relativ unbekannte Biotechperle aus Israel
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Für das Q4 2014 werden die Daten von der Phase III Studie von RHB-105 für H. pylori Infektion erwartet. Darüber hinaus stehen für Q3/2014 die Anträge zur Vertriebszulassung für RHB-102 (Chemotherapie-induzierte Übelkeit und Brechreiz) und RHB-102 (akute Migräne) sowie die Initiierung der Phase III Studie für RHB-102 für eine weitere (noch nicht veröffentlichte) Indikation an.
Cash liegt aktuell bei USD 34 Mio, nachdem letztes Quartal von WILEX das Phase II Medikament MESUPRON übernommen wurde. Cashburn von etwa USD 4 Mio derzeit mit erhöhtem Forschungsaufwand durch die aktuellen Studien und ohne Berücksichtigung von Meilensteinzahlungen oder zukünftigen Verkäufen nach Zulassung.
Definitiv ein Topwert mit einer attraktiven Bewertung nach der jüngsten Konsolidierung von USD 21 auf unter USD 15.
Hier der aktuelle Quartalsbericht:
http://finance.yahoo.com/news/...eports-results-second-140000257.html
RedHill Biopharma Acquires Option for Phase II Pancreatic Cancer Drug RP101
By GlobeNewswire, August 13, 2014, 10:15:00 AM EDT
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Potentially expanding its gastrointestinal-focused pipeline, RedHill has secured an option to acquire RP101 from Dresden-based RESprotect GmbH, a spin-off from the Fraunhofer-Society
RP101 has completed several Phase I and Phase II clinical studies
RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
TEL-AVIV, Israel, Aug. 13, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, and RESprotect GmbH ("RESprotect"), a privately-held biotech company located in Dresden, Germany, today announced that they have entered into a binding exclusive option agreement for the acquisition of the oncology drug candidate RP101 and next generation compounds. RP101 is a proprietary, first-in-class, heat shock protein 27 (Hsp27) inhibitor, administered orally, which may prevent the induction of resistance to chemotherapy (chemoresistance), thus maintaining sensitivity of the tumor to chemotherapy and potentially enhancing patient survival.
Under the terms of the agreement, RedHill has the option to acquire the worldwide exclusive rights to RP101 for all indications, other than to the pancreatic cancer indication in South Korea. RedHill has agreed to pay RESprotect for a one year option, which may be extended by RedHill under certain agreed terms. During the option period, RedHill may, at its discretion, conduct development activities with RP101. If RedHill elects to exercise the option, it will acquire the exclusive rights to RP101 for a total payment, for both the option and the acquisition of the rights, of $100,000, as well as potential milestone payments and tiered royalties on net revenues, ranging from single-digit to mid-teens.
RP101 is an orally administered, patent-protected small molecule which binds to Hsp27, a chaperone protein which is found in abnormally high levels in cancer cells, and inhibits its activity. The overexpression of Hsp27, which results in the amplification of a multidrug-resistance (MDR) gene, has been linked to tumor resistance to cytotoxic drugs and the development of metastasis. Chemoresistance limits the effectiveness of chemotherapy and can ultimately lead to treatment failure. By inhibiting Hsp27, RP101 may prevent chemoresistance and enhance the sensitivity of tumors to chemotherapy. RP101 is based on a new mechanism of action of the anti-viral drug brivudine, a nucleoside analogue approved and marketed in several European countries for the treatment of herpes zoster. RP101 has completed several clinical studies, including Phase II studies in pancreatic cancer. RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Dror Ben-Asher, RedHill's CEO, said: "Today's acquisition of an option for the Hsp27 inhibitor RP101 reflects RedHill's increasing strategic focus on new, clinical-stage, orally-administered treatments for patients suffering from gastrointestinal and inflammatory diseases, including pancreatic cancer and other gastrointestinal cancers, where there is a particularly strong need for better therapeutic options. Across several clinical studies, pancreatic cancer patients co-treated with RP101 and one or more chemotherapy agents were found to have longer overall survival than historical control pancreatic cancer patients treated with chemotherapy alone. In a randomized, placebo-controlled Phase II pancreatic cancer study, median overall survival was longer in patients receiving chemotherapy plus RP101 than in those receiving chemotherapy plus placebo in a subset of patients with high body surface area in the U.S. A scientific advice meeting with Germany's BfArM provided a possible pathway forward for the development of RP101." Mr. Ben-Asher added: "there are many government and other research and development grants available for gastrointestinal cancers and specifically for pancreatic cancer which we could potentially pursue, and there is also potential for regulatory designation of RP101 as an expedited program for a serious condition and unmet medical need. We are looking forward to exploring further development of RP101 with our new partners at RESprotect."
Prof. Rudolf Fahrig, RESprotect's CEO said: "We are delighted to sign this option agreement with RedHill Biopharma and look forward to work with our new partners at RedHill on the development of RP101."
About RP101:
RP101, invented by Prof. Rudolf Fahrig at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany, is an orally administered, patent-protected small molecule which binds to heat shock protein 27 (Hsp27) and inhibits its multidrug-resistance gene amplification activity. Hsp27 is a chaperone protein which is found in abnormally high levels in cancer cells and plays a key role in the development of therapy resistance and metastases. By inhibiting Hsp27, RP101 may prevent the induction of resistance to chemotherapy (chemoresistance) and maintain sensitivity of tumors to chemotherapy, thus potentially enhancing patient survival. RP101 has completed several Phase I and Phase II clinical studies with a total of 249 subjects treated, including Phase II studies in pancreatic cancer. RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. RedHill's current pipeline of proprietary products includes: (i) RHB-104- an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study; (ii) RHB-105- an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; (iii) RHB-102- a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting in advanced stages of development for multiple indications, including a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting planned for the third quarter of 2014. In addition, a Phase III study for an undisclosed indication is planned to commence in the third quarter of 2014, (iv) RHB-106- an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) MESUPRON® - a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vi) 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; (vii) RHB-103- an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review and a European marketing application planned for the third quarter of 2014; and (viii) RHB-101- a once-daily oral pill formulation of the cardio drug carvedilol. For more information please visit www.redhillbio.com
About RESprotect:
RESprotect GmbH is a Dresden-based, privately-held biotech company specializing in the development of drugs for the prevention and treatment of chemotherapeutic drug resistance and radiation therapy resistance. For more information, please visit www.resprotect.de
Read more: http://www.nasdaq.com/press-release/...1-20140813-00610#ixzz3AIq82JZ5
http://finance.yahoo.com/news/...s-eradicate-study-rhb-214002329.html
RedHill Biopharma Ltd. (RDHL) provided an update on the ongoing phase III study ERADICATE Hp, on pipeline candidate RHB-105, a fixed-dose combination therapy for Helicobacter pylori infection (H. pylori).
RedHill is now expanding the study to include additional subjects and clinical sites for better statistical powering and to expedite recruitment, respectively.
Based on prior discussions with the FDA, RedHill is now evaluating RHB-105 for the first line treatment of H. pylori infection irrespective of the ulcer status.
