Halozyme Announces Janssen's Receipt Of CHMP Positive Opinio

|Apr 30|magazine12 min read

SAN DIEGO, April 30, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen-Cilag International NV (Janssen)  received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX® (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings.  The CHMP's Positive Opinion for daratumumab SC formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients. 

The DARZALEX® SC formulation utilizes Halozyme's ENHANZE® drug delivery technology and reduces the treatment time from several hours to approximately five minutes with comparable efficacy to intravenous DARZALEX® and lower rates of infusion-related reactions.

"We are excited that a subcutaneous formulation of DARZALEX® is one step closer to transforming the treatment experience for multiple myeloma patients and physicians in the European Union," said Dr. Helen Torley, president and chief executive officer. "Once available, multiple myeloma patients may benefit from a shorter infusion time when compared with a multi-hour intravenous infusion."

The CHMP opinion is supported by data from Janssen's Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed and refractory multiple myeloma, and the Phase 2 PLEIADES study. In the COLUMBA study, subcutaneous DARZALEX®, using ENHANZE® drug delivery technology, was found to be non-inferior to intravenous DARZALEX® with regard to the co-primary endpoints of overall response rate and maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.

About ENHANZE® Technology 
Halozyme's proprietary ENHANZE® drug delivery technology is 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.

About Halozyme
Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Halozyme 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, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports 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.

Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
[email protected]

 

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SOURCE Halozyme Therapeutics, Inc.