Subcutaneous Herceptin Formulated with Halozyme's Recombinant Enzyme Technology Halozyme to Receive Milestone Payment of $5 Million New Subcutaneous Route of Delivery May Reduce Hospital Time for Patients with HER2-Positive Breast Cancer and Ease Strain on Medical ResourcesSAN DIEGO, Oct 22, 2009 (BUSINESS WIRE) -- Halozyme Therapeutics, Inc. (Nasdaq:HALO) and Roche today announced
dosing of the first patient in a Phase 3 registration trial using Enhanze(TM)
technology (rHuPH20, recombinant human hyaluronidase) in a
subcutaneous formulation with Roche's anticancer biologic, Herceptin
(trastuzumab). This represents the first Roche product to enter a Phase
3 registration study as part of the Halozyme Roche collaboration and
initiation of the clinical trial has triggered a milestone payment of $5
million to Halozyme. Herceptin is approved to treat HER2-positive
breast cancer and currently is given intravenously (IV).
This innovative technology is anticipated to allow patients with
HER2-positive breast cancer to administer Herceptin themselves with or
without the support of a healthcare professional via a simple
subcutaneous injection. Infusion-free administration with subcutaneous
Herceptin means for example that patients with early breast cancer
completing their one year of Herceptin therapy would have greater
convenience of being able to receive treatment at their family doctor's
office or at home without having to go to a hospital, a significant and
"The start of this Phase 3 subcutaneous Herceptin trial is a major
achievement for the Halozyme and Roche collaboration, representing the
first Roche target to reach a pivotal trial. It reflects years of focus,
dedication, and teamwork with the aim of providing an innovative
solution for improved patient care," said Jonathan Lim, M.D., Halozyme's
President and CEO. "I congratulate the alliance on the speed of progress
to Phase 3."
In addition, offering Herceptin treatment outside of the hospital
setting could reduce costs and potentially help to maximize the
efficient use of hospital resources. Subcutaneous Herceptin would come
in a ready-to-use administration device instead of an infusion-bag that
needs to be prepared by a pharmacist. Physicians and nurses would
conduct fewer infusions at the hospital freeing up infusion chair time
for other procedures. Additional information about this Phase 3
subcutaneous Herceptin clinical trial can be found at clinicaltrials.gov
Halozyme Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to apply
Halozyme's proprietary Enhanze technology to Roche's biological
therapeutic compounds. Under the terms of the agreement, Roche made an
initial payment to Halozyme for the application of its recombinant human
enzyme, rHuPH20, to three pre-defined biologic targets exclusive to
Roche. In December 2008, Roche selected a fourth biologic target
followed by selection of a fifth target in June 2009 and has the option
to exclusively develop and commercialize rHuPH20 with an additional
eight potential targets. Pending the successful achievement of a series
of clinical, regulatory, and sales events, Roche will pay Halozyme
additional milestones as well as royalties on future product sales.
Under the collaboration, Roche has access to Halozyme's expertise in
developing and applying rHuPH20 to Roche biologics directed at multiple
targets. Roche obtained a worldwide, exclusive license to develop and
commercialize product combinations of rHuPH20 and Roche compounds
resulting from the collaboration.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide.i
Each year more than one million new cases of breast cancer are diagnosed
worldwide, and nearly 400,000 people will die of the disease annually.ii
In HER2-positive breast cancer, increased quantities of the HER2 protein
are present on the surface of the tumor cells. This is known as 'HER2
positivity' and affects approximately 20-25% of women with breast cancer.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the endocrinology,
oncology, dermatology and drug delivery markets. The company's portfolio
of products and product candidates is based on intellectual property
covering the family of human enzymes known as hyaluronidases and
additional enzymes that affect the extracellular matrix. Halozyme's
Enhanze(TM) technology is a novel drug delivery platform designed to
increase the absorption and dispersion of biologics. The company has key
partnerships with Roche to apply Enhanze technology to Roche's
biological therapeutic compounds for up to 13 targets and with Baxter
BioScience to apply Enhanze technology to Baxter's biological
therapeutic compound, GAMMAGARD Liquid(R). Halozyme's research
pipeline candidates target significant areas of unmet medical need. For
more information visit www.halozyme.com.
i World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/
ii Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence,
Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0.
IARCPress, Lyon, 2004. 2004
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without
limitation, statements concerning, (i) Roche's progress
under the collaboration, (ii) the potential achievement of
various milestones, and (iii) the advantages of subcutaneous
Herceptin) that involve risk and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements. The forward-looking statements are also identified through
use of the words "believe," "enable," "may," "will," "could," "intends,"
"estimate," "anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar meaning.
Actual results could differ materially from the expectations contained
in forward-looking statements as a result of several factors, including
regulatory approval requirements and competitive conditions. These and
other factors that may result in differences are discussed in greater
detail in the company's reports on Forms 10-K, 10-Q, and other filings
with the Securities and Exchange Commission.
SOURCE: Halozyme Therapeutics, Inc.
Halozyme Therapeutics, Inc.
Robert H. Uhl
Senior Director, Investor Relations