- Subcutaneous MabThera formulated with Halozyme's recombinant human enzyme -
- Halozyme to receive milestone payment of $5 million -
SAN DIEGO, Feb. 16, 2011 /PRNewswire via COMTEX/ -- Halozyme
Therapeutics, Inc. (Nasdaq: HALO) and Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced the first patient received subcutaneous (SC) MabThera
(rituximab), an anticancer biologic, in a Phase 3 registration trial
using Enhanze((TM) technology (rHuPH20, recombinant human hyaluronidase). This represents the second Roche cancer medicine, in addition to Herceptin(R)
SC (trastuzumab), to enter a Phase 3 registration study as part of the
Halozyme-Roche collaboration. Initiation of the clinical trial has
triggered a milestone payment of $5 million to Halozyme. MabThera is approved to treat non-Hodgkin's lymphoma
(NHL) and chronic lymphocytic leukemia (CLL) using different induction
and maintenance treatments that are currently given intravenously (IV).
(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)
"The start of this Phase 3 subcutaneous MabThera trial in patients
with follicular NHL signifies another major achievement for the
Halozyme-Roche partnership, and represents the second Roche target to
begin a pivotal trial. I congratulate the team on this important
accomplishment," said Gregory Frost,
Ph.D., Halozyme's president and CEO. "MabThera is the standard of care
for several serious forms of blood cancer and we expect this
subcutaneous alternative could provide a compelling administration
option."
This innovative technology may allow patients with NHL to receive
MabThera in less than 10 minutes via a simple SC injection at their
physician's office. Administration of SC MabThera means that patients
with NHL undergoing induction therapy or completing two years of
maintenance treatment with MabThera would have the greater convenience
of being able to receive a much shorter drug administration, a
compelling and welcome benefit.
Offering SC MabThera treatment outside of the IV infusion center or
hospital setting could also reduce costs and potentially help to
maximize the efficient use of hospital resources. Additional information
about this Phase 3 SC MabThera clinical trial can be found at clinicaltrials.gov and roche-trials.com.
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 three 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 Follicular Lymphoma and Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma is diagnosed in approximately 356,000 people
worldwide each year according to the WHO. Follicular lymphoma, a cancer
of the blood, is a common type of NHL and accounts for about 20% of the
new cases of NHL each year. NHL unfortunately remains incurable and
patients ultimately relapse and require additional treatments.
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company developing and
commercializing products targeting the extracellular matrix for the
endocrinology, oncology, dermatology and drug delivery markets. The
company's product portfolio is based primarily 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 therapeutics, including Herceptin(R) and MabThera(R), and
with Baxter BioScience to apply Enhanze technology to immunoglobulin.
Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with
mealtime insulins, which may produce more rapid absorption, faster
action, and improved glycemic control. The product candidates in
Halozyme's pipeline target multiple areas of significant unmet medical
need. For more information visit http://www.halozyme.com/.
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 SC MabThera) 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.
Halozyme Contact |
|
Robert H. Uhl |
|
Senior Director, Investor Relations |
|
(858) 704-8264 |
|
ruhl@halozyme.com |
|
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SOURCE Halozyme Therapeutics, Inc.