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RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules

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RedHill Biopharma Ltd. , a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer.

Announced that it has entered into a commercialization agreement with ParaPRO LLC (“ParaPRO”), an Indiana-based specialty pharmaceutical company, granting RedHill the exclusive rights to promote Esomeprazole Strontium Delayed-Release Capsules to gastroenterologists in certain U.S. territories.

Esomeprazole Strontium DR Capsules 49.3 mg is a prescription proton pump inhibitor (PPI) indicated for adults for the treatment of gastroesophageal reflux disease (GERD), risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence and for pathological hypersecretory conditions, including Zollinger-Ellison syndrome1. Esomeprazole Strontium DR Capsules 49.3 mg is a proprietary prescription drug approved by the FDA under a New Drug Application (NDA).

Craig Miller, RedHill’s VP U.S. Business Operations, Market Access, said: “RedHill’s U.S. commercial operations, headquartered in Raleigh, NC, include a gastrointestinal (GI)-focused sales force of 40 sales representatives promoting Donnatal®2 and EnteraGa®3 in select U.S. territories. We are excited to promote a third GI specialty commercial product and to offer patients an additional therapeutic option. Esomeprazole Strontium DR Capsules 49.3 mg complements RedHill’s rapidly growing U.S. GI specialty commercial product portfolio. RedHill is pursuing additional commercial opportunities in the specialty GI area to further expand its commercial presence in the U.S. We thank our new partner ParaPRO for their trust and cooperation, and are looking forward to a fruitful partnership.”

Patrick O’Shea, ParaPRO’s VP of Marketing, added: “Our partnership with RedHill will generate a synergistic effort to commercialize the benefits of Esomeprazole Strontium DR Capsules 49.3 mg, and address the unmet need for therapeutic consistency we believe is sought by both healthcare practitioners and patients.”

Under the terms of the agreement, RedHill is not required to make any upfront or milestone payments, and the parties will share the revenues generated from the promotion of Esomeprazole Strontium DR Capsules 49.3 mg by RedHill based on an agreed upon split between them. The initial term of the commercialization agreement is for three years. RedHill expects to initiate the U.S. promotion of the product in the coming weeks.

PPIs are one of the most commonly prescribed class of medications in the U.S., with an estimated market value exceeding $20 billion in 20164.

RedHill currently promotes two GI specialty products in the U.S., Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) and EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI).

Donnatal® is a prescription oral drug used with other drugs for the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). RedHill has an exclusive co-promotion agreement with Concordia Pharmaceuticals Inc., a subsidiary of Concordia International Corp. (NASDAQ: CXRX) (TSX: CXR) (“Concordia”), granting RedHill certain U.S. promotion rights for Donnatal®. Under the terms of the agreement, RedHill and Concordia will share the revenues generated from the promotion of Donnatal® by RedHill, based on an agreed upon split.

EnteraGam® is a medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. RedHill has a license agreement with Entera Health Inc. (“Entera Health”), granting RedHill the exclusive U.S. rights to EnteraGam®. Under the terms of the agreement, RedHill will pay Entera Health royalties based on net sales generated from the sale of EnteraGam® by RedHill.           

About Esomeprazole Strontium Delayed-Release Capsules 49.3 mg and 24.65 mg

Esomeprazole Strontium Delayed-Release Capsules 24.65 mg and 49.3 mg are indicated for adults: 

  • for the short-term treatment (4-8 weeks) of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and/or in healing and symptomatic resolution of erosive esophagitis (EE).
  • to reduce the risk of stomach ulcers in some people taking non-steroidal anti-inflammatory drugs (NSAIDs) (controlled studies did not extend beyond 6 months).

Esomeprazole Strontium Delayed-Release Capsules 49.3 mg

  • in combination with amoxicillin 1000 mg and clarithromycin 500 mg is indicated for the treatment of patients with a stomach infection (Helicobacter pylori) and duodenal ulcer disease.
  • is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

About Donnatal®
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast-acting liquid.

About EnteraGam®
EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision. EnteraGam® binds microbial components5, such as toxic substances released by bacteria, that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools in people who have specific intestinal disorders6.

About ParaPRO LLC
ParaPRO is a Specialty Pharmaceutical Company created in 2002 to acquire, develop, and commercialize proprietary products in focused high potential markets. ParaPRO is a wholly owned subsidiary of SePRO Corporation, a management owned life-sciences business. Started in 1994, SePRO Corporation is a research-based life sciences company providing innovative products and services for specialty environmental and human health markets worldwide. SePRO is recognized as a preeminent leader in the aquatics industry and as a vital player in professional turf, horticulture and landscape markets.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools, and has a U.S. commercialization agreement with ParaPRO for Esomeprazole Strontium Delayed-Release Capsules 49.3 mg. RedHill’s clinical-stage pipeline includes: (i) TALICIA™ (RHB-105)- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis, and a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).

Company contact

Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
This email address is being protected from spambots. You need JavaScript enabled to view it.

IR contact (U.S.)
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
This email address is being protected from spambots. You need JavaScript enabled to view it.

1 For more information, please see the prescribing information:              
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display

2 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  For more information, please see the prescribing information:
http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf

3 EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a commercially-available medical food, intended for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, which must be administered under medical supervision.

4 Symphony Health.

5 Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein isolate binds to pathogen-associated molecular patterns. Poster presented at: Federation of American Societies for Experimental Biology; April 26-30, 2014; San Diego, CA.

6 Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.

Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights into the pathophysiology of IBS: intestinal microflora, gas production and gut motility. Eur Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.

 

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