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RedHill Biopharma Announces Positive New Data with Opaganib for Nuclear Radiation Injury
https://finance.yahoo.com/news/redhill-biopharma-announces-positive-data-133000587.html
Positive in vivo results from a new study of opaganib in radiation-induced hematologic and renal toxicity reaffirms opaganib's potential protective impact on hematological and kidney function following total body irradiation (TBI)
These new preclinical results are consistent with recently published, U.S. government funded, in vivo efficacy data suggestive of opaganib's potential as a nuclear radiation injury therapeutic for homeland security medical countermeasures (MCM)
Opaganib is an oral, highly stable, novel small molecule pill potentially suitable, if approved, for central stockpiling by governments against mass casualty nuclear radiation incidents
Following prior FDA guidance specific to opaganib, and subject to further FDA guidance, development of opaganib as a homeland security nuclear medical countermeasure is expected to follow the Animal Rule under which human efficacy studies may not be required
Opaganib, if approved, may be eligible for a medical countermeasure Priority Review Voucher
Discussions regarding further support and pathway to potential approval have been initiated with U.S. and other governments
Development continues for COVID-19, other pandemic preparedness antiviral indications and oncology, strongly positioning opaganib as a pipeline-in-a-product
TEL AVIV, Israel and RALEIGH, NC, Nov. 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive in vivo results from a new pre-clinical study evaluating the effects of opaganib[1] on radiation-induced hematologic and renal toxicity, undertaken by RedHill and its partner Apogee Biotechnology Corporation ("Apogee"). The results, suggesting that opaganib exerts a protective impact on key hematological and kidney function parameters following total body irradiation (TBI), are consistent with recently published U.S. government-funded in vivo opaganib data[2] and are further supportive of opaganib's planned development under the Animal Rule for nuclear radiation protection.
Lynn W. Maines, PhD., Apogee's VP of Research, said: "These results, as well as the established scientific understanding that disruption of S1P production reduces damaging pathologic inflammation, further support the hypothesis that opaganib's inhibition of SK2, and subsequent reduction S1P production, suppresses Heme-ARS and kidney damage by lethal total body irradiation, and may play a key role in protecting against generalized radiation injury."
"These new results add to, and are consistent with, the positive indications towards opaganib's radioprotective capabilities reported in the recent peer-reviewed International Journal of Molecular Sciences (IJMS) publication and support further studies of opaganib in this indication," said Dr Mark Levitt, MD, PhD, Chief Scientific Officer at RedHill. "Our assessment of the pathway towards approval, and following recent discussions with key government agencies, gives us an understanding of the progress already made, and of the areas of ongoing work still to be completed, which we believe can be done in an expedited manner given the prevailing need for new radioprotective treatment options."
Recently published, U.S. government funded results, from eight preclinical studies and additional experiments, indicate opaganib's potential as a nuclear radiation injury therapeutic for homeland security material threat medical countermeasures (MCM) and for antitumor radiotherapy. These results indicate that opaganib may protect normal tissue from damage due to ionizing radiation exposure or cancer radiotherapy, improve antitumor activity and response to chemoradiation, and enhance tolerability and survival.
Opaganib is a novel oral small molecule sphingosine kinase 2 (SK2) inhibitor that is potentially suitable to current government research priorities for material threat medical countermeasures suitable for central stockpiling for use in mass casualty nuclear radiation incidents. Opaganib can be administered 24 hours or later after radiation exposure, is highly stable with a more than five-year shelf-life, easy to administer and distribute, and demonstrated its clinical safety profile in various human clinical studies and expanded access uses in other indications.
Multiple discussions with government agencies in the U.S. and internationally are ongoing regarding funding and medical countermeasure development pathways.
Sponsors of approved medical countermeasures product applications may be eligible for a medical countermeasure Priority Review Voucher.
About Opaganib (ABC294640)
Opaganib a new chemical entity, is an orally administered, first-in-class proprietary selective inhibitor of sphingosine kinase-2 (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity.
Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS).
In an oncology & radiological setting, opaganib has been observed to elevate certain ceramides and reduces sphingosine 1-phosphate (S1P) in cells, conditions that increase the antitumor efficacy of radiation while concomitantly suppressing inflammatory damage to normal tissue, leading to the potential to suppress toxicity from unintended ionizing radiation (IR) exposure and improve patient response to chemoradiation. Opaganib has received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma. Patient accrual, treatment and analysis in a prostate cancer study is ongoing. Opaganib has a Phase 1 chemoradiotherapy study protocol ready for IND submission.
Opaganib has demonstrated broad-acting, host-directed, antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
One huge disappointment
of a company!
So what happened to being cash flow positive now they are talking like they may have to cease operations? Are they just bold faced liars?
I sent an email to:
Adi Frish
Chief Corporate and Business Development Officer
To approach US/Barda which is stockpiling for
emergency usage.
https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx
(I own another company MDWD which has a product not yet
FDA approved, still BARDA stockpiled it)
Good thing "RedHill Accelerates Opaganib's Nuclear Radiation Protection Program", because Russia just "accidentally bombed Poland",
RedHill Accelerates Opaganib's Nuclear Radiation Protection Program - Positive Data Published
https://finance.yahoo.com/news/redhill-accelerates-opaganibs-nuclear-radiation-120000187.html
Strong preclinical data, recently published in the International Journal of Molecular Sciences, from eight U.S government-funded in-vivo opaganib studies, supports opaganib's potential as a nuclear radiation injury therapeutic for homeland security material threat medical countermeasures (MCM) and for antitumor radiotherapy
As an oral, small molecule pill that is highly stable with a more than five-year shelf-life, opaganib is easy to administer and distribute, supporting, if approved, potential central stockpiling by governments for possible use in mass casualty nuclear radiation incidents
Unlike current approved options such as iodine pills, opaganib's suggested protective effect in radiation injury is not thought to be limited to specific radioactive materials or individual parts of the body. Rather, opaganib's mechanism of action is believed to suppress ionizing radiation toxicity and inflammatory damage to normal tissue, and promote the robustness of hematopoietic stem cells from radiation damage, potentially supporting increased survival and decreased morbidity
Observations from multiple GI-focused in-vivo models indicate that opaganib may protect normal tissue from damage due to ionizing radiation exposure or cancer radiotherapy, improve antitumor activity and response to chemoradiation and enhance tolerability and survival
Independent external in-vivo studies of the radioprotective capacity of opaganib in bone marrow also show enhanced survival against both lethal and half-lethal whole-body irradiation
Another study has been initiated recently, by RedHill and its partner Apogee Biotechnology Corporation, to assess protective effects of opaganib against radiation-induced hematologic and renal toxicity
Based on FDA guidance specific to opaganib, and subject to a recently scheduled follow-on meeting with FDA, RedHill expects development of opaganib as a homeland security nuclear medical countermeasure to follow the Animal Rule, under which pivotal animal model efficacy studies are applicable when human clinical trials are not ethical or feasible; Discussions regarding further support, funding and development pathway to approval have been initiated with US and other governments
Sponsors of approved medical countermeasures product applications are eligible for a medical countermeasure Priority Review Voucher
Opaganib's development continues for COVID-19, other pandemic preparedness antiviral indications and oncology, strongly positioning opaganib as a major pipeline-in-a-product intended for multiple indications
TEL AVIV, Israel and RALEIGH, NC, Nov. 14, 2022 /CNW/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced acceleration of opaganib's development program for protection against radiation injury and cancer radiotherapy. A recent publication in the International Journal of Molecular Sciences, entitled "Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy", describes the collective results of eight U.S. government-funded in vivo studies by RedHill and Apogee Biotechnology Corporation ("Apogee"), as well as additional experiments, establishing opaganib's[1] potential nuclear radiation protection capabilities[2].
