Halozyme and Acumen Pharmaceuticals Enter Global Collaboration and Non-Exclusive License Agreement for the ENHANZE® Technology in Alzheimer's Disease

Rhea-AI Summary

Halozyme Therapeutics announces a collaboration and license agreement with Acumen Pharmaceuticals for the use of their ENHANZE® drug delivery technology in the development of ACU193, a monoclonal antibody candidate for the treatment of early Alzheimer's disease. Acumen will make upfront and milestone payments to Halozyme, and Halozyme will receive royalties on net sales of commercialized medicines with the ENHANZE® technology.

Positive

• Acumen's positive Phase 1 results for ACU193 and its Fast Track designation by the FDA demonstrate its potential as a treatment for early Alzheimer's disease.
• The collaboration with Acumen expands Halozyme's ENHANZE® technology to its thirteenth license partner, further establishing its presence in the market.
• The Alzheimer's disease market is large and expanding, with over 55 million people suffering from dementia worldwide and Alzheimer's disease accounting for 60-70% of cases.

Negative

• None.

Acumen represents thirteenth license partner for ENHANZE^®

Alzheimer's disease is a large and expanding market opportunity

SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced a global collaboration and non-exclusive license agreement with Acumen Pharmaceuticals that provides Acumen access to Halozyme's ENHANZE^® drug delivery technology, a proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) for rapid subcutaneous drug delivery, for a single target. Acumen intends to explore the potential use of ENHANZE^® for ACU193, Acumen's clinical-stage monoclonal antibody (mAb) candidate to target Amyloid-β Oligomers (AβOs) for the treatment of early Alzheimer's disease (AD).

Under the terms of the agreement, Acumen will make an upfront payment to Halozyme, and potential future milestone payments related to development progress, regulatory approvals, and sales attainment. Halozyme will also be entitled to single digit royalties on net sales of commercialized medicines with the ENHANZE^® technology.

This partnership presents an exceptional opportunity to provide additional treatment options to patients with Alzheimer's disease. According to the World Health Organization, over 55 million people suffer from dementia worldwide, and Alzheimer's disease can be attributed to 60-70% of cases.

Acumen reported positive Phase 1 results that demonstrated ACU193 was generally well-tolerated with a compelling overall safety profile, meeting the primary objective of its first-in-human, randomized, double-blind, placebo-controlled study in both single and multiple doses in patients with early AD. ACU193 has been granted Fast Track designation for the treatment of early Alzheimer's disease by the U.S. Food and Drug Administration.

"Our collaboration with Acumen for ENHANZE reinforces our commitment to provide innovative solutions to improve the patient treatment experience, particularly for such a challenging disease in a large patient population," said Dr. Helen Torley, president and chief executive officer. "We share Acumen's view that the Alzheimer's disease treatment paradigm is at a key inflection point with recent and expected approvals paving a new path for treatment. We appreciate the opportunity to enter this market and look forward to supporting the development of ACU193 to emerge as a potential treatment of choice."

This deal marks Halozyme's thirteenth global collaboration and license partner for the ENHANZE^® technology. These collaborations cover more than 60 therapeutic targets and include seven commercialized products to date.

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^® drug delivery 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 700,000 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 XYOSTED^® and TLANDO^® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical 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 and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development and commercialization efforts of Halozyme's ENHANZE^® partner (including the potential regulatory approval and launch of ENHANZE^® products as a result of such efforts and the potential future market opportunity for such products) and Halozyme's potential receipt of an upfront payment and payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products. 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 "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 risks that the clinical trial results may not be replicated, uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized and the potential future market for such products, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected 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 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

Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com

Shannia Coley
CG Life
443-471-6830
scoley@cglife.com

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SOURCE Halozyme Therapeutics, Inc.

What is the collaboration between Halozyme Therapeutics and Acumen Pharmaceuticals?

Halozyme has entered into a collaboration and license agreement with Acumen Pharmaceuticals to provide Acumen access to their ENHANZE® drug delivery technology for the development of ACU193, a monoclonal antibody candidate for early Alzheimer's disease.

What is ENHANZE® drug delivery technology?

ENHANZE® is Halozyme's proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) that enables rapid subcutaneous drug delivery.

What are the financial terms of the agreement?

Acumen will make an upfront payment to Halozyme and potential future milestone payments. Halozyme will receive single digit royalties on net sales of commercialized medicines with the ENHANZE® technology.

What are the potential benefits of ACU193 for Alzheimer's disease?

Positive Phase 1 results and Fast Track designation by the FDA indicate the potential of ACU193 as a treatment for early Alzheimer's disease.

How large is the Alzheimer's disease market?

According to the World Health Organization, over 55 million people suffer from dementia worldwide, with Alzheimer's disease accounting for 60-70% of cases.