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Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE®

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  • HALO

- For Use of Subcutaneous Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (D-VCd) in Newly Diagnosed Adult Patients with Systemic Light Chain (AL) Amyloidosis -

- For Use of Subcutaneous Daratumumab in Combination with Pomalidomide and Dexamethasone (D-Pd) in Adult Patients with Relapsed or Refractory Multiple Myeloma -

SAN DIEGO, May 21, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Pharmaceutica N.V. (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX® (daratumumab) subcutaneous (SC) formulation, which uses ENHANZE® technology, in two new indications. One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd), for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. The second recommendation is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. These two positive opinions will next be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

"Janssen's obtaining positive CHMP opinions is an important step forward in the EU and we are delighted subcutaneous DARZALEX® may soon be available in these important new indications," said Helen Torley, president and chief executive officer at Halozyme. "This would be the first approval in Europe for the treatment of AL amyloidosis and also introduces a new treatment option for certain patients with multiple myeloma."

The Positive CHMP Opinion for the AL amyloidosis indication is supported by data from Janssen's Phase 3 ANDROMEDA study.1 Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response.

The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of relapsed or refractory multiple myeloma is supported by data from the Phase 3 APOLLO study conducted in collaboration with the European Myeloma Network. 2 Janssen reported that the study met its primary endpoint of improved progression-free survival (PFS).

For more information related Phase 3 ANDROMEDA and APOLLO study findings, please view Janssen's press release.

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 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 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, 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.


1 Comenzo RL et al., Reduction in Absolute Involved Free Light Chain and Difference Between Involved and Uninvolved Free Light Chain Is Associated with Prolonged Major Organ Deterioration Progression-Free Survival in Patients with Newly Diagnosed AL Amyloidosis Receiving Bortezomib, Cyclophosphamide, and Dexamethasone With or Without Daratumumab: Results From ANDROMEDA. Abstract #552. Presented at 2020 American Society of Hematology Annual Meeting.
2 Dimopoulos, MA et al. APOLLO: Phase 3 Randomized Study of Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM). Abstract #412. Oral presentation, presented at 2020 American Society of Hematology Annual Meeting.

Al Kildani
Vice President, Investor Relations and Corporate Communications

Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.) (PRNewsfoto/Halozyme Therapeutics, Inc.)
Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.) (PRNewsfoto/Halozyme Therapeutics, Inc.)

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SOURCE Halozyme Therapeutics, Inc.