Halozyme Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications
Rhea-AI Summary
Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb received a positive CHMP opinion recommending approval for a new subcutaneous formulation of Opdivo® (nivolumab) developed with ENHANZE® technology across multiple adult solid tumor indications in the EU.
The subcutaneous formulation, which utilizes Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), would offer cancer patients a faster and more flexible treatment option. The European Commission's decision on marketing authorization is expected by June 2, 2025.
The recommendation is supported by positive Phase 3 CheckMate -67T trial results. The formulation was previously approved in the U.S. on December 27, 2024 under the brand name Opdivo Qvantig.
Positive
- CHMP positive opinion received for subcutaneous Opdivo with ENHANZE technology
- FDA approval already secured in December 2024
- Expands application of ENHANZE technology across multiple solid tumor indications
Negative
- None.
Insights
Halozyme's announcement of Bristol Myers Squibb receiving a positive CHMP opinion for subcutaneous Opdivo utilizing ENHANZE® technology represents a significant commercial advancement for Halozyme's drug delivery platform. This recommendation encompasses multiple solid tumor indications and builds upon the December 2024 FDA approval of Opdivo Qvantig in the U.S.
This development validates Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) platform as a facilitator for subcutaneous administration of traditionally intravenous biologics. For Halozyme, each commercial implementation of ENHANZE typically generates tiered royalties on net sales plus potential milestone payments, though specific financial terms for this particular agreement weren't disclosed.
The subcutaneous formulation offers substantial clinical advantages including reduced administration time compared to IV infusions, potentially expanding Opdivo's competitive positioning against rival checkpoint inhibitors. With European Commission approval expected by June 2, 2025, this represents a near-term potential revenue catalyst for Halozyme.
Bristol Myers Squibb's Phase 3 CheckMate -67T trial provided the efficacy and safety data supporting this recommendation, suggesting the subcutaneous formulation maintained Opdivo's therapeutic profile while offering administration benefits. For Halozyme, this advancement bolsters its technology's commercial viability in high-value oncology applications while potentially reducing healthcare resource utilization – a key selling point for future ENHANZE partnerships.
A decision on the European marketing authorization extension for the subcutaneous formulation of Opdivo is expected by June 2, 2025
The CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union. A decision on the European extension of marketing authorization for the subcutaneous formulation of Opdivo is expected by June 2, 2025.
"We are delighted that the subcutaneous formulation of Opdivo developed with Halozyme's ENHANZE drug delivery technology was recommended for approval in the European Union. Subcutaneous delivery of Opdivo would provide cancer patients a faster and more flexible treatment option and may help alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme.
The CHMP positive opinion is supported by positive results from the Phase 3 CheckMate -67T trial. For more information on the study and its findings, please view Bristol Myers Squibb's press release issued on March 28, 2025.
On December 27, 2024, nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, was approved by the
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 one million patient lives in post-marketing use in nine 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 Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in
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 alleviating pressure on healthcare system resources, facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indications referred to in this press release. Forward-looking statements may also include statements regarding the product development efforts of Halozyme's ENHANZE® partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation referred to in this press release and the timing of such potential approval. 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 "expect," "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 the extension of marketing authorization for the subcutaneous formulation referred to in this press release is delayed or ultimately approved, unexpected results or delays in the launch or commercialization of our partner's product for the indications referred to in this press release, unexpected adverse events or patient experiences or 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.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
FAQ
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