As per RedHill, the current standard treatments for H. pylori infection are approved to treat patients with only active or recent history of ulcers.
Consequently, RedHill has increased the number of subjects to be enrolled from 90 to 120 for the ERADICATE Hp study as a larger population will improve the study's statistical powering and reduce the potential impact of non-compliant subjects in meeting the primary endpoint of H. pylori eradication. RedHill is also increasing the total number of clinical sites to 12 from 8 in order to expedite recruitment.
The top line data from the study is expected to come out in the first half of 2015.
Moreover, under the Generating Antibiotic Incentives Now (GAIN) Act, H.pylori has been added to the FDA’s list of qualifying pathogens. Subsequently, new drugs indicated to treat H. pylori may be designated as a Qualified Infectious Diseases Product (:QIDP) and will be entitled for additional five years of exclusivity, along with fast track status and priority review by the FDA.
RedHill also plans to conduct a confirmatory phase III study to support its NDA filing for RHB-105. Hence, the successful development and commercialization of RHB-105 will be a significant boost for RedHill.
RedHill Biopharma Initiates Phase III Study of RHB-102 for Gastroenteritis
•§The randomized, double-blind, placebo-controlled, parallel group Phase III study with RHB-102 (the GUARD study) will enroll 320 acute gastroenteritis patients in the U.S.
•§Acute gastroenteritis is an inflammation of the gastrointestinal tract causing nausea and vomiting, with a potential worldwide market estimated to exceed $650 million
•§If approved for marketing by the FDA, RHB-102 is expected to be the first-ever 5-HT3 antagonist drug indicated for acute gastroenteritis
•§Dr. Robert A. Silverman, MD, MS, Emergency Medicine specialist at the Hofstra North Shore-Long Island Jewish ("LIJ") Medical Center and Associate Professor at the Hofstra North Shore-LIJ School of Medicine will act as the lead investigator for the GUARD study
•§RedHill is focused on inflammatory and gastrointestinal ("GI") diseases, including GI cancers, and is currently conducting three Phase III GI studies in the U.S., including the RHB-102 GUARD study for gastroenteritis, the RHB-104 MAP US study for Crohn's disease and the RHB-105 ERADICATE Hp study for H. pylori infection
TEL-AVIV, Israel, Sept. 3, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that it is initiating a Phase III clinical study designed to evaluate the safety and efficacy of RHB-102 in patients suffering from acute gastroenteritis, an inflammation of the gastrointestinal tract which causes, among other symptoms, nausea and vomiting. RHB-102 is a proprietary, oral, extended-release, once-daily formulation of the antiemetic drug ondansetron.
Acute gastroenteritis is an inflammation of the mucus membranes of the gastrointestinal tract, most commonly caused by a viral infection. Symptoms of gastroenteritis include nausea, vomiting, diarrhea and abdominal pain. With over 179 million cases annually in the U.S. alone1, the worldwide potential market could exceed $650 million annually2.
The randomized, double-blind, placebo-controlled, parallel group Phase III study will be conducted in up to 10 clinical sites in the U.S. and is expected to enroll 320 adults and children over the age of 12 who suffer from acute gastroenteritis. Patients will be randomized to receive either RHB-102 or a placebo. The primary endpoint for the study is the absence of vomiting from 30 minutes after the first dose through the discharge from the emergency department. Secondary endpoints include frequency of vomiting, severity and time to resolution of nausea, and time to resumption of normal activities. Top-line results from the RHB-102 Phase III GUARD study are expected during the second half of 2015.
Following prior discussions with the U.S. Food and Drug Administration ("FDA") and the UK Medicines and Healthcare Products Regulatory Agency ("MHRA"), the GUARD study is intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. If approved for marketing by the FDA, RHB-102 could become the first-ever 5-HT3 antiemetic drug indicated for the treatment of acute gastroenteritis.
Dr. Robert A. Silverman, MD, MS, RHB-102 GUARD Phase III study lead investigator, said: "I am very pleased to take part in this important study in which we will assess the efficacy of RHB-102 in patients presenting to the hospital emergency room with acute gastroenteritis. If approved, RHB-102 could potentially decrease the number of emergency room visits of patients suffering from acute gastroenteritis by offering them a long-lasting oral treatment which can be taken in the comfort of their home."
Dr. Reza Fathi, RedHill's Senior VP Research and Development, added: "The GUARD study with RHB-102 for acute gastroenteritis further establishes RedHill's focus on gastrointestinal and inflammatory diseases and expands the Company's reach into this high unmet-need therapeutic space. It is the third GI-focused Phase III study that RedHill is currently conducting in the U.S., along with the RHB-104 MAP US study for Crohn's disease and the RHB-105 ERADICATE Hp study for H. pylori infection."
Ondansetron, a 5-HT3 antagonist and the active pharmaceutical ingredient in RHB-102, has been approved in the U.S. and Europe, in oral immediate release and non-oral forms, for the prevention and treatment of chemotherapy and radiotherapy-induced nausea and vomiting. No formulation of ondansetron or any other 5-HT3 antagonist has been approved by the FDA for the treatment of gastroenteritis. RHB-102 is a proprietary, extended-release (24 hours), oral pill formulation of ondansetron.
In parallel to the Phase III study for gastroenteritis, RedHill is pursuing marketing approval of RHB-102 for the indications of chemotherapy-induced and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively) in the U.S. and Europe. Following a positive European scientific advice meeting with the UK's MHRA, and a successful comparative bioavailability study comparing RHB-102 to a European reference drug, RedHill plans to submit a European Marketing Authorization Application for RHB-102 by October 2014 for the indications of CINV and RINV prevention. RedHill has also held a pre-New Drug Application (pre-NDA) meeting with the FDA regarding the development of RHB-102 for CINV and RINV prevention in the U.S. Following the pre-NDA meeting and in light of the FDA's feedback, RedHill provided the FDA with additional information and is currently awaiting the FDA's response.
About RHB-102:
RHB-102 is a patent-protected, extended-release (24 hours) oral pill formulation of ondansetron, the active ingredient in GlaxoSmithKline's Zofran® for the prevention of radiotherapy-induced nausea and vomiting (RINV) and chemotherapy-induced nausea and vomiting (CINV). RedHill is developing RHB-102 for the treatment of gastroenteritis as well as for the prevention of CINV and RINV. A Phase III clinical study of RHB-102 for acute gastroenteritis is currently being initiated in the U.S., with top-line data expected by the second half of 2015. Gastroenteritis is an inflammation of the gastrointestinal tract causing symptoms which include nausea, vomiting, diarrhea and abdominal pain. There are over 179 million cases of acute gastroenteritis in the U.S. annually3 resulting in estimated related costs to the U.S. healthcare system of 3.88 billion annually4. The worldwide potential market for RHB-102 for acute gastroenteritis could exceed $650 million annually5. If approved for marketing by the FDA, RHB-102 is expected to be the first-ever 5-HT3 antiemetic indicated for acute gastroenteritis. In addition to gastroenteritis, RHB-102 is being developed for oncology support indications as it holds clear potential advantages to cancer patients over the immediate release oral ondansetron tablets currently on the market, including enhanced patient compliance and adherence due to increased convenience of use. A pre-NDA meeting with the FDA was held in the first quarter of 2014 and an MAA submission in Europe for prevention of chemotherapy and radiotherapy-induced nausea and vomiting is planned by October of 2014. RHB-102 is targeting a considerable segment of the existing 5-HT3 antiemetic market which is estimated to have worldwide sales of approximately $940 million in 20136.
