RedHill Biopharma (RDHL) Issues Update on Pipeline, Upcoming Key Milestones

RedHill Biopharma (NASDAQ: RDHL) provided an update on its development pipeline and anticipated key milestones.

Key highlights and upcoming anticipated milestones include:

• Phase III top-line results with RHB-105 for the treatment of H. pylori bacterial infection are expected during the third week of June 2015, subject to completion of review requirements
• Phase III top-line results with BEKINDA™ for gastroenteritis and gastritis are expected in Q4/15 - Q1/16
• Phase III interim analysis of MAP US Crohn's study with RHB-104 expected in H2/16; European applications submitted for a second Phase III Crohn's study with RHB-104
• Notice of Allowance received from the USPTO for two new U.S. patents covering RHB-104, expected to be valid until at least 2029
• Last patient screened in the Phase IIa Proof of Concept study with RHB-104 for multiple sclerosis, with interim results expected in Q4/15 - Q1/16
• Phase Ib/II study of ABC294640 for refractory/relapsed diffuse large B cell lymphoma, supported by the National Cancer Institute, expected to commence in Q2 - Q3/2015

RHB-105 - for H. pylori bacterial infection

• Top-line results from the first Phase III clinical study with RHB-105 are expected in the third week of June 2015. The Phase III study (the ERADICATE Hp study) is currently ongoing in the U.S. for the treatment of H. pylori bacterial infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer, and mucosa associated lymphoid tissue (MALT) lymphoma
• RHB-105 was designated by the FDA as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act, allowing RedHill to benefit from fast-track development status for RHB-105, priority review, and, if ultimately approved by the FDA, an additional five years of marketing exclusivity, for a total of 8 years
• The 2015 global and U.S. market potential for H. pylori eradication therapies, at current branded prices, were recently estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication1

BEKINDA™ (RHB-102) - for gastroenteritis and gastritis, and for chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively)

• Top-line results from the Phase III study with BEKINDA™ for acute gastroenteritis and gastritis (the GUARD study), currently ongoing in the U.S., are expected either in the fourth quarter of 2015 or the first quarter of 2016. The results are intended to support potential future submissions of marketing applications in both the U.S. and Europe, targeting an estimated potential worldwide market exceeding $650 million annually2
• A meeting with the FDA is planned during the third quarter of 2015 to discuss the regulatory path of BEKINDA™ for the indications of acute gastroenteritis and gastritis, as well as a potential filing of a New Drug Application (NDA) for CINV
• RedHill recently received feedback from European regulatory agencies regarding the European Marketing Authorization Application (MAA) submitted by RedHill in December 2014 for the oncology support indications of CINV and RINV. Clinical and manufacturing-related comments have been discussed with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and a six-month extension was agreed to, in principle, with the MHRA
• A Phase IIa Proof of Concept study for a new undisclosed indication is planned to commence in the second half of 2015

RHB-104 - for Crohn's disease, multiple sclerosis and other inflammatory diseases

• Interim analysis of the Phase III study with RHB-104 for Crohn's disease (the MAP US study) is expected in the second half of 2016, after half of the 270 patients expected to be enrolled in the study have completed 26 weeks of treatment. The primary endpoint is remission at week 26 of treatment
• The Phase III MAP US study is currently enrolling patients in approximately 80 sites in the U.S., Canada, Israel and New Zealand, with new sites in Australia, New Zealand and Europe currently being added, for a total of up to 120 clinical sites
• Clinical trial applications have been submitted in Europe, and initial comments received and responded to, for RHB-104's second Phase III Crohn's disease study (the MAP EU study) with potential European regulatory clearance expected in the third quarter of 2015
• RedHill recently received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for two new patents covering RHB-104. Once granted, the patents are expected to be valid until at least 2029
• The last patient has been screened in the ongoing Phase IIa Proof of Concept study with RHB-104 for the treatment of multiple sclerosis (MS) (the CEASE-MS study), with interim results expected either in the fourth quarter of 2015 or the first quarter of 2016

ABC294640 - for multiple inflammatory-GI diseases and related oncology indications

ABC294640 is a proprietary, first-in-class, orally administered, new chemical entity (NCE) sphingosine kinase-2 (SK2) inhibitor, which has successfully completed numerous pre-clinical studies and a Phase I study in cancer patients with advanced solid tumors.

ABC294640 targets multiple inflammatory, gastrointestinal and oncology indications within RedHill's therapeutic focus.

• A Phase Ib/II study of ABC294640 for refractory/relapsed diffuse large B cell lymphoma, primarily funded by the National Cancer Institute/STTR, is planned to commence either in the second or third quarter of 2015
• A Phase II study in multiple myeloma is planned, subject to a pending National Cancer Institute/SBIR grant
• A Phase II study to assess ABC294640 as a radio-protectant and radiation enhancer in cancer patients receiving radiotherapy is being planned by RedHill

RHB-106 - bowel cleanser pill

• In February 2014, RedHill and Salix Pharmaceuticals, Inc. ("Salix") entered into a license agreement under which Salix acquired worldwide exclusive rights to RHB-106 and other purgative developments. In April 2015, Valeant Pharmaceuticals International, Inc. ("Valeant") announced the completion of its acquisition of Salix. The RHB-106 program is under review by Valeant following its acquisition of Salix

MESUPRON® - for pancreatic cancer and other solid tumors

• RedHill is preparing nonclinical studies to further evaluate the mechanism of action and define the patient population for MESUPRON®, a Phase II orally-administered small molecule drug targeting pancreatic cancer and other solid tumors. MESUPRON® is a first-in-class urokinase-type plasminogen activator (uPA) inhibitor

RP101 - for pancreatic cancer and other solid tumors

• RedHill is preparing nonclinical studies to further evaluate the mechanism of action and define the patient population for RP101, a Phase II orally-administered small molecule drug targeting pancreatic cancer and other solid tumors. RP101 is a first-in-class heat shock protein 27 (Hsp27) inhibitor

Ebola virus disease - early stage development program

• As part of a previously disclosed nonclinical research collaboration with a U.S. government agency, initial nonclinical studies have been completed, and RedHill is currently planning the next stage of development

RIZAPORT™ (RHB-103) - for acute migraines

• Regulatory feedback regarding the MAA submitted in October 2014 is expected either in the fourth quarter of 2015 or the first quarter of 2016
• RedHill and its Canadian co-development partner IntelGenx Corp. continue to work with the FDA to address the remaining Chemistry, Manufacturing and Controls (CMC) matters, and to secure a compliant source of raw material. The existing source of raw material for RIZAPORT™ has been successfully audited in recent months by non-U.S. regulatory agencies, as well as an independent auditor on behalf of RedHill, and is currently awaiting another FDA inspection, after which, and subject to a successful audit, a new FDA PDUFA date is expected

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