RedHill Biopharma to Host Webcast Today at 8:30 am EDT Following Announcement of Progress Update on RHB-104 Phase III Crohn's Disease Program Including the Introduction of an Option for Early Stop for Success in Q2/2017
TEL-AVIV, Israel, Oct. 06, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it will host an interactive webcast and conference call today, Thursday October 6th, 2016, at 8:30 a.m. EDT, to discuss the progress update on the RHB-104 Phase III Crohn's disease program.
Earlier today, the Company provided an update on its RHB-104 Phase III Crohn's disease development program including the introduction of an option for early stop for success for overwhelming efficacy in the second quarter of 2017, planned enhancements to the first Phase III study with RHB-104 (the MAP US study) and expected milestones and timelines.
Ira Kalfus, MD, Medical Director at RedHill Biopharma, noted: "The increased number of patients and new open-label program reflect the strong and growing interest we have had from our current investigators who see the potential benefit of RHB-104 and the value of participating in this important study." Dr. Kalfus further stated: "We do not expect these changes to significantly impact timelines and the addition of an interim analysis for early stop for success, expected in the second quarter of 2017, may in fact substantially shorten time to study completion."
RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. RedHill is developing RHB-104 for the treatment of Crohn's disease, with the ongoing MAP US Phase III study and for multiple sclerosis, with a Phase IIa study pending final results (the CEASE-MS study).
The interactive webcast and conference call will be held today, Thursday, October 6th, 2016 at 8:30 a.m. EDT. Participants who wish to ask questions during the event can do so by telephone.
The live interactive webcast of the event, including slide presentation, followed by a question-and-answer session, will be available through the Company's website at: ir.redhillbio.com/events.cfm. Please access the Company's website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
Audio-only access to the webcast and an option of asking questions during the event will also be available by telephone using the following dial-in information: United States: +1-877-280-1254; Israel: +972-3-763-0146; International: +1-646-254-3360. The access code for the call is: 8723708. The webcast and accompanying presentation materials will be archived and available for replay on the Company's website for 30 days.
About RHB-104: Currently in a first Phase III study for the treatment of Crohn's disease (the MAP US study), RHB-104 is a proprietary and potentially groundbreaking oral antibiotic combination therapy, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn's disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by Pharmacia/Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study. RHB-104 is covered by several issued and pending patents. RedHill is also conducting the CEASE-MS 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), with top-line interim results announced and top-line final results expected in the fourth quarter of 2016.
On October 6, 2016, RedHill Biopharma Ltd. (NASDAQ: RDHL) announced a number of changes and protocol enhancements to the ongoing Phase 3 Crohn's Disease (CD) program with RHB-104, dubbed MAP-U.S. The changes are designed to enhance the overall robustness of the study and provide a more comprehensive assessment of RHB-104’s treatment effect. These changes will allow RedHill to increase the pace of enrollment, as well as better evaluate all patients enrolled in the study and bolster the likelihood of success.
RedHill has both increased the size of the trial and the amount of data they plan to collect as part of the trials key endpoints. Importantly, an independent data safety monitoring board (DSMB) review of the trial will take place in the second quarter of 2017. This review will include both a safety and interim efficacy analysis, and could potentially provide the opportunity to expedite the data locking process for the final analysis. Furthermore, this DSMB review will also evaluate the option of an early stop for success, according to a pre-specified statistical significance threshold for analysis requiring overwhelming efficacy of RHB-104 versus placebo in the primary endpoint.
A Little Background Info
RHB-104 is a proprietary and potentially groundbreaking oral antibiotic combination therapy with potent intracellular, anti-mycobacterial, and anti-inflammatory properties. Development programs with RHB-104 include the Phase 3 MAP U.S. study for CD and a Phase 2a exploratory study for multiple sclerosis. The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by Mycobacterium avium paratuberculosis (MAP) infection in susceptible patients.