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 drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. RedHill's current pipeline of proprietary products includes: (i) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study; (ii) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection, with an ongoing Phase III study; (iii) RHB-102 - a once-daily oral pill formulation of ondansetron with a Phase III study in the U.S. for acute gastroenteritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting planned by October 2014; (iv) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) MESUPRON® - a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vi) 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; (vii) RHB-103 - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review and a European marketing application planned for the third quarter of 2014; and (viii) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol. For more information please visit www.redhillbio.com
RedHill Biopharma Business Outlook and Anticipated Key Milestones for 2015
Upcoming milestones include:
•§Top-line data from ongoing first Phase III study with RHB-105 for H. pylori infection expected Q2/2015
•§Top-line data from ongoing Phase III study with BEKINDA™ (RHB-102) for gastroenteritis and gastritis expected Q3-Q4/2015
TEL-AVIV, Israel, Jan. 5, 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 selected key milestones and events anticipated in 2015.
Dror Ben-Asher, RedHill's CEO, noted: "Heading into 2015, our pipeline is well balanced, with three ongoing Phase III programs and two products for which three marketing applications have been filed, as well as a number of new earlier-stage development programs reflecting our continued commitment to addressing unmet medical needs. We are looking forward to important development and regulatory milestones throughout the year."
Gastrointestinal-Inflammatory Diseases and Oncology
RHB-105 for H. pylori bacterial infection
•§Q2/2015 - Top-line data expected from the first Phase III study with RHB-105, currently ongoing in the U.S. (the ERADICATE Hp study).
The Phase III ERADICATE Hp study follows a successful Phase II study which demonstrated eradication rates exceeding 90% in 130 subjects who had previously failed at least one course of standard of care therapy for H. pylori infection.
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, intended to encourage new antibiotic drugs for the treatment of serious or life-threatening infections. This designation allows for an additional five years of market exclusivity, Fast-Track status (an expedited development pathway) and Priority Review status (shortened review time for marketing applications).
In addition, RedHill is pursuing a significantly broader indication with RHB-105 than existing treatments by targeting H. pylori infection as a first line treatment regardless of ulcer status, and estimates the potential target U.S. market at approximately $1-1.5 billion annually1. Approximately two-thirds of the world's population is infected with H. pylori, a major cause of chronic gastritis, peptic ulcer disease and gastric cancer2.
BEKINDA™ (RHB-102) - for gastroenteritis and gastritis, and for chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV respectively)
•§Q3-Q4/2015 - Top-line data expected from the Phase III study for acute gastroenteritis and gastritis (the GUARD study), currently ongoing in the U.S. 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 annually3.
•§H2/2015 - Expected regulatory feedback regarding the European Marketing Authorization Application (MAA) submitted by RedHill in December 2014 for the oncology support indications of CINV and RINV. If approved in Europe, RedHill intends to use post-marketing data, along with data generated from prior studies, to further support a potential New Drug Application (NDA) in the U.S. for CINV.
•§Q2-Q3/2015 -Planned commencement of a Phase IIa proof of concept study for a new undisclosed indication.
RHB-104 - for Crohn's disease and other inflammatory diseases
•§Q2/2015 - Expected announcement of planned timelines for the interim analysis by the independent DSMB (Data Safety and Monitoring Board) and for the completion of the ongoing first Phase III study with RHB-104 for the treatment of Crohn's disease (the MAP US study).
•§H1/2015 - Expected announcement of regulatory and development plan for the Mycobacterium avium subspecies paratuberculosis (MAP) diagnostic test following FDA meeting scheduled for January 2015.
•§Q2-Q3/2015 - Potential European regulatory clearance of the Clinical Trial Authorization (CTA) application for the second Phase III study with RHB-104 for the treatment of Crohn's disease (the MAP Europe study).
•§H2/2015 - Top-line interim results expected from the ongoing Phase IIa proof of concept study with RHB-104 for the treatment of multiple sclerosis (MS) (the CEASE-MS study).
•§H2/2015 - Planned commencement of a proof-of-concept study to further assess the efficacy and safety of RHB-104 for the treatment of rheumatoid arthritis (RA).
RHB-106 - encapsulated bowel cleanser
•§Q2-Q3/2015 - Planned initiation of a clinical study by Salix Pharmaceuticals, Inc. ("Salix").
In February 2014, RedHill and Salix entered into an exclusive worldwide license agreement for RHB-106 and other purgative developments.
RedHill received an upfront payment of $7 million and Salix agreed to pay an additional $5 million in subsequent potential milestone payments to RedHill, as well as tiered royalties on net sales ranging from low single digits up to low double digits.
Salix publicly estimated its encapsulated bowel prep prescription share outlook at 20% of the market and annual revenues of $280 million (peak year).
MESUPRON® and RP101 - for GI-oncology indications
•§H2/2015 - Initial data from nonclinical studies which RedHill plans to conduct to further evaluate the mechanisms of action and define the patient populations for its newly acquired Phase II orally-administered oncology drugs targeting GI (pancreatic cancer in particular) and other solid tumors; MESUPRON®, a first-in-class urokinase-type plasminogen activator (uPA) inhibitor, and RP101, a first-in-class heat shock protein 27 (Hsp27) inhibitor.
Other Programs
RIZAPORT™ (RHB-103) - for acute migraines
•§H2/2015 - Expected regulatory feedback regarding the European Marketing Authorization Application (MAA) submitted in October 2014 by RedHill and its Canadian co-development partner IntelGenx Corp. ("IntelGenx").
•§H2/2015 - Expected FDA announcement of a new PDUFA date. RedHill and IntelGenx continue to work with the FDA to address the remaining Chemistry, Manufacturing and Controls (CMC) matters and secure a compliant source of raw material.
•§H1/2015 - RedHill and IntelGenx continue negotiations with potential commercialization partners and, to the extent feasible, plan to conclude discussions with a U.S. commercialization partner.
RHB-101 for heart failure, left ventricular dysfunction and hypertension
•§H1/2015 - A non-binding letter of intent (LoI) for the out-licensing of RHB-101 has been executed between RedHill and a potential European partner for the manufacturing and commercialization of RHB-101 in a specified EU territory, as well as the supply of finished product to RedHill or its sublicensees for the rest of the EU. RedHill plans, to the extent feasible, to complete the above-mentioned transaction during the first half of 2015.
Following a Scientific Advice meeting with the Danish Health and Medicines Authority (DKMA) and a Type B meeting with the FDA, RedHill believes that no further clinical studies will be required prior to submission of the MAA in Europe, and that a comparative bioavailability study and a dose linearity study will be required prior to submission of an NDA to the FDA.
