SAN DIEGO, June 25, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) announced today that the
commercial launch of MabThera® SC in
Europe has triggered a
$5 million milestone payment to
Halozyme during the second quarter under the License and
Collaboration Agreement between Halozyme and Roche. Following the
launch of Herceptin® SC in September 2013, MabThera SC is the second novel
subcutaneous formulation of one of Roche's oncology products using
Halozyme's patented EnhanzeTM (recombinant human
hyaluronidase) technology to be launched in Europe.
The approval of MabThera SC in Europe in March
2014 for the treatment of patients with follicular lymphoma
and diffuse large B-cell lymphoma was primarily based on a clinical
development program which showed that SC administration enabled the
delivery of MabThera over approximately five minutes versus 2.5
hours intravenously without compromising its proven efficacy and
safety. This innovative formulation could potentially save time for
patients, physicians and other health care providers in
Europe.
About non-Hodgkin lymphoma
There are two main types of
lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL).
NHL represents approximately 85% of all lymphoma
diagnosed1 and was responsible for approximately 200,000
annual deaths worldwide in 20122.
Lymphomas are a cancer of the lymphatic system (composed of
lymph vessels, lymph nodes and organs) which helps to keep the
bodily fluid levels balanced and to defend the body against
invasion by disease. Lymphoma develops when white blood cells
(usually B-lymphocytes) in the lymph fluid become cancerous and
begin to multiply and collect in the lymph nodes or lymphatic
tissues such as the spleen. Some of these cells are released into
the bloodstream and spread around the body, interfering with the
body's production of healthy blood cells.
Halozyme-Roche Collaboration
In December 2006,
Halozyme entered into an agreement with Roche to apply
Halozyme's patented Enhanze™ technology (recombinant human
hyaluronidase or rHuPH20) to Roche's biological therapeutic
compounds. To date, Roche has elected to explore the use of rHuPH20
for up 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. 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 any
other product candidates which would be successfully developed and
commercialized under the agreement.
About Halozyme
Halozyme Therapeutics is 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
dispersion and absorption of biologics, drugs and fluids.
Halozyme's pipeline addresses therapeutic areas, including
oncology, diabetes and dermatology that have significant unmet
medical need today. The Company markets Hylenex®
recombinant (hyaluronidase human injection) and has partnerships
with Roche, Pfizer and Baxter. Halozyme is headquartered in San
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
MabThera SC to patients, physicians and the healthcare system, and
the possible receipt by Halozyme of future milestones and royalties
under the Halozyme-Roche 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 product candidates under the Halozyme-Roche
collaboration by applicable regulatory authorities; satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; issues encountered in the sale of
MabThera SC and other product candidates under the Halozyme-Roche
collaboration including the countries where the product is
approved, approval timelines, the rate of conversion of IV
formulation users to SC users, pricing and other commercial
factors; 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 12,
2014. Halozyme does not undertake to update its
forward-looking statements.
References:
1 Globocan (2012) Table by cancers. Worldwide
incidence of cancers in males and females.
http://globocan.iarc.fr/ (URL accessed 3.03.14).
2 Globocan (2012) Cancer Incidence and Mortality
Worldwide. World, non-Hodgkin lymphoma, 2010. (URL accessed
18.09.13).
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx (URL
accessed 03.03.14).
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Denise
Powell
510-703-9491
dpowell@wcgworld.com
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SOURCE Halozyme Therapeutics, Inc.