The publication highlights observations from numerous studies undertaken in both protection against radiation toxicity and cancer radiotherapy settings. In the relevant study models, opaganib was associated with protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy, as well as improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival. Additional independent studies demonstrate the radioprotective capacity of opaganib in bone marrow, with opaganib showing enhanced survival in mice which were irradiated with both lethal and half-lethal whole-body radiation[3].
"Subject to further alignment with FDA, we intend to follow the Animal Rule path to approval for opaganib, based on prior FDA guidance specific to opaganib for the intended indication. Development for medical countermeasures may follow the Animal Rule, with pivotal animal model studies of efficacy applicable when human clinical trials are not ethical or feasible. In addition, we intend to seek an expedited development timeframe and eligibility for a Medical Counter Measure Priority Review Voucher. Amid the growing awareness of the need for material threat medical countermeasures and the positive observations seen in these in vivo gastrointestinal focused radiation toxicity and cancer radiotherapy studies, along with external data indicating potential radioprotective capacity of opaganib in bone marrow, we have accelerated our development plans to further test opaganib as a protective agent against nuclear radiation toxicity. We have recently initiated a new study to assess protective effects of opaganib on radiation-induced hematologic and renal toxicity, with our partner Apogee. Another meeting with the FDA is scheduled to seek further guidance on the path to homeland security medical countermeasure approval. Discussions with multiple government agencies in the U.S. and internationally, regarding funding and other governmental support, have been initiated," said Gilead Raday, Chief Operating Officer and Head of R&D at RedHill. "Importantly, opaganib has demonstrated its safety and tolerability profile in more than 470 people in studies in other indications as well as expanded access use. As an oral, small molecule pill that is highly stable with a greater than five-year shelf-life, opaganib is easy to administer and distribute, supporting potential central countermeasures stockpiling by governments."
Mitigation of radiation toxicity is an area of governmental concern. A key priority for US government research efforts is focused on finding long shelf-life and easy to distribute and administer drugs for potential inclusion in the Strategic National Stockpile. Such drugs, to be used in mass casualty nuclear radiation incidents involving improvised nuclear or radiological dispersal devices, should have broad-acting protective capability, be able to be administered 24 hours or later after radiation exposure, be safe and be easy to distribute to large numbers of people needing treatment for the acute effects of high dose, whole-body radiation exposure.
Currently, to the best of the Company's knowledge, only four FDA-approved medical countermeasure therapies are available. Three of these options are limited to effects caused by a small number of specific radioactive materials or to specific parts of the body. Potassium iodide (iodine pills) is intended to be used to protect against thyroid damage from the release of radioiodine. It works by preventing the thyroid from taking up radioactive iodine but seems to offer no protection to the rest of the body from irradiation and is of limited benefit unless given immediately upon exposure. The other two, Prussian Blue and DTPA (diethylenetriamine pentaacetate) provide protection by limiting the half-life in the body of specific materials: radioactive cesium and thallium, in the case of Prussian Blue, and radioactive plutonium, americium, and curium, in the case of DTPA. The fourth option, filgrastim, is intended for acute radiation syndrome resulting from high-dose radiation. Filgrastim does not seem to protect the body against the radiation itself and works by stimulating the creation of new white blood cells to protect the body from infections, which the body can no longer do in the presence of radiation-induced bone marrow destruction - as long as there are viable stem cells to stimulate.
We believe that opaganib's protection would not be limited to specific radioactive materials or individual parts of the body. Much of the damage caused by radiation exposure is caused by inflammation secondary to the effects of ionizing radiation itself – known as Acute Radiation Syndrome. Opaganib, a sphingosine kinase-2 (SK2) inhibitor, is thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate (S1P) in human cells - suppressing inflammatory damage to normal tissue and thus suppressing toxicity from unintended ionizing radiation exposure. It has also been reported in the literature that inhibition of sphingosine kinase 2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.
Protection against radiation toxicity studies with opaganib funded by U.S. government – summary of results:
Effect of opaganib on the lethality of TBI (Total Body Irradiation) in C57BL/6 mice
Vehicle-treated mice had pronounced symptoms indicative of severe GI damage, and all animals had to be euthanized within 14 days of radiation exposure. In contrast, protection was observed in the opaganib-treated group, in which 71% of the mice survived indefinitely.
Accumulation and pharmacodynamics of opaganib in mouse small intestine
In vehicle-treated mice, TNFa expression in the small intestines was observed to be up-regulated as early as 1 hour after Total Body Irradiation (TBI) and remained highly elevated for at least 26 hours. In contrast, pretreatment with opaganib was observed to not only block the induction of TNFa by TBI but also to reduce tissue TNFa levels below the baseline level indicating prolonged biodistribution of opaganib into the small intestine at sufficient levels to inhibit SK2 and suppress radiation-induced inflammation.
Effects of opaganib on GI damage following TBI
Post-radiation decreases in villus height (villi are a critical component of the intestines ability to absorb nutrients and indicative of intestinal health) were observed in the vehicle-treated animals compared with non-irradiated controls. In contrast, villus height was maintained in the opaganib-treated mice. Additionally, while there was evidence of cell depletion after 10 days in all groups, there were significantly more cells present at 4 days after irradiation in the opaganib-treated mice compared to vehicle controls (p<0.001) with this difference between treatments nearly resolving by Day 10.
Effect of opaganib on the lethality of partially shielded irradiation in C57BL/6 mice
In multiple scenarios, utilizing partial bone marrow shielding, involving different levels of irradiation and with different dosing regimens, opaganib was observed to reduce mortality, with the greatest improvement seen when opaganib was given both before and after irradiation, reducing mortality from 82% down to 4% (p<0.001) in the mice given the highest dose of radiation, 16 Gray (Gy).
Cancer radiotherapy studies with opaganib funded by U.S. government – summary of results:
In vitro effects of opaganib on cell radiosensitivity
Opaganib appeared to provide protection from IR-induced cell death, with observations showing the level of radiation need to kill 50% and 90% of intestinal epithelial cells increasing from 5.56 and 12.16 Gy respectively up to 6.46 and 13.2 Gy, respectively. Furthermore, opaganib was observed to increase the killing of transformed pancreatic cancer cells by radiation, particularly at the high dose of 15 Gy (p<0.05).
In vivo effects of combination of opaganib with radiation on tumor growth (multiple cancer-types):
Pancreatic cancer model: Treatment with either TBI alone or opaganib alone substantially reduced tumor growth (p<0.05 and p<0.001, respectively). Treatment with opaganib in combination with TBI was associated with significantly reduced tumor growth compared to the control group or to the TBI alone group (p<0.01 for each comparison) but was not significantly different from opaganib alone because of the strong antitumor activity of the drug in this model. Importantly, treatment with opaganib did not protect tumors from radiation treatment.
Melanoma and E0771 breast cancer model: Opaganib plus TBI was observed to have equal or better antitumor activity than TBI alone. Again, opaganib was not associated with a diminished tumor response to fractionated radiation treatment and increased weight loss from radiation treatment was not observed.
Head & neck cancer model: Treatment with opaganib alone was observed to slightly reduce tumor growth, while TBI + cisplatin was observed to substantially reduce tumor growth as compared to the control (vehicle) group (p<0.001). Treatment with opaganib in combination with TBI + cisplatin was associated with the greatest reduction in tumor growth and such treatment group had significantly better observations than TBI + cisplatin on Day 21 and after (p<0.02). Again, opaganib was not associated with diminished tumor response or increased weight loss.
About Opaganib (ABC294640)
Opaganib a new chemical entity, is an orally administered, first-in-class proprietary selective inhibitor of sphingosine kinase-2 (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity.
Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS).
In an oncology & radiological setting, opaganib has been observed to elevate ceramide and reduces sphingosine 1-phosphate (S1P) in cells, conditions that increase the antitumor efficacy of radiation while concomitantly suppressing inflammatory damage to normal tissue, leading to the potential to suppress toxicity from unintended ionizing radiation (IR) exposure and improve patient response to chemoradiation. Opaganib has received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma. Patient accrual, treatment and analysis in a prostate cancer study is ongoing. Opaganib has a Phase 1 chemoradiotherapy study protocol ready for IND submission.
