October 21, 2008
Neurotech Announces the Opening of Its GMP Manufacturing Facility in Cumberland, Rhode Island
CUMBERLAND, R.I., Oct. 21 /PRNewswire/ -- Neurotech Pharmaceuticals, Inc., a privately-held biotechnology company focused on the development of sight-saving therapeutics for chronic retinal diseases, announced today the opening of its new 27,000 square-foot GMP manufacturing facility in Cumberland, Rhode Island.
With support from the Rhode Island Economic Development Corporation (RIEDC) and its financing programs, Rhode Island Industrial Facilities Corporation (RIIFC) and Rhode Island Industrial-Recreational Building Authority (IRBA), Neurotech was approved for a $4 million financing to help pay for the cost of equipping this facility.
The Company's lead development program is NT-501 for the treatment of Retinitis Pigmentosa (RP) and the dry form of age-related macular degeneration (dry AMD). NT-501 is an intraocular, cell containing polymer implant designed to provide continuous, long-term release of the therapeutic protein Ciliary Neurotrophic Factor (CNTF) directly into the back of the eye by means of the Company's proprietary Encapsulated Cell Technology. CNTF, a well established neurotrophic factor, rescues dying retinal photoreceptors and protects them from degeneration.
"We are extremely pleased to locate our manufacturing facility in Cumberland, RI and to have the support of the State in helping us equip the facility," said Ted Danse, President and CEO of Neurotech. "Due to the State's support we were able to finance the costs of the manufacturing equipment at a very attractive cost of capital. We are looking forward in continuing to work with the State as we continue to develop our unique technology and expand our infrastructure."
"High tech manufacturing in the biotechnology industry is a critical component of our economic development and job growth strategy," said Governor Donald L. Carcieri. "I commend Neurotech for their commitment to expand operations and create new job opportunities here in Rhode Island, and am pleased to join the company in this exciting celebration today."
"Through the support of our RIEDC financing tools, we were able to assist Neurotech, a very promising Rhode Island biotechnology company, grow and expand their operations in our state. Strengthening Rhode Island's life sciences sector and creating more high-wage jobs for Rhode Islanders is a very high priority of our Economic Growth Plan," said Saul Kaplan, executive director, Rhode Island Economic Development Corporation. "Today's announcement is an excellent example of how the public and private sectors can work together to help great companies grow and expand here. We are proud of Neurotech's success and recognize the importance of assisting promising biotechnology companies as their therapies move from the lab to commercialization."
About Neurotech's Clinical Programs: Phase 2/3 Studies in Retinitis Pigmentosa (RP)
Neurotech is conducting two Phase 2/3 trials of NT-501 for the treatment of visual loss associated with RP-one consisting of patients with earlier stage disease (60 patients) and the second consisting of patients with later stage disease (60 patients). Both trials are randomized, multi-centered, double-masked, sham-controlled dose ranging studies. Each patient receives either a high or low dose NT-501 implant in one eye and a sham treatment in the fellow eye. The primary efficacy endpoint is visual field sensitivity for the early-stage RP study and best corrected visual acuity for the late-stage RP study.
Phase 2 Study - Dry Age-related Macular Degeneration (Dry AMD)
This randomized, multi-centered, double-masked, sham-controlled study is evaluating NT-501 in 48 subjects with an advanced stage of dry AMD called geographic atrophy. Each subject receives either a high or low dose NT-501 implant or a sham treatment in one eye only. Best corrected visual acuity is the primary efficacy endpoint of this study.
About the Diseases
Retinitis Pigmentosa (RP) is an inherited disease that causes the retina's rod and cone photoreceptors to gradually degenerate leading to loss of vision and blindness. The symptoms of RP predominately appear in young adults and affect approximately 100,000 people in the United States and over 1 million people worldwide. At this time there is no known cure or effective treatment for RP.
Age-related macular degeneration (AMD) is a chronic progressive disease of the macula that results in the loss of central vision. It is the leading cause of blindness in elderly people in the developed world. There are two forms of AMD.dry and wet. Dry AMD is the most common form of AMD representing approximately 90% of all AMD cases. In its later stages dry AMD can lead to the degeneration of photoreceptors and retinal pigment epithelial cells, a chronic condition called geographic atrophy (GA). GA affects approximately 1 million people in the United States for which there currently are no effective treatments.
About Encapsulated Cell Technology
Neurotech's core technology platform is Encapsulated Cell Technology (ECT), a unique technology that allows for the long term, sustained delivery of therapeutic factors to the back of the eye. ECT implants consist of cells that have been genetically modified to produce a specific therapeutic protein and are encapsulated in a semi-permeable hollow fiber membrane. The diffusive characteristics of the hollow fiber membrane are designed to promote long-term cell survival by allowing the influx of oxygen and nutrients while simultaneously preventing direct contact of the encapsulated cells with the cellular and molecular elements of the immune system. The cells continuously produce the therapeutic protein which diffuses out of the implant at the target site. ECT therefore enables the controlled, continuous delivery of therapeutic factors directly to the retina, bypassing the blood-retina barrier.
About Neurotech Pharmaceuticals, Inc.
Neurotech is developing sight-saving therapeutics for the treatment of chronic retinal diseases. The Company's lead product candidate, NT-501, is currently in late-stage clinical development for retinitis pigmentosa (RP) and dry age-related macular degeneration (dry AMD). RP is the leading inherited cause of blindness for which there is no current treatment. The Company's portfolio of product candidates also includes treatments for wet AMD. All of Neurotech's development programs are based on the Company's proprietary Encapsulated Cell Technology (ECT). ECT uniquely enables the controlled, continuous delivery of biologics directly to the back of the eye, overcoming a major obstacle in the treatment of retinal disease.
To learn more about Neurotech and the clinical studies of NT-501, please visit our web site at http://www.neurotechusa.com/
Neurotech Pharmaceuticals, Inc.
CONTACT: Rich Small, Vice President, CFO of Neurotech Pharmaceuticals,Inc., +1-401-495-2403, [email protected]
Web site: http://www.neurotechusa.com/