Redhill Biopharma Ltd. CEO Dror Ben-Asher told BioWorld that the 2 million patients targeted by just-approved, delayed-release Talicia, previously known as RHB-105, for adult infection by Helicobacter pylori represents "the baseline where we start our promotion," and there's an opportunity to help many more patients. "When you combine the high prevalence of roughly 100 million Americans infected and more than half of the world's population with the association with gastric cancer, it's a major public health concern," he said. About 800,000 people worldwide die every year from gastric cancer, and about 90% of cases are caused by H. pylori.

Shares of the company (NASDAQ:RDHL) closed Monday at $7.35, up 43 cents.

Due to launch in the first quarter of next year, Talicia combines two antibiotics – amoxicillin and rifabutin – and the proton pump inhibitor omeprazole, to create a "paradigm-changing approach" thanks to rifabutin, which "overcomes the main challenge with H. pylori. Over a few years [from 2009 to 2013], you see doubling of the resistance and this keeps growing," Ben-Asher said. The label in first-line therapy "allows us to promote Talicia very broadly to prescribers and maybe also eventually also to patients directly. Unlike many other companies launching their first drug for the first time, we have been building and preparing for this moment for nearly three years," with commercial operations of the Tel-Aviv, Israel-based firm headquartered in Raleigh, N.C., and "primarily comprised of people [who] joined us from Salix" Pharmaceuticals Inc., of Bridgewater, N.J., with a focus on gastrointestinal (GI) disease. "We know what we are doing," he added. "We have already launched several products."

Research has shown H. pylori's ability to fend off attacks by clarithromycin has more than doubled between 2009 and 2013, and the infection hits about 35% of the adult population. Classified as a group 1 carcinogen, H. pylori stands as the strongest risk factor for peptic ulcer disease as well as gastritis and non-cardia gastric cancer.

Clearance of Talicia was based on two phase III studies, one yielding data in 2015 and a confirmatory experiment that finished last year. "The p value in the second one was even higher" than the first, Ben-Asher noted. The follow-on bid brought an 84% eradication of H. pylori infection with Talicia vs. 58% in the active comparator arm (p<0.0001). Further analysis showed that subjects with measurable blood levels of drug at day 13 had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm. No resistance to rifabutin turned up. Treatment discontinuation due to an adverse reaction occurred in 1% of patients (4/305) given Talicia. Problems leading to the patients' discontinuation of Talicia were nausea and vomiting, nausea, nasal congestion and nasopharyngitis, respectively. In a July report, Wainwright analyst Swayampakula Ramakanth said the candidate bore "a high likelihood of being approved," adding that "all eyes" were on the prospect. He projected revenues of $5 million in this year, growing to $60 million by 2025. (See BioWorld, June 16, 2015.)

Redhill filed the NDA in May, and U.S regulators granted Talicia qualified infectious disease product status as well as fast track designation. The compound's patent protection lasts until 2034.

At the United European Gastroenterology Week in Barcelona, Spain, last month, more disturbing numbers rolled out about H. pylori. A study analyzed 1,232 patients from 18 countries across Europe, investigating resistance to antibiotics regularly taken for the bug. Resistance to clarithromycin increased from 9.9% in 1998 to 21.6% last year, with increases in resistance also seen for levofloxacin and metronidazole.

Analyst Ramakanth issued another report Monday, reminding investors that Redhill's commercial team "has been gaining traction within the GI physician community" as the firm markets three in-licensed products: Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide) for irritable bowel syndrome (IBS) and acute enterocolitis; Enteragam (serum-derived bovine immunoglobulin/protein isolate) for chronic diarrhea; and Mytesi (crofelemer) for diarrhea in HIV/AIDS patients taking antiretroviral therapy. "To support Talicia's launch, the company plans to expand its sales force to approximately 140 representatives from the current size of 40," he wrote. "With the approval of Talicia in the rearview mirror, we believe investors would welcome a well-thought commercialization plan, and we expect a successful launch of Talicia to be a significant catalyst for the stock." Redhill has slated an analyst and investor day later this month.

Phase III winners in pipeline

Debt-free Redhill holds $59 million in cash and short-term investments, thanks to an influx last month from the deal with Dublin-based Cosmo Pharmaceuticals NV. That arrangement included an exclusive license agreement for the U.S. rights for Redhill to commercialize Aemcolo (rifamycin) and a simultaneous private investment by Cosmo of $36.3 million in Redhill at $7 per American depositary share, which was about 13.5% over the closing price the day before the pact was made public. Last November, Aemcolo 194-mg delayed-release tablets, a minimally absorbed antibiotic that is delivered to the colon, won FDA clearance for adults with travelers' diarrhea caused by non-invasive strains of Escherichia coli.

"We have a lot going on in R&D," Ben-Asher said, pointing to late-stage programs in Crohn's disease and gastroenteritis, as well as oncology programs supported by the National Cancer Institute. He promised "constant and exciting news flow" ahead. Recently, at the American College of Gastroenterology annual meeting in San Antonio, Texas, the company offered data with Talicia and RHB-104, a fixed-dose oral antibiotic combo for Crohn's disease (CD). RHB-104 is based on increasing evidence supporting the hypothesis that CD is caused by the Mycobacterium avium subspecies paratuberculosis infection in susceptible patients. The product has yielded positive data in a randomized, double-blind, placebo-controlled first phase III experiment in CD, meeting the primary endpoint and key secondary endpoints. Redhill said RHB-104 could work nicely as an add-on to standard treatments such as anti-TNF therapies. A phase IIa proof-of-concept study for multiple sclerosis was completed in Israel with encouraging top-line final results disclosed in December 2016

Redhill also has gained positive phase III results in gastritis and gastroenteritis with RHB-102 (to be branded Bekinda), described as an oral, extended-release (24 hours) once-daily pill formulation of the antiemetic drug ondansetron, a 5-HT3 serotonin receptor antagonist which is marketed under various trade names, including London-based Glaxosmithkline plc's Zofran. In diarrhea-predominant IBS, RHB-102 brought positive phase II data.

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