Opaganib has demonstrated broad-acting, host-directed, antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed, SK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness and is in Phase 3-stage development as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that opaganib will not be shown to elevate ceramide and reduce sphingosine 1-phosphate (S1P) in cells, increasing the antitumor efficacy of radiation while concomitantly suppressing inflammatory damage to normal tissue, leading to the potential to suppress toxicity from unintended ionizing radiation (IR) exposure and improve patient response to chemoradiation in an oncology & radiological setting, the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials, the risk that opaganib will not be shown to be broad acting, host-directed candidate therapies for pandemic preparedness, the risk that a pivotal Phase 3 trial for opaganib will not be initiated or that such trial be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 17, 2022, and the Company's Report on Form 6-K filed with the SEC on November 10, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: R&D
[1] Opaganib is an investigational new drug, not available for commercial distribution.
[2] Maines LW, Schrecengost RS, Zhuang Y, Keller SN, Smith RA, Green CL, Smith CD. Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy. International Journal of Molecular Sciences. 2022; 23(21):13191. https://doi.org/10.3390/ijms232113191.
[3] Li C. et al., Loss of Sphingosine Kinase 2 Promotes the Expansion of Hematopoietic Stem Cells by Improving Their Metabolic Fitness. Blood. October 2022;140(15):1686-1701.
[4] Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com
[5] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[6] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
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RedHill Biopharma Reaches Agreement in Principle with HCR to Extinguish All Debt Obligations in Exchange for Movantik®
https://finance.yahoo.com/news/redhill-biopharma-reaches-agreement-principle-110000642.html
TEL AVIV, Israel and RALEIGH, N.C., Nov. 14, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has reached a non-binding agreement in principle with HCR Collateral Management, LLC ("HCR") with respect to the terms of a transfer of RedHill's rights in Movantik® (naloxegol) to HCR in exchange for the extinguishment of all RedHill's obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's U.S. subsidiary RedHill Biopharma Inc. and HCR dated as of February 23, 2020 (as amended). RedHill would retain substantially all pre-closing liabilities relating to Movantik and HCR would assume substantially all post-closing liabilities. It is expected that RedHill would provide transition services to HCR to ensure a seamless process so that patient care will not be interrupted. Subject to certain approvals, the definitive agreements are expected to be signed and the transaction is expected to close by year-end, but there can be no assurance that the parties will enter into definitive agreements or that the transaction will be completed.
RedHill Biopharma Provides H1/22 Highlights and Q3/22 Estimates
https://finance.yahoo.com/news/redhill-biopharma-provides-h1-22-144900193.html
Financial update: Q2/22: Net revenues of $18.3 million; Operating loss of $9.2 million; Cash balance[1] of $43.2 million as of June 30, 2022; Restated Q1/22: Net revenues of $13.1 million; Q3/22: Net revenues estimated[2] to be between $16.5million to $18.5 million; Operating loss estimated to be in the range of $5.5 million to $7.5 million; Q3/22 cash flow from operating activities is estimated positive for U.S operations, before interest payments[3]
Commercial update: Upward trajectory continues with Talicia® and Movantik® new prescriptions up 11.2% and 4.0% over Q1/22, respectively; Commercial PBM win for Talicia improves coverage for 58 million more lives – Talicia on track to become the most prescribed branded H. pylori therapy in 2023; Market leader, Movantik, also anticipated to benefit from PAMORA class growth trends; With strong increases in gross sales, primary focus on improving gross-to-net yields
Corporate update: Substantial impact from cost-reduction program expected in 2H/22, supporting planned improvement in cash from operations; Discussions advancing with HCR regarding default status and repayment of loan; Movantik sale process advancing rapidly aimed at satisfying outstanding obligations under the HCR credit agreement; Multiple RHB-204 out-licensing discussions progressing; Addition of significant revenue-generating GI products ongoing; Litigation against Kukbo initiated without counter-arguments from Kukbo and a favorable judgement is expected within weeks, strengthening the balance sheet significantly if collected
R&D update: Opaganib and RHB-107 COVID-19 programs advancing; RHB-107 development funding and potential inclusion in a key platform trial, as well as other external non-dilutive financing, well advanced. Both broad-acting, host-directed, antiviral candidates subject of ongoing discussions with the U.S. government for pandemic preparedness and other government programs, and both demonstrated in vitro inhibition of Omicron BA.5 sub-variant. Opaganib granted new COVID-19 treatment patent and, separately, demonstrated in vitro efficacy against Influenza; RHB-204 for NTM disease granted EU Orphan Designation
TEL AVIV, Israel and RALEIGH, N.C., Nov. 7, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its second quarter 2022 financial results and operational highlights, restatement of first quarter 2022 financial results and the provision of third quarter 2022 estimates.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Quarter two, and our expectations for the second half of the year, reflect significant operational and strategic progress by RedHill in the face of persistent negative biotech sector sentiment. Our commercial team is streamlined, with much reduced operational spend, and continues to rapidly grow new prescriptions. It is this growth, at this stage in its lifecycle, that is making Movantik such a valuable and saleable asset, and which has led Talicia to be the most prescribed branded agent by the Gastroenterology community, on track to become the most prescribed branded H. pylori therapy in 2023. With increased gross sales, we are applying substantial efforts to improving gross-to-net yields, using multiple parallel mechanisms. We are fully committed to refining our pre-pandemic debt structure in a way that helps us rapidly grow our business both organically and externally, through the intended sale of Movantik and the planned addition of new revenue-generating products currently under discussions. We continue to work relentlessly to maximize the value of our products and optimize our business. As such, the cost-reduction program we implemented is expected to deliver its major impact in the second half of the year."
Mr. Ben-Asher continued: "With an urgent need to develop broad-spectrum, host-directed antivirals for pandemic preparedness, RedHill is driving forward its opaganib and RHB-107 COVID-19 and other antiviral programs. We are currently in advanced discussions regarding external non-dilutive development funding for RHB-107 and are in the process of finalizing RHB-107's inclusion in a key platform study to be supported by a U.S. government arm. Both opaganib and RHB-107 continue to demonstrate the variant-agnostic value of being host-directed, demonstrating in vitro inhibition of the Omicron BA.5 sub-variant in testing conducted at the University of Tennessee. We are also delighted with the grant of a new COVID-19 treatment patent for opaganib. Beyond COVID-19, we have established several cooperative research projects, with both government and non-government entities, to evaluate opaganib and RHB-107 across multiple targets, including influenza, which opaganib recently demonstrated in vitro efficacy against, Ebola, and others. We are also pleased with the important recognition of EU Orphan Designation for RHB-204, currently in Phase 3 study as the first stand-alone standard of care first-line therapy for NTM disease, and for which prospective partnership discussions are advancing across multiple territories."
Financial results for the six months ended June 30, 2022 (Unaudited)[4]
Net Revenues for the six months ended June 30, 2022, were $31.5 million, as compared to $42.1 million for the six months ended June 30, 2021. The increase in units sold in the six months ended June 30, 2022, as compared to the six months ended June 30, 2021, was accompanied by increased gross-to-net allowances as the percentage of Medicare part D and Medicaid prescriptions increased.
The Company has restated its condensed consolidated interim financial statements as of and for the three months ended March 31, 2022, due to errors in the calculation of allowance for deductions from revenue. Cost of revenues, gross profit and operating loss were adjusted accordingly. This does not affect any other accounting period and is unlikely to impact the full-year outlook.
Cost of Revenues for the six months ended June 30, 2022, was $15.3 million, as compared to $20.8 million for the six months ended June 30, 2021.
Gross Profit for the six months ended June 30, 2022, was $16.2 million, as compared to $21.2 million for the six months ended June 30, 2021. The decrease was primarily attributed to the impact of increased gross-to-net allowances outlined above.
