RedHill Acquires Commercialization Rights to Ferring's Rebyota and Clenpiq in Transformational GI Repositioning
核心洞察
RedHill Biopharma secured exclusive global and U.S. commercialization rights to Rebyota and Clenpiq from Ferring Pharmaceuticals (搜索) for a $12 million upfront payment plus tiered royalties and milestones.
The two FDA-approved gastrointestinal products generated approximately $37.5 million in combined 2025 U.S. net sales, with Rebyota contributing $16.9 million and Clenpiq $20.6 million.
The transaction, fully funded by RedHill's $18 million Talicia divestiture to Apotex (搜索), completes a strategic repositioning toward a larger, fully controlled commercial GI business.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has acquired exclusive commercialization rights to two established, FDA-approved gastrointestinal (GI) therapies—Rebyota and Clenpiq—from Ferring Pharmaceuticals (搜索), completing what the company describes as a "transformational" strategic repositioning of its commercial GI business. Announced September 1, 2026, the agreement grants RedHill an exclusive global commercialization license for Rebyota and an exclusive U.S. commercialization license for Clenpiq, in exchange for a $12 million upfront payment plus tiered royalties on net sales and potential milestones.
The transaction follows RedHill's previously announced divestiture of Talicia to Apotex (搜索) for $18 million in cash upfront plus up to $35 million in potential worldwide net sales milestones. The $12 million upfront payment to Ferring is fully funded through that divestment, leaving RedHill with a materially larger, fully controlled commercial business and a stronger liquidity position.
"Rebyota and Clenpiq are expected to generate a positive cash contribution to RedHill," said Dror Ben-Asher, RedHill's Chief Executive Officer. "This, combined with RedHill's experienced and lean commercial team and proven development capabilities, creates a scalable foundation for further growth, including additional acquisition of complementary revenue-generating products."
Two Revenue-Generating, FDA-Approved GI Assets
The two acquired products together generated approximately $37.5 million in 2025 U.S. net sales. Rebyota, a proprietary first-in-class microbiota-based therapy, generated approximately $16.9 million in 2025 U.S. net sales, while Clenpiq, a ready-to-drink low-volume bowel preparation, delivered $20.6 million in net sales with minimal promotion.
Rebyota is the first and only single-dose FDA-approved Fecal Microbiota Transplant (FMT) for the prevention of recurrent Clostridioides difficile infection (搜索) (rCDI). FDA-approved in 2022 and Health Canada-approved in 2025, Rebyota received Breakthrough Therapy and Orphan Drug designations, with exclusivities and other patent protections that could run to 2036.
"Rebyota is a first-in-class microbiota-based therapy for prevention of recurrent Clostridioides difficile (C. diff) infection (rCDI) in individuals 18 years of age and older following antibiotic treatment for rCDI," said Rick Scruggs, RedHill's Chief Commercial Officer. "FDA-approved in 2022, it generated approximately $16.9 million in U.S. net sales in 2025 through its clinical profile, broad coverage and an established customer base of approximately 600 active accounts."
Rebyota is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of live microbes, administered by a healthcare professional in one visit. Its one-time administration requires no fasting, bowel prep, or extended treatment timeframe, and has demonstrated more than a 70% success rate at preventing rCDI.
Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a ready-to-drink, low-volume bowel preparation used to cleanse the colon prior to colonoscopy, indicated for adults and pediatric patients 9 years of age and older. It combines sodium picosulfate, a stimulant laxative, with magnesium oxide and anhydrous citric acid, which form magnesium citrate, an osmotic laxative.
Clinical Significance and Disease Burden
C. diff (CDI) infection is a distressing and life-threatening condition—in developed countries it is the most common cause of healthcare-associated diarrhea. An estimated 3.6 million cases of CDI occur globally each year, including approximately half a million cases in the U.S. Approximately 30,000 Americans die every year due to CDI, with a global mortality rate of 1-in-10, rising to almost 1-in-3 in high-risk settings. In the U.S., up to approximately 165,000 CDI cases result in one or more recurrences, underscoring the need for prevention strategies.
Rebyota's streamlined ordering and reimbursement process is already in place for physicians, and broad and improving U.S. payer coverage means that 93% of lives have coverage, including 43% with coverage after first recurrence.
Colonoscopy is the cornerstone of GI practice, with more than 15 million colonoscopies performed in the U.S. annually. This number is rising, driven by follow-up after positive noninvasive screening tests, an aging population, and guidelines recommending testing at age 45 instead of age 50. Clenpiq has broad commercial and government payer coverage, with more than 108 million lives (63%) holding unrestricted commercial coverage, including 57 million (33%) with preferred position, and 23 million lives (41%) of Medicare Part D lives with unrestricted access.
Strategic Repositioning and Future Outlook
Under the terms of the agreement, Ferring retains its Rebyota manufacturing facilities and will continue to supply Rebyota through the term of the agreement. The acquisition, together with the Talicia divestiture, positions RedHill to pursue additional growth and expansion opportunities, including further acquisitions of complementary revenue-generating products.
RedHill was advised by Morningstar Law Group and Greenberg Traurig LLP on the transaction. The company's broader pipeline includes opaganib, a first-in-class orally administered sphingosine kinase-2 (SPHK2) selective inhibitor; RHB-102 (Bekinda); RHB-204 for Crohn's disease; and RHB-107 (upamostat), an oral serine protease inhibitor.