Halozyme Announces Janssen Submission Of Applications In US And EU Seeking Approval Of DARZALEX FASPRO™/ DARZALEX® Subcutaneous (SC) Formulation Utilizing ENHANZE® Technology, Combination With Pomalidomide And Dexamethasone For Patients With Relapsed Or Re
Halozyme Therapeutics (NASDAQ: HALO) announced that Janssen Pharmaceutical submitted applications to both the FDA and EMA for the approval of DARZALEX FASPRO™ subcutaneous formulation. This treatment, aimed at relapsed or refractory multiple myeloma patients, allows administration in 3-5 minutes, vastly reducing the time from the traditional intravenous method. The application is backed by positive results from the Phase 3 APOLLO study suggesting longer progression-free survival compared to the standard treatment. The full study results will be presented at the ASH Annual Meeting on December 6, 2020.
- Regulatory applications submitted for DARZALEX FASPRO™ to FDA and EMA.
- Significantly reduced administration time compared to IV formulation.
- Supported by positive Phase 3 APOLLO study results showing improved progression-free survival.
- None.
SAN DIEGO, Nov. 12, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the Janssen Pharmaceutical Companies submitted regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of the daratumumab subcutaneous (SC) formulation, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S. and as DARZALEX® (daratumumab) SC in the European Union (EU). The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. As a fixed-dose formulation, DARZALEX FASPRO™/ DARZALEX® SC can be administered over approximately three to five minutes under the skin, significantly less time than the intravenous (IV) formulation of DARZALEX®, which is given over several hours.
The supplemental Biologics License Application (sBLA) to the U.S. FDA and Type II variation application to the EMA are supported by positive findings from the Phase 3 APOLLO study (MMY3013), which met its primary endpoint of significantly longer progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma who received D-Pd compared with Pd alone.1
"We are pleased that Janssen has submitted applications in both the US and EU to expand the label for the subcutaneous form of DARZALEX® utilizing our ENHANZE® technology," said Dr. Helen Torley, president and chief executive officer. "We look forward to the subcutaneous forms of DARZALEX® becoming available for a broader group of patients with multiple myeloma, offering them the potential for reduced administration time from hours to minutes compared with the IV formulation."
These applications are supported by positive results from the Phase 3 APOLLO study, which demonstrated improved significant progression-free survival in patients receiving the subcutaneous formulation of daratumumab.2
Full results from the Phase 3 APOLLO study, a collaboration between Janssen Research & Development, LLC and the European Myeloma Network (EMN), will be presented in an oral session at the upcoming American Society of Hematology (ASH) Annual Meeting on Sunday, December 6, 2020 at 3:00 p.m. ET (Abstract #412).
The D-Pd regimen received approval from the U.S. FDA for the IV formulation of DARZALEX® in 2017 for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. This regimen for the IV formulation is not approved for use in Europe by the EMA.
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 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.
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 DARZALEX® is a trademark of Janssen Pharmaceutica NV.
References:
1 Chari, Ajai et al. "Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma." Blood vol. 130,8 (2017): 974-981. doi:10.1182/blood-2017-05-785246
2 Comparison of Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide and a Proteasome Inhibitor Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). Available at: https://clinicaltrials.gov/ct2/show/record/NCT03180736 Last accessed: October 2020.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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