For a detailed look at RHB-104, see my article from July 2016: → RedHill's Phase 3 Crohn's Drug Is A Potential Game-Changer
RedHill is currently enrolling patients in a Phase 3 clinical study called MAP U.S. at up to 150 clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand. Target enrollment for the study is 410 patients. This is the first Phase 3 study conducted by the company with RHB-104. Additional studies will likely be required to support a U.S. approval of RHB-104 in CD.
The MAP U.S. study is a randomized, double-blind, placebo-controlled study intended to evaluate the safety and efficacy of RHB-104 in patients with moderately to severely active Crohn’s Disease, defined as Crohn’s Disease Activity Index (CDAI) from 220 to 450. Subjects enrolled in the study are randomized in a 1:1 fashion to receive RHB-104 or a placebo, with a primary endpoint of disease remission, defined as a reduction in CDAI to less than 150 at week 26. Secondary and exploratory endpoints include state of response at 26 weeks, maintenance of remission through week 52, and efficacy outcome measures in relation to the presence of Mycobacterium avium paratuberculosis (MAP) bacterial infection. Exploratory endpoints include endoscopic evaluation of mucosal healing.
Important Changes To The Study
As noted above, RedHill has made several important changes to the MAP U.S. study designed to enhance the overall robustness of the study and provide a more comprehensive assessment of the drug's treatment effect.
Size & Scope: Planned enrollment in the study has been increased from 270 patients to 410 patients. Management has increased the size of the study to expand the collection of clinical data including colonoscopic mucosal healing and compensate for early terminations. While expanding the enrollment may push back the final data analysis, management believes the costs associated with increasing the size of the study are manageable. Management also plans to add up to 30 new clinical sites in Europe, including sites in four new countries, which will bring the total number of sites actively recruiting patients to 150. This should help speed enrollment to 410 patients.
Increasing both the size and scope of the trial will allow RedHill to provide more data to the U.S. FDA ahead of discussions around the second Phase 3 program. The number of sites in Europe has been doubled, which should facilitate conversations with the EU EMA around approval of RHB-104 in Europe as well. Importantly, the primary endpoint of the study has not been changed; however, because the sample sizes have been increased, the detectable effect has been reduced from 21% to 15% to show statistically significant separation between RHB-104 and the placebo. This means the trial has a better chance of success.
Increased Review: An interim safety review by the independent DSMB is scheduled to take place here in the fourth quarter 2016. Subsequent reviews will take place when 50% and 75% of the patients complete 26 weeks of treatment. Management believes 50% completion will take place in the second quarter 2017. Importantly, this interim review will now include both a safety and efficacy analysis. The modifications to the design allow for sequential tests to be made. If the pre-specified statistical significance threshold for overwhelming efficacy (i.e. p-value < 0.003) is met at the interim analysis in the second quarter of 2017, the study could be stopped for early success. Should the pre-specified threshold not be met in the interim analysis, the study is planned to proceed through completion of randomization of the 410 patients and follow-up at 26 weeks, with final efficacy testing performed using a two-sided p-value of 0.049.
The introduction of the potential for early termination of the study is very interesting. This presents a clear major catalyst for the shares coming in the next 6-9 months. In my "RDHL Valuation" article published in September 2016, I noted that I believe RHB-104 is RedHill's most valuable asset, with a current net present value of $200 million. This exceeds the total current market value of the company at only $175 million.
Increased Retention: To improve patient retention and further expedite recruitment, RedHill is preparing to initiate an open-label extension study, offering all patients who complete 26 weeks of study drug administration and remain out of remission (CDAI>150) the opportunity to receive treatment with RHB-104 for a 52-week period. This not only helps RHB-104 provide additional data to the FDA and EMA on RHB-104's long-term safety profile but also assures that any patient that responds to the drug will have access for a full year. This has been heavily requested by principle investigators.