Research and Development Expenses for the six months ended June 30, 2022, were $4.5 million, as compared to $17.8 million for the six months ended June 30, 2021. The decrease was attributed to the ongoing optimization of R&D costs and completion of components of the opaganib and RHB-107 development programs.
Selling, Marketing and General and Administrative Expenses for the six months ended June 30, 2022, were $37.4 million, as compared to $46.5 million for the six months ended June 30, 2021. The decrease was mainly attributed to various cost-control measures implemented during the period.
Operating Loss for the six months ended June 30, 2022, was $25.8 million, as compared to $43 million for the six months ended June 30, 2021. The decrease was primarily attributed to reductions in operating expenses.
Net Cash Used in Operating Activities for the six months ended June 30, 2022, was $20.7 million, as compared to $31.2 million for the six months ended June 30, 2021. The decrease was attributed to the completion of components of the opaganib and RHB-107 development programs as well as various cost reduction measures.
Restated financial results for the three months ended March 31, 2022 (Unaudited)[5]
The Company has restated its condensed consolidated interim financial statements as of and for the three months ended March 31, 2022, due to errors in the calculation of allowance for deductions from revenue which resulted in net revenues being overstated. Cost of revenues, gross profit and operating loss were adjusted accordingly. This does not affect any other accounting period and is unlikely to impact the full-year outlook. The comparison below reflects this restatement.
Net Revenues for the first quarter of 2022 were $13.1 million, as compared to $22.1 million in the fourth quarter of 2021, the difference being attributable to typical cyclical trends in Movantik sales and increased gross-to-net deductions related mainly to increased formulary coverage.
Cost of Revenues for the first quarter of 2022 was $6.3 million, as compared to $19.3 million in the fourth quarter of 2021. The decrease was attributed to recognition of an approximately $9 million impairment related to the intangible asset of Aemcolo® for travelers' diarrhea in the fourth quarter of 2021.
Gross Profit for the first quarter of 2022 was $6.8 million, as compared to $2.7 million in the fourth quarter of 2021. The increase was attributed to the impairment recognized in the fourth quarter of 2021, as detailed above.
Research and Development Expenses for the first quarter of 2022 were $3.1 million, as compared to $5.9 million in the fourth quarter of 2021. The decrease was attributed to the ongoing optimization of R&D costs and completion of elements of the opaganib and RHB-107 development programs.
Selling, Marketing and General and Administrative Expenses for the first quarter of 2022 were $20.4 million, as compared to $17.6 million in the fourth quarter of 2021. The increase was mainly attributed to a one-off positive adjustment in the fourth quarter of 2021 and expenses related to professional services and other related expenses in the first quarter of 2022.
Operating Loss for the first quarter of 2022 was $16.6 million, as compared to $20.7 million in the fourth quarter of 2021. The decrease was mainly attributed to the impairment recognized in the previous quarter, as detailed above.
Net Cash Used in Operating Activities for the first quarter of 2022 was $4.2 million, as compared to $14.9 million in the fourth quarter of 2021. The decrease was mainly due to changes in working capital and continued implementation of cost-reduction measures.
Net Cash Used in Financing Activities for the first quarter of 2022 was $4.9 million, as compared to Net Cash Provided by Financing Activities of $17.6 million in the fourth quarter of 2021, comprised mostly from proceeds of equity offerings completed in the fourth quarter of 2021. The additional decrease of $5 million was due to a reduction of Movantik acquisition liabilities.
With respect to the Q1/22 restatement, the Company determined that a material weakness existed within its internal control over financial reporting as it related to recognition of certain allowances for deductions from revenues. Management, with the oversight of the audit committee and external advisors, has implemented additional processes and controls with respect to recognition of certain allowances for deduction from revenues to address this deficiency.
Liquidity and Capital Resources
Cash Balance[1] as of June 30, 2022, was $43.2 million, as compared to $45 million as of March 31, 2022, and $54.2 million as of December 31, 2021.
On May 9, 2022, the Company announced that it had entered into a definitive agreement with a single leading healthcare investor for the purchase and sale of 10,563,380 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents) in a registered direct offering at a price per ADS of $1.42. The gross proceeds to the Company from this offering were approximately $15 million, before fees and expenses. RedHill also agreed to issue to the investor unregistered private warrants to purchase up to an aggregate of 13,204,225 ADSs in a concurrent private placement. The warrants have an exercise price of $1.48 per ADS, are exercisable six months after the issuance date and have a term of five and one-half years.
On June 17, 2022, the Company and HCR entered into an amendment to the HCR Credit Agreement reducing the minimum net sales requirement to $75.0 million for the trailing four quarter periods ending on June 30, 2022, and September 30, 2022, with a 0.5% increase in interest rate in these quarters. Redhill Inc. shall also be required to maintain minimum net sales of $14 million for Movantik each fiscal quarter starting the fiscal quarter ending June 30, 2022.
On September 13, 2022, the Company received a notice from HCR asserting certain events of default under the Credit Agreement, resulting in the outstanding obligations under the Credit Agreement now bearing interest at the default rate under the Credit Agreement. The Company disagrees with the assertions made by HCR and is engaged with HCR in good faith in order to establish a consensual business resolution to this dispute. RedHill continues operating its business as usual, while also concurrently evaluating strategic alternatives to satisfy its outstanding obligations under the Credit Agreement through the potential sale of Movantik.
In addition to the previously reported breach of the 60 days quarterly reporting covenant in connection with the second quarter financial statements, the possibility of also being in default of the $75.0 million net sales covenant for the trailing four fiscal quarter period ending on September 30, 2022, remains. We are working with our creditor toward an agreement on constructive solutions and repayment of debt, including the potential sale of Movantik in order to satisfy the outstanding loan obligations.
On November 3, 2022, the Company received a termination notice from SVB Securities LLC ("SVB Securities"), with respect to itself, in connection with the Sales Agreement dated July 29, 2022, by and among the Company, SVB Securities and Cantor Fitzgerald & Co.
On September 2, 2022, the Company filed a lawsuit against Kukbo Co. Ltd. ("Kukbo") in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result of Kukbo's default in delivering to the Company $5.0 million under the Subscription Agreement, dated October 25, 2021, in exchange for ADSs, and a further payment of $1.5 million due under the Exclusive License Agreement, dated March 14, 2022. Kukbo has not raised counter arguments and we believe a favorable judgement is expected within weeks, strengthening the balance sheet significantly if collected.
Discussions regarding the potential sale of Movantik, RHB-204 out-licensing in multiple territories and the in-licensing of a new revenue-generating GI product are advancing.
Quarter Three, 2022, Estimates:
Based on unaudited and preliminary estimates, total net revenues for the quarter ended September 30, 2022, were in the range of $16.5 million to $18.5 million.
The Company further estimates that its operating loss for the quarter ended September 30, 2022, was in the range of $5.5 million to $7.5 million.
The Company's current estimate for Q3/22 cash flow from operating activities is approximately $6.7 million and positive for U.S. operations[3].
As of September 30, 2022, RedHill's cash, short-term investments and restricted cash were approximately $31.4 million, compared to $54.2 million as of December 31, 2021.
The above-estimated revenue and operating loss figures for the quarter ended September 30, 2022, reflect RedHill's current preliminary review, which is still ongoing and could result in changes to the estimated revenues and operating loss figures. These estimates were not reviewed by our independent accountants.