Ebola virus disease - early stage, nonclinical, development program
•§H1/2015 - As part of its commitment to address unmet medical needs, RedHill is planning to commence in the coming weeks a first nonclinical research collaboration with a U.S. government agency to test the antiviral activity of a proprietary experimental combination therapy of orally-administered actives.
The Ebola virus is highly prioritized by the U.S. government (as a "Category A" agent) and other governments. RedHill is currently focused on establishing additional early-stage research collaborations with other governments and public health authorities for the development of a treatment for the Ebola virus infection and secondary bacterial infections. The Ebola virus can cause severe hemorrhagic fever in humans and has a mortality rate ranging from 25% to 90%4.
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™ (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) MESUPRON® - a Phase II-stage uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vi) 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; (vii) RIZAPORT™ (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 (viii) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol. For more information please visit www.redhillbio.com
RedHill Biopharma to Present at Biotech Showcase(TM) 2015 Conference in San Francisco
TEL-AVIV, Israel, Jan. 9, 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 Adi Frish, RedHill's Senior VP Business Development and Licensing, will be presenting at Biotech Showcase™ 2015 Conference on Monday, January 12, 2015, at 14:00 PST in the Mission II room at the Parc 55 Wyndham San Francisco Union Square Hotel.
Mr. Frish will provide an overview of RedHill's business and anticipated key milestones for 2015 and will be available to participate in one-on-one meetings. Meetings with management may also be scheduled outside of the conference by contacting RedHill or The Trout Group (see contact details below).
A live webcast and subsequent archived replay of the presentation to be made will be available, along with a copy of the presentation, on the Company's website at: http://ir.redhillbio.com/events.cfm.
RedHill Biopharma to Present at the 3rd Annual Autoimmune & Inflammation Leaders' Forum 2015
EL-AVIV, Israel, March 23, 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 Ira Kalfus, MD, RedHill's Medical Director, will present at the 3rd Annual Autoimmune & Inflammation Leaders' Forum 2015 on Wednesday, March 25, 2015, at 12:15 pm EDT, at the Hilton Boston Logan Airport Hotel, in Boston, MA.
Dr. Kalfus will present a case study utilizing therapy targeting Mycobacterium avium paratuberculosis and the study rationale for RedHill's ongoing RHB-104 Phase III Crohn's disease development program, under the topic of "Clinical data/strategy updates on the most promising and innovative novel therapeutic candidates against a range of target indications - comparing and contrasting approaches and results."
Statement Adi Frish: With the acquisition of ABC294640 we adhere to RedHill's multiple-shots-on-goal strategy.
Damit wird die Wahrscheinlichkeit immer höher, dass eines der Medikamente der prallen eine Zulassung erhält und damit weitaus höhere Bewertungen für Redhill rechtfertigt.
Charttechnisch sieht es auch gut aus, die MA 50 wurde gestern übersprungen. In Q2 stehen Daten einer PIII Phase an, meiner Meinung nach stehen wir hier noch in Q2 über 20 USD.
Hier die News:
RedHill Biopharma Acquires Phase II First-in-Class Oral Small Molecule SK2 Inhibitor From Apogee Biotech
•§ABC294640 is a proprietary, first-in-class, new chemical entity (NCE) sphingosine kinase-2 (SK2) inhibitor, administered orally, 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, and is in line with RedHill's pipeline of mid-to-late clinical-stage, proprietary, oral small molecule drug candidates
•§RedHill has acquired the exclusive worldwide rights to ABC294640 from U.S.-based Apogee Biotechnology Corp., funded to date by over $14 million primarily through grants and contracts from U.S. federal and state government agencies, such as the FDA, Department of Defense (DoD), and the National Institutes of Health (NIH), including the National Cancer Institute and BARDA
•§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 in Q2/2015; A second Phase II study in multiple myeloma is planned, subject to a pending National Cancer Institute/SBIR grant; A third Phase II study is planned by RedHill to assess ABC294640 as a radio-protectant and radiation enhancer in cancer patients receiving radiotherapy
TEL-AVIV, Israel, March 31, 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, and Apogee Biotechnology Corporation ("Apogee"), a privately-held biotech company located in Hummelstown, Pennsylvania, U.S., today announced that they have entered into an exclusive worldwide license agreement under which RedHill has acquired the rights to the Phase II drug candidate ABC294640 and additional intellectual property rights. ABC294640 is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal (GI) and oncology indications.
Under the terms of the agreement, RedHill has acquired the exclusive worldwide development and commercialization rights to ABC294640 and additional intellectual property for all indications. RedHill will pay Apogee an upfront payment of $1.5 million, as well as an additional $4 million in potential milestone payments, and potential tiered royalties starting in the low double-digits.
ABC294640 inhibits SK2, a lipid kinase that catalyzes formation of the lipid signaling molecule sphingosine 1-phosphate (S1P). S1P promotes cancer growth, and proliferation and pathological inflammation, including TNFα signaling and other inflammatory cytokine production. Specifically, by inhibiting the SK2 enzyme, ABC294640 blocks the synthesis of S1P which regulates fundamental biological processes such as cell proliferation, migration, immune cell trafficking and angiogenesis, and are also involved in immune-modulation and suppression of innate immune responses from T cells. Preliminary evidence suggests that because of its specificity for targeting SK2, rather than SK1, ABC294640 may have a better therapeutic ratio than nonspecific sphingosine kinase inhibitors or those targeting only SK1.
Apogee received cumulative funding exceeding $14 million to support the development of ABC294640, primarily through grants and contracts from U.S. federal and state government agencies such as the NIH Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) program, including funding from the National Cancer Institute (NCI), the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), the Department of Defense (DoD), the FDA Office of Orphan Products Development and the Pennsylvania Department of Health.
With this funding Apogee has completed numerous successful pre-clinical studies with ABC294640 in GI-inflammation, radioprotection and oncology models, as well as a successful Phase I clinical study in cancer patients with advanced solid tumors. The open-label, dose-escalation Phase I clinical study demonstrated the drug's safety and assessed its pharmacokinetics and pharmacodynamics in cancer patients with advanced solid tumors.
A Phase Ib/II clinical study with ABC294640 for refractory/relapsed diffuse large B cell lymphoma (DLBCL) is planned to commence in the second quarter of 2015 and will be funded by a $1.5 million grant awarded by the National Cancer Institute under the NIH SBIR/STTR program to Apogee in conjunction with the Louisiana State University Health Science Center. The study will include approximately 30 patients and is intended to assess the tolerability of ABC294640 within the DLBCL population, as well as provide a preliminary evaluation of efficacy. A second Phase II clinical study of ABC294640 for the treatment of multiple myeloma is planned, subject to funding by a pending grant from the National Cancer Institute. A third Phase II clinical study is being planned by RedHill in order to evaluate ABC294640 as a radio-protectant and radiation enhancer in cancer patients undergoing radiotherapy.
Furthermore, multiple pre-clinical studies funded by the NIH (BARDA) and the DoD have demonstrated activity of ABC294640 against gastrointestinal injury from accidental acute radiation exposure. Therefore, a possible additional indication of protection against accidental radiation exposure may qualify as a medical countermeasure under the Animal Rule, under which no human efficacy studies would be required for FDA approval.
