RedHill Biopharma Ltd.
RedHill Biopharma Announces Exclusive U.S. License from Entera Health for Commercial GI Product EnteraGam(R)
DGAP-News: RedHill Biopharma Ltd. / Key word(s): Agreement RedHill Biopharma Announces Exclusive U.S. License from Entera Health for Commercial GI Product EnteraGam(R)
TEL-AVIV, Israel, April 5, 2017 RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal (GI) and inflammatory diseases and cancer, today announced the signing of an exclusive license agreement with Entera Health Inc. (“Entera Health”), a privately held U.S. company focused on the research, manufacturing, and commercialization of value-added proteins and protein co-products, granting RedHill the exclusive U.S. rights to EnteraGam(R)2. EnteraGam(R) is a commercially-available medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. 2016 net sales of EnteraGam(R) in the U.S. were over $5 million. EnteraGam(R) is a serum-derived bovine immunoglobulin/protein isolate (SBI) with a unique mechanism of action intended to restore gut balance. EnteraGam(R) has been studied for various uses, such as diarrhea-predominant irritable bowel syndrome (IBS-D), inflammatory bowel disease (IBD) and human immunodeficiency virus (HIV)-associated enteropathy[3]. Guy Goldberg, RedHill’s Chief Business Officer, said: “We look forward to initiating the promotion of Donnatal(R)[4] and EnteraGam(R) in mid-2017. We are currently in advanced stages of building RedHill’s commercial operations in the U.S. and are excited to complement our product portfolio with a second commercial product geared towards gastroenterologists. We would like to thank our new partners at Entera Health and look forward to a successful long-term partnership.” Adi Frish, RedHill’s Senior VP, Business Development and Licensing, said: “This is another important step in implementing our strategic plan of becoming a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S. We continue to pursue additional commercial product opportunities in the specialty GI area to further expand our commercial operations. In parallel, we continue to advance the development of our three Phase III GI products, which, if approved by the FDA, we intend to commercialize in the U.S.” Aage Lauridsen, Entera Health’s CEO, said: “We are very pleased to partner with RedHill to secure the continued marketing of EnteraGam(R) in the U.S. and are confident that RedHill’s sales team will continue to grow the value of this unique product.” Under the terms of the agreement, RedHill licensed the exclusive U.S. rights to EnteraGam(R) for all indications for human use. RedHill will pay Entera Health tiered royalties on net sales generated from the sale of EnteraGam(R) by RedHill, and is not required to make any upfront or milestone payments. Under the terms of the agreement, Entera Health will also grant RedHill certain U.S. rights to its FDA-approved dicyclomine hydrochloride[5] oral solution USP (10 mg/5 ml), an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome. Numerous publications of clinical studies and retrospective chart reviews support the use of SBI in the dietary management of chronic diarrhea and loose stools4. The combined effect of SBI is intended to fulfill a distinctive nutritional requirement associated with various gastrointestinal conditions, where chronic diarrhea or loose stools are present and normal dietary proteins alone are insufficient. SBI has been shown in clinical studies to reduce loose stools and improve stool consistency as well as other symptoms, such as abdominal pain, bloating and urgency, in patients with chronic diarrhea and loose stools4. Several studies in patients suffering from inflammatory bowel diseases, such as ulcerative colitis and Crohn’s disease, suggest that SBI improves clinical symptomatic management of patients who are not fully managed on traditional therapies4. SBI has also been studied in patients with fecal incontinence with chronic diarrhea, in patients with celiac and non-celiac gluten sensitivity with chronic diarrhea and in additional gastrointestinal indications4. No significant interactions of EnteraGam(R) with commonly prescribed medications or therapies have been reported. According to Entera Health, it is estimated that since EnteraGam(R) was introduced in 2013, nearly 3 million doses of EnteraGam(R) have been administered to patients in the U.S., with an overall adverse events rate of less than 0.2%, with no serious adverse events attributed to EnteraGam(R) during post-marketing surveillance. In January 2017, RedHill announced an exclusive co-promotion agreement with a subsidiary[6] of Concordia International Corp., granting RedHill certain promotional rights in the U.S. for Donnatal(R), a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). About EnteraGam(R): Safety Information: EnteraGam(R) does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam(R) is gluten-free, dye-free and soy-free. Please see full Product Information. To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch. Important Safety Information: Further information, including prescribing information, can be found on www.donnatal.com. Please see the following website for complete important safety information about Donnatal(R): http://www.donnatal.com/professionals/important-safety-information/ This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal(R) and EnteraGam(R), (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
[1] Donnatal(R) (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.
05.04.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |