| Baxter Announces the Commercial Launch of HYLENEX at ACEP for use in Pediatric Rehydration |
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06/10/2009 16:05 (157 Day 20:20 minutes ago) | |||||
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The FINANCIAL -- Baxter International Inc. (NYSE: BAX) on October 5 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).
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 loss.
“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 experience.1
“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.
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