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Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that Takeda received FDA approval for HYQVIA® co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. HYQVIA® is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase for subcutaneous immunoglobulin (SCIG) infusion. The treatment can be administered by a healthcare professional in various settings and can also be self-administered after training.
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The FDA approval of HYQVIA® for chronic inflammatory demyelinating polyneuropathy (CIDP) represents a significant development in the treatment landscape for this rare neurological disorder. The utilization of Halozyme's ENHANZE® technology in this formulation underscores the growing trend towards innovative drug delivery systems aimed at improving patient outcomes and convenience. The technology facilitates the dispersion and absorption of large volumes of immunoglobulin directly into the subcutaneous space, potentially reducing the frequency of infusions needed for effective maintenance therapy.

This approval could lead to increased demand for HYQVIA®, which would positively impact Halozyme's revenue streams. The market for CIDP treatments is relatively niche due to the rarity of the condition, but the approval for an additional indication broadens the potential patient base for HYQVIA®. The ability to administer the drug subcutaneously and the option for home infusion may offer competitive advantages over intravenous treatments, potentially leading to market share gains.

The FDA's endorsement of HYQVIA® for CIDP maintenance therapy is a pivotal moment not only for Halozyme and Takeda but also for the broader healthcare market. It exemplifies the FDA's support for treatments that enhance patient quality of life through less invasive administration methods. The approval could stimulate further research and development in facilitated subcutaneous immunoglobulin (SCIG) therapies, a market that is expected to grow with the rising prevalence of autoimmune diseases and the aging population.

From a business perspective, this news could positively affect Halozyme's stock valuation in the short term due to investor optimism about expanded market opportunities. In the long term, sustained sales growth will depend on the adoption rate among healthcare providers and patient preference for this treatment modality over existing therapies. It's crucial to monitor post-approval commercialization efforts and payer coverage decisions, as these will play a significant role in determining the financial impact of this approval on Halozyme's performance.

The announcement of FDA approval for a new indication of an existing drug typically triggers a positive response in the stock market for the involved companies. For Halozyme, this approval could potentially enhance the company's valuation, as it diversifies the application of its proprietary ENHANZE® technology and demonstrates its successful partnership with Takeda. The financial implications hinge on the ability of Halozyme to capitalize on this approval through royalties or revenue-sharing agreements with Takeda.

Investors will be keenly observing the impact of this approval on Halozyme's future earnings reports, particularly looking for increases in revenue and potential upward revisions of sales forecasts. It's also important to consider the competitive landscape and pricing strategies, as these will influence the market uptake of HYQVIA® for CIDP. The long-term financial success will be contingent upon the sustained demand for the drug and the management's ability to navigate market challenges, including competition from other treatments and insurance reimbursement policies.

SAN DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. HYQVIA® was first granted FDA approval in 2014 for the treatment of primary immunodeficiency (PI) in adults, which has since been expanded to include children 2-16 years old.1 

HYQVIA® is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin (SCIG) infusion. For adults with CIDP, HYQVIA® can be infused up to once monthly (every two, three or four weeks) due to ENHANZE®, which facilitates the dispersion and absorption of large IG volumes in the subcutaneous space. Because it is delivered subcutaneously, HYQVIA® can be administered by a healthcare professional in a medical office, infusion center or at a patient's home. In addition, it can be self-administered after appropriate patient or caregiver training.1

"We are pleased that Takeda continues to expand the indications for HYQVIA®, providing a new personalized maintenance treatment option for adult patients with CIDP," said Dr. Helen Torley, president and chief executive officer of Halozyme.

For Full U.S. Prescribing Information, please visit:
https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf

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 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 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 HYQVIA® . 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 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

References

1 HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] U.S. Prescribing Information.

Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.) (PRNewsfoto/Halozyme Therapeutics, Inc.)

 

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SOURCE Halozyme Therapeutics, Inc.

The FDA approved HYQVIA® co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

HYQVIA® is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase for subcutaneous immunoglobulin (SCIG) infusion.

HYQVIA® can be administered by a healthcare professional in a medical office, infusion center, or at a patient's home. It can also be self-administered after appropriate training.
Halozyme Therapeutics Inc.

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About HALO

we are a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapies that target the tumor microenvironment. our lead proprietary program, investigational drug pegph20, applies a unique approach to targeting solid tumors, potentially providing increased tumor access for co-administered cancer therapies. by breaking down potential barriers to cancer, pegph20 may help make existing treatments more effective by allowing therapies to reach the tumor. we are built on a foundation of value-driving partnerships with leading pharmaceutical companies including, roche, pfizer, janssen, baxalta, abbvie and lilly, for our enhanze™ drug delivery technology platform, which enables biologics and small molecule compounds currently administered intravenously to be delivered subcutaneously. this technology may also allow for more rapid delivery of therapies that are already delivered subcutaneously. we are a diverse team, who are committed to bringing therapies