Additional Studies: RedHill has also reported that it plans to initiate two additional open-label, ex-U.S. clinical studies in up to 20 Crohn’s disease patients each to further evaluate the safety of efficacy of RHB-104, including generation of additional efficacy data in newly diagnosed and treatment-naïve Crohn’s disease patients and as an add-on therapy to current standard-of-care. Also, an extensive pharmacokinetic (PK) program is ongoing, including a population PK study which is being conducted as part of the MAP U.S. study along with previously completed food effect and drug-drug interaction studies. This additional data will help support the future potential marketing applications in both the U.S. and EU.
Separately, the company plans to present top-line data from the Phase 2a CEASE-MS study with RHB-104 for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the fourth quarter of 2016. Back in April 2016, RedHill provided an interim look at the trial. The data showed patients on RHB-104 achieved an annualized relapse rate (ARR) at 24 weeks of only 0.288 in the mITT population and 0.0 in the PP population. The 0.288 ARR number in the mITT group compares favorably with previously reported pivotal studies of interferon beta-1a therapies Avonex® (0.67)(1) and Rebif® (0.87-0.91)(2). The data also compares well to other first-line therapies referenced in Nature in 2011 (3).
RHB-104 Companion Diagnostic
Many researchers have noted the high correlation between MAP infection and incidence of CD. For example, MAP can be cultured from the peripheral mononuclear cells from 50–100% of patients with Crohn’s disease, and less frequently from healthy individuals (4, 5). Obviously, the association does not prove causation, but MAP would not be the first pathogenic bacteria known to cause gastrointestinal inflammatory conditions. The obligate pathogen H. pylori are the proven instigator of gastric and peptic ulcer disease (6).
Independent work conducted by a number of institutions has confirmed the link between CD and MAP infection. For example, a systemic review and meta-analysis published in Lancet Infectious Disease in 2007 noted a greater than 7x increase in odds for MAP infection (via PCR in tissue samples) and 1.7x increase in odds (via ELISA in serum) for patients with CD versus healthy controls (7). The authors, having looked at 28 case-controlled studies, concluded that, "The association of MAP and Crohn's disease seems to be specific, but its role in the aetiology of Crohn's disease remains to be defined."
In this regard, RedHill and Q2 Solutions (formerly Quest Diagnostics) continue to advance the development program for a commercial companion diagnostic for the detection of MAP bacteria in Crohn’s disease patients.
The collaboration with Q2 Solutions has led to successful results, including initial validation of RedHill’s platform PCR detection methodology licensed from the University of Central Florida (UCF) and developed by Professor Saleh A. Naser, a leading investigator in the field of MAP and its association with Crohn’s. Further testing of the technology at three different U.S. laboratories has successfully identified MAP DNA in blood samples drawn from patients with CD outside of the MAP U.S. study. Optimization of the processes for rapid detection of MAP is currently in progress.
Critical to the successful development of a companion diagnostic will be ensuring that any future commercial test is accurate and reproducible. RedHill believes that PCR (polymerase chain reaction) technology is the most promising approach currently available and is focusing its efforts in that direction. RedHill has recently initiated a collaboration with Baylor College of Medicine intended to advance further the efforts to develop a companion diagnostic for MAP. This collaboration is on top of the previous collaborations with UCF and the University of Minnesota.
I think things just got more interesting for investors in RedHill Biopharma around RHB-104. As noted above, this is the flagship asset in my opinion. I'm confident that RHB-105, which is about to start a second Phase 3 program for the treatment of H. pylori infection, has tremendous value. I'm also incredibly intrigued by Yeliva®, currently in Phase 2 studies for multiple solid tumor indications.
That being said, given the flurry of deals we have seen in the UC/CD space over the past few years, RHB-104 is the drug that will make RedHill a major player in specialty pharma. So far, 219 of the 410 patients have been enrolled. Full enrollment of the Phase 3 MAP U.S. study is expected by the end of 2017, which puts top-line data likely in the third quarter of 2018. This is admittedly a long way off; however, the interim analysis that will take place in the second quarter 2017 is now meaningful. Positive data has the potential to end the trial, after which RedHill will likely start entertaining partnership talks. It's a major catalyst for the shares only six months away.