Commercial Highlights
Movantik® (naloxegol)[6]
Movantik delivered a 4% growth in new prescriptions in Q2/22, compared to Q1/22, representing the highest quarterly prescribing volume for Movantik since RedHill acquired the product rights
Movantik continues to hold a firm grip on its PAMORA class leadership position, with more than 70% market share. As market leader, Movantik is anticipated to benefit further from positive PAMORA class growth trends - up 7% for the three months ending August 2022 as compared to the same period in the previous year
Two new Movantik analyses, from pooled data from two Phase 3 studies, were presented at PAINWeek in September, demonstrating that Movantik (naloxegol) provides healthcare-related quality of life (HR-QOL) and clinically meaningful symptom improvements, compared to placebo, in patients with opioid-induced constipation (OIC)
Movantik retains best-in-class coverage with Preferred Status in two of the three largest Commercial PBMs and 92% Preferred Status within Medicare Part D[7]
New updated Centers for Disease Control and Prevention (CDC) guidelines, issued November 2022, provided for increased flexibility in opioid prescribing
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[8]
An 11.2% increase in Talicia prescriptions in Q2/22, compared to Q1/22, builds on the record quarterly prescription levels seen in Q1/22 and Q4/21 and represents 86.4% growth in Talicia prescriptions compared to Q2/21
Talicia is the most prescribed branded agent by the Gastroenterology community and is on track to become the most prescribed branded H. pylori therapy in 2023.
New Talicia data analyses were presented at Obesity Week (November 2022) and the World Gastro 2022 congress (August 2022) support the efficacy and safety of Talicia as empiric first-line treatment for H. pylori infection in patients regardless of obesity, body mass index (BMI) or diabetic status and demonstrating that:
- Talicia's efficacy in the pooled data from two Phase 3 studies was unaffected by presence of diabetes, obesity or BMI
- Intragastric rifabutin exposure was unaffected by patient BMI, and that Talicia provides favorable intragastric rifabutin concentrations compared to generically available rifabutin
- The safety profile of Talicia in these patients was generally similar to the overall population and no cases of hypoglycemia were reported. This is clinically relevant as clarithromycin has a risk of drug interactions with commonly used diabetes medications such as insulin and metformin, as well as potential for increased risk of hypoglycemia
The addition of Florida Medicaid unrestricted preferred coverage increased Medicaid coverage of Talicia by 4.9% to 23%. An additional 1.9 million lives gained coverage in May 2022. A commercial PBM win improved coverage to "preferred" for an additional 58.0 million lives starting July 1, 2022. As of August 2022, total Talicia coverage stood at almost 200 million American lives, equating to seven out of ten commercial lives and six out of ten Government lives
Aemcolo® (rifamycin)[9]
The first post-pandemic prescriptions for Aemcolo are beginning to be seen and the Company is planning additional commercialization initiatives focused on driving growth in the primary care segment
R&D Highlights
Opaganib (ABC294640)[10] & RHB-107 (upamostat)[11] – COVID-19, variants and other viruses
With an urgent need to develop broad-spectrum, host-directed antivirals for pandemic preparedness, RedHill is:
- Currently in late-stage discussions regarding funding for a pivotal Phase 3 study for RHB-107 and close to finalizing inclusion in a key platform study
- Working on several cooperative projects, with government and non-government bodies, on a range of preclinical studies with opaganib and RHB-107 (upamostat) against multiple viral targets, including influenza and Ebola (amongst others)
Both once-daily RHB-107 (upamostat) and twice-daily opaganib demonstrated in vitro inhibition of Omicron BA.5 sub-variant in testing conducted by the University of Tennessee in October 2022
The United States Patent and Trademark Office (USPTO), in October 2022, granted a new method of use patent for opaganib for the inhibition of a disease caused by a coronavirus in patients having pneumonia and receiving supplemental oxygen at a fraction of inspired oxygen (FiO2) up to and including 60%
In July 2022, opaganib's suggested host-directed mechanism of action was published in the journal Drug Design, Development and Therapy, describing opaganib's multi-faceted potential to: inhibit multiple pathways, induce autophagy and apoptosis, and disrupt the viral RTC (replication-transcription complex) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS)
In June 2022, opaganib demonstrated potent in vitro inhibition of influenza A H1N1, at low concentrations and with no evidence of toxicity at these levels in a Normal Human Bronchial Epithelial Cells (NHBE) assay, the natural human target of the virus, making it a realistic model
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease[12]
In August 2022, the European Commission granted Orphan Drug Designation to RHB-204, which is in an ongoing U.S. Phase 3 study, for the treatment of nontuberculous mycobacteria (NTM) disease, providing 10 years of post-approval EU market exclusivity
The Company is advancing discussions with prospective partners for RHB-204 across multiple territories including the EU and others.
RedHill Presents New Talicia® Data Analyses at Obesity Week 2022
https://finance.yahoo.com/news/redhill-presents-talicia-data-analyses-110000783.html
Talicia's efficacy, in this analysis of pooled data from two Phase 3 studies, was unaffected by presence of diabetes or elevated body mass index (BMI); additionally, pharmacokinetic modeling results indicate that intragastric rifabutin exposure was unaffected by elevated patient BMI
Published data suggest that elevated BMI and presence of diabetes may be associated with the failure of clarithromycin-based H. pylori treatments, further supporting the use of Talicia as a first-line therapy in all populations
Talicia, the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, is an empiric first-line therapy for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population
RALEIGH, N.C. and TEL AVIV, Israel, Nov. 4, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the presentation of new Talicia® data analyses for the treatment of H. pylori, at the Obesity Week Annual Meeting, November 1-4, 2022.
Rates of obesity continue to rise in the US, with over 70% of the population being overweight or obese[1], and understanding the efficacy of antibiotics in this population is paramount. Additionally, obesity is associated with a higher risk of diabetes, which affects over 11% of the overall US population[2]. Published data have shown that both obesity and diabetes have been associated with failure of clarithromycin-based therapies for the treatment of H. pylori infection. Obesity can negatively impact intragastric exposure to key antibiotics used to treat H. pylori and high intragastric exposure is known to be essential for successful eradication. These analyses assessed the safety and efficacy of Talicia in achieving H. pylori eradication in patients who are either obese or have diabetes. Furthermore, Physiologically-Based Pharmacokinetic (PBPK) modeling was used to compare intragastric rifabutin concentrations with Talicia (low-dose rifabutin 50 mg) across different body mass index (BMI) subgroups. Results showed that Talicia was unaffected by presence of diabetes or elevated BMI, with modeling results indicating that intragastric rifabutin exposure was unaffected by patient BMI.
"This work supports that patient diabetic status, body mass index, and race/ethnicity have negligible impact on the high eradication rates achieved with Talicia. This is clinically important given the high prevalence of obesity and of diabetes," said Dr. Dana Portenier, Division Chief, Metabolic and Weight Loss Surgery, Duke University School of Medicine. "Moreover, Talicia was shown to maintain high intragastric rifabutin concentrations regardless of patient obesity status, further supporting its use as a rational choice for empiric first-line therapy."
Poster title: Low-dose Rifabutin (50 mg) Triple Therapy for H. pylori is Efficacious and Well Tolerated in Patients with Obesity or Diabetes
Presenting Author: Dr. Dana Portenier, Division of Metabolic and Weight Loss Surgery, Duke University School of Medicine.
This work builds upon a previous post hoc analysis of phase 3 clinical studies, demonstrating that patient BMI had no statistically significant impact on eradication outcomes with Talicia. PBPK modeling supports minimal differences in intragastric rifabutin concentration time above MIC90 for H. pylori between patients with normal BMI or those who are overweight or obese (approximately 22 hours [93%] of the day across groups).
Additionally, a post hoc analysis of phase 3 clinical studies demonstrated that diabetes had no statistically significant impact on eradication outcomes with Talicia. Furthermore, the safety profile of Talicia in these patients was generally similar to the overall population, and no cases of hypoglycemia were reported. This is clinically relevant as clarithromycin has a risk of drug interactions with commonly used diabetes medications such as insulin and metformin[3], as well as potential for increased risk of hypoglycemia[4]. Furthermore, low-dose rifabutin (50mg Q8H) triple therapy for 14 days produced high eradication rates and displayed favorable safety and tolerability across all subjects.
These data support the efficacy and safety of Talicia as empiric first-line treatment for H. pylori infection in patients regardless of obesity or diabetic status.
