Halozyme Wins Preliminary Injunction Against Merck's Keytruda SC in Germany

SAN DIEGO, Dec. 4, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme), announced today that a German court has granted its request for a preliminary injunction ordering Merck to refrain from distributing and offering Keytruda SC in Germany.

The Munich Regional Court's 7th Civil Division found that there is imminent infringement for Keytruda SC in Germany regarding one of Halozyme's MDASE™ patents in Europe, European Patent No. 2 797 622 (EP 622). As a consequence, Merck's launch activities for Keytruda SC in Germany that are within the scope of the order must be halted. Although the preliminary injunction decision is appealable, Halozyme believes the order will withstand attack if appealed. Separate nullity proceedings against this patent initiated by Merck in August 2025 are pending before the German Federal Patent Court.

Importantly, patients who want to use Keytruda will have access to the IV version of Keytruda, which is not covered by Halozyme's patent or the court's injunction order.

"We are very pleased the German court followed our arguments on the validity and infringement of one of our European MDASE patents and granted a preliminary injunction against Merck's imminent infringement of our patent. The MDASE technology was developed through years of rigorous research to enable rapid, high-volume subcutaneous drug delivery," said Mark Snyder, chief legal officer of Halozyme. "We are committed to vigorously defending and enforcing our MDASE patents and are confident that we will prevail at trial."

The German proceedings are part of Halozyme's global enforcement of its MDASE™ patents against infringement by Merck's Keytruda SC. Halozyme has also sued Merck for patent infringement in U.S. federal district court in New Jersey. In that case, Halozyme alleges the subcutaneous formulation of Keytruda, which is being marketed in the U.S. as QLEX, infringes 15 patents that Halozyme filed beginning in 2011 to protect its MDASE™ technology. The patents at issue arise from Halozyme's extensive research into nearly 7,000 modifications to human hyaluronidases. Among their uses, these hyaluronidases pioneered by Halozyme provide a mechanism for the rapid SC administration of therapeutic drugs. Halozyme's comprehensive studies and innovations were a significant advancement to the field of human-derived hyaluronidases.

The MDASE™ patents are not included in Halozyme's ENHANZE^® licensing program and are distinct from its ENHANZE^® patents. Therefore, the outcome of the infringement lawsuit against Merck will not impact ENHANZE^®, the ability of any licensee to use ENHANZE^®, or revenues Halozyme receives from ENHANZE^® licensees.

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 facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE^® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V.

Halozyme is also developing Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyper concentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson, Eli Lilly, and argenx.

Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex^® and XYOSTED^®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.

Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. 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 Halozyme's ENHANZE^® and MDASE™ drug delivery technologies, the possible method of action of these technologies, their potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of these technologies including facilitating more rapid delivery of high-volume injectable medications through subcutaneous delivery and potentially easing the treatment burden for patients and improving patient outcomes. These forward-looking statements include statements with respect to the decision of the Munich Regional Court's 7th Civil Division to issue a preliminary injunction against Keytruda SC in Germany, any appeal of the preliminary injunction, nullity proceedings, and statements with respect to the strength and validity of Halozyme's intellectual property. These forward-looking statements also include statements with respect to Halozyme's patent infringement suit against Merck Sharp & Dohme, Corp., to enforce Halozyme's patent rights, including Halozyme's allegation that Merck's SC Keytruda infringes multiple Halozyme patents and Halozyme's belief that the outcome of the lawsuit will not impact its ENHANZE^® licensing program or the revenues Halozyme receives from ENHANZE^® licensees. These forward-looking statements involve risks and uncertainties beyond Halozyme's control 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 and Halozyme can offer no assurance with respect to such forward-looking statements and cautions the reader not to place undue reliance on these forward-looking statements. In particular, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. Actual results could also differ materially from expectations contained in this press release as a result of other risks and uncertainties including those related to future decisions by the courts in Germany with respect to the preliminary injunction referred to in this press release, the strength, enforceability and validity of our patents, future revenues and the cost of litigation. These and other factors that may result in material differences from the forward-looking statements contained in this press release 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
[email protected]

Paul Gallagher
Teneo
917-573-5051
[email protected]

SOURCE Halozyme Therapeutics, Inc.