On January 12, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE: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 and inflammatory diseases and cancer, reported update on key programs, potential milestones and estimated timelines (Press release, RedHill Biopharma, JAN 12, 2017, View Source [SID1234517389]).
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Micha Ben Chorin, RedHill’s CFO, said: "We are heading into 2017 with important potential catalysts in the coming months and with several ongoing Phase III and Phase II programs for gastrointestinal indications. Following the recently announced U.S. co-promotion agreement for Donnatal1, RedHill is advancing its strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with commercial presence in the U.S. This transition is planned to support potential future commercialization of RedHill’s Phase III-stage gastrointestinal drugs, if approved by the FDA. We are backed by strong institutional investors and maintain a debt-free balance sheet with approximately $70 million in cash, allowing us to continue to diligently execute our plans."
RHB-105 – H. pylori bacterial infection (confirmatory Phase III)
The confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection, expected to enroll 440 patients in up to 55 U.S. sites, is planned to be initiated by April 2017 following completion of an ongoing supportive pharmacokinetic (PK) program.
RHB-104 – Crohn’s disease (Phase III)
254 of the planned total of 410 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled first Phase III study in the U.S. and additional countries with RHB-104 for Crohn’s disease (the MAP US study).
A second independent data and safety monitoring board (DSMB) meeting of the MAP US study is expected in the second quarter of 2017, with an interim efficacy analysis and an option for early stop for success for overwhelming efficacy.
BEKINDA (RHB-102) – acute gastroenteritis (Phase III) and IBS-D (Phase II)
291 of the planned total of 320 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study). Top-line results are expected by mid-2017.
83 of the planned total of 120 subjects have been enrolled to date in the randomized, double-blind, placebo-controlled Phase II clinical study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results are expected in mid-2017.
YELIVA – Phase I/II studies for multiple oncology and inflammatory indications
RedHill is currently pursuing several Phase I/II clinical studies with YELIVA in the U.S., targeting oncology indications, with support from National Cancer Institute (NCI) grants awarded to Apogee Biotechnology and U.S. universities, including ongoing studies for advanced hepatocellular carcinoma (Medical University of South Carolina), refractory or relapsed multiple myeloma (Duke University Medical Center ) and refractory/relapsed diffuse large B-cell lymphoma and Kaposi sarcoma (Louisiana State University Health Sciences Center).
Additional Phase I/II studies with YELIVA are in various stages of preparation, including a Phase Ib study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy, planned to be initiated in the first half of 2017.
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)
As part of RedHill’s strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with a commercial presence in the U.S., the Company entered earlier this month into an exclusive co-promotion agreement with a subsidiary2 of Concordia International Corp. (NASDAQ:CXRX) (TSX:CXR), granting RedHill certain U.S. promotion rights for Donnatal, 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)3. RedHill expects to initiate promotion of Donnatal in the coming months.
RIZAPORT (RHB-103) – acute migraines (approved for marketing in Germany)
Re-submission of the RIZAPORT NDA to the FDA is expected in the first half of 2017. RIZAPORT was approved for marketing in Germany under the European Decentralized Procedure (DCP) in October 2015 and a first commercialization agreement was signed with Grupo JUSTE S.A.Q.F for Spain and a second commercialization agreement was signed with Pharmatronic Co. for South Korea. RedHill continues discussions with additional potential commercialization partners for RIZAPORT in the U.S., Europe and other territories.
About Donnatal:
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal comes in two formulations: immediate release Donnatal Tablets and immediate release Donnatal Elixir, a fast acting liquid.
Donnatal is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.
Further information, including prescribing information, can be found on www.donnatal.com.
Please see the following website for important safety information about Donnatal: View Source