Healthcare Industry News: Humira
News Release - January 21, 2016
Halozyme Announces First Clinical Dosing Of Adalimumab (Humira) Using ENHANZE(TM) TechnologySAN DIEGO, Jan. 21, 2016 -- (Healthcare Sales & Marketing Network) -- Halozyme Therapeutics, Inc. (HALO) today announced that AbbVie has dosed the first subject in a clinical trial evaluating the safety and pharmacokinetics of adalimumab with Halozyme's proprietary ENHANZE™ technology.
"We are pleased that the first product candidate with AbbVie has been advanced into clinical testing just seven months after forming our collaboration agreement," said Dr. Helen Torley, president and chief executive officer. "The progress is encouraging as we seek to help an even broader population of patients with our ENHANZE platform."
The initiation of clinical evaluation triggered a $5 million milestone payment to Halozyme under the Collaboration and License Agreement between the companies.
Halozyme's ENHANZE technology is based on a proprietary recombinant human enzyme (rHuPH20) that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.
Halozyme Collaboration with AbbVie
In June 2015, Halozyme and AbbVie entered into a collaboration and license agreement. Under the terms of the agreement, Halozyme has granted to AbbVie a worldwide license to develop and commercialize products for up to nine targets, combining rHuPH20 with AbbVie's proprietary compounds. Halozyme received an initial payment of $23 million, and is eligible to receive additional payments upon AbbVie's achievement of specified development, regulatory and sales-based milestones, totaling up to $130 million per target. Halozyme is also entitled to tiered royalty payments based on net sales of products using the ENHANZE™ technology.
ENHANZE™ is Halozyme's proprietary drug delivery platform based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE™ drug delivery platform. Halozyme is headquartered in San Diego. 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 the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, the number of targets licensed for future product development and commercialization with ENHANZE, potential receipt of future milestone payments, and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery 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 typically, but not always, 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 the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
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