Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse

Rhea-AI Summary

Halozyme Therapeutics announced that Janssen Biotech received FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone for adult patients with relapsed or refractory multiple myeloma. This marks the ninth indication for DARZALEX FASPRO. The approval is based on data from Janssen's PLEIADES Study, which achieved its primary endpoint of overall response rate. The product leverages Halozyme's ENHANZE technology, facilitating rapid treatment administration that may enhance patient experience.

Positive

• FDA approval for DARZALEX FASPRO expands treatment options for multiple myeloma.
• Novel combination therapy could boost market share and revenue potential.
• ENHANZE technology enhances treatment delivery, reducing administration time.

Negative

• Approval is contingent on ongoing clinical performance and market acceptance.

SAN DIEGO, Dec. 1, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj) in combination with Kyprolis^® (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. This approval follows Janssen's regulatory submission to the FDA in February 2021.

"We are pleased that Janssen received U.S. FDA approval for the ninth indication for DARZALEX FASPRO^® in multiple myeloma, this time in combination with Kyprolis^® (carfilzomib) and dexamethasone," said Helen Torley, president and chief executive officer at Halozyme. "With its three-to-five-minute subcutaneous administration, DARZALEX FASPRO is now a treatment option for a broader range of patients suffering from multiple myeloma."    

The FDA approval for DARZALEX FASPRO^® is based on data from Janssen's PLEIADES Study, which met its primary endpoint of overall response rate. For more information about the PLEIADES study and its findings, please view Janssen's press release issued today. 

DARZALEX FASPRO^® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE^® drug delivery technology.

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 touched more than 500,000 patient lives via five 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 enzyme rHuPH20 forms the basis of the ENHANZE^® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE^® technology to leading pharmaceutical and biotechnology companies including AbbVie, Alexion, argenx, Baxalta, Bristol-Myers Squibb, Horizon, Lilly, Pfizer, Roche and ViiV Healthcare. 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 Halozyme.com and connect with us on LinkedIn and Twitter.

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 and potentially lowering the treatment burden for patients. 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 for the indications referred to in this press release, 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 from being treated with the ENHANZE^® co-formulated treatment referred to in this press release, 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 is DARZALEX FASPRO and its market potential?

DARZALEX FASPRO is a subcutaneous treatment for multiple myeloma, providing a faster administration option, which may lead to increased adoption and revenue.

What does the FDA approval for DARZALEX FASPRO involve?

The FDA approved DARZALEX FASPRO in combination with Kyprolis and dexamethasone for patients with relapsed or refractory multiple myeloma after receiving one to three prior therapies.

What is the significance of the PLEIADES Study in this approval?

The PLEIADES Study met its primary endpoint of overall response rate, providing pivotal data for the FDA approval of the new therapeutic regimen.

How does ENHANZE technology improve treatment for patients?

ENHANZE technology reduces the time required for treatment administration from hours to just three to five minutes, improving patient experience.