Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO™ Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With Multiple Myeloma

- Janssen's DARZALEX FASPRO™ is a subcutaneous co-formulation of DARZALEX® and Halozyme's ENHANZE® technology -

- Innovative, fixed-dose formulation demonstrates consistent efficacy to intravenous DARZALEX® with lower rate of infusion-related reactions -

- Can be administered in three to five minutes compared to multi-hour infusions with intravenous DARZALEX® -

News provided by

Halozyme Therapeutics, Inc.

May 01, 2020, 15:16 ET

SAN DIEGO, May 1, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj). DARZALEX FASPRO™ is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.

"We are delighted that DARZALEX FASPRO™ has been approved in the U.S. making it possible for patients diagnosed with multiple myeloma to receive daratumumab (DARZALEX^®) treatment in 3-5 minutes with a subcutaneous injection rather than through a multi-hour intravenous infusion. This can reduce the treatment burden for patients, significantly shortening the time required in the physician clinic, hospital in-patient and out-patient treatment centers," said Dr. Helen Torley, president and chief executive officer. "We are also pleased with the breadth of indications granted to DARZALEX FASPRO™, which includes the majority of the indications granted for the IV DARZALEX^® formulation."

DARZALEX FASPRO™ is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

About ENHANZE^® Technology
Halozyme's proprietary ENHANZE^® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE^® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

About Halozyme
Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHUPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. 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 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 product 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
[email protected]

SOURCE Halozyme Therapeutics, Inc.