RGEN - FDA approval today - One of a kind drug.|
Monday February 14, 6:45 am Eastern Time
Company Press Release
SOURCE: Repligen Corporation
Repligen Issued Broad U.S. Patent For Use of Secretin In The Treatment of Autism
NEEDHAM, Mass., Feb. 14 /PRNewswire/ -- Repligen Corporation (Nasdaq: RGEN - news) today announced it was awarded a U.S. patent for the use of secretin in the treatment of autism spectrum disorder and its symptoms. U.S. patent No. 6,020,310 is entitled ``Method for assisting in differential diagnosis and treatment of autistic syndromes.'
The patent, which will remain in force until 2018, covers intravenous administration of secretin for the treatment of autism spectrum disorder and its symptoms, as well as methods where secretin is co-administered with a permeation-enhancing agent.
In March 1999, Repligen acquired exclusive rights to a series of patent applications for the use of secretin, a naturally-occurring hormone currently approved to diagnose certain gastrointestinal conditions, as a potential autism therapy. Some autistic children who have received the hormone therapeutically have made improvements in social behavior, communication, gastrointestinal function and sleep. Repligen is developing a human synthetic form of secretin for evaluation in clinical trials in pediatric autism.
``This patent allowance gives us a strong proprietary position with regard to secretin as a potential new treatment for autism, a pervasive and debilitating developmental disorder for which there are no FDA approved treatments currently available,' said Walter C. Herlihy, Ph.D., President and CEO of Repligen. ``We are currently prosecuting additional patent applications in the United States and Europe to further strengthen our position.'
The patent also discloses a previously unrecognized relationship between the response of the pancreas to secretin stimulation and autism. A recent study published in the Journal of Pediatrics (Horvath et al, Journal of Pediatrics 135 (5): 559-63) showed that 75% of autistic children with gastrointestinal symptoms had a significantly greater pancreatic response to secretin compared to children without the disorder, suggesting lack of normal secretin stimulation in this subset of autistic patients. Conducted at the University of Maryland Medical Center, the study was designed to understand the underlying biology of secretin in autism.
Autism is a neurological disorder that typically appears during the first three years of life and is characterized by defects in social interaction, communication and abnormal behavior. It is the third most common developmental disability in the United States today, affecting at least half-a-million people. There is no FDA-approved 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.