Halozyme Announces Roche's OCREVUS® SC with ENHANZE® Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis
Halozyme announced that the European Commission has approved Roche's OCREVUS® SC, co-formulated with Halozyme's ENHANZE® enzyme, for treating relapsing and primary progressive multiple sclerosis. This new subcutaneous injection offers a 10-minute administration alternative to the traditional intravenous infusion, maintaining the same twice-yearly schedule. The approval is based on Phase III OCARINA II trial data, demonstrating comparable efficacy and safety between the SC and IV formulations. This new option aims to improve patient accessibility and treatment flexibility.
- European Commission approval for OCREVUS® SC enhances market presence.
- The 10-minute SC injection offers a significant time-saving benefit over IV infusions.
- Phase III OCARINA II trial showed comparable efficacy and safety to the IV formulation.
- Enhanced flexibility for treatment administration both in-clinic and outside clinic settings.
- None.
Insights
The European Commission's approval of Roche's OCREVUS® SC with ENHANZE® marks a significant development in the treatment of multiple sclerosis (MS). The key innovation here is the shift from intravenous (IV) infusion to subcutaneous (SC) injection. This change reduces the administration time from several hours to just 10 minutes, potentially increasing patient compliance and overall quality of life.
From a clinical standpoint, the approval is supported by data from the Phase III OCARINA II trial, which demonstrated non-inferior blood levels of OCREVUS® and a comparable safety and efficacy profile to the IV formulation. This suggests that the SC version is not only effective but also maintains a similar safety profile, which is important for long-term treatment adherence.
The new administration method also allows for greater flexibility in treatment settings, moving beyond traditional clinical environments and into more accessible locations. This can significantly ease the burden on healthcare systems, particularly in regions with limited medical infrastructure.
The approval of OCREVUS® SC with ENHANZE® by the European Commission is poised to bring notable shifts in the MS treatment market. By reducing the need for IV facilities and shortening administration time to just 10 minutes, the new formulation offers substantial convenience and cost savings. This can potentially capture a larger market share by appealing to both patients and healthcare providers.
Financially, this development is promising for Halozyme as it leverages its ENHANZE® technology. The recurring revenue from royalties and milestone payments could positively impact the company's financials. For Roche, it strengthens its already robust portfolio in the MS market, potentially driving higher sales volumes due to the increased convenience of the SC formulation.
Additionally, the approval reflects positively on Europe's regulatory environment, signaling a willingness to embrace innovative treatments that can improve patient outcomes and healthcare efficiency.
From an investment perspective, Halozyme's announcement of the European Commission's approval of OCREVUS® SC with ENHANZE® could be a positive catalyst for the company’s stock. The key financial takeaway is the potential for increased revenue through enhanced market penetration and new royalty streams from Roche.
Moreover, timing the announcement ahead of quarterly results could help boost investor sentiment, potentially driving stock price appreciation. However, investors should also consider the competitive landscape in the MS treatment market and the existing alternatives which may impact the long-term financial prospects.
Overall, the approval underscores Halozyme's innovative capabilities and strategic partnerships, positioning the company for sustained growth and profitability in the biopharmaceutical sector.
OCREVUS® subcutaneous (SC) injection offers a new 10-minute administration with comparable efficacy and safety to intravenous (IV) infusion
Provides an additional treatment option without the need for IV facilities, expanding accessibility for patients
OCREVUS® SC is a 10-minute injection that maintains the same twice-yearly schedule as the approved IV infusion. The SC injection was designed to be administered by healthcare professionals, with the flexibility to be administered either in the clinic or in settings outside the clinic.
"With OCREVUS SC, multiple sclerosis patients in the EU can now have their medicine administered in just 10 minutes, twice per year, and without the need for an IV facility," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This creates enhanced flexibility for both patients and providers and represents another example of how Halozyme's breakthrough technologies help to create improved treatment options."
The EC 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 IV formulation in patients with RMS and PPMS. OCREVUS® SC was well tolerated, and no new safety concerns were identified.
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 reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven 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
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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's ENHANZE® drug delivery technology including the possible 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, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE® including lowering the treatment burden for patients and alleviating pressure on health care system resources, including potential out-of-hospital administration of OCREVUS® SC. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts (including anticipated regulatory submissions, PDUFA dates, potential regulatory approvals, indications and product launches). These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered products, 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 the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company 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
609-359-3016
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® SC and for what conditions has it been approved?
What is the administration time for OCREVUS® SC compared to the IV infusion?
How does the efficacy and safety of OCREVUS® SC compare to the IV formulation?
What is the significance of the European Commission's approval of OCREVUS® SC for Halozyme?
What technology does Halozyme's ENHANZE® enzyme use in OCREVUS® SC?
