Delivering a Volume of Benefits...ENHANZE® drug delivery technology may enable and optimize...
Transcript of Delivering a Volume of Benefits...ENHANZE® drug delivery technology may enable and optimize...
Delivering a Volume of BenefitsENHANZE® drug delivery technology may enable and optimize subcutaneous (SC) drug delivery
for appropriate co-administered therapeutics, which may improve patient experiences,1,2 increase health system efficiencies,3-5 and optimize brand revenue.6
Enabling and Optimizing Subcutaneous Delivery
Patients Providers Payers Pharma
ENHANZE® drug delivery technology utilizes rHuPH20, Halozyme’s proprietary recombinant human
hyaluronidase PH20. rHuPH20 works locally and transiently to degrade hyaluronan (HA) in the
extracellular matrix (ECM) of the SC space. HA, a naturally occurring glycosaminoglycan found
throughout the body, creates resistance to bulk fluid flow in the ECM that limits large-volume
SC drug delivery, dispersion, and absorption.
By degrading HA in the ECM at the local injection site, rHuPH20 enables SC bulk fluid flow and
increased dispersion and absorption of co-administered therapeutics.
rHuPH20 is approved, sold, and/or reimbursed in 50+ countries through:
Products coformulated with ENHANZE® drug
delivery technology have received widespread
endorsements from healthcare system stakeholders:
RITUXAN HYCELA®
MABTHERA® SCRITUXAN® SC
HERCEPTIN® SC HYQVIA®
Discover the Opportunities With ENHANZE® Drug Delivery TechnologyDiscover the Opportunities With ENHANZE® Drug Delivery Technology
Optimization in Your HandsIncreasing Health System Efficiencies
Conversion from intravenous (IV) to SC delivery with ENHANZE® drug delivery
technology may potentially:
• Reduce administration and nursing time associated with IV delivery1,4,5
• Increase available chair time and patient throughput4,5
• Decrease healthcare costs and reduce patient management needs7
Optimizing Product Revenue
ENHANZE® drug delivery technology may enable revenue optimization for
coformulated therapeutics through:
• Lower cost of goods/decreased amount of drug product needed8
• Rapid post-launch adoption9
• Extended patent protection
Improving Patient Experiences
ENHANZE® drug delivery technology may enable an improved
patient experience by potentially:
• Reducing administration time and frequency1,2,10,11
• Reducing pain/discomfort1,2
• Reducing some side effects12
• Reducing induration (bleb formation)7,13
• Enabling at-home administration1,7,11
Discover the Opportunities With ENHANZE® Drug Delivery Technology
Discover the Opportunities With ENHANZE® Drug Delivery Technology
Guidance at Your FingertipsStreamlining the Drug Development Process
To help partners efficiently navigate the drug development process, comprehensive
services and SC expertise are provided by the Alliance Support team.
Alliance Support has a proven track record of streamlining development for
potential partners by enabling:
• Rapid entry into Phase 1 trials in less than 1 year after deal signing, on average9
• Collection of meaningful patient clinical trial data within 1 year thereafter9
• Potential regulatory approval in less than 5 years from first trial (HERCEPTIN® SC)9
Alliance Support spans the drug development process, from the preclinical stage
through commercialization, and includes:
• Formulation development assistance
• Clinical development strategy
• Comprehensive data packages
• Preclinical and clinical drug product
• Preclinical experiments and predictive modeling
• Regulatory expertise
Possibilities Within Your GraspOvercoming Drug Delivery Barriers
ENHANZE® drug delivery technology may help co-administered therapeutics overcome administration,
time, and volume barriers by potentially enabling:
• IV to SC administration conversion and SC delivery optimization13-15
• Shortened dose administration time, from hours to minutes
- HERCEPTIN® SC reduced administration time compared to IV-administered HERCEPTIN®, from
30-90 minutes to 2-5 minutes16,17
- RITUXAN HYCELA®/MABTHERA® SC/RITUXAN® SC reduced administration time compared to
IV-administered RITUXAN®, from as long as 4 hours to as few as 5-7 minutes18,19
• Reduced administration frequency (eg, from weekly to monthly), as well as decreased number
of injections/doses
- HYQVIA® is dosed in a single, monthly SC infusion, compared to weekly, multisite infusions
required for SC immunoglobulin formulated without rHuPH2011,20,21
• Large volumes for rapid SC injections (~ 2-20 mL)9,16,18 and even larger SC infusions (up to 600 mL)20
Improving PK Profiles
ENHANZE® drug delivery technology may enable potential improvements
to the pharmacokinetic (PK) profiles of co-administered drugs, including22,23:
• Improved absorption
• Increased bioavailability
• Accelerated Tmax
• Increased Cmax
• Decreased PK variability, which may also improve efficacy and safety
Discover the Opportunities With ENHANZE® Drug Delivery Technology
Learn how an ENHANZE® drug delivery technology licensing agreement may benefit your product pipeline.