EPS of $-0.07 beats by $0.51 | Revenue of $ (+ NaN% Y/Y) RedHill maintains a debt-free balance sheet with $40.5 million in cash at the end of the third quarter, allowing the Company to continue to diligently execute its three ongoing Phase III gastrointestinal disease programs and other clinical-stage programs
Recent key milestones include: Enhancement of the RHB-104 Phase III Crohn’s disease program, including the introduction of an option for early stop for success for overwhelming efficacy, expected in Q2/2017
Initiation of Phase II studies with YELIVA™ for multiple myeloma and hepatocellular carcinoma
Signing of an exclusive license agreement with Grupo JUSTE for the commercialization in Spain of RIZAPORT® oral thin-film migraine drug and filing of a national Marketing Authorization Application in Spain by Grupo JUSTE
Signing of a binding term sheet with Pharmatronic Co. for the commercialization of RIZAPORT® in South Korea
Potential milestones expected in the coming year include: Q4/2016 - Safety-focused independent data and safety monitoring board (DSMB) meeting for the MAP US Phase III study with RHB-104 for Crohn’s disease
Q4/2016 - Top-line final results from the ongoing Phase IIa CEASE-MS study with RHB-104 for multiple sclerosis
Q2/2017 - Independent DSMB evaluation of the MAP US Phase III study with RHB-104 for Crohn’s disease, including option for early stop for success for overwhelming efficacy
H1/2017 - Initiation of a confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection
Mid-2017 - Top-line results from the ongoing Phase III study with BEKINDA® for gastroenteritis and gastritis in the U.S. (the GUARD study)
Mid-2017 - Top-line results from the ongoing Phase II study with BEKINDA® for diarrhea-predominant irritable bowel syndrome (IBS-D) in the U.S.
H1/ 2017 - Re-submission of the RIZAPORT® U.S. NDA to the FDA TEL-AVIV, Israel, Nov. 14, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported its financial results for the quarter ended September 30, 2016.
The Company will host a conference call on Monday, November 14, 2016, at 9:00 am EST to review the financial results and business highlights, dial-in details are included below.
Financial highlights for the quarter ended September 30, 20161
Research and Development Expenses for the third quarter of 2016 were $7.0 million, an increase of $3.1 million, compared to $3.9 million in the third quarter of 2015 and an increase of $1.0 million, compared to $6.0 million in the second quarter of 2016. Research and Development Expenses for the nine months ended September 30, 2016 were $17.7 million, an increase of $4.9 million, compared to $12.8 million in the comparable period of 2015. The increase in 2016 resulted primarily from the ongoing Phase III MAP US study with RHB-104 (Crohn's disease), the ongoing Phase II and Phase III studies with BEKINDA® (IBS-D and gastroenteritis, respectively) and from preparations for several Phase I/II studies with YELIVA™ for multiple indications.
General, Administrative and Business Development Expenses in the third quarter of 2016 were $1.4 million, an increase of $0.7 million, compared to $0.7 million in the third quarter of 2015 and an increase of $0.2 million, compared to $1.2 million in the second quarter of 2016. General, Administrative and Business Development Expenses for the nine months ended September 30, 2016 were $3.8 million, an increase of $1.4 million, compared to $2.4 million in the comparable period of 2015. The increase was mainly due to enhanced business development and investor relations activities.
Operating Loss in the third quarter of 2016 was $8.5 million, an increase of $3.9 million, compared to $4.6 million in the third quarter of 2015 and an increase of $1.3 million, compared to $7.2 million in the second quarter of 2016. Operating Loss for the nine months ended September 30, 2016 were $21.6 million, an increase of $6.4 million, compared to $15.2 million in the comparable period of 2015. The increase was mainly due to increases in Research and Development Expenses, as detailed above.
Net Cash Used in Operating Activities in the third quarter of 2016 was $7.4 million, an increase of $3.7 million, compared to $3.7 million in the third quarter of 2015 and an increase of $1.7 million, compared to $5.7 million in the second quarter of 2016. Net Cash Used in Operating Activities for the nine months ended September 30, 2016 was $18.1 million, an increase of $6.3 million, compared to $11.8 million in the comparable period of 2015. The increase mainly reflects the increase in Operating Loss, as detailed above.
