Laureate Pharma L.P. announces technology transfer and manufacturing agreement with Discovery Laboratories, INC.
PRINCETON, NJ - January 21, 2004 - Laureate Pharma L.P. announces entering into a manufacturing
agreement with Discovery Laboratories, Inc. Under the contract, Laureate Pharma will provide
manufacturing services that support Discovery Laboratories' product requirements. Terms of the
agreement were not disclosed.
In the first phase of the manufacturing implementation plan, Discovery has transferred its
existing manufacturing equipment to Laureate's microparticle manufacturing facility located in
Totowa, N.J. Project plans include manufacture of clinical material for Discovery's ongoing
development programs, as well as process validation and manufacturing to support the anticipated
commercialization of its indication of Respiratory Distress Syndrome (IRDS) in premature infants.
The second phase of this plan contemplates scale-up and enhancement to support potential
late-stage clinical-scale production of SurfaxinŽ for treatment of Acute Respiratory Distress
Syndrome (ARDS) in adults.
"We are delighted to be working with Discovery Laboratories. There is an excellent fit
between Discovery Laboratories' product requirements and Laureate's capabilities in cGMP
manufacturing," said Robert P. Morgan, P.E., Sr. Director of Operations at Laureate Pharma.
Robert J. Broeze, Ph.D., President of Laureate Pharma adds, "We view this agreement as the
first step in a longer-term relationship with Discovery. In working with Discovery, we have
implemented an integrated quality team approach in order to decrease technology transfer time
and achieve a high level of productivity and success. "
"Discovery Laboratories is excited to have entered into this manufacturing agreement
with Laureate Pharma," said Ronald J. Ritz, Vice President Manufacturing Operations.
"We believe Laureate is a qualified manufacturer that has the capabilities to supply us with
our clinical and commercial requirements."
About Laureate Pharma
Laureate Pharma is a privately held contract manufacturing services company with
headquarters in Princeton, NJ. The company is dedicated to supporting the development
and commercialization of pharmaceutical products for pharmaceutical and biopharmaceutical
companies. Laureate Pharma's biopharmaceutical division, located in Princeton, NJ,
provides a wide range of product development services from process design and development
to full-scale cGMP production, purification and aseptic filling, as well as corresponding
analytical services and regulatory support. The division is focused on two active
segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein
products. Mammalian cells are grown in stirred-tank or hollow-fiber bioreactors for
production of biopharmaceutical proteins, which are purified by state-of-the-art
semi-automated chromatography systems. Laureate Pharma's extended release technologies
division, located in Totowa, NJ, supplies sustained release development, formulation and
filling services through commercial scale at its cGMP manufacturing facility.
For more information on Laureate Pharma,
contact the company directly at (609) 919-3400, by email at info@laureatepharma.com or visit
www.laureatepharma.com.
Contact:
Laureate Pharma L.P.
John Morris
Vice President, Controller & Strategic Planning
(609) 919-3388
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