Halozyme Announces Positive Opinion from CHMP On Roche's Herceptin SC for
SAN DIEGO, June 28, 2013
SAN DIEGO, June 28, 2013 /PRNewswire/ --Halozyme Therapeutics, Inc. (NASDAQ:
HALO) announced today that Roche received a positive recommendation from the
European Medicines Agency's Committee for Medicinal Products for Human Use
(CHMP) for the subcutaneous formulation of Herceptin^® (trastuzumab) using
Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of
patients with HER2-positive breast cancer in Europe.
Roche's pivotal Phase 3 HannaH study, conducted in 102 sites outside the US,
demonstrated that Herceptin SC may help decrease the time patients spend
receiving treatment at a hospital or physician's practice, by reducing the
administration time. A typical IV infusion of Herceptin can take 30 to 90
minutes, per dose, whereas the same dose delivered subcutaneously can be
administered in two to five minutes by an injection under the skin.^1
"Pending European approval, this subcutaneous formulation of Herceptin will
provide a new route of administration that could potentially save time for
both physicians and HER2-positive breast cancer patients in Europe," said
Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme
Therapeutics. "We are pleased that our technology has helped enable this new
option for patients."
Study results showed that the safety and efficacy of the subcutaneous
formulation of Herceptin is comparable to treatment with Herceptin
administered intravenously.^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
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.^2In HER2-positive breast
cancer, increased quantities of the human epidermal growth factor receptor 2
(HER2) are present on the surface of the tumour cells. This is known as "HER2
positivity" and affects approximately 15-20 percent of women with breast
cancer.^3 HER2-positive cancer is a particularly aggressive form of breast
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.
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 to 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). 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.
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 approval of Herceptin SC by the European Union; 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 May 8, 2013. Halozyme does not undertake to update its
^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, published online August 2012.
^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, January
^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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