"With a unique mechanism of action, ABC294640 is a novel potential treatment for multiple inflammatory and oncology diseases with strong unmet medical needs. In particular, the drug may be a unique and important treatment for prevention of severe toxicity and inflammation induced in many cancer patients by radiotherapy, while at the same time potentially enhancing the effectiveness of the radiotherapy treatment," said Dr. Terry Plasse, Medical Director at RedHill. "We are looking forward to further advancing this promising program into clinical studies, and plan a Phase II study to evaluate the ability of ABC294640 to decrease radiotherapy-induced toxicity."
Adi Frish, Senior VP Business Development and Licensing at RedHill added: "With the acquisition of ABC294640 we adhere to RedHill's multiple-shots-on-goal strategy. The acquisition of this potential blockbuster further expands our late clinical-stage pipeline, reflecting RedHill's solid commitment to patients suffering from inflammatory and gastrointestinal diseases, including cancer, who are in need of new treatment options. Thanks to the thorough development work conducted by Apogee, ABC294640 is supported by extensive pre-clinical, clinical and CMC package, as well as strong intellectual property protection, and we believe in its potential to become a leading treatment for multiple inflammatory, gastrointestinal and oncology indications. We are excited to continue advancing this important novel drug candidate, and would like to thank our new partners at Apogee for entrusting us with the development and commercialization of ABC294640."
Dr. Charles Smith, President and CEO at Apogee stated: "We are very pleased to be collaborating with RedHill to advance the clinical development of ABC294640 for the potential benefit of cancer patients. We view RedHill as an outstanding partner for this effort, and are particularly impressed by their demonstrated commitment to tackling the difficult problem of improving therapeutic outcomes and the quality of life for cancer patients. Additionally, RedHill's expertise with gastrointestinal inflammatory diseases provides a very strong foundation for clinical testing of this drug candidate, and we are looking forward to a successful outcome of this collaboration."
In addition to the three ongoing Phase III studies in GI indications (RHB-105 for H. pylori infection, BEKINDA™ (RHB-102) for gastroenteritis, and RHB-104 for Crohn's disease), RedHill's pipeline now includes three proprietary, Phase II-stage, orally-administered, first-in-class small molecule drug candidates intended to treat gastrointestinal and other solid tumor cancers, as well as other potential indications: Mesupron®, a urokinase-type plasminogen activator (uPA) inhibitor, RP101 (under an option-to-acquire), a heat shock protein 27 (Hsp27) inhibitor, and the newly-acquired SK2 inhibitor, ABC294640.
About ABC294640
ABC294640 is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting a number of potential inflammatory, oncology and gastrointestinal indications. By inhibiting the SK2 enzyme, ABC294640 blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. ABC294640 has completed multiple successful pre-clinical studies in inflammatory, GI, radioprotection and oncology models, as well as a Phase I clinical study in cancer patients with advanced solid tumors.
About Apogee Biotechnology Corp.
Apogee was founded in 2001 as a spinoff from Pennsylvania State University by Charles D. Smith, Ph.D., and is based at the Hershey Center for Applied Research in Hummelstown, Pennsylvania. Apogee's lead technology platform is orally available, small molecule inhibitors of the enzyme sphingosine kinase. The inhibitors have shown excellent preclinical efficacy in numerous tumor and inflammation models. Apogee is privately held, and has been financed to date exclusively through NIH and other grants and contracts.
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™ (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® - 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™ (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.
RedHill Biopharma Announces Completion of Patient Enrollment in the Phase IIa Study of RHB-104 for Multiple Sclerosis
•§The last patient has been enrolled in the Phase IIa, proof-of-concept clinical study evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing-remitting multiple sclerosis (the CEASE-MS study)
•§Interim results from the Phase IIa CEASE-MS study are expected in Q4/2015 - Q1/16
•§RHB-104 is also being evaluated as a treatment for Crohn's disease with an ongoing Phase III clinical study (the MAP US study) and a second Phase III study being planned (the MAP EU study)
TEL-AVIV, Israel, June 9, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that the last patient has been enrolled in the Phase IIa, proof-of-concept clinical study evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis (RRMS). RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
Seventeen patients were enrolled in the open label Phase IIa study (the CEASE-MS study), which is designed to assess the efficacy and safety of RHB-104 as an add-on therapy to interferon beta-1ain patients suffering from RRMS following 24 weeks of treatment. Patients are evaluated for an additional term of 24 weeks after completing treatment with RHB-104. The primary endpoint of the study is the number of combined unique active lesions after 24 weeks of treatment, as compared to baseline, and secondary endpoints include changes in cytokine levels, Mycobacterium avium subsp. paratuberculosis (MAP) status, relapse rate, Expanded Disability Status Scale (EDSS) and safety and tolerability of RHB-104. The CEASE-MS study is being conducted at two medical centers in Israel and interim results are expected either in the fourth quarter of 2015 or the first quarter of 2016.
Clara Fehrmann, RedHill's Director of Clinical Operations, said: "We are very pleased to have completed patient enrollment in the Phase IIa CEASE-MS study with RHB-104. The CEASE-MS study was initiated following four successful pre-clinical studies and is based on the hypothesis that a bacterially induced dysregulated immune system plays a role in the pathogenesis of multiple sclerosis. We are hopeful that the interim results from the CEASE-MS study, expected in late 2015 or early 2016, will contribute to the understanding of the development of multiple sclerosis and will provide new treatment alternatives for patients suffering from this disease."
RHB-104 is also being evaluated as a treatment for Crohn's disease and is currently undergoing a first Phase III clinical study in the U.S. and other countries (the MAP US study). Interim analysis of the MAP US study is expected in the second half of 2016. The primary endpoint is remission at week 26 of treatment. A second Phase III study with RHB-104 for Crohn's disease is planned in Europe (the MAP EU study) and clinical trial applications have been submitted.
•§Top-line results from the RHB-105 Phase III study demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105
•§The Phase III study successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70%, with high statistical significance (p < 0.001); No serious adverse events or unexpected safety issues identified
•§A meeting with FDA is being planned by RedHill to discuss the clinical and regulatory path for approval of RHB-105 as a potential best-in-class, first-line therapy for H. pylori infection, a major cause of gastric diseases, gastric cancer and MALT lymphoma
•§RHB-105 received FDA QIDP designation under the GAIN Act for serious or life-threatening infections, including Fast-Track development, Priority Review and extended market exclusivity for a total of 8 years
•§The 2015 global and U.S. market potential for H. pylori eradication therapies are estimated at approximately $4.83 billion and $1.45 billion, respectively
•§RedHill will host a conference call to discuss the Phase III top-line results today, June 15, 2015, at 8:30 a.m. EDT
TEL-AVIV, Israel, June 15, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced positive top-line results from its Phase III study with RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection. Top-line results from the study demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105.
The ERADICATE Hp first Phase III study successfully met its primary endpoint of superiority over historical standard of care efficacy levels of 70%, with high statistical significance (p < 0.001). No serious adverse events, new or unexpected safety issues were noted in the study.
