Halozyme Announces Findings From Janssen's Phase 3 Andromeda Study Evaluating Subcutaneous Daratumumab Utilizing ENHANZE® In Light-Chain Amyloidosis Presented At European Hematology Association 25th Annual Congress

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced positive results from Janssen's Phase III ANDROMEDA study of subcutaneous daratumumab with ENHANZE technology, presented at the European Hematology Association's 25th Annual Congress. The study achieved its primary endpoint, showing hematologic complete response in newly diagnosed light-chain amyloidosis patients. This innovative treatment offers potential benefits for a previously underserved patient population with few options. Halozyme's ENHANZE technology may enhance patient experience by reducing treatment time significantly.

Positive

• ANDROMEDA study met primary endpoint for complete response in patients with light-chain amyloidosis.
• Subcutaneous daratumumab formulation addresses an underserved treatment population.

Negative

• None.

SAN DIEGO, June 13, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced  that Janssen Research & Development, LLC (Janssen) presented data from its Phase III ANDROMEDA (AMY3001) study of subcutaneous (SC) daratumumab utilizing ENHANZE^® in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) for patients with newly diagnosed light-chain (AL) amyloidosis at the 25^th Annual Congress of the European Hematology Association. Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response. Additional information can be accessed here.

"We are excited that the subcutaneous formulation of daratumumab utilizing ENHANZE^® has demonstrated positive results in a potentially new indication addressing an underserved population with limited treatment options," said Dr. Helen Torley.

About Halozyme

Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE^® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via four commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary recombinant human hyaluronidase enzyme rHuPH20 forms the basis of the ENHANZE^® drug delivery technology and is used to facilitate the subcutaneous delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE^® drug delivery technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE^®. 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
ir@halozyme.com

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What were the results of the Phase III ANDROMEDA study for HALO stock?

The ANDROMEDA study met its primary endpoint, indicating a positive outcome for HALO stock.

What is the significance of daratumumab using ENHANZE technology in the study?

The use of ENHANZE technology allows for a subcutaneous formulation, potentially improving patient experience and treatment efficiency.

When was the ANDROMEDA study data presented?

The data was presented on June 13, 2020, at the European Hematology Association's 25th Annual Congress.

How does the ANDROMEDA study impact Halozyme's market potential?

The study's success could enhance Halozyme's market potential by addressing a significant medical need in light-chain amyloidosis.

What is the next step for Halozyme after the ANDROMEDA study?

Following the successful results, Halozyme and its partners may advance further development and commercialization efforts.