About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35%[5] of the U.S. population, with an estimated two million patients treated annually[6]. Worldwide, more than 50% of the population has
H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[7] and a major risk factor for peptic ulcer disease[8] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[9]. More than 27,000 Americans are diagnosed with gastric cancer annually[10]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[11].
RedHill Biopharma Ltd.'s (NASDAQ:RDHL) Path To Profitability
https://finance.yahoo.com/news/redhill-biopharma-ltd-nasdaq-rdhl-125851022.html
Simply Wall St
Sun, October 30, 2022 at 2:58 PM
We feel now is a pretty good time to analyse RedHill Biopharma Ltd.'s (NASDAQ:RDHL) business as it appears the company may be on the cusp of a considerable accomplishment. RedHill Biopharma Ltd., a specialty biopharmaceutical company, primarily focuses on gastrointestinal and infectious diseases. The US$40m market-cap company’s loss lessened since it announced a US$98m loss in the full financial year, compared to the latest trailing-twelve-month loss of US$92m, as it approaches breakeven. Many investors are wondering about the rate at which RedHill Biopharma will turn a profit, with the big question being “when will the company breakeven?” In this article, we will touch on the expectations for the company's growth and when analysts expect it to become profitable.
View our latest analysis for RedHill Biopharma
RedHill Biopharma is bordering on breakeven, according to the 2 American Pharmaceuticals analysts. They expect the company to post a final loss in 2023, before turning a profit of US$5.9m in 2024. The company is therefore projected to breakeven around 2 years from now. How fast will the company have to grow each year in order to reach the breakeven point by 2024? Working backwards from analyst estimates, it turns out that they expect the company to grow 68% year-on-year, on average, which is rather optimistic! Should the business grow at a slower rate, it will become profitable at a later date than expected.
earnings-per-share-growth
Given this is a high-level overview, we won’t go into details of RedHill Biopharma's upcoming projects, however, bear in mind that typically pharmaceuticals, depending on the stage of product development, have irregular periods of cash flow. So, a high growth rate is not out of the ordinary, particularly when a company is in a period of investment.
Before we wrap up, there’s one issue worth mentioning. RedHill Biopharma currently has negative equity on its balance sheet. This can sometimes arise from accounting methods used to deal with accumulated losses from prior years, which are viewed as liabilities carried forward until it cancels out in the future. These losses tend to occur only on paper, however, in other cases it can be forewarning.
They are taking the steps to control expenses and regain compliance.
After job cuts, Raleigh drugmaker considers selling lead product
https://www.bizjournals.com/triangle/news/2022/10/27/redhill-biopharma-movantik-sale-layoffs.html?utm_source=sy&utm_medium=nsyp&utm_campaign=yh
By Zac Ezzone – Staff writer, Triangle Business Journal
Oct 27, 2022
Months after reducing its commercial workforce in the U.S., a Raleigh drugmaker may be looking to offload its lead commercial product.
RedHill Biopharma, an Israeli company with its U.S. headquarters in Raleigh, is "negotiating with a potential acquirer" for its drug Movantik, according to an Oct. 14 securities filing. In the first quarter of the year, sales from the drug made up the majority of the company's net revenue – about $14.6 million of a total $18.2 million.
The company acquired the drug from AstraZeneca (Nasdaq: AZN) with financing from a February 2020 credit agreement worth up to $115 million. Through this loan with HCR Collateral Management, RedHill borrowed $30 million to support its commercial operations and another $50 million to fund the acquisition of the drug.
But on Sept. 13, RedHill received a "notice of events of default and reservation of rights letter" from HCR. In a Sept. 16 securities filing, the company said it "disagrees with the assertions made by HCR" and disputes the "alleged events of default." The filing didn't include details on the company's alleged breaches of the credit agreement.
RedHill declined to comment on the situation.
The company, however, did acknowledge that it has not yet delivered its second quarter financial statements to HCR. RedHill planned to publicly release its financial results by Sept. 23, a deadline that was then moved back to Oct. 14. As of Wednesday, the company has not yet released its financial results for the quarter.
In the Oct. 14 filing, the company said it expects to finalize its second quarter financial statements and restate its first quarter statements "as soon as practicable following completion of the audit committee's review." In the filing, RedHill also states that "the company has determined that a material weakness exists within its internal control over financial reporting as it relates to recognition of certain allowances for deductions."
Additionally, the company said that it's "continuing to engage in constructive discussion with HCR ... to evaluate strategic alternatives to satisfy its outstanding obligations under the credit agreement." This includes the company's discussions with a potential acquirer of Movantik, a treatment for constipation caused by prescription pain medicines.
Negotiations involving RedHill's lead product follow the company disclosing in June its intentions to cut one-third of its U.S. commercial workforce as part of a plan to save $50 million over the next 18 months.
At the end of 2021, RedHill had 201 employees, of which 182 were based in the U.S. and 19 in Israel. The company also worked with 10 consultants throughout the U.S., Israel and Canada, according to an annual financial report filed in March. Commercial operations made up the vast majority of the company's headcount at 182 employees, while 17 were described as management and administration and two, plus the 10 consultants, focused on research and development.
Aside from Movantik, the company has two other commercial products, Talicia and Aemcolo, and a pipeline of investigational drugs, including two late-stage candidates targeting Covid-19. At the time RedHill announced the layoffs, the company said it would try to move the Covid-19 programs forward from external funding, like grants and industry partnerships.
RedHill's stock fell sharply last year on news that one of those late-stage candidates, opaganib, failed to meet its primary endpoints in a phase 2/3 study in severe Covid-19 patients. The stock has mostly been trending down ever since, leading the company to recently fall out of compliance with a Nasdaq listing rule that establishes a minimum bid price for companies.
Nasdaq officials notified the company Oct. 12 that its stock closed below $1 a share for 30 consecutive business days. The company has an initial 180-day period to regain compliance and could be eligible for a subsequent 180-day extension.
RedHill's stock price closed at $0.67 on Wednesday, down about 77 percent from the beginning of the year. Its 52-week high is $5.77.
Over the years I have observed, “smart money” - whoever they are - consider an investment carefully for days (or weeks) following a news like that, then buy or tell their buyers to buy, using market not limit orders. The sudden influx of volume can cause big spikes that are not sustained in the near term.
Slow, gradual build in pps after great news is not the worst thing that could happen. And I think they have an
Important drug in Talicia,
Lukewarm market reaction,
attributed to their financial
chaos reporting.
Otherwise todays news would
have fetched a more substantial
increase.
Here’s hoping!...
Indeed so, hopefully the market shows
some appreciation to be reflected in sp.
And maybe $2 to $5.
But I think RDHL will see $1 again.
It’s happened to so many stocks and crypto-currencies. And the federal agencies are making everything worse, as regards the markets.
RedHill Presents New Talicia® and Movantik® Data Analyses at ACG 2022
https://finance.yahoo.com/news/redhill-presents-talicia-movantik-data-110000031.html
Physiologically-Based Pharmacokinetic (PBPK) modeling study of Talicia evaluated intragastric antibiotic exposure, critical for successful H. pylori eradication, comparing low-dose rifabutin 50 mg every 8 hours to generic rifabutin triple therapy 150mg twice a day or 300 mg once a day.
Talicia, the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, is intended for empiric first-line eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population
Pooled analyses of Movantik phase 3 studies in opioid-induced constipation assess impact on patient quality of life and symptom improvement
Movantik is the most prescribed oral PAMORA prescribed by U.S. pain specialists for opioid-induced constipation with over 3.2 million prescriptions written since 2015
RALEIGH, N.C. and TEL-AVIV, Israel, Oct. 26, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the presentation of new data analyses for Talicia®, for the treatment of H. pylori, and Movantik®, for the treatment of opioid -induced constipation (OIC), at the American College of Gastroenterology Annual Meeting (ACG) October 21-26, 2022.