The top-line results from the RHB-105 Phase III study, demonstrating achievement of primary endpoint, were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the clinical study report (CSR), expected in the third quarter of 2015.
Prof. David Graham, M.D., M.A.C.G., of the Baylor College of Medicine, a key opinion leader in the field of gastric cancer and H. pylori infection and Principal Investigator of the ERADICATE Hp study, said: "The outstanding results of the RHB-105 Phase III study, which demonstrated a 89.4% cure rate of H. pylori, are consistent with the hypothesis that this may represent a promise for a new and improved treatment for H. pylori infection, and could significantly contribute to the prevention of gastric cancer, MALT lymphoma and other gastrointestinal diseases and conditions. Given the current high levels of antibiotic resistance and treatment failures with current standard of care therapies, RHB-105 could become, if approved, a best-in-class treatment, improving and potentially saving patients' lives."
Ira Kalfus, M.D., RedHill's Medical Director, added: "On the basis of the clear success of the ERADICATE Hp study, and the Fast-Track designation of RHB-105, we look forward to meeting with FDA to discuss the clinical and regulatory path towards marketing approval in the U.S. No new or unexpected safety issues were identified. Efficacy and safety data from this study will be submitted for presentation at an upcoming medical meeting."
Gilead Raday, RedHill's Senior VP Corporate and Product Development, said: "We are enthusiastic about the strong Phase III top-line results of RHB-105 and its potential benefit to patients. Coupled with the QIDP designation, patent protection and expanded indication, RHB-105 should be well-positioned, if approved, for commercial success as a first-line therapy for the treatment of H. pylori infection. We would like to thank the patients, investigators and service providers who participated in this study."
The randomized, placebo-controlled, ERADICATE Hp Phase III study was designed to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori infection. A total of 118 dyspepsia patients with confirmed H. pylori infection were enrolled and treated in the ERADICATE Hp study, which was conducted in 13 clinical sites in the U.S. Subjects were randomized in a 2:1 ratio to receive either RHB-105 or a placebo, for a period of 14 days, and assessed for the eradication of H. pylori infection 28 to 35 days after completion of treatment and for the protocol-defined primary endpoint of superiority over historical standard of care efficacy levels of 70%.
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 the treatment of H. pylori infection - a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. Gastric cancer is the second most common cause of cancer deaths worldwide with approximately 1 million deaths per year, of which 95% are caused by H. pylori and may be preventable. Several countries have already started, or are planning, population-based H. pylori screening and treatment programs designed to eliminate gastric cancer1.
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 indicated only in patients with active or recent history of duodenal ulcer disease. 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 for this drug candidate. The ERADICATE Hp Phase III study is planned to be followed by a second Phase III study and additional studies may be required, subject to FDA feedback.
RHB-105 was designated by the FDA as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to incentivize the development of 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 in addition to the standard exclusivity period, for a total of 8 years of market exclusivity.
The 2015 global and U.S. market potential for H. pylori eradication therapies, at current branded prices, was 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 eradication2.
RedHill will host two conference calls, in English and in Hebrew, to review the top-line results of the RHB-105 ERADICATE Hp Phase III study. Please visit the Company's website for dial-in information and webcast access: http://ir.redhillbio.com/events.cfm
The English conference call will be held today, June 15, 2015, at 8:30 a.m. EDT (15:30 Israel time)
The Hebrew conference call will be held Tuesday, June 16, 2015, at 10:00 a.m. Israel time.
RedHill Biopharma Initiates Phase I/II Study of ABC294640 for Refractory Lymphoma
•§The Phase I/II study, led by Dr. Chris Parsons, MD, associate professor at Louisiana State University Health Sciences Center, is intended to evaluate the safety and tolerability of ABC294640 in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL), primarily patients with HIV-related DLBCL
•§ABC294640 is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal and oncology indications
•§To date, the development of ABC294640 has been funded primarily through grants and contracts in excess of $14 million from U.S. federal and state government agencies, such as the FDA, Department of Defense (DoD) and the National Institutes of Health (NIH), including the National Cancer Institute and BARDA
•§A second Phase II study is planned to evaluate ABC294640 as a radioprotectant in cancer patients undergoing therapeutic radiotherapy; A third Phase II study is planned for the treatment of multiple myeloma and is subject to a pending National Cancer Institute/STTR grant
TEL-AVIV, Israel, June 29, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that it has initiated a Phase I/II clinical study in the U.S. evaluating ABC294640 in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL).
ABC294640 is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal (GI) and oncology indications. SK2 is an innovative molecular target for anti-cancer therapy because of its critical role in catalyzing the formation of the lipid-signaling molecule sphingosine 1-phosphate (S1P), which is known to regulate cell proliferation and activation of inflammatory pathways. By inhibiting SK2, ABC294640 could potentially be effective in treating multiple inflammatory, oncologic and gastrointestinal diseases.
The Phase I/II study is intended to evaluate the safety and tolerability of ABC294640, as well as provide a preliminary evaluation of efficacy of the drug in patients with refractory/relapsed DLBCL, primarily patients with HIV-related DLBCL. Up to 33 patients are expected to be enrolled in the study, which will be conducted at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans. The study is funded primarily by a grant awarded by the National Cancer Institute (NCI) Small Business Technology Transfer (STTR) program. Dr. Chris Parsons, MD, an associate professor in the Departments of Medicine and Microbiology, Immunology & Parasitology at LSUHSC, is the lead investigator for the study.
Dr. Terry Plasse, MD, RedHill's Medical Director, said: "We are excited to initiate this translational study with ABC294640, carrying Dr. Parson's laboratory evaluations into an important clinical population of patients with refractory/relapsed diffuse large B-cell lymphoma, primarily patients with HIV-related DLBCL, a group of patients with substantial unmet medical needs. RedHill continues to advance towards additional Phase II clinical studies with ABC294640 as a radioprotectant in cancer patients undergoing therapeutic radiotherapy and, subject to a pending NCI/SBIR grant, multiple myeloma."
DLBCL is the most common subtype of non-Hodgkin's lymphoma, accounting for an estimated 30% of the 70,000 projected non-Hodgkin's lymphoma cases diagnosed in the U.S. in 20151. Many DLBCLs are etiologically linked to the human viruses which encode unique oncogenes contributing to tumor onset and progression. Standard treatments for DLBCL exhibit limited efficacy and incur significant toxicities.
The Phase I/II study was initiated following positive pre-clinical studies, led by Dr. Parsons, indicating the therapeutic activity of ABC294640 for virus-associated DLBCL, in an established xenograft model for Kaposi's sarcoma-associated herpesvirus-associated DLBCL, including reversal of disease progression for established tumors. The pre-clinical studies were performed in parallel with a successful Phase I study that demonstrated the drug's safety and assessed its pharmacokinetics and pharmacodynamics in cancer patients with advanced solid tumors.