Net Cash Used in Investment Activities in the third quarter of 2016 was $10.7 million, compared to Net Cash Used in Investment Activities of $2.4 million in the third quarter of 2015. Net Cash Used in Investment Activities for the nine months ended September 30, 2016 was $3.2 million, an increase of $4.3 million, compared to Net Cash Provided by Investment Activities of $1.1 million in the comparable period of 2015. The increase in Net Cash Used in Investment Activities was due to an increase in bank deposits and marketable securities in 2016.
Cash Balance2 as of September 30, 2016 was $40.5 million, a decrease of $17.6 million, compared to $58.1 million as of December 31, 2015. The decrease was a result of the ongoing operations, mainly related to research and development activities.
“We are very pleased with the important operational milestones achieved during this quarter, including the significant enhancements to the RHB-104 Phase III development program for Crohn’s disease and the initiation of several clinical studies with our novel Phase II oncology drug YELIVA™” said Mr. Micha Ben Chorin, RedHill’s CFO. “We maintained a debt-free balance sheet and a cash position of $40.5 million at the end of the third quarter of 2016 as we continue to advance several Phase III and Phase II gastrointestinal programs toward important data points in the coming months. We also continue to advance our strategic plan to build a U.S. specialty GI pharmaceutical company.”
Conference Call and Webcast Information:
The Company will host a conference call on Monday, November 14, 2016, at 9:00 am EST to review the financial results and business highlights.
To participate in the conference call, please dial the following numbers 5-10 minutes prior to the start of the call: United States: +1-877-280-2342; International: +1-646-254-3367; and Israel: +972-3-721-9510. The access code for the call is 2341628.
The conference call will be broadcasted live and available for replay on the Company's website, ir.redhillbio.com/events.cfm, for 30 days. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.
Recent operational highlights:
On July 5, 2016, RedHill and its co-development partner, IntelGenx Corp. (IntelGenx), announced the signing of an exclusive license agreement with Grupo JUSTE S.A.Q.F (Grupo JUSTE), for the commercialization of RIZAPORT® oral thin-film for acute migraines. Under the terms of the agreement, RedHill granted Grupo JUSTE the exclusive rights to register and commercialize RIZAPORT® in Spain and a right of first refusal for a predefined term for additional territories. RedHill and IntelGenx received an upfront payment and are entitled to receive additional milestone payments upon the achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. Further financial terms of the agreement were not disclosed. Grupo JUSTE recently filed a national Marketing Authorization Application for RIZAPORT® in Spain and commercial launch in Spain is expected to take place in the second half of 2017.
On July 13, 2016, RedHill announced the signing of a research collaboration agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), intended to evaluate RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease. The new research collaboration follows encouraging results from preliminary non-clinical studies conducted in conjunction with the NIAID using RedHill’s proprietary experimental therapy. If successful, this study is intended to provide supportive data for discussions with the FDA for potential use of the Animal Rule pathway for approval. Ebola virus disease is a severe and often fatal illness, which can cause severe hemorrhagic fever in humans and has a mortality rate ranging from 25% to 90%3. There is currently no FDA-approved treatment for Ebola virus disease.
On July 21, 2016, RedHill announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering RHB-105. The patent application, entitled “Pharmaceutical Compositions For The Treatment Of Helicobacter Pylori” expands RedHill’s patent portfolio covering RHB-105 and is expected to be valid until 2034, once granted.
On August 1, 2016, RedHill announced that the last patient completed the final scheduled follow-up visit in the Phase IIa proof-of-concept clinical study evaluating RHB-104 in patients treated for relapsing-remitting multiple sclerosis (the CEASE-MS study). The analysis of the study is ongoing, with top-line final results expected in Q4/2016. Previously announced interim results after completion of the 24-week RHB-104 treatment period of the study demonstrated positive safety and efficacy signals and support further clinical development.
