Halozyme Announces argenx Received Approval in Japan for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Co-Formulated with ENHANZE® for Generalized Myasthenia Gravis
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Insights
The approval of VYVDURA® by Japan's Ministry of Health, Labour and Welfare represents a significant milestone for Halozyme Therapeutics, potentially impacting its market share and revenue in the Japanese pharmaceutical market. The ability for patients to self-administer the medication at home could lead to increased patient adherence and satisfaction, which are critical factors in the success of chronic disease treatments.
Moreover, the incorporation of Halozyme's ENHANZE® drug delivery technology in VYVDURA® may set a precedent for future partnerships and licensing agreements with other pharmaceutical companies aiming to improve the delivery and efficacy of their drugs. This could be a key driver of Halozyme's long-term growth and diversification of its revenue streams.
The clinical relevance of VYVDURA® lies in its demonstrated efficacy through the ADAPT-SC study, which showed a comparable reduction in IgG levels to the intravenous form, VYVGART® IV. For stakeholders, this approval could mean a broader range of treatment options for patients with generalized myasthenia gravis, a market that is relatively underserved. The self-administration aspect may also reduce healthcare costs associated with hospital administration and potentially improve the quality of life for patients.
It's important to note that the efficacy of VYVDURA® as a subcutaneous formulation could attract attention from the medical community, as it offers a less invasive option compared to intravenous treatments. This could lead to an increase in its adoption and recommendation by healthcare professionals.
From a financial perspective, the approval of VYVDURA® in Japan is likely to have a positive impact on Halozyme's stock performance in the near term. The expansion into the Japanese market, which is one of the largest pharmaceutical markets globally, opens up a new revenue channel for Halozyme. Investors should monitor the uptake of VYVDURA® post-launch, as it will be indicative of the drug's market potential and the effectiveness of Halozyme's commercial strategy.
Additionally, the cost-effectiveness of self-administration could be a competitive advantage in pricing negotiations with healthcare providers and insurers, which may lead to favorable reimbursement scenarios. However, investors should also consider the potential for market competition and regulatory changes that could influence Halozyme's market position and profitability.
VYVDURA® provides patients with option for self-administration
"We are pleased that argenx continues to expand its global reach of ENHANZE-enabled subcutaneous VYVGART to
The approval of VYVDURA® is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVDURA® by demonstrating a reduction in percent change from baseline in total immunoglobulin G (IgG) levels comparable to VYVGART® IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART® in
VYVDURA® is the brand name in
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to 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, AbbVie, Eli Lilly, Bristol Myers Squibb, Alexion, argenx, Horizon Therapeutics, 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 technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including Hylenex® and XYOSTED® and 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 self-administration of VYVDURA® . 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, potential regulatory approvals, indications and product launches). These 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 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 Reports on Form 10-Q filed with the Securities and Exchange Commission.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
617-877-9710
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
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