RedHill acquired the rights to ABC294640 in March 2015 from U.S.-based Apogee Biotechnology Corporation ("Apogee"). Prior to the acquisition, Apogee completed numerous successful pre-clinical studies with ABC294640 in GI, inflammation, radioprotection and oncology models, as well as a successful Phase I clinical study in cancer patients with advanced solid tumors. The open-label, dose-escalation, Phase I clinical study demonstrated the drug's safety and assessed its pharmacokinetics and pharmacodynamics in cancer patients with advanced solid tumors. The development of ABC294640 was funded to date primarily through grants and contracts in excess of $14 million from U.S. federal and state government agencies, such as the FDA, Department of Defense (DoD) and the National Institutes of Health (NIH), including the National Cancer Institute and BARDA.
A second Phase II study of ABC294640 is planned to evaluate ABC294640 as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy. RedHill also plans a third Phase II clinical study for the treatment of multiple myeloma, subject to funding by a pending grant from the National Cancer Institute.
The Phase I/II study with ABC294640 for refractory/relapsed diffuse large B-cell lymphoma is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies: https://www.clinicaltrials.gov/ct2/show/...term=abc294640&rank=2.
http://finance.yahoo.com/news/...eports-results-second-100500980.html
Strong cash position of approximately $26.6 million at the end of the second quarter of 2015 and approximately $66 million as of July 28, 2015, following the Company's July 2015 public offering in the U.S.
Gross proceeds of $44.5 million from the Company's July 2015 public offering in the U.S., including the exercise of 277,143 ADSs by the underwriters under their over-allotment option; Participants in the public offering included prominent U.S. healthcare institutional investors
RedHill's partner, Salix Pharmaceuticals, confirmed that it continues the development of RedHill's RHB-106 solid oral bowel preparation program
Key milestones achieved in the second quarter of 2015 included positive top-line results from the RHB-105 (H. pylori) first Phase III study which successfully met its primary endpoint, completion of patient enrollment in the Phase IIa study with RHB-104 for multiple sclerosis, initiation of a Phase I/II study with ABC294640 for refractory lymphoma and acceptance of the RHB-104 Crohn's disease Phase III Clinical Trial Application in Europe
•§The publication in the peer-reviewed journal Molecular Cancer Research details promising pre-clinical results suggesting ABC294640 significantly inhibits prostate cancer tumor growth
•§RedHill filed a trademark application with the U.S. Patent and Trademark Office for the new brand name YELIVA™ for ABC294640
•§YELIVA™ (ABC294640) is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal and oncology indications
•§A Phase I/II study of YELIVA™ (ABC294640), supported by a grant from the National Cancer Institute (NCI), was recently initiated in the U.S. in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL), primarily in patients with HIV-related DLBCL
•§A second Phase II study is planned to evaluate YELIVA™ (ABC294640) as a radioprotectant in cancer patients undergoing therapeutic radiotherapy; A third Phase II study is planned for the treatment of multiple myeloma and is subject to a pending NCI grant
TEL-AVIV, Israel, Aug. 24, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal (GI) diseases, including gastrointestinal cancers, today announced the publication of an article evaluating the therapeutic potential of ABC294640, the Company's orally-administered first-in-class Sphingosine kinase 2 (SK2) selective inhibitor, in the treatment of prostate cancer. The article, authored by scientists from Apogee Biotechnology Corporation ("Apogee") and from the Kimmel Cancer Center at Thomas Jefferson University, will be published in Molecular Cancer Research and is available online on the journal's website. RedHill acquired the rights to YELIVA™ (ABC294640) in March 2015 from U.S.-based Apogee.
RedHill has also filed a trademark application with the U.S. Patent and Trademark Office (USPTO) for the new brand name YELIVA™ for ABC294640. Subject to USPTO and FDA approval, the new brand name for the potential commercial product will be YELIVA™.
•§Patients enrolled in the placebo arm of the ERADICATE Hp Phase III study received open-label standard-of-care (SoC) therapy for persistent Helicobacter pylori (H. pylori) infection; results from this group demonstrated a 63% H. pylori eradication rate, compared to the previously announced 89.4% eradication rate demonstrated in the RHB-105 arm of the study
•§These results further support the potential superior efficacy of RHB-105 over SoC, and validate the use of the historical SoC eradication threshold of 70% implemented as the control for the Phase III study's primary endpoint
•§RedHill entered into an agreement with Recipharm AB, a leading Swedish manufacturer, for the planned second Phase III study and potential future commercial supply of RHB-105; Recipharm will invest approximately $1.55 million in RHB-105 manufacturing capabilities
•§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
•§RedHill reported in June 2015 that the RHB-105 ERADICATE Hp Phase III study successfully met its primary endpoint with high statistical significance (p < 0.001); no serious adverse events related to the drug product or unexpected safety issues were identified; the clinical study report (CSR) for the study is expected in the fourth quarter of 2015
•§A meeting with the FDA is planned for Q4/2015 or Q1/2016, to discuss the path for approval of RHB-105 as a potential best-in-class, first-line therapy for H. pylori infection, a major cause of gastric diseases, gastric cancer and MALT lymphoma; RHB-105 received FDA QIDP designation under the GAIN Act, including Fast-Track development, Priority Review and extended market exclusivity for a total of eight years
TEL-AVIV, Israel, Sept. 8, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced additional supportive data from the first Phase III study with RHB-105 for eradication of H. pylori (the ERADICATE Hp Study). Results from the subsequent open-label treatment of patients in the placebo arm with standard-of-care (SoC) therapy for persistent H. pylori infection demonstrated a 63% eradication rate with SoC, compared to the previously reported 89.4% eradication rate demonstrated in the RHB-105 arm of the controlled study.
These results further support the potential superior efficacy of RHB-105 over SoC and validate the use of the historical SoC efficacy threshold of 70% implemented in the ERADICATE Hp study as the control for the study's primary endpoint. RedHill announced in June 2015 positive top-line results from the ERADICATE Hp Phase III study for the treatment of H. pylori bacterial infection. The top-line results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. The study successfully met its primary endpoint of superiority over historical SoC eradication rate levels of 70%, with high statistical significance (p < 0.001). No serious adverse events related to the drug product, new or unexpected safety issues were identified in the study.
Prof. David Graham, M.D., M.A.C.G., of the Baylor College of Medicine, a key opinion leader in the field of gastric cancer and H. pylori infection and Principal Investigator of the ERADICATE Hp Study, said: "The study's results of 63% eradication rate of H. pylori infection with standard-of-care (SoC) are in-line with recent literature and clinical experience and are indicative of the increasing and alarming rates of resistance of H. pylori bacteria to SoC treatment. Furthermore, it strengthens the RHB-105 Phase III study's primary endpoint results, and supports the potential superior efficacy of RHB-105 over SoC, with an 89.4% eradication rate. H. pylori is a leading cause of gastric cancer, peptic ulcer disease and MALT lymphoma, and the falling cure rates of SoC therapies represent a significant concern for healthcare authorities worldwide. Despite existing therapies becoming increasingly ineffective in eradicating H. pylori, no new therapies have been approved for this indication in the last decade."
