EnteraGam™ (Serum-derived bovine immunoglobulin/protein isolate, SBI) Now Available
CARY, NC (Business Wire August 20, 2013) – Entera Health, Inc. announces the commercial availability of EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI). EnteraGam™ is a prescription medical food* product indicated for the clinical dietary management of enteropathy (intestinal disorder) under medical supervision for patients who, because of therapeutic or chronic medical needs, have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, in patients who, because of therapeutic or chronic medical needs, have chronic loose or frequent stools (e.g., diarrhea-predominant irritable bowel syndrome or IBS-D) and in patients with chronic loose or frequent stools who are infected with HIV. EnteraGam™ has been shown in clinical studies in diverse disorders to improve GI nutrient absorption as well as manage immune function and mucosal barrier function in the intestine.1-3 Maria Vicario’s group (Digestive Diseases Research Unit, Institut de Recerca, Department of Gastroenterology, Barcelona, Spain) has “demonstrated structural abnormalities in the jejuna mucosa of IBS-D patients, which suggests that this is an organic rather than a functional disorder.”4 For more information, please go to www.enteragam.com
Entera Health will have a dedicated sales force promoting EnteraGam™ throughout the United States. To support the commercial launch, Entera Health will offer a savings program where insured patients will pay as little as $25 for their EnteraGam™ prescription. The program will be available in over 40,000 pharmacies.
Utilization of nutrition depends on proper ingestion and digestion of foodstuffs along with optimal gut metabolism and absorption of nutrients. Some patients due to chronic conditions, diseases or specific drug therapies have an impaired ability to ingest, digest, absorb, or metabolize food and certain nutrients. Medical foods are meant to manage conditions or diseases in which there is a distinct nutritional need to manage these and/or restore a homeostasis to these processes.
Important Safety Information: EnteraGam™ contains beef protein; therefore, patients who have an allergy to beef or any component of EnteraGam™ should not take this product. The most commonly reported adverse events in clinical studies (incidence of 2–5%) included mild nausea, constipation, stomach cramps, headache, and increased urination. Patients who are pregnant or nursing should not take EnteraGam™, as there are no data regarding the effects of serum-derived bovine immunoglobulin/protein isolate (SBI) in these populations. EnteraGam™ does not contain any milk products such as lactose, casein, or whey. It is gluten-free, dye-free, and soy-free. It contains the following inactive ingredients: dextrose and sunflower lecithin.
* Medical foods are regulated by the FDA under the Orphan Drug Act5; specially formulated to be consumed or administered orally or enterally; to be used under medical supervision (eg, dispensed by prescription) as part of ongoing care to ensure proper, safe use; specifically for management of distinctive nutrient needs, resulting from a specific chronic condition or disease; and specially formulated and processed, as results are not achievable by normal dietary intake. Ingredients in medical foods must be generally recognized as safe (GRAS).6
About Entera Health, Inc.
Entera Health, Inc. is a biotherapeutic company focused on improving worldwide health through development of clinically safe biotherapeutics to address unmet needs. Entera Health conducts continuing research utilizing value added proteins and protein co-products to find additional compounds that positively impact human health. Products are being developed for oncology, gastroenterology, and immune disorders. Visit our site: www.enterahealth.com
Contact:Tom Heck, VP of Corporate Development; 515-963-7599; firstname.lastname@example.org
1. Asmuth DM, et al. Changes In Stool Microbiota, Bacterial Translocation and Mucosal Immunity after Oral Serum-Derived Bovine Immunoglobulin (SBI) Administration. Poster Presented at: 20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, GA.
2. Asmuth DM, Ma Z-M, Albanese A, et al. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy. AIDS. doi:10.1097/QAD.0b013e328362e54c
3. Lembcke JL, Peerson JM, Brown KH. Acceptability, safety, and digestibility of spray-dried bovine serum added to diets of recovering malnourished children. J Pediatr Gastroenterol Nutr. 1997;25(4):381-384.
4. Martinez C, Lobo B, Pigrau M, et al. Diarrhoea-predominant irritable bowel syndrome: an organic disorder with structural abnormalities in the jejuna epithelial barrier. Gut 2013;62:1160-1168.
5. Orphan Drug Act. FDA website. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default.htm. Accessed May 8, 2013.
6. 21CFR 170.3 and 21 CFR 170.30