Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced FDA approval of Roche's OCREVUS ZUNOVO™, a subcutaneous formulation incorporating Halozyme's ENHANZE® technology, for treating relapsing and primary progressive multiple sclerosis. This new formulation offers a twice-yearly, 10-minute injection, expanding treatment options to centers without IV infrastructure. The approval is based on the Phase III OCARINA II trial, which demonstrated non-inferior blood levels and a comparable safety and efficacy profile to the IV formulation. The subcutaneous version showed 97% suppression of relapse activity and MRI lesions through 48 weeks, with over 92% of patients reporting satisfaction with the administration method.

Positive

• FDA approval of OCREVUS ZUNOVO™ for multiple sclerosis treatment
• Expansion of treatment options to centers without IV infrastructure
• Comparable efficacy to IV formulation with 97% suppression of relapse activity and MRI lesions
• High patient satisfaction (92%) with subcutaneous administration
• Potential for increased market penetration due to simplified administration

Negative

• Potential for injection site reactions, although reported as mild to moderate

Insights

Medical Research Analyst

The FDA approval of OCREVUS ZUNOVO™ marks a significant advancement in multiple sclerosis (MS) treatment. This subcutaneous formulation, utilizing Halozyme's ENHANZE® technology, offers a 10-minute injection alternative to the traditional IV infusion. The non-inferior efficacy and comparable safety profile to the IV form, as demonstrated in the OCARINA II trial, are particularly noteworthy.

Key points to consider:

• High patient satisfaction (92%) with SC administration
• Consistent suppression of relapse activity and MRI lesions (97% for both)
• Potential for expanded treatment access in centers without IV infrastructure

This approval could reshape MS treatment paradigms, potentially improving patient convenience and adherence while maintaining efficacy. However, long-term real-world data will be important to confirm these initial positive outcomes.

Financial Analyst

This FDA approval is a significant milestone for Halozyme, potentially boosting its revenue stream through increased adoption of its ENHANZE® technology. Key financial implications include:

• Expanded market reach for OCREVUS, now accessible to centers without IV capabilities
• Potential for increased royalties from Roche, depending on sales performance
• Enhanced value proposition of ENHANZE® technology, possibly attracting new partnerships

While specific financial projections aren't provided, this approval strengthens Halozyme's position in the drug delivery market. Investors should monitor OCREVUS ZUNOVO™'s market penetration and its impact on Halozyme's royalty revenues. The company's future guidance and quarterly reports will be important in assessing the financial impact of this approval.

OCREVUS ZUNOVO™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints

SAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Roche received U.S. Food and Drug Administration (FDA) approval for OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) with Halozyme's ENHANZE® drug delivery technology for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) as a twice-a-year, approximately 10-minute subcutaneous (SC) injection to be administered by a healthcare practitioner.

"We are pleased that the subcutaneous formulation of OCREVUS, OCREVUS ZUNOVO, which contains our ENHANZE drug delivery technology, is now approved in the U.S. for patients with these two forms of multiple sclerosis," said Dr. Helen Torley, president and chief executive officer of Halozyme. "OCREVUS ZUNOVO offers greater treatment flexibility and optionality for patients with multiple sclerosis and their healthcare providers."

The FDA approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood when administered subcutaneously, and a safety and efficacy profile comparable to the intravenous (IV) formulation in people with RMS and PPMS. The most common adverse events with OCREVUS ZUNOVO were injection reactions, all of which were either mild or moderate, and none of which led to treatment withdrawal. Out of the exploratory outcomes measured, OCREVUS ZUNOVO was consistent with IV, demonstrating suppression of relapse activity (97%) and MRI lesions (97%) through 48 weeks. Additionally, there were patient-reported outcomes measured during the study, that showed more than 92% of trial participants reported being satisfied or very satisfied with the SC administration of OCREVUS ZUNOVO.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.

For more information visit www.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 and broadening the treatment options for the indications referred to in this press release. 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 unexpected results or delays in launch or commercialization of our partner's product referred to in this press release, 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.

OCREVUS ZUNOVO™ is a trademark of Genentech, a member of the Roche Group.

Contacts:

Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com

Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is OCREVUS ZUNOVO™ and what was it approved for?

OCREVUS ZUNOVO™ is a subcutaneous formulation of ocrelizumab approved by the FDA for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). It incorporates Halozyme's ENHANZE® drug delivery technology.

How is OCREVUS ZUNOVO™ administered and how often?

OCREVUS ZUNOVO™ is administered as a twice-yearly, approximately 10-minute subcutaneous injection by a healthcare practitioner.

What were the key findings from the OCARINA II trial for OCREVUS ZUNOVO™?

The OCARINA II trial showed non-inferior blood levels of OCREVUS when administered subcutaneously, with a safety and efficacy profile comparable to the IV formulation. It demonstrated 97% suppression of relapse activity and MRI lesions through 48 weeks.

How did patients respond to OCREVUS ZUNOVO™ in clinical trials?

Over 92% of trial participants reported being satisfied or very satisfied with the subcutaneous administration of OCREVUS ZUNOVO™.

What is the significance of OCREVUS ZUNOVO™ approval for Halozyme (HALO)?

The approval of OCREVUS ZUNOVO™ validates Halozyme's ENHANZE® drug delivery technology and potentially expands the market for OCREVUS to centers without IV infrastructure, which could positively impact Halozyme's revenue.