ENHANZE® Drug Delivery Technology

Inspiring New Possibilities

ENHANZE technology helps break through subcutaneous volume limitations to facilitate rapid high-dose, high-volume subcutaneous drug delivery.

Improved Patient ExperienceHealth Systems EfficienciesOptimized Product Profile

Our ENHANZE technology is based on our patented recombinant human hyaluronidase PH20 enzyme, rHuPH20, which locally degrades hyaluronan (HA) in the subcutaneous (SC) space temporarily removing a barrier to fluid flow. This allows for large volume SC injection with increased dispersion and absorption of co-administered therapies.

Potential Benefits of Co-Formulation With ENHANZE Technology

Large volume injections may allow some biologics and small molecule drugs that are administered intravenously to be delivered subcutaneously, opening the door to potential benefits for patients, healthcare systems and manufacturers.

To review ENHANZE technology clinical data and published articles, email enhanze@halozyme.com

Five products have received regulatory approvals in the United States and/or global markets as subcutaneous products utilizing ENHANZE® drug delivery technology and are marketed by the following companies:

  • Darzalex FASPRO®(daratumumab and hyaluronidase – fihj): Janssen
  • Herceptin®(trastuzumab): Roche. Marketed as Herceptin Hylecta SC (trastuzumab and hyaluronidose-oysk) (US) and Herceptin® SC (trastuzumab subcutaneous) in Europe
  • HYQVIA® (Immune Globulin Infusion 10%): Takeda
  • Phesgo(pertuzumab and trastuzumab): Roche
  • Rituxan®/MabThera®(rituximab): Roche. Marketed as RITUXAN HYCELA(rituximab/hyaluronidase human) (US) and MabThera® SC (rituximab subcutaneous) (EU)

ENHANZE® by the Numbers

500000

Patient Lives Touched (and More Every Day)

5

Commercialized Products

100+

Global Markets

Partners

Commercially Validated and Globally Approved

With ENHANZE technology, it’s possible to break through traditional subcutaneous limitations and rapidly deliver high-dose, high-volume therapeutics to the patients who need it in the clinic or at home.

ENHANZE technology is commercially validated to facilitate the subcutaneous administration of five approved therapeutics.

  • Darzalex FASPRO® (daratumumab and hyaluronidase – fihj) injection for subcutaneous use (US) / DARZALEX® SC (daratumumab) (International)
  • Herceptin Hylecta (trastuzumab and hyaluronidose-oysk) (US) / Herceptin® SC (trastuzumab subcutaneous) (International)
  • HYQVIA® (Immune Globulin Infusion 10%)
  • Phesgo® (pertuzumab/trastuzumab/hyaluronidase-zzxf) subcutaneous injection
  • Rituxan Hycela® (rituximab/hyaluronidase human) (US) / MabThera®(rituximab) (International)

Additionally, we continue to increase the number of products in development through our collaborations with leading pharmaceutical and biotechnology companies, including Abbvie, Alexion, argenx, Baxalta, Bristol-Myers Squibb, Horizon, Janssen, Lilly, Pfizer, Roche and ViiV Healthcare.

 
  • Bristol Myers Squibb
  • Janssen
  • Lilly
  • Abbvie
  • Alexion
  • argenx
  • Pfizer
  • Takeda
  • Horizon
  • ViiV Healthcare
  • Roche

Are you interested in learning more about our partnerships and business development opportunities? Contact bd@halozyme.com.

Inspiring New Options

Partner Pipeline

ENHANZE technology is globally validated and is used in five approved therapeutics providing subcutaneous administration, with additional products currently in development.

