RedHill Biopharma Ltd (RDHL)

[midastouch017]

RedHill Biopharma and Gaelan Medical Enter Into License Agreement for Talicia® for the United Arab Emirates

https://finance.yahoo.com/news/redhill-biopharma-gaelan-medical-enter-141500473.html

Gaelan Medical to pay RedHill $2 million upfront plus potential regulatory and sales milestones and tiered royalties on net sales, for the exclusive rights in the United Arab Emirates to Talicia®

Talicia is a U.S. FDA-approved treatment for H. pylori, a bacterial infection that affects more than 50% of the world's adult population representing significant unmet need

RALEIGH, N.C. and TEL-AVIV, Israel, Jan. 6, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Gaelan Medical Trade LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1], an H. pylori therapy, in the United Arab Emirates (UAE).

Under the terms of the agreement, RedHill will receive an upfront payment of $2 million and is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE. Gaelan Medical will receive the exclusive rights to commercialize Talicia in the UAE, as well as a right of first refusal to commercialize Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period.

"We are delighted to partner with Gaelen Medical to help bring Talicia to H. pylori patients in the UAE and potentially other territories in the region," said Dror Ben-Asher, RedHill's CEO. "This partnership is particularly important given that H. pylori, a major public health concern, impacts up to 84% of the population in the region[2] and is one of the strongest risk factors for gastric cancer, leading to a recent regional clinical consensus meeting calling for eradication therapy to be offered to all individuals infected with H. pylori[3]. We are seeing rapid growth of Talicia in the U.S. in light of the alarming failure rates of clarithromycin-based therapies and growing physician awareness of the need for highly effective first-line H. pylori therapy. We continue to explore with potential partners the expansion of Talicia's reach into additional ex-U.S. territories."

"H. pylori can cause extensive damage if not properly eradicated first-time and there is considerable need for a therapy like Talicia in the UAE, where 41% of the population[4] is affected and have limited options for treatment," said Ghassan Aboud, Chairman of GAG. "Talicia would become the first approved combination product in the UAE specifically designed to treat H. pylori, and we are excited to be partnering with RedHill and at the prospect of realizing Talicia's potential to help patients with H. pylori infection in the UAE and potentially other territories in the region."

About Talicia®

Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.

Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[5] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[6].

Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.