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 1.608.916.3570, by email at [email protected] or visit www.laureatepharma.com.
Laureate Pharma L.P.
Vice President, Controller & Strategic Planning