Wave 1

Products Approved 2013-2018

Herceptin® SC

HER2+ Early Breast Cancer (US & EU)

Approved

Roche

Rituxan HYCELA / MabThera® SC

Multiple Blood Cancers

Approved

Roche

HYQVIA®

Primary & Secondary Immunodeficiency

Pediatric PID, CIDP, MMN

Approved

Takeda

Approved

Roche

Approved

Roche

Approved

Takeda

Wave 2

Products Approved in 2020

DARZALEX FASPRO®/DARZALEX® SC

Multiple Myeloma, AL Amyloidosis

Multiple Myeloma

Approved

Janssen

Phesgo™

HER2+ Early Breast Cancer (US & EU)

Approved

Roche

Approved

Janssen

Approved

Roche

Wave 3

Potential approval target 2023-2025

Atezolizumab

Non-small Cell Lung Cancer

Phase 3

Roche

Efgartigimod

Pemphigus vulgaris

Phase 3

argenx

Efgartigimod

Chronic Inflammatory Demyelinating Polyneuropathy

Phase 3

argenx

Efgartigimod

Immune Thrombocytopenia

Phase 3

argenx

Efgartigimod

Myasthenia Gravis

Phase 3

argenx

NIVOLUMAB

Clear Cell Renal Cell Carcinoma

Phase 3

Bristol Myers Squibb

Phase 3

Roche

Phase 3

argenx

Phase 3

argenx

Phase 3

argenx

Phase 3

argenx

Phase 3

Bristol Myers Squibb

Wave 4

Potential approval target 2025-2027

Anti-CD73

Solid Tumors

Phase 1

Bristol Myers Squibb

Anti-TIM3

Solid Tumors

Phase 1

Bristol Myers Squibb

ARGX-117

Multifocal Motor Neuropathy

Phase 1

argenx

CAP256V2LS

HIV (vaccine)

Phase 1

Caprisa

N6LS bnAb

HIV (treatment)

Phase 1

NIAID Vaccine Research Center (VRC)

Nivolumab+Relatlimab

Solid Tumors

Phase 1

Bristol Myers Squibb

Ocrelizumab

Multiple Sclerosis

Phase 1

Roche

Teprotumumab-trbw

Thyroid Eye Disease

Phase 1

Horizon

UNDISCLOSED

Undisclosed

Phase 1

Undisclosed

UNDISCLOSED

Undisclosed

Phase 1

Undisclosed

Phase 1

Bristol Myers Squibb

Phase 1

Bristol Myers Squibb

Phase 1

argenx

Phase 1

Capirsa

Phase 1

NIAID Vaccine Research Center (VRC)

Phase 1

Bristol Myers Squibb

Phase 1

Roche

Phase 1

Horizon

Phase 1

Undisclosed

Phase 1

Undisclosed

As of August 9, 2021

Publications

The content below contains information on investigational products and uses that have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of development programs and should not be construed as conclusions of efficacy, safety, or future approval of any product.

About rHuPH20

Halozyme’s primary technology is based on its proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) that degrades hyaluronan, or HA. HA is a glycosaminoglycan, a chain of natural sugars that is a component of normal tissue, such as skin and cartilage.

The effects of rHuPH20 are local and transient. By degrading HA, rHuPH20 facilitates the dispersion and absorption of other drugs and fluids that are injected under the skin.

HA IN THE SUBCUTANEOUS SPACE

What is Hyaluronan?

Hyaluronan (HA) is a megadalton polymeric glycosaminoglycan made up of repeating disaccharide subunits of N-acetylglucosamine and glucuronic acid. It is found in most tissues and body fluids of vertebrates, but is most abundant in the extracellular matrix of connective tissues. High concentrations of HA can be found in tissues, such as the skin, umbilical cord, synovial fluid and vitreous humour. HA is rapidly turned over in normal skin with a half-life of less than two days, but relatively constant levels are maintained by similar rates of synthesis and degradation.

In skin, HA fills the interstitial space within the collagenous matrix and acts as a physical barrier to bulk fluid flow in the subcutaneous space. It does this by binding up to 15 water molecules per disaccharide subunit forming a viscous gel-like fluid. This gel-like HA limits fluid flow in the subcutaneous space, acts as a lubricant in other compartments, such as the synovial fluid within joints, and functions as a viscoelastic cushion to protect tissues and joints. In addition, HA may be involved in various receptor-mediated cell signaling events with proposed roles in areas, such as cell detachment, wound healing, cell migration, inflammation, and tumor development.