Halozyme Announces Roche Receives Marketing Authorization for Herceptin SC in
SAN DIEGO, Sept. 2, 2013
SAN DIEGO, Sept. 2, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:
HALO) announced today that the European Commission has granted Roche European
Union (EU) marketing authorization for the use of a time-saving subcutaneous
(SC) formulation of Herceptin^® (trastuzumab) for the treatment of
HER2-positive breast cancer. This formulation utilizes Halozyme's recombinant
human hyaluronidase (rHuPH20) and is administered in two to five minutes,
rather than 30 to 90 minutes with the standard intravenous form.
"This approval is great news for the more than 80,000 patients who receive
treatment with Herceptin each year in the EU," stated Gregory I. Frost, Ph.D.,
President and Chief Executive Officer of Halozyme. "The reduced administration
time and enhanced convenience may enable patients in the EU to spend less time
in the hospital while also increasing efficiency for physicians and other
health care providers. We're excited that patients will soon benefit from this
application of Halozyme's technology."
The European Commission's approval was based on data from the HannaH study
which showed that the subcutaneous formulation of Herceptin was associated
with comparable efficacy (pathological complete response, pCR) to Herceptin
administered intravenously in women with HER2-positive early breast cancer and
resulted in non-inferior trastuzumab plasma levels.^1 Overall, the safety
profile in both arms of the HannaH study was consistent with that expected
from standard treatment with Herceptin and chemotherapy in this setting. No
new safety signals were identified.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide.^2 Each year,
about 1.4 million new cases of breast cancer are diagnosed worldwide, and over
450,000 women will die of the disease annually.^2 In HER2-positive breast
cancer, increased quantities of the human epidermal growth factor receptor 2
(HER2) are present on the surface of the tumor cells. This is known as "HER2
positivity" and affects approximately 15% to 20% of women with breast
cancer.^3 HER2-positive cancer is a particularly aggressive form of breast
InDecember 2006, Halozyme entered into an agreement withRocheto apply
Halozyme's proprietary Enhanze™ technology toRoche's biological therapeutic
compounds. To date, Roche has elected to develop and commercialize products
using rHuPH20 with a total of five exclusive targets, and Roche retains the
option to apply rHuPH20 to three additional targets through the payment of
annual license maintenance fees. InFebruary 2011,Rochebegan a Phase 3
registration trial of subcutaneous (SC) MabThera (rituximab), an anticancer
biologic, in patients with non-Hodgkin's lymphoma (NHL) and chronic
lymphocytic leukemia (CLL) and submitted a line extension application to the
European Medicines Agency for MabThera SC in December 2012. Subject to the
successful achievement of clinical, regulatory, and sales events,Roche will
pay Halozyme additional milestones as well as royalties on product sales for
Herceptin SC, MabThera SC and other product candidates developed and
commercialized under the agreement.
Halozyme Therapeuticsis a biopharmaceutical company dedicated to developing
and commercializing innovative products that advance patient care. With a
diversified portfolio of enzymes that target the extracellular matrix, the
company's research focuses primarily on a family of human enzymes, known as
hyaluronidases, which increase the absorption and dispersion of biologics,
drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including
diabetes, oncology and dermatology that have significant unmet medical need.
The company markets Hylenex^® recombinant (hyaluronidase human injection) and
has partnerships withRoche, Pfizer,Baxter,ViroPharmaand Intrexon. Halozyme
is headquartered inSan Diego, CA.For more information on how we are
innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor Statement
This release includes forward-looking statements such as the potential
benefits of Herceptin SC to patients, physicians and the healthcare system,
and the possible receipt by Halozyme of future milestones and royalties under
the Roche/Halozyme collaboration agreement. The statements are based on
assumptions about many important factors, including the following, which could
cause actual results to differ materially from those in the forward-looking
statements: the satisfaction of regulatory and other requirements; actions of
regulatory bodies and other governmental authorities; unexpected adverse
events; changes in laws and regulations; competitive conditions; and other
risks identified in Halozyme's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on August 7, 2013. Halozyme does not
undertake to update its forward-looking statements.
^1Gustavo Ismael, et al. Subcutaneous versus intravenous administration of
(neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III
breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised
trial. Lancet Oncology, 2012 Sep;13(9):869-78.
^2Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM GLOBOCAN 2008,
Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet].
Lyon, France: International Agency for Research on Cancer; 2010. Available
^3 Wolff A.C. et al. American Society of Clinical Oncology/ College of
American Pathologists Guideline Recommendations for Human Epidermal Growth
Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med—Vol 131,
^4Slamon D et al. Adjuvant Trastuzumab in HER2-Positive Breast Cancer. N Engl
J Med 2011; 365:1273-83.
SOURCE Halozyme Therapeutics, Inc.
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