Data from the First Pediatric Rehydration Study, INFUSE-PEDS 1,
Published Today in Pediatrics
BOSTON--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX - News) today announced the commercial
launch of HYLENEX recombinant (hyaluronidase human injection) for use in
pediatric rehydration at the 2009 American College of Emergency
Physicians (ACEP) scientific assembly (Boston). HYLENEX, an enzyme,
allows fluids to be administered under the skin (subcutaneously) rather
than through a vein. This allows for rapid treatment initiation and
delivery of intravenous (IV)-like fluid rates, which can help lead to
successful rehydration of children in a less invasive manner.
Additionally, data from Baxter’s Increased Flow Utilizing
Subcutaneously-Enabled (INFUSE) PEDS 1 study are debuting today in the
preeminent pediatric journal, Pediatrics. The study was designed
to assess the efficacy, safety and clinical utility of HYLENEX
recombinant-facilitated subcutaneous rehydration in mild to moderately
dehydrated children ages two months to 10 years. This approach was found
to be effective, easy to use and well-tolerated.1 Baxter
licensed HYLENEX, the first and only recombinant human hyaluronidase,
from Halozyme Therapeutics, Inc. (Nasdaq: HALO - News).
The commercial launch and data publication coincide with the approaching
cold/flu season, offering an alternative to IV therapy for children with
dehydration, a potentially serious consequence of viral respiratory
diseases including influenza and other conditions that can cause fluid
“HYLENEX exemplifies Baxter’s ongoing commitment to innovation and
introducing products that help to improve the treatment experience and
overall standard of care – in this case for parents, patients and
caregivers alike,” said Camille Farhat, general manager of Baxter
Pharmaceuticals and Technologies, part of Baxter’s Medication Delivery
business. “The data published today indicate that treatment facilitated
by HYLENEX was considerably preferred by parents, and highly rated by
clinicians, for its ability to effectively rehydrate mild to moderately
dehydrated children in a much less invasive way.”
“Baxter’s launch of HYLENEX for use in pediatric hydration is an
important achievement for our alliance,” said Jonathan Lim, M.D.,
president and CEO of Halozyme. “We look forward to continuing to partner
with Baxter to pursue HYLENEX use in additional patient populations as
the benefits of subcutaneous administration of fluids and medications
are increasingly realized.”
Baxter manufactures and markets HYLENEX and continues to build clinical
evidence to support its use. Baxter licensed the HYLENEX technology from
Halozyme, which discovered and completed development work to secure U.S.
Food and Drug Administration (FDA) approval. As HYLENEX is being
introduced into the pediatric rehydration market, Baxter continues to
study its use in other areas.
Pediatric Rehydration Clinical Program
The safety and efficacy of HYLENEX has been demonstrated through
clinical trial results in mild to moderately dehydrated children as part
of the INFUSE clinical research program. New data published today from
the INFUSE-PEDS 1 study (n=51) showed that subcutaneous treatment
facilitated by HYLENEX successfully rehydrated 94 percent of pediatric
patients. The data also showed HYLENEX was fast and simple to initiate
as median time from insertion to start of subcutaneous therapy was two
minutes. In addition, the therapy was easy to administer, as 90 percent
of catheters were successfully inserted on the first attempt and 96
percent of clinicians rated the procedure easy to perform. HYLENEX
recombinant-facilitated subcutaneous rehydration was also highly
preferred by parents, as nine out of 10 surveyed were satisfied or very
satisfied with the procedure and reported their experience with
treatment facilitated by HYLENEX was the same or better than previous IV
“To have another option for rehydration is very important to clinicians,
because our options were fairly limited previously and in the case of
IV, could take 20 to 40 minutes on average to initiate. With HYLENEX, we
can start infusing fluids into children in a matter of minutes,” said
Coburn Allen, M.D., assistant professor, Department of Pediatrics,
Section of Emergency Medicine and Section of Infectious Diseases, Baylor
College of Medicine, Houston. “These data, in mild to moderately
dehydrated children, show HYLENEX is efficacious, that we are
successfully hydrating children, and that we are able to give clinically
relevant fluid volumes in the same timeframe that we typically have
given them by IV.”
Research continues to progress, with interim results from a follow-up
study, INFUSE-PEDS 2, being presented at ACEP on October 5, 2009, at
8:00 am ET. This phase IV, multi-center, randomized controlled study
compares HYLENEX recombinant-facilitated subcutaneous rehydration to
IV administration of fluids for mild to moderately dehydrated children.
Please see Important Risk Information for HYLENEX at the end of the
Full Prescribing Information is available at http://www.hylenex.com/pdf/prescribe.pdf.
HYLENEX, approved by the FDA for subcutaneous fluid administration,
works by temporarily making the tissue beneath the skin more permeable
(capable of being passed through) and able to absorb fluid, allowing
fluids to be more readily absorbed into the blood vessels. HYLENEX can
be given in a site that is convenient for both the child and caregiver,
such as in the child’s upper back, while the child is held by a parent.
