Halozyme Announces Takeda Received Regulatory Approval for HYQVIA® 10% Subcutaneous Injection Set with ENHANZE® in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced that Takeda received regulatory approval from Japan's MHLW for HYQVIA®, a combination therapy using Halozyme's ENHANZE® technology, for patients with agammaglobulinemia or hypogammaglobulinemia.

HYQVIA® is Japan's first plasma-derived subcutaneous therapy combining Immunoglobulin 10% with Recombinant Human Hyaluronidase PH20. The therapy allows for reduced dosing frequency (every 3-4 weeks) compared to conventional treatments (weekly/bi-weekly).

The approval is based on two Phase 3 studies in Japan involving 16 patients aged 2+ years. The trials showed maintained IgG trough levels of 9.494g/L, comparable to traditional treatments. Main adverse reactions included pyrexia (31.3%) and various injection site reactions (12.5%).

Positive

• First approved plasma-derived subcutaneous therapy of its kind in Japan
• Reduces dosing frequency from weekly/bi-weekly to every 3-4 weeks
• Clinical trials demonstrated maintained efficacy comparable to traditional treatments

Negative

• Significant adverse reactions reported: pyrexia in 31.3% of patients
• trial size of only 16 patients in Japanese studies

Insights

Pharmaceutical Market Analyst

The Japanese approval of HYQVIA® with ENHANZE® technology represents a significant market expansion for Halozyme, opening access to Japan's $3.5 billion immunoglobulin market. The reduced dosing frequency (every 3-4 weeks vs. weekly/bi-weekly) provides a compelling competitive advantage. The efficacy data showing comparable IgG trough levels to existing treatments, combined with manageable safety profile (31.3% pyrexia as main side effect), positions HYQVIA® favorably. This approval should drive incremental royalty revenue through Takeda's commercialization, supporting Halozyme's recurring revenue model. For context, subcutaneous administration represents roughly 20% of the global IG market, suggesting meaningful revenue potential in Japan's mature healthcare market.

Medical Research Analyst

The clinical significance of this approval lies in addressing a critical unmet need in immunodeficiency treatment. The ENHANZE® technology's ability to facilitate larger volume subcutaneous infusions translates to practical benefits: reduced treatment burden through less frequent dosing while maintaining therapeutic IgG levels (9.494g/L vs 9.624g/L baseline). The safety profile appears manageable, with mostly mild-to-moderate injection site reactions. The approval encompassing both primary (PID) and secondary immunodeficiency (SID) expands the addressable patient population. Think of ENHANZE® as a "molecular highway" that allows better distribution of medication under the skin - a simple concept with profound clinical implications.

Regulatory Affairs Expert

The MHLW approval, supported by robust Phase 3 data from both Japanese and North American trials, demonstrates strong regulatory execution. The inclusion of pediatric patients (≥2 years) in the approval scope is particularly valuable for market access. Japan's regulatory framework typically requires local clinical data and the successful completion of two Japanese studies (NCT05150340, NCT05513586) with positive outcomes strengthens Halozyme's regulatory track record. This approval validates ENHANZE® technology's safety profile in a stringent regulatory environment, potentially expediting future applications for other ENHANZE®-enabled products in Japan.

SAN DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Takeda received regulatory approval for HYQVIA^® [Immune Globulin Infusion 10% (Human) with Halozyme's Recombinant Human Hyaluronidase] by the Japanese Ministry of Health, Labour and Welfare (MHLW) for patients with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID).

HYQVIA^® is the first plasma-derived therapy for subcutaneous injection in Japan that consists of a combination of one vial of Immunoglobulin 10% and one vial of Recombinant Human Hyaluronidase PH20 (rHuPH20), which is Halozyme's ENHANZE^® drug delivery technology. The administration of ENHANZE^® increases the dispersion and absorption of immunoglobulin (IG) in the subcutaneous tissue, allowing larger volumes to be infused in the infusion site. This allows for less frequent dosing compared to other subcutaneous IG products, while avoiding the need for venous access. The ability to infuse a larger infusion volume is expected to increase administration flexibility for patients with agammaglobulinemia or hypogammaglobulinemia by decreasing the dosing frequency to once every 3 or 4 weeks, as compared to weekly or bi-weekly with conventional SCIG treatments.

"We are very pleased that patients in Japan with agammaglobulinemia or hypogammaglobulinemia can now access HYQVIA, which represents the first and only subcutaneous immunoglobulin therapy that offers the potential of a reduced dosing frequency," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We appreciate the opportunity to continue to provide patients with more flexible treatment options with our innovative drug delivery technology."

The MHLW approval is based on data from two pivotal Phase 3, open-label, non-controlled studies evaluating the efficacy, safety, tolerability and pharmacokinetics in Japanese subjects with PID (NCT05150340, NCT05513586). In these studies, the efficacy and safety profile of HYQVIA^® in 16 patients aged 2 years or older in Japan were evaluated based on the results of the clinical trials. The Geo Mean of IgG trough level at the last 3 visits was 9.494g/L and was maintained at level comparable to treatment with intravenous or subcutaneous immunoglobulin (Geo Mean of IgG trough level 9.624g/L). The major adverse reactions were pyrexia 5 patients (31.3%) and infusion site erythema, injection site erythema, infusion site swelling, infusion site pain, and headache (12.5%)1. Data from two Phase 3 clinical trials conducted in patients with PID in North America (NCT00814320, NCT01175213) was also included in the submission.

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 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 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 larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including less frequent dosing and offering flexibility to receive treatment in more convenient locations 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 "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 unexpected results or delays in launch or commercialization of our partner's product for the indication 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
609-359-3016
tbui@halozyme.com

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

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is the significance of HYQVIA's approval in Japan for Halozyme (HALO)?

HYQVIA's approval represents the first plasma-derived subcutaneous therapy in Japan using Halozyme's ENHANZE technology, expanding their market presence and providing a new treatment option with reduced dosing frequency.

What are the key advantages of HYQVIA over conventional treatments?

HYQVIA allows for less frequent dosing (every 3-4 weeks vs weekly/bi-weekly), larger infusion volumes, and eliminates the need for venous access while maintaining comparable efficacy.

What were the efficacy results from HYQVIA's Japanese clinical trials?

The trials showed a Geo Mean IgG trough level of 9.494g/L, comparable to traditional treatments (9.624g/L), demonstrating maintained efficacy in Japanese patients.

What are the main side effects reported in HYQVIA's Japanese trials?

The main adverse reactions included pyrexia in 31.3% of patients and injection site reactions (erythema, swelling, pain) and headache in 12.5% of patients.