On August 29, 2016, RedHill announced that it had received from the European Patent Office a Notice of Intention to Grant for a new patent covering the use of RHB-104 in the treatment of multiple sclerosis. Upon grant by the European Patent Office, the patent is expected to be valid until 2032 and can be officially validated in up to 38 European countries.
On September 8, 2016, RedHill announced that a Phase Ib/II clinical study evaluating YELIVA™ in patients with refractory or relapsed multiple myeloma was initiated. The open-label, dose escalation Phase Ib/II study is being conducted at Duke University Medical Center and will enroll up to 77 patients with refractory or relapsed multiple myeloma who have previously been treated with proteasome inhibitors and immunomodulatory drugs. The study is supported by a $2 million grant from the National Cancer Institute Small Business Innovation Research Program awarded to Apogee Biotechnology Corp., in conjunction with Duke University, with additional support from RedHill.
On September 12, 2016, RedHill announced a research collaboration with Stanford University School of Medicine for the evaluation of YELIVA™. The research collaboration is intended to complement RedHill’s planned Phase Ib clinical study to evaluate YELIVA™ as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy. Results from the research collaboration are expected in mid-2017.
On September 21, 2016, RedHill and IntelGenx, announced that they had entered into a binding term sheet with Pharmatronic Co., granting Pharmatronic Co. the exclusive license to commercialize RIZAPORT® in the Republic of Korea (South Korea). Under the term sheet, RedHill and IntelGenx are to receive an upfront payment and will be eligible to receive additional milestone payments upon achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. Subject to the satisfaction of the remaining conditions, the parties will endeavor to enter into a definitive agreement within 60 days of the execution of the term sheet. Further financial terms of the term sheet were not disclosed.
On October 5, 2016, RedHill announced that a Phase II clinical study evaluating YELIVA™ in patients with advanced hepatocellular carcinoma (HCC) was initiated at the Hollings Cancer Center at the Medical University of South Carolina (MUSC), subject to IND clearance by the FDA. The study is supported by a grant from the U.S. National Cancer Institute (NCI) awarded to MUSC, with additional support from RedHill. The HCC study protocol is still under FDA review. Enrolment in the study is expected to begin following successful completion of the FDA’s review process, anticipated by end of 2016.
On October 6, 2016, RedHill provided an update on the RHB-104 Phase III Crohn’s disease development program, planned enhancements to the MAP US first Phase III study and expected milestones, including: An increase in the total number of patients planned to be enrolled in the study from 270 to 410 and the addition of an open-label extension study offering all patients who complete 26 weeks of study participation and remain out of remission (Crohn’s disease active index (CDAI) >150) the opportunity to receive treatment with RHB-104 for a 52-week period.
A first safety-focused independent DSMB meeting is on track to take place in the fourth quarter of 2016. A second independent DSMB meeting is expected in the second quarter of 2017 and will include safety and interim efficacy analysis, with evaluation of an early stop for success for overwhelming efficacy, under pre-specified efficacy criteria.
Two small-scale, open-label ex-U.S. clinical studies with RHB-104, each with up to 20 Crohn’s disease patients, are planned to be initiated and are intended to provide additional supportive clinical data to potential future marketing applications, as well as to evaluate RHB-104’s efficacy in newly diagnosed and treatment-naïve Crohn’s disease patients, and as an add-on therapy to current standard-of-care.
RedHill will remain blinded to the interim and ongoing results from the Phase III study and no changes are planned to the MAP US Phase III study’s primary endpoint or 90% power.
Assuming enrollment of all 410 planned subjects, completion of patient recruitment in the MAP US Phase III study is expected by the end of 2017.
On October 18, 2016, RedHill announced that it had received from the Japan Patent Office a Notice of Allowance for a new patent covering RHB-104 for the treatment of multiple sclerosis, which is expected to be valid until 2032, once granted.
