAN DIEGO, April 16 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc.
(Nasdaq: HALO), a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix, today announced new pre-clinical
findings on the local tolerability and pharmacokinetics of bisphosphonates
combined with rHuPH20 at the American Association for Cancer Research (AACR)
The objectives of the presented studies were to investigate in animal
models whether increasing the dispersion and absorption of bisphosphonates in
the skin and subcutaneous tissues with rHuPH20 could modify injection site
reaction (ISR) profiles from two intravenous bisphosphonate formulations,
zoledronic acid and ibandronate. The pharmacokinetics of bisphosphonates in
blood were also examined and compared to intravenous infusion. Key findings
from the study were as follows:
-- In rodent intradermal models, injection of bisphosphonates without
rHuPH20 created injection site reactions characterized by erythema,
induration, and ulceration in a concentration dependent manner.
-- In rodent intradermal models, the maximal concentration of
bisphosphonates that could be administered without producing ISRs was
increased 3- to 5-fold when co-administered in combination with
-- In porcine pharmacokinetic models, absolute bioavailability by
subcutaneous (SC) injection with rHuPH20 was comparable to IV
"Historically, hyaluronidase products have been utilized as an antidote to
local extravasations of certain chemotherapy agents," said Gregory Frost, PhD,
Halozyme's Vice President and Chief Scientific Officer. "We reasoned that if
rHuPH20 hyaluronidase could rapidly disperse, dilute and systemically absorb
bisphosphonates, it could prevent local irritation and facilitate conversion
from intravenous infusion to a more convenient subcutaneous route of
administration. These pre-clinical findings support this program's objective
of developing what would be the only SC bisphosphonate on the market, in the
event of continued success." The Company plans to bring its SC bisphosphonate
program into the clinic in the third quarter of this year.
Bisphosphonates are a class of molecules that bind to mineralized bone
matrix and inhibit bone resorption. Currently, there are oral and intravenous
bisphosphonates. Oral Bisphosphonates often cause gastrointestinal side
effects and require a cumbersome dosing regimen. The gastrointestinal side
effects of oral bisphosphonates is a significant cause of patient
non-compliance to prescribed therapy. Certain bisphosphonates are indicated
for the treatment of osteoporosis and skeletal metastases, but can only be
administered today by intravenous infusion. As such, patients often have to
travel to an infusion center or see a specialist to receive their intravenous
bisphosphonate infusion. Subcutaneous injections of bisphosphonates are not
considered feasible due to injection site toxicity in the skin and/or
impractical injection volumes.
The recombinant protein, rHuPH20, is a human hyaluronidase enzyme that
increases the dispersion and systemic absorption of locally injected drugs by
temporarily degrading hyaluronan under the skin.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the drug delivery, oncology
and dermatology markets. The company's portfolio of products and product
candidates is based on intellectual property covering the family of human
enzymes known as hyaluronidases. The company's Enhanze(TM) Technology is a
novel drug delivery platform designed to increase the absorption and
dispersion of biologics. Its key partnerships are with Roche to apply Enhanze
Technology to Roche's biological therapeutic compounds for up to 13 targets
and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic
compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA
approval for two products: Cumulase(R), for use in in-vitro fertilization, and
HYLENEX, for use as an adjuvant to increase the absorption and dispersion of
other injected drugs and fluids. HYLENEX is partnered with Baxter
International Inc. The Company also has a number of different enzymes in its
portfolio that are targeting significant areas of unmet need.
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without limitation, statements
concerning (i) the pre-clinical results of the company's rHuPH20 enzyme with
bisphosphonates (ii) and the timing of entering the clinic for the company's
subcutaneous bisphosphonate program) 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 regulatory approval requirements and competitive conditions. These
and other factors that may result in differences are discussed in greater
detail in the company's reports on Forms 10-K, 10-Q, and other filings with
the Securities and Exchange Commission.
SOURCE Halozyme Therapeutics, Inc.
CONTACT: David A. Ramsay, Chief Financial Officer of Halozyme
Therapeutics, Inc., +1-858-704-8260, email@example.com; or Karen Sparks,
+1-858-455-5500, ext. 275, firstname.lastname@example.org, or Joleen Schultz,
+1-858-455-5500, ext. 215 email@example.com, both of Mentus, for Halozyme