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Biotech / Medical : Repligen Corp (RGEN) -- Ignore unavailable to you. Want to Upgrade?

To: LLCF who wrote (221)	4/28/2000 8:36:00 AM
From: Curtis E. Bemis	Read Replies (1) \| Respond to of 395

Secretin-Repligen, the synthetic form for pancreatic diagnostics, is just an approval letter away !! This should provide a modest sustainable income source for RGEN. FDA Issues Approvable Letter For Diagnostic Secretin PR Newswire - April 28, 2000 07:14 NEEDHAM, Mass., April 28 /PRNewswire/ -- Repligen Corporation (Nasdaq: RGEN) announced today that the U.S. Food and Drug Administration (FDA) has issued an "approvable letter" to its development partner ChiRhoClin, Inc. regarding a new drug application (NDA) for diagnostic applications of synthetic porcine secretin. The FDA's letter indicates that the NDA can be approved upon the receipt of a satisfactory response to questions concerning the product and agreement upon product labeling and a product brand name. A written response to the "approvable letter" and proposed labeling are currently being prepared for submission to the FDA along with the product brand name of Secretin-Repligen(TM). An "approvable letter" usually represents the final step before a product receives FDA clearance for marketing in the United States. For the past 20 years an FDA approved form of secretin extracted from pigs has been marketed by Ferring Pharmaceuticals for the assessment of exocrine pancreatic function. The manufacture of this product was discontinued by Ferring in 1999. Secretin-Repligen(TM) is a chemically synthesized form of secretin which has been evaluated in clinical trials for pancreatic function assessment. It has received orphan drug designation from the FDA to increase pancreatic fluid secretion in conjunction with the diagnosis of pancreatic disorders, for use in the evaluation of exocrine pancreas function and for use in the diagnosis of gastrinoma. "The FDA's approvable letter is an important step towards the commercialization of diagnostic secretin," said Walter Herlihy, Ph.D., President and CEO of Repligen. "ChiRhoClin and Repligen are committed to working with the FDA to expeditiously fulfill the remaining requirements for approval." Secretin-Repligen(TM) is also being clinically evaluated for new diagnostic applications including the reduction of the incidence of pancreatitis resulting from an endoscopic procedure (ERCP) to diagnose and treat a variety of pancreatic and biliary diseases. There are more than 500,000 ERCP procedures carried out annually in the U.S. Repligen Corporation develops new drugs for autism, organ transplant and cancer. Repligen also manufactures and markets a set of patented products based on Protein A, which are used by the pharmaceutical industry to produce therapeutic antibodies. Its corporate headquarters are located at 117 Fourth Avenue, Needham MA, 02494. Additional information may be requested from www.repligen.com. This press release contains forward-looking statements based on current management expectations. There are certain key factors which could cause future results to differ materially from those anticipated by management. Such factors include, but are not limited to: uncertainty in the realization of future revenues, the uncertain timeline for clinical activity, results of pending or future clinical trials, the Company's ability to continue to establish collaborative arrangements with third parties, the Company's ability to maintain financial stability, the technical risks associated with development and manufacture of clinical products, the fact that there can be no assurances that patents relating to the Company's potential products will afford adequate protection to the Company, the risks of technological change and competition, and the competitive environment of the biotechnology and pharmaceutical industries. These factors are more fully discussed in the Company's periodic filings with the Securities and Exchange Commission. SOURCE Repligen Corporation

To: LLCF who wrote (221)	6/9/2000 3:33:00 PM
From: Cheryl Galt	Read Replies (1) \| Respond to of 395

UW receives $10 million to study autism A $5 million donation from a Microsoft executive, coupled with a matching $5 million gift from an anonymous donor, will be used to establish a center for the study and treatment of autism at the University of Washington. June 7, 2000 -- by Benjamin Shors, Seattle Times staff reporter seattletimes.nwsource.com ----------------------------- ... The donation ... is the largest private gift ever made to the UW for the study of a specific disorder. ... the Autism Center will be established at the university's Center on Human Development and Disability and will be a place where parents of autistic children can learn, health officials can be trained and the newest research can be put to use. The facility also will provide early treatment services for children with autism and increase public awareness of the disease. Autism, a neurological disorder manifested in the first three years of life, affects one in 500, making it more common that childhood cancer, deafness and Down syndrome, said Dr. Geraldine Dawson, a UW professor of psychology who will be the director of the new center. Autism often results in severe mental retardation and the inability to speak or form social relationships. But Dawson said intensive intervention when a child is young can increase a child's IQ by an average of 28 points. ... ---------- The last decade has seen an increase in the number of children with autism, an illness thought to have genetic roots but which may also be affected by environmental conditions, Dawson said. "One of the most exciting recent discoveries is that autism is a treatable disorder," Dawson said. "Unfortunately most health professionals do not recognize autism until the child is 4 years of age when the optimal time for treatment has passed." Commonly characterized by a child's failure to make eye contact, autism can be diagnosed as early as 12 months. ...