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FDA APPROVES FIRST SYNTHETIC SECRETIN

The Food and Drug Administration (FDA) has approved SecreFlo™ (secretin) for Injection for use as an aid in confirming the diagnosis of pancreatic dysfunction and the presence of a pancreatic tumor (gastrinoma) that may become cancerous.

Secreflo™ is a synthetic formulation of the naturally occurring porcine hormone secretin. As such, it is the first of its kind to receive FDA approval. Since 1999, no secretin product of any kind has been available to patients in the United States except through participation in clinical research.

Patients with pancreatic dysfunction are unable to digest food properly. Thick mucus obstructs the pancreas and prevents essential enzymes from breaking down food. Left untreated, this condition can cause patients to become severely malnourished and dehydrated.

Secreflo™ aids in confirming the diagnosis of pancreatic dysfunction by stimulating the pancreas to secrete pancreatic juice and bicarbonate that is used to measure the functioning of the pancreas.

Secreflo™ aids in confirming the presence of a gastrinoma by stimulating the stomach to release a hormone called gastrin that is further tested to confirm the diagnosis.

ChiRhoClin, Inc. of Silver Spring, Md. is the sponsor of the approved New Drug Application (NDA) for SecreFlo™.

Secreflo™ is manufactured by Chesapeake Biological Laboratories of Baltimore, Md. for RepliGen Corporation of Needham, Mass.

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