Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis

SAN DIEGO, Jan. 15, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO^® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.¹ DARZALEX FASPRO^® is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.¹ This indication is approved under accelerated approval and is based on the combination's hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.  DARZALEX FASPRO^® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

"We are delighted that DARZALEX FASPRO^® utilizing our ENHANZE^® technology has become the first and only FDA-approved treatment for newly diagnosed patients with AL amyloidosis," said Dr. Helen Torley, president and chief executive officer. "AL amyloidosis represents an area of high unmet medical need."

The FDA approval is based on positive results from the Phase 3 ANDROMEDA study, which were recently presented at the American Society of Hematology (ASH) 2020 Annual Meeting. The study evaluated DARZALEX FASPRO^® in combination with VCd, compared with VCd alone, a common treatment regimen offered to adult patients with newly diagnosed AL amyloidosis. ⁵  Patients receiving treatment with DARZALEX FASPRO^® experienced a hemCR more than triple that of patients receiving VCd alone (42 percent for D-VCd and 13 percent for VCd; P<0.0001).¹

Approximately 4,500 people in the U.S. develop this rare disease each year.⁴  AL amyloidosis is a life-threatening blood cell disorder that occurs when blood plasma cells in the bone marrow produce amyloid deposits, which build up in vital organs and eventually cause organ deterioration.³  The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, gastrointestinal tract and nervous system.^2,3  About one-third of patients visit five or more doctors before receiving a diagnosis, and 72 percent are diagnosed more than one year after they first experience symptoms.^3,4  Patients often have a poor prognosis due to the delay in diagnosis of AL amyloidosis, which frequently presents with non-specific symptoms that can mimic other, more common conditions.⁶  As many as 30 percent of patients with AL amyloidosis die within the first year after diagnosis.⁷   

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 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 Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. 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.

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 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 from being treated with the newly-approved 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.

¹ DARZALEX FASPRO^® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
² Mayo Clinic. Amyloidosis overview: symptoms and causes. https://www.mayoclinic.org/diseases-conditions/amyloidosis/symptoms-causes/syc-20353178. Accessed January 2021.
³ Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928.
⁴ McCausland KL, et al. Patient. 2018;11(2):207-216.
⁵ Kastritis E, et al. Subcutaneous Daratumumab + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary Results from the Phase 3 ANDROMEDA Study. Available at: https://library.ehaweb.org/eha/2020/eha25th/303396/efstathios.kastritis.subcutaneous.daratumumab.2B.cycl%20ophosphamide.bortezomib.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Amedia%3D3%2Ace_i. Accessed January 2021. 
⁶ Mayo Clinic. Amyloidosis diagnosis and treatment. https://mayocl.in/3jK50G4. Accessed January 2021.
⁷ Merlini G, et al. Light chain amyloidosis: the heart of the problem. Haematologica. 2013;98(10):1492-1495.

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

SOURCE Halozyme Therapeutics, Inc.

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