On November 1, 2016, RedHill announced that it had intended to offer its American Depositary Shares (ADSs), each representing 10 of its ordinary shares, in an underwritten public offering. RedHill subsequently announced, on November 2, 2016, that it had withdrawn the proposed underwritten public offering of its ADSs due to market conditions.
On November 1, 2016, RedHill announced that it had entered into a non-binding term sheet with a pharmaceutical company as part of its potential strategic vertical integration plan to build a U.S. specialty pharmaceutical company by establishing a commercial presence and capabilities. Under the term sheet, RedHill would be granted the right to exclusively promote a specialty gastrointestinal product in certain territories in the U.S. The parties would share revenues generated in such territories based on an agreeable split between the parties. RedHill is not required to make any upfront or milestone payments under the term sheet. Although RedHill’s goal is to complete the transaction pertaining to the commercial asset in the fourth quarter of 2016, the term sheet is non-binding and there is no certainty as to the execution nor timing of execution of a definitive agreement between RedHill and its potential partner. There is no assurance that satisfactory due diligence will be completed or that the parties will obtain all necessary corporate approvals.
On November 3, 2016, RedHill announced that top-line results from both the ongoing Phase III clinical study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) and the ongoing Phase II clinical study with BEKINDA® 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) are expected in mid-2017. Over two-thirds of the planned total of 320 subjects have been enrolled in the Phase III GUARD study with BEKINDA® 24 mg for acute gastroenteritis and gastritis in the U.S. Approximately half of the planned total of 120 subjects have been enrolled in the Phase II clinical study with BEKINDA® 12 mg for the treatment of IBS-D in the U.S.
On November 10, 2016, RedHill announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) discussing the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program. The confirmatory Phase III study with RHB-105 for H. pylori infection is planned to be initiated in H1/2017, after completion of the ongoing supportive PK program. Subject to a successful outcome, the confirmatory Phase III study and the supportive PK program are expected to complete the package required for a U.S. NDA for RHB-105, including clinical data and CMC.
Exclusive: RedHill Biopharma CEO Talks Steering His Company Through A Year Heavy With Potential Catalysts Taylor Cox , Benzinga Staff Writer FOLLOW June 05, 2017 3:54pm Comments Exclusive: RedHill Biopharma CEO Talks Steering His Company Through A Year Heavy With Potential Catalysts Related 22 Stocks Moving In Thursday's Pre-Market Session RedHill Biopharma Higher Off Positive Phase III Results For BEKINDA RedHill Biopharma Announces Last Patient Visit in BEKINDAÂ® Phase II Study for IBS-D (GuruFocus) If investors were to sum up the year 2017 for specialty drug maker RedHill Biopharma Ltd - ADR RDHL 0.78% in one phrase, it might be this: “catalyst-rich.”
A specialty biopharmaceutical company based in Israel, RedHill has a treasure trove of developing drugs in its pipeline to treat cancers and gastrointestinal diseases. Investors anxiously await interim efficacy analysis for its RHB-104 compound for treating Crohn’s disease, as well as top-line data from two separate studies of what may be considered its lead drug candidate, Bekinda.
In a recent telephone interview with Benzinga, RedHill CEO Dror Ben-Asher talked clinical progress, financing and the difficulties of being headquartered outside the U.S.
Tale Of 2 Indications
Bekinda is a once-daily pill formulation of ondansetron currently undergoing a Phase III study for the treatment of gastroenteritis, and a Phase II study for use in cases of irritable bowel syndrome with diarrhea.
It’s been proposed that with positive enough results in gastroenteritis, Bekinda could potentially bypass a second Phase 3 study and move directly for regulatory approval with the Food and Drug Administration.
“It will have to do with significance,” Ben-Asher said. “We do not know the exact number we need to achieve beyond just meeting endpoint in order to be able to file an NDA (new drug application) immediately. But the FDA has been telling us, and we have been telling the market, that if the results are strong enough we expect to file a new drug application based on this single Phase III study.”
