Halozyme Delivers Notice of Breach to Baxter Healthcare Due to HYLENEX(R) Manufacturing Failures
SAN DIEGO, May 16, 2010 /PRNewswire via COMTEX/ --Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced the delivery of a notice of breach to Baxter Healthcare Corporation due to Baxter's failure to provide HYLENEX(R) (hyaluronidase human injection) in accordance with the terms of the parties' existing development and supply contracts. Baxter recently informed Halozyme that certain materials produced by Baxter are not in compliance with the requirements of the HYLENEX agreements. This noncompliance, along with Halozyme's concerns over the quality and capabilities of Baxter's manufacturing operations, has led Halozyme to deliver the notice of breach. In the event that Baxter is unable to remedy all material breaches within 120 days, Halozyme may terminate the HYLENEX relationship.
No medical events have been reported in connection with noncompliant HYLENEX product. Halozyme is working with the U.S. Food and Drug Administration and Baxter to ensure patient safety. Halozyme and Baxter are actively investigating both the causes and the extent of these manufacturing issues.
Halozyme believes that Baxter's manufacturing deficiencies are specific to the 150U HYLENEX product. Neither the rHuPH20 bulk enzyme nor any other products containing the enzyme are believed to be affected.
Halozyme management will host a conference call and webcast on May 17, 2010 to discuss these topics beginning at 6:00 a.m. PDT (9:00 a.m. EDT). To participate via telephone, please call 877.407.8037 for domestic callers or 201.689.8037 for international callers. A telephone replay will be available for seven days beginning approximately two hours after the call by dialing 877.660.6853 from the U.S. or 201.612.7415 for international callers and using account # 367 and replay ID # 350979. The conference call will be broadcast live over the Internet at www.halozyme.com.
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, when administered for pediatric rehydration, 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.
Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio 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(TM) technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin(R) and MabThera(R), for up to 13 targets, and with Baxter BioScience to apply Enhanze technology to GAMMAGARD Liquid(R). Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit 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, (i) the safety of non-compliant HYLENEX, and (ii) the scope of the manufacturing deficiencies) 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.
Robert H. Uhl
Senior Director, Investor Relations