- First patient dosed with Roche biologic formulated with Halozyme's
recombinant enzyme technology -
- Halozyme grants exclusive, global rights to Roche for use of Enhanze(TM)
Technology with biologics directed against fourth target -
- Halozyme to receive an aggregate payment of $10.25 million -
SAN DIEGO, Dec. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc.
(Nasdaq: HALO), a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix, today announced that Roche has
dosed the first patient in a Phase 1 pharmacokinetic clinical trial with a
subcutaneous formulation using Enhanze Technology of a biologic directed to a
Roche exclusive target. This has triggered a milestone payment under the
Roche has also selected an additional exclusive target under the existing
license and collaboration agreement. Under the terms of the agreement, Roche
will pay Halozyme for exclusive, global rights for the application of its
hyaluronidase enzyme, rHuPH20, to a fourth biologic target selected by Roche.
"Roche and Halozyme have successfully completed the necessary drug product
formulation and preclinical studies required to initiate a clinical trial.
Entering the clinic is a significant achievement and demonstrates Roche's
strong commitment to a successful partnership," said Jonathan Lim, M.D.,
Halozyme's President and CEO. "We are very pleased with the progress that is
being made through our collaboration. Roche is a global leader in the
development of biologics and we are excited that they have selected a fourth
exclusive target, in addition to the three already under development, further
validating Halozyme's core technology."
Roche has also maintained its rights to other targets covered in the
license and collaboration agreement. An aggregate payment of $10.25 million
will be made to Halozyme for commencing a Phase 1 clinical trial, exercising
exclusive global rights to a fourth biologic target and for annual maintenance
Halozyme also announced that it has entered into a supply agreement with
Roche to provide rHuPH20 for use in formulations with biologics directed
against Roche targets covered under the licensing and collaboration agreement.
Halozyme continues to scale up its manufacturing processes to enhance yields
and efficiencies in order to produce multi-kilogram quantities of enzyme. As
specified in the agreement, Halozyme will supply rHuPH20 to Roche to fulfill
all of its clinical development and commercialization requirements.
Halozyme Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to apply
Halozyme's proprietary Enhanze(TM) Technology to Roche's biological
therapeutic compounds. Under the terms of the agreement, Roche paid Halozyme
an initial payment for the application of its recombinant human enzyme,
rHuPH20, to three pre-defined Roche biologic targets. Roche has now selected a
fourth biologic target and has the option to exclusively develop and
commercialize rHuPH20 with an additional nine targets. Pending the successful
achievement of a series of clinical, regulatory, and sales events, Roche may
pay Halozyme additional milestones as well as royalties on potential future
product sales. Under the collaboration, Roche has access to Halozyme's
expertise in developing and applying rHuPH20 to Roche targets. Roche obtained
a worldwide, exclusive license to develop and commercialize product
combinations of rHuPH20 and Roche target compounds resulting from the
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. The company's Enhanze(TM) Technology is
a novel drug delivery platform designed to increase the absorption and
dispersion of biologics. Its key partnerships are with Roche to apply Enhanze
Technology to Roche's biological therapeutic compounds for up to 13 targets
and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic
product, GAMMAGARD LIQUID 10%. In addition, the company has received FDA
approval for two products: Cumulase(R), for use in in-vitro fertilization, and
HYLENEX, for use as an adjuvant to increase the absorption and dispersion of
other injected drugs and fluids. HYLENEX is partnered with Baxter
International Inc. Halozyme also has a number of different enzymes in its
portfolio that target significant areas of 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 Roche's progress under the collaboration) 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.
CONTACT: Robert H. Uhl, Senior Director, Investor Relations of Halozyme
Therapeutics, Inc., +1-858-704-8264, email@example.com;
or Karen Sparks,
+1-858-455-5500, ext. 275, firstname.lastname@example.org,
or Joleen Schultz,
+1-858-455-5500, ext. 215, email@example.com, both of Mentus for Halozyme
Web site: http://www.halozyme.com /