The FDA hasn’t told RedHill the exact p-value that would qualify Bekinda to move straight to an NDA submission, but generally p<0.001 is considered “highly significant.”
IBS-D represents a significant unmet need, with the market for treatments expected to reach more than $1.115 billion by 2022, but RedHill will face more than a bit of competition in that space from companies like Allergan plc Ordinary Shares AGN 0.67% .
“IBS-D is an important indication,” Ben-Asher explained. “Also, the market is growing very rapidly. There are several new products on the market that are doing very well. Bekinda is a unique approach.” If Bekinda is successful in its Phase II study, Ben-Asher feels it will have significant advantages, most notably it being a single-dose per day. Combined with the convenience this offers, Bekinda also offers a relatively low dose.
“In terms of pricing, we will have significant pricing elasticity.” Ben-Asher emphasized, “IBS treatments are pretty expensive. Fully reimbursed, we can do very well in that market.”
Financing, Partnerships And Timelines
“On the R&D side, the pipeline of products under development is pretty rich,” said Ben-Asher. “We needed to decide over the last few years, is are we going to stay a pure development company.” This would mean RedHill would forego the development of a commercial operation, focusing solely on clinical research, supporting itself through licensing partnerships of its successful drug candidates in return for royalties. Or, the company could opt to “go it alone.”
“We decided to go for the latter,” Ben-Asher said. “We built a commercial operation in the United States. We also built a sales force of over 30 sales reps. They’re employed by RedHill, they’re not rented sales force, they’re not outsourced.”
This month, RedHill will commence the launch of Donnatal and EnteraGam. Donnatal is an IBS treatment RedHill Is co-promoting with Concordia International Corp CXRX 0.7% , while the company has exclusive U.S. rights to EnteraGam, used to treat chronic diarrhea.
This begs the question, in the event RedHill succeeds in gaining FDA approval for Bekinda in gastroenteritis, will the company seek to raise money on its own — through a secondary stock offering for example? Or, will RedHill facilitate bringing Bekinda to market through a licensing agreement or partnering with another pharmaceutical company?
“Bekinda is an interesting case. RedHill, alone, is unlikely to be able to launch Bekinda in the U.S., which means we would probably need a co-promotion with someone else, who would co-promote with us in the U.S. Or license the product entirely to someone else,” Ben-Asher said.
Asked whether those discussions are underway or if other financing avenues are being explored at present, the CEO would only point to the relative strength of the company’s “solid” balance sheet and the expectation of additional revenues to be generated through the launch of Donnatal and EnteraGam.
“We do not a plan for any immediate or short-term financing from the financial markets, but continue to evaluate in the future,” Ben-Asher added, while choosing not to share any details around licensing or pharma partner talks.
May I Have Your Attention
Despite the fact that RedHill has the potential to score multiple clinical wins this year, any one of which could significantly affect the stock, the company still experiences a dearth of attention from the financial media and sell-side analysts.
The company’s CEO acknowledges that being headquartered outside the U.S. certainly plays a part in this.
“It’s a question we’ve been asking ourselves. On the one hand we’re seeing increasing awareness, and liquidity and interest in general. On the other hand, one might argue that it’s less awareness than you would expect from a U.S. company with the same scale of activity that we have. The jury is out, there’s no verdict yet whether it has anything to do with our Israeli presence or not.”
To spread the good word about the company, Ben-Asher said RedHill has been initiating plenty of investor relations activity. He conceded, however, that the company has been conservative and “old-fashioned” in its approach, and hasn’t harnessed the power of social media.
One analyst that has taken notice of the company is Swayampakula Ramakanth of H.C. Wainwright & Co., who said positive results from Bekinda’s Phase III trial could be a major catalyst. The analyst thinks there is a “high likelihood of success,” and in a recent research note maintains a Buy rating for RedHill shares with a $33 price target.
The stock is trying to put in a bottom but as long as the market knows they need to raise capital, the stock will remain undervalued. Either an equity raise or a sale/collaboration appears required to allow this pipeline to be fully valued.
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6