Sufficient intragastric antibiotic exposure is critical for eradication of H. pylori, consequently, understanding the influence of antibiotic dosing on intragastric exposure is imperative. This study used Physiologically-Based Pharmacokinetic (PBPK) modeling to compare intragastric rifabutin concentrations with Talicia (low-dose rifabutin 50 mg) administered every 8 hours (Q8H) vs. rifabutin 150 mg (the generically available dose) administered twice daily (BID) or 300 mg administered once daily (QD). This analysis indicates that Talicia provides favorable intragastric rifabutin concentration and as a result provides high potential for H. pylori eradication while minimizing systemic antibiotic exposure.
Poster title (poster number: A0683): Modeling Gastric Luminal Rifabutin Concentrations: RHB-105 (Rifabutin 50mg Q8H) Provides More Favorable Exposure for H. pylori Eradication Than Generic Rifabutin 150mg BID or 300mg QD
Presenting Author: Dr. Colin W. Howden, MD, Professor Emeritus, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center.
This analysis builds upon previous work and demonstrates that two generically available rifabutin regimens (150 mg BID and 300 mg QD) did not maintain the intragastric rifabutin concentrations seen with Talicia, despite containing twice the total daily dose of rifabutin. This may help to explain the lower eradication rates seen with generic rifabutin triple therapy regimens (about 70% eradication)[1] than seen in the Talicia clinical trial program (about 84-90% eradication)[2].
"These important new data enhance the body of evidence supporting the use of Talicia as a first line therapy for H. pylori," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer. "This work demonstrates sustained intragastric exposure providing optimized conditions for eradication of H. pylori. Given the need to aim for the most effective empiric first-line eradication therapy, it is important to utilize a therapy with the highest likelihood of eradication success, such as Talicia."
The two Movantik posters are pooled analyses (n= 1337) of two phase 3 clinical studies (KODIAC-04 and -05) of Movantik in patients with OIC and assess the impact of Movantik on patient quality of life according to the validated patient assessment of constipation, quality of life questionnaire (PAC-QOL), and symptom improvement according to the patient assessment of constipation, symptoms questionnaire (PAC-SYM):
Poster title (poster number: A089): Naloxegol Provides Clinically Meaningful Healthcare Related Quality of Life (HR-QoL) Improvement (PAC-QOL) in Patients With Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Global Phase 3 Studies of Naloxegol
Presenting Author: Dr. Darren M. Brenner, MD, Professor of Medicine and Surgery (Gastroenterology and Hepatology), Northwestern University, Feinberg School of Medicine.
This poster evaluated the efficacy of naloxegol in providing clinically meaningful HR-QOL improvement in patients with OIC. Data showed that Movantik demonstrated rapid and clinically meaningful constipation related quality of life improvement in the overall population (40-70% more likely to achieve clinically meaningful QOL improvement) as well as in patients >65 years old (2.5-4.4-fold higher likelihood of achieving clinically meaningful QOL improvement) compared with placebo.
Poster title (poster number: A090): Naloxegol Provides Clinically Meaningful Symptom Improvement (PAC-SYM) in Patients With Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Global Phase 3 Studies of Naloxegol
Presenting Author: Dr. Darren M. Brenner, MD, Professor of Medicine and Surgery (Gastroenterology and Hepatology), Northwestern University, Feinberg School of Medicine.
This second Movantik poster evaluated the efficacy of Movantik in providing clinically meaningful symptom improvement, based on the PAC-SYM patient reported outcome, in patients with OIC. Data showed that Movantik demonstrated rapid and clinically meaningful constipation related symptom improvement in the overall population (20-80% more likely to achieve clinically meaningful QOL improvement) as well as in older patients >65 years old (2.4-4.1-fold higher likelihood of achieving clinically meaningful symptoms improvement) compared with placebo.
In both analyses Movantik was well tolerated and demonstrated a favorable safety profile.
About H. pylori infection H. pylori is a bacterial infection that affects approximately 35%[3] of the U.S. population, with an estimated two million patients treated annually[4]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[5] and a major risk factor for peptic ulcer disease[6] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[7]. More than 27,000 Americans are diagnosed with gastric cancer annually[8]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[9].
About Talicia Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[10] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[11]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
TALICIA: IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.
You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.
You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole.
Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:
Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.
Have severe kidney disease or liver disease.
When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.
Call your healthcare provider immediately if while taking Talicia you develop:
New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.
What are the common side effects of Talicia?
The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.
Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light, or pain when taking a deep breath.
Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.
You may experience a brown-orange discoloration of your urine or tears while taking Talicia.
The information here is not comprehensive. Talk to your healthcare provider to learn more.
APPROVED USE FOR TALICIA
TALICIA is a prescription medicine for the treatment of a bacteria, Helicobacter pylori (H. pylori), in the stomach of adults.
Click here for the full Prescribing Information for TALICIA.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About opioid-induced constipation
Opioid-induced constipation (OIC) affects 40-80% of patients taking chronic opioid therapy and OIC is the most common adverse event associated with opioids. OIC negatively impacts patients' healthcare related quality of life (HR-QOL). Older adults are particularly susceptible to OIC due to comorbidities, polypharmacy, and reduced physical activity. OIC occurs as a result of opioid attachment to peripheral mu-opioid receptors in the digestive tract, disrupting bowel function leading to a variety of related symptoms such as: infrequent bowel movements - fewer than 3 times week, incomplete bowel movements - a sense of not being finished, feeling like you need to "go" but not being able to, straining and hard stools. Opioid-induced constipation can start at the beginning of treatment and last the entirety of opioid treatment.
About Movantik® (naloxegol)
Movantik® is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
MOVANTIK: IMPORTANT SAFETY INFORMATION
MOVANTIK may cause serious side effects, including:
- Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with MOVANTIK, including sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning. Patients taking methadone to treat their pain may be more likely to experience stomach pain and diarrhea. Tell your doctor if you have any of these symptoms
- Severe Stomach Pain and/or Diarrhea. This can happen within a few days of starting MOVANTIK and can lead to hospitalization. If either of these side effects occurs, stop taking MOVANTIK and call your doctor immediately
- Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that gets worse or does not go away, stop taking MOVANTIK and get emergency medical help right away
Do not take MOVANTIK if you:
- Have a bowel blockage (intestinal obstruction) or have a history of bowel blockage
- Are allergic to MOVANTIK or any of the ingredients in MOVANTIK
MOVANTIK can interact with other medicines and cause side effects, including opioid withdrawal symptoms (see symptoms above). Tell your doctor or pharmacist before you start or stop any medicines during treatment with MOVANTIK
Before you take MOVANTIK, tell your doctor about all of your medical conditions, including if you:
- Have any stomach, bowel (intestines) problems, including inflammation in parts of the large intestine (diverticulitis), or inflammation and injury of the intestines caused by reduced blood flow (ischemic colitis)
- Have had recent surgery on the stomach or intestines
- Have any kidney, or liver problems
- Are pregnant or plan to become pregnant. Taking MOVANTIK during pregnancy may cause opioid withdrawal symptoms in you or your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with MOVANTIK
- Are breastfeeding or plan to breastfeed. It is not known if MOVANTIK passes into your breast milk. Taking MOVANTIK while you are breastfeeding may cause opioid withdrawal in your baby. You and your healthcare provider should decide if you will take MOVANTIK or breastfeed. You should not breastfeed if you take MOVANTIK
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way MOVANTIK works
If you stop taking your opioid pain medicine, stop taking MOVANTIK and tell your doctor
Avoid eating grapefruit or drinking grapefruit juice during treatment with MOVANTIK
The most common side effects of MOVANTIK include: Stomach (abdomen) pain, diarrhea, nausea, gas, vomiting, headache, and excessive sweating
APPROVED USE FOR MOVANTIK
MOVANTIK is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults with long-lasting (chronic) pain that is not caused by active cancer.
Click here for the Medication Guide and full Prescribing Information for MOVANTIK.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RedHill Biopharma Inc. supports the responsible use of medications, including those containing opioids, as treatment options for patients with chronic non-cancer pain.