Gilead Raday, RedHill's Senior VP Corporate and Product Development, added: "The positive top-line results from the first Phase III study with RHB-105 and the new SoC data lead us to believe that RHB-105 can potentially be positioned as a best-in-class, first-line therapy for eradication of H. pylori. We plan to meet with the FDA during the fourth quarter of 2015 or the first quarter of 2016 to discuss the future development plan of RHB-105 and the path to marketing approval of this important drug candidate in the U.S."
The randomized, placebo-controlled, ERADICATE Hp Phase III study was intended to evaluate the safety and efficacy of RHB-105 as a first-line treatment for confirmed H. pylori bacterial infection. A total of 118 non-investigated dyspepsia patients with confirmed H. pylori infection were enrolled and treated in the study, which was conducted in the U.S. Subjects were randomized in a 2:1 ratio to receive either RHB-105 or a placebo for a period of 14 days and assessed for the eradication of H. pylori infection. Subsequent to completion of the treatment period and the un-blinding of the study, subjects enrolled in the placebo arm were entitled to receive SoC therapy as prescribed by the treating physician in an open-label setting, and were assessed for the eradication of H. pylori infection 28-35 days after completion of treatment.
RedHill recently entered into an agreement with Recipham AB, a leading CMO (Contract Manufacturing Organization) for the manufacture of RHB-105. Under the terms of the agreement, Recipharm will be responsible for manufacturing RHB-105 for the planned second Phase III study and for future potential commercial supply of RHB-105. In order to support the manufacturing of RHB-105, Recipharm will invest approximately 13 million SEK (approximately $1.55 million) in manufacturing capabilities. Recipharm operates development and manufacturing facilities with approximately 2,200 employees in Sweden, France, the UK, Germany, Spain, Italy and Portugal and is headquartered in Jordbro, Sweden.
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.
Top-line and other results from the ERADICATE Hp Phase III study, demonstrating achievement of primary endpoint, were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures. Completion of the clinical study report (CSR) is expected in the fourth quarter of 2015.
RedHill Biopharma Announces $2 Million National Cancer Institute Grant for YELIVA(TM) (ABC294640) Phase II Study for Multiple Myeloma
•§The National Cancer Institute (NCI) $2 million grant is intended to support the Phase II study with YELIVA™ (ABC294640) for refractory or relapsed multiple myeloma, planned to be initiated by RedHill at Duke University Medical Center by the end of 2015
•§YELIVA™ (ABC294640) is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications
•§A Phase I/II study with YELIVA™ (ABC294640), also supported by a grant from the NCI, was recently initiated in the U.S. in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL)
•§A third Phase II study is planned to evaluate YELIVA™ (ABC294640) as a radioprotectant in cancer patients undergoing therapeutic radiotherapy
•§Top-line results from the Phase I study with YELIVA™ (ABC294640) for the treatment of advanced solid tumors are expected early in the fourth quarter of 2015, and a full analysis and final Clinical Study Report (CSR) are expected by the end of this year or early 2016
TEL-AVIV, Israel, Sept. 9, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal (GI) diseases, including cancer, today announced that the National Cancer Institute (NCI) has awarded a $2 million Small Business Innovation Research Program (SBIR) grant to support the planned Phase II study with YELIVA™ (ABC294640) for the treatment of refractory or relapsed multiple myeloma.
The grant covers a three year period and was awarded to Apogee Biotechnology Corporation ("Apogee") in conjunction with Duke University. RedHill acquired the rights to YELIVA™ (ABC294640), a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, from Apogee in March 2015.
RedHill plans to initiate the Phase II study of YELIVA™ (ABC294640) for the treatment of refractory or relapsed multiple myeloma by the end of 2015. The open-label, dose escalation Phase II study will be conducted at Duke University Medical Center and is planned to enroll up to 77 patients with refractory or relapsed multiple myeloma who have previously been treated with proteasome inhibitors and immunomodulatory drugs. Dr. Yubin Kang, MD, Associate Professor in the Division of Hematologic Malignancies and Cellular Therapy in the Department of Medicine at Duke University Medical Center, will be the lead investigator for the study, which received Institutional Review Board (IRB) approval from Duke University (DUHS IRB).
The primary objectives of the first portion of the study (Phase Ib) are to assess safety and determine the maximum tolerated dose (MTD) in this group of patients. Secondary objectives include assessment of antitumor activity and determination of the pharmacokinetic (PK) and pharmacodynamic (PD) properties of YELIVA™ (ABC294640) in refractory or relapsed multiple myeloma patients.
The primary objectives of the second portion of the study (Phase II) are to assess the overall treatment response rate and overall survival. Secondary objectives include evaluating the treatment response of YELIVA™ (ABC294640) in patients with refractory or relapsed multiple myeloma after three cycles of treatment and evaluation of pharmacodynamic markers.
YELIVA™ (ABC294640) is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-cancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and GI indications. SK2 is an innovative molecular target for anti-cancer therapy because of its critical role in catalyzing the formation of the lipid-signaling molecule sphingosine 1-phosphate (S1P), which is known to regulate cell proliferation and activation of inflammatory pathways. By inhibiting SK2, YELIVA™ (ABC294640) could potentially be effective in treating multiple oncology, inflammatory, and gastrointestinal indications.
RedHill recently initiated a Phase I/II clinical study in the U.S. evaluating YELIVA™ (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL), primarily in patients with HIV-related DLBCL, also supported by a grant from the NCI Small Business Technology Transfer (STTR) program. A third Phase II clinical study is planned to evaluate YELIVA™ (ABC294640) as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy.
The ongoing and planned Phase II studies follow numerous successful pre-clinical studies conducted with YELIVA™ (ABC294640) in GI, inflammation, radioprotection and oncology models, as well as a Phase I study in patients with advanced solid tumors, supported by grants from the National Cancer Institute (NCI) and the FDA's Office of Orphan Products Development (OOPD). RedHill recently announced that the last patient has completed the final scheduled follow-up visit in the Phase I study with YELIVA™ (ABC294640). Preliminary positive data from the Phase I study was presented by Apogee at the November 2013 Molecular Targets and Cancer Therapeutics meeting. The analysis of the study is currently ongoing and top-line results are expected to be announced early in the fourth quarter of 2015. A full analysis and the final Clinical Study Report (CSR) are expected by the end of the year or early 2016.
The studies with YELIVA™ (ABC294640) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.
•§The German Federal Institute for Drugs and Medical Devices (BfArM) has confirmed the positive outcome of the European Decentralized Procedure and informed RedHill and IntelGenx that the European Marketing Authorization Application (MAA) for RIZAPORT™ (RHB-103) is approvable
•§RedHill and IntelGenx plan to submit the final required documentation to the BfArM and to the Luxembourg regulatory authority next week, which is expected to lead to marketing approval of RIZAPORT™ in both countries, and will continue their close cooperation in order to obtain national phase approvals in other Decentralized Procedure (DCP) European territories
•§RIZAPORT™, an oral thin film formulation of rizatriptan for acute migraines, offers an innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water and pleasant flavor
•§RedHill and IntelGenx continue to work with the FDA to advance potential approval of the U.S. New Drug Application (NDA) submitted by the companies
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