To: Curtis E. Bemis who wrote (185 ) 12/8/1999 8:53:00 AM From: Curtis E. Bemis Read Replies (1) | Respond to of 395
Repligen comments on decline-- Repligen Comments on Recent Stock Activity PR Newswire - December 08, 1999 08:46 NEEDHAM, Mass., Dec. 8 /PRNewswire/ -- Repligen Corporation (Nasdaq: RGEN) today released the following statement in response to recent stock activity. It has come to the attention of Repligen management that a preliminary study focused on secretin, a hormone the company is studying for the treatment of autism, will be published in the December 9, 1999 issue of the New England Journal of Medicine. In the study 18 patients with autism and 10 with pervasive developmental disorder (PDD) were administered a single dose of secretin and evaluated for four weeks against a placebo group. While the authors acknowledge limitations related to the study's length, dosing and design, they conclude that secretin is not an effective treatment for autism. Commented Repligen CEO Walter C. Herlihy, Ph.D., "The experimental design of this study is too limited to establish a conclusion about the role of secretin in autism. The study is lacking in several key aspects: 1) The authors tested a single dose of secretin. We have consistently maintained that a single dose would not produce significant results in a general group of autism spectrum patients; 2) The authors made no attempt to select a set of potentially responsive patients. Since autism has many different causes, no single treatment is likely to work for all patients. Published research by a leading academic institution has found that there is a subset of autistic patients who exhibit systemic gastrointestinal dysfunction, including an enhanced pancreatic response to secretin. Any study seeking to establish the potential of secretin would include an analysis of its effects in this subset of patients." In conclusion, Dr. Herlihy stated, "Our growing understanding of the biology of secretin in autism will enable us to direct its development to those patients with the highest potential to benefit. Furthermore, we believe that large-scale studies with multiple dosings are necessary to establish the potential of secretin as a treatment for autism." 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 /CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen, 781-449-9560, ext. 2000, or Brad Miles of BMC Communications, 212-477-9007, ext. 17, or Jonathan Fassberg of The Trout Group, 212-477-9007, ext. 16/ /Web site: repligen.com (RGEN)