RedHill Biopharma Receives Notice of Allowance for Additional U.S. Patent for RHB-105 H. pylori Bacterial Infection Treatment
-- The U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new formulation patent application covering RHB-105 H. pylori bacterial infection treatment, to expire no earlier than 2034
-- Top-line results from the ongoing Phase III study with RHB-105 are expected in June 2015
-- RHB-105 targets a significantly broader indication than existing H. pylori therapies, as a first line treatment of H. pylori infection regardless of ulcer status, with the U.S. market for H. pylori eradication therapies estimated at approximately $1-1.5 billion annually
-- RHB-105 has been granted a QIDP designation by the FDA under the GAIN Act, thus benefiting from Fast-Track development status, Priority Review of a potential New Drug Application (NDA) and additional five years of exclusivity, for a total of 8 years of market exclusivity
TEL-AVIV, Israel, April 16, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent No. 14/179,197 covering the RHB-105 formulation. RHB-105 is a proprietary fixed-dose combination therapy of two antibiotics and a proton pump inhibitor (PPI), in an all-in-one oral capsule, targeting an indication of first line treatment of Helicobacter pylori (H. pylori) infection.
The new RHB-105 patent application is entitled "Pharmaceutical Compositions for the Treatment of Helicobacter Pylori". Once granted, the patent is expected to be valid until at least 2034.
"This new patent application strengthens the RHB-105 intellectual property estate and extends patent protection until at least 2034." said Guy Goldberg, RedHill's Chief Business Officer. "RHB-105 is intended to overcome the growing resistance of H. pylori bacteria to standard antibiotic treatments, which results in increasing treatment failure rates. With the new patent protection and QIDP designation from the FDA, which extends the market exclusivity period to a total of 8 years, RHB-105 could be well positioned commercially in the H. pylori treatment market, if approved. We look forward to receiving top-line results from the ongoing Phase III study with RHB-105 in June 2015."
RHB-105 is currently undergoing a first Phase III clinical study in the U.S. (the ERADICATE Hp study). The randomized, placebo-controlled study is intended to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori bacterial infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer, and mucosa associated lymphoid tissue (MALT) lymphoma. Top-line data from the Phase III study is expected in June 2015.
With RHB-105, RedHill is pursuing an indication of first line treatment of H. pylori infection regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori, which are typically limited and indicated to treat patients with an active or recent history of ulcers. If approved, RHB-105 may be the first H. pylori eradication therapy to target this broader indication, which would significantly expand the potential patient population on the label for this drug.
In November 2014, the U.S Food and Drug Administration (FDA) designated RHB-105 as a Qualified Infectious Disease Product (QIDP) under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage new antibiotic drugs for the treatment of serious or life-threatening infections. The designation allows RedHill to benefit from Fast-Track development status for RHB-105, providing for an expedited development pathway as well as Priority Review status, potentially leading to a shorter review time by the FDA of a New Drug Application (NDA), if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of 8 years of market exclusivity.
It is estimated that approximately two-thirds of the world's population is infected with H. pylori, and the potential market of H. pylori eradication therapies in the U.S. is estimated at approximately $1-1.5 billion annually1.
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for treatment of H. pylori infection. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer, and mucosa associated lymphoid tissue (MALT) lymphoma. RHB-105 is currently undergoing a first Phase III clinical study in the U.S. (named ERADICATE Hp) planned to be
followed, if successful, by a second Phase III study. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing for a Fast Track development pathway as well as Priority Review status, potentially leading to a shorter review time by the FDA of a New Drug Application (NDA), if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of 8 years of market exclusivity.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage, proprietary, orally-administered drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. RedHill's current pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection, with an ongoing first Phase
III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing first Phase III study; (iii) BEKINDA(TM) (RHB-102) - a once-daily oral pill formulation of ondansetron with a Phase III study in the U.S. for acute gastroenteritis and gastritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting submitted in December 2014; (iv) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) ABC294640 - a Phase II-stage orally-administered SK2 inhibitor targeting multiple inflammatory-GI diseases and related oncology indications; (vi) MESUPRON(R) - a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vii) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT(TM) (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA currently under discussions with the FDA and a European marketing application submitted in October 2014; and (ix) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.
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1 Approximately three million H. pylori infected patients are treated
per annum in the U.S. (Colin W. Howden, MD, et. al (2007), The American
Journal of Managed Care). Market size is estimated by the Company based
on the above number and the price of current treatments.
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The Trout Group