ENHANZE® Drug Delivery Technology
Bristol Myers Squibb
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
600000
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.
Are you interested in learning more about our partnerships and business development opportunities? Contact bd@halozyme.com
Wave 1
Products Approved 2013-2018
Herceptin® SC
HER2+ Early Breast Cancer (US & EU)
Roche
Rituxan HYCELA™ / MabThera® SC
Multiple Blood Cancers
Roche
HYQVIA®
Primary & Secondary Immunodeficiency
Pediatric PID, CIDP, MMN
Takeda
Roche
Roche
Takeda
Wave 2
Products Approved in 2020
DARZALEX FASPRO®/DARZALEX® SC
Multiple Myeloma, AL Amyloidosis
Multiple Myeloma
Janssen
Phesgo™
HER2+ Early Breast Cancer (US & EU)
Roche
Janssen
Roche
Wave 3
Potential approval target 2023-2025
Efgartigimod
Pemphigus vulgaris
argenx
Efgartigimod
Chronic Inflammatory Demyelinating Polyneuropathy
argenx
Efgartigimod
Immune Thrombocytopenia
argenx
Efgartigimod
Myasthenia Gravis
argenx
NIVOLUMAB
Clear Cell Renal Cell Carcinoma
Bristol Myers Squibb
Atezolizumab
Non-small Cell Lung Cancer
Roche
argenx
argenx
argenx
argenx
Bristol Myers Squibb
Roche
Wave 4
Potential approval target 2025-2027
ARGX-117
Multifocal Motor Neuropathy
argenx
Nivolumab+Relatlimab
Solid Tumors
Bristol Myers Squibb
Anti-TIM3
Solid Tumors
Bristol Myers Squibb
CAP256V2LS
HIV (vaccine)
Caprisa
Teprotumumab-trbw
Thyroid Eye Disease
Horizon
UNDISCLOSED
Undisclosed
Undisclosed
Rilpivirine
HIV
Undisclosed
Ocrelizumab
Multiple Sclerosis
Roche
UNDISCLOSED
Undisclosed
Roche
TAK-881
Undisclosed
Takeda
Cabotegravir
HIV
ViiV Healthcare
N6LS BNAB
HIV (treatment)
NIAID Vaccine Research Center (VRC)
argenx
Bristol Myers Squibb
Bristol Myers Squibb
Capirsa
Horizon
Janssen
Janssen
Roche
Roche
Takeda
ViiV Healthcare
NIAID Vaccine Research Center (VRC)
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.
ENHANZE® Drug Delivery Technology
Other
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.