Once HYLENEX has been injected, fluids can be administered
subcutaneously. Special care must be taken in pediatric patients to
avoid over hydration by controlling the rate and total volume of the
infusion.2 When solutions devoid of inorganic electrolytes
are given subcutaneously, some complications may occur.2
About Dehydration and IV Fluid Administration
Dehydration often results from an illness in which fluid loss is greater
than fluid intake, such as vomiting or diarrhea.
One of the most common causes of dehydration in children in the U.S. is
acute gastroenteritis (or stomach flu), which is responsible for more
than 1.5 million outpatient visits, 200,000 hospital stays, and
approximately 300 deaths per year.3 Many pediatric emergency
physicians will treat mild to moderately dehydrated children via IV
therapy. Yet, a study has shown that IV treatment was considered one
common source of “worst pain” for children during hospitalization.4
Re-sticks can be particularly common with children – a study at an
academic children’s hospital found that nearly half of pediatric
patients required two or more IV sticks.5
Baxter International Inc. (NYSE: BAX - News), through its subsidiaries,
develops, manufactures and markets products that save and sustain the
lives of people with hemophilia, immune disorders, infectious diseases,
kidney disease, trauma, and other chronic and acute medical conditions.
As a global, diversified healthcare company, Baxter applies a unique
combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care worldwide.
Halozyme Therapeutics, Inc. (Nasdaq: HALO - News) is a biopharmaceutical
company developing and commercializing products targeting the
extracellular matrix for the endocrinology, oncology, dermatology and
drug delivery markets. The company's portfolio of products and product
candidates is based on intellectual property covering the family of
human enzymes known as hyaluronidases and additional enzymes that affect
the extracellular matrix. Halozyme’s Enhanze™ Technology is a
novel drug delivery platform designed to increase the dispersion and
absorption of biologics. The company has key partnerships with Roche to
apply Enhanze Technology to Roche’s biological therapeutics for up to 13
targets and with Baxter BioScience to apply Enhanze Technology to
Baxter’s biological therapeutic compound, GAMMAGARD LIQUID™.
The product candidates in Halozyme’s research pipeline target multiple
areas of significant unmet medical need. For more information visit www.halozyme.com.
This release includes forward-looking statements concerning the use
of HYLENEX recombinant for pediatric rehydration, HYLENEX
recombinant-facilitated subcutaneous rehydration and the companies’
expectations related to HYLENEX. The statements are based on assumptions
about many important factors, including the following, which could cause
actual results to differ materially from those in the forward-looking
statements: the anticipated timing of regulatory filings and the success
of certain regulatory events; the effectiveness of the products
described in this release; demand for and market acceptance of the
products described in this release; the impact of competitive products
and pricing; internal and external factors that could impact
commercialization; and other risks discussed in each company’s filings
with the Securities and Exchange Commission (SEC) that could cause
actual results to differ materially from those in the forward-looking
statements. Each company’s SEC filings are available on its respective
website. The companies do not undertake any obligation to update
any forward-looking statements. Actual results or experience
could differ materially from the expectations contained in the
Important Risk Information
Hypersensitivity to hyaluronidase or any other ingredient in the
formulation is a contraindication to the use of this product.
Discontinue HYLENEX recombinant (hyaluronidase human injection) if
Hyaluronidase should not be used to enhance the absorption and
dispersion of dopamine and/or alpha agonist drugs.
Hyaluronidase should not be injected into or around an infected or
acutely inflamed area because of the danger of spreading a localized
Hyaluronidase should not be used to reduce the swelling of bites or
Hyaluronidase should not be used for intravenous injections because
the enzyme is rapidly inactivated.
Furosemide, the benzodiazepines and phenytoin have been found to be
incompatible with hyaluronidase.
The most frequently reported adverse experiences have been local
injection site reactions.
Hyaluronidase has been reported to enhance the adverse events
associated with co-administered drug products.
Anaphylactic-like reactions following retrobulbar block or intravenous
injections have occurred, rarely.
Edema has been reported most frequently in association with
subcutaneous fluid administration.
The rate and volume of subcutaneous fluid administration should not
exceed those employed for intravenous infusion. As with all parenteral
fluid therapy, use the same precautions for restoring fluid and
Special care must be taken in pediatric patients to avoid over
hydration by controlling the rate and total volume of the infusion.
When solutions devoid of inorganic electrolytes are given
subcutaneously, hypovolemia may occur.
Baxter and Hylenex are trademarks of Baxter International Inc.
1 Baxter Data on File.
2 HYLENEX Full Prescribing Information.
3 King C, Glass R, Bresee J, et al. Managing Acute
Gastroenteritis Among Children. Atlanta, GA: Department of Health and
Human Services, Centers for Disease Control and Prevention; 2003. Nov.
4 Cummings EA, Reid, GJ, et al. Prevalence and Source of Pain
in Pediatric Inpatients. Pain. 1996; 68; 25-31.
5 Spandorfer PR, Evaline A., Joffe MD, et al. Oral Versus
Intravenous Rehydration of Moderately Dehydrated Children: A Randomized,
Controlled Trial. Pediatrics. 2005; 115; 295-301.