Contact the Business Development Team at [email protected]
Current Partners
Roche | Shire | Pfizer | AbbVie | Lilly | Janssen | Bristol-Myers Squibb | Alexion
References1. Pivot X, Gligorov J, Müller V, et al. Ann Oncol. 2014;25(10):1979-1987. 2. Rummel M, Kim TM, Aversa F, et al. Ann Oncol. 2017;28:836-842. 3. Pivot X, Gligorov J, Müller V, et al. Lancet Oncol. 2013;14:962-970. 4. DeCock E, Pivot X, Hauser N, et al. Cancer Medicine. 2016;5(3):389-397. 5. Burcombe R, Chan S, Simcock R, et al. Adv Breast Cancer Res. 2013;2:133-140. 6. Walzer S, Era S, Profico A, Canciani M, Farina M, Ponzetti C. Poster presented at: ISPOR 18th Annual European Congress; 2015; Milan, Italy. 7. Kang DW, Nekoroski TA, Printz MA, et al. Drug Deliv and Transl Res. 2012;2:254. 8. Wasserman RL, Melamed I, Stein M, et al. Presented at: Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology; November 3-8, 2011; Boston, MA. 9. Data on file. Halozyme, Inc. 10. Martin A, Lavoie L, Goetghebeur M, Schellenberg R. Transfus Med. 2013;23(1):55-60. 11. Ponsford M, Carne E, Kingdon C, et al. Clin Exp Immunol. 2015;182(3):302-313. 12. Chari A, Nahi H, Mateos M-V, et al. Presented at: American Society of Hematology Annual Meeting; December 9-12, 2017; Atlanta, GA. 13. Shpilberg O, Jackisch C. Br J Cancer. 2013;109(6):1556-1561. 14. Bittner B. Drug Res (Stuttg). 2014;64(11):569-575. 15. Wynne C, Harvey V, Schwabe C, Waaka D, McIntyre C, Bittner B. J Clin Pharmacol. 2013;53(2):192-201. 16. HERCEPTIN® SC [product information]. Sydney, Australia: Roche Products Limited: 2017. 17. HERCEPTIN® [prescribing information]. South San Francisco, CA: Genentech, Inc; 2017. 18. RITUXAN HYCELA® [prescribing information]. South San Francisco, CA: Genentech, Inc; 2018. 19. RITUXAN® [prescribing information]. South San Francisco, CA: Genentech, Inc: 2018. 20. HYQVIA® [prescribing information]. Lexington, MA: Shire: 2016. 21. Immune Deficiency Foundation. Characteristics of immunoglobulin products used to treat primary immunodeficiency diseases licensed for use in the United States. February 2017. 22. Morcos PN, Zhang X, McIntyre C, Bittner B, Rowell L, Hussain Z. Int J Clin Pharmacol Ther. 2013;51(7):537-548. 23. Morrow L, Muchmore DB, Ludington EA, Vaughn DR, Hompesch M. Diabetes Tech Ther. 2011;13(10):1-7.
© 2018 Halozyme, Inc. All rights reserved. ENHANZE®, Halozyme®, Halozyme Therapeutics®, and the H logo are registered trademarks of Halozyme, Inc. RITUXAN HYCELA® (rituximab/hyaluronidase human) and RITUXAN® (rituximab)/RITUXAN® SC (rituximab subcutaneous) are registered trademarks of Biogen. HERCEPTIN® (trastuzumab)/HERCEPTIN® SC (trastuzumab subcutaneous) is a registered trademark of Genentech, Inc. MABTHERA® SC (rituximab subcutaneous) is a registered trademark of Hoffmann-La Roche Inc. HYQVIA® [immune globulin infusion 10% (human) with recombinant human hyaluronidase] is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc. All other trademarks are the property of their respective owners.