MOVANTIK is a registered trademark of the AstraZeneca group of companies.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[12], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[13], and Aemcolo® for the treatment of travelers' diarrhea in adults[14]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for hospitalized COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a Phase 3-stage study as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
I have not looked at this is about five days. Amazing how quick they can run it back down almost back to where it was before the patent news. Mind boggling.
I predict it can achieve 1.75 to 2.50 at least, on recent news of Patent grant. Keep in mind, was previously near $6.00.
I actually bought a bunch more yesterday at .48 cents. Talk about good timing. I have no doubt the shorts will try and drive this down tomorrow but if we get more good news soon they will get slaughtered.
RDHL: I'm in too --- grabbed it at the 45-minutes-past-Open 'Witching Hour' --- GOD help us both!!!
GO-GO-GO-RDHL!!!!
Almost touched fib retracement too. Im in 685
RDHL: Don't buy this yet, Peeps! WAIT until at least 45-minutes into this day's Open!! THAT is the 'Witching Hour' --- every day!!
Very well stated, Sir!!! CAVEAT EMPTOR routine! (My motto? Don't buy ANYTHING until precisely 45-minutes into each day's OPEN.)
Makes sense to me... been watching since 8... LOL tired of buying dipppers... I would ultimately stay away if you missed this at 8am... Covid was a fishy a*ss pr scheme all around and the narratives are failing, CEOs are being questioned, Flip-Flop Fauchi can't answer simple questions, Adam Borla not showing up in Parliamentary meetings, More people dying now then 2020... It was easy to say Covid was the cause for everything in 2020 because it was fresh and everyone trusts the feds over all... (LOL)... don't know why... but okay...
As i was saying, they tried on 2020 to keep the narrative going, everyone who died in 2020 and 2021 more or less was labeled as a Covid death because they tested people repeatedly until they got a positive result...
What happened with Monkey Pox, it failed to grab people's attention right from the start. And they had to let it go....
In closing, people making money on the Covid narrative hand over fist... I wouldn't support it... to me, that's like buying shares in a stock which supports the U.S military, even though we know what corruption the U.S government and military generals are involved in as seen in Afghanistan, Iraq, Venezuela, Syria, Iran, Ukraine etc etc etc They pillaged Russia too in the 90s and everybody took a piece of China during the 100 years of shame. Nobody forgets...
And buy the time I've completed typing this post up, it's already down about. 22 cents
RDHL: Wants to EXPLODE out of the starting gate!!! Gonna-be a MONSTER GAPPER this morning, Peeps!!! Be CAREFUL!!! Let it settle-down for at least 45-minutes --- compare it then to everything else --- then JUMP on it??????
Finally the beginning of good news period?
Fingers crossed!
RedHill oral antiviral opaganib gets US patent for COVID treatment
Oct. 19, 2022 7:34 AM ETRedHill Biopharma Ltd. (RDHL)
By: Ravikash, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) on Wednesday said that the U.S. Patent and Trademark Office (USPTO) granted a new method of use patent which protects the administration of its oral antiviral drug opaganib for certain patients with COVID-19.
The new method of use patent for opaganib was for the inhibition of a disease caused by coronavirus in a subgroup of patients having pneumonia and receiving supplemental oxygen at a fraction of inspired oxygen (FiO2) up to and including 60%, according to the company.
RedHill added that the new patent — which expires in 2041 — is titled 'Sphingosine Kinase 2 Inhibitor for Treating Coronavirus Infection in Moderately Severe Patients with Pneumonia.'
The patent protects the results from a post-hoc analysis of a global phase 2/3 trial in hospitalized patients with COVID-19 pneumonia, the company noted.
RedHill's Oral Broad-Acting Antiviral, Opaganib, Granted New COVID-19 Treatment Patent
https://finance.yahoo.com/news/redhills-oral-broad-acting-antiviral-110000597.html
USPTO grants new method of use patent for the inhibition of a disease caused by a coronavirus in patients having pneumonia and receiving supplemental oxygen at a fraction of inspired oxygen (FiO2) up to and including 60%
Previous variant-agnostic efficacy data for opaganib, an investigational new drug for COVID-19 disease and several other viral diseases, highlights its promising profile as a broad acting, host-directed candidate therapy for pandemic preparedness
Development of opaganib for moderately severe COVID-19 patients is ongoing, including ongoing and planned pandemic preparedness research collaborations with US governmental agencies, pivotal Phase 3 trial design and regulatory clearances, and securing of external non-dilutive funding
TEL AVIV, Israel and RALEIGH, N.C., Oct. 19, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the granting by the United States Patent and Trademark Office (USPTO) of a further method of use patent that protects the administration of opaganib[1] for the inhibition of a disease caused by a coronavirus in a subgroup population of patients requiring a fraction of inspired oxygen (FiO2) up to and including 60% at baseline, adding to the existing strong patent suite covering opaganib.
The new patent, expiring in 2041, titled "Sphingosine Kinase 2 Inhibitor for Treating Coronavirus Infection in Moderately Severe Patients with Pneumonia", protects the results from a post-hoc analysis from the global Phase 2/3 study in hospitalized patients with COVID-19 pneumonia (NCT04467840). This analysis of 251 study participants requiring a FiO2 up to and including 60% at baseline (54% of study participants) demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality, improved outcomes in time to room air and median time to hospital discharge, and a reduced likelihood of intubation and mechanical ventilation in this large group of hospitalized, moderately severe COVID-19 patients.
"COVID-19 continues to challenge public health providers and patients across the world and continues to be the cause of significant mortality and morbidity. Patients with moderately severe COVID-19 and pneumonia face a lack of treatment options capable of reducing mortality and getting patients out of hospital more quickly," said Danielle T. Abramson, Ph.D., SVP Global Head of Intellectual Property at RedHill. "This latest patent not only adds to the strong existing IP suite for opaganib but further provides for coverage for the patients most likely to benefit from its potential to treat people with COVID-19, pneumonia and who require supplemental oxygen – a key patient sub-group for which opaganib has already demonstrated nominally statistically significant efficacy in a large Phase 2/3 clinical trial."
Recent shifts in international and governmental policy, research, and funding have directed focus toward development of broad-acting, host-pathway targeting antivirals with activity against a range of viruses with the potential to prevent future viral pandemics. RedHill's novel, broad-acting, host-directed antiviral, opaganib, has shown, despite three years of continual viral mutation, encouraging signs of its potential against the COVID-19-causing SARS-CoV-2 variants, as well as additional data suggesting potential activity against various other viruses, including influenza A.
Opaganib's suggested host-directed mechanism of action was recently described in a manuscript entitled "Recent Progress in the Development of Opaganib for the Treatment of COVID-19" published in the journal Drug Design, Development and Therapy in July 2022. The paper outlines opaganib's multi-faceted potential to: inhibit multiple pathways, induce autophagy and apoptosis, and disrupt the viral RTC (replication-transcription complex) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS). These mechanisms support the hypothesis of broad antiviral effect and attenuation of multi-organ dysfunction in COVID-19 patients. Moreover, because of its host-directed targeting, opaganib is unlikely to encounter viral resistance due to mutation, which may be a problem for direct-acting antivirals.
Late-stage development of opaganib is ongoing pending Phase 3 trial design regulatory approvals and securing of external funding.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, investigational sphingosine kinase-2 (SK2) selective inhibitor, with suggested dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and, based on data accumulated to date, is expected to maintain effect against emerging viral variants, having already shown in vitro inhibition against variants of concern, including Omicron and Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
In prespecified analyses of Phase 2/3 clinical data, oral opaganib has demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, published in Open Forum Infectious Diseases.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in the prostate cancer study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.
References:
[1] Opaganib is an investigational new drug, not available for commercial distribution.
[2] Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com
[3] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[4] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
Ditto that!
Very sad indeed!
Stock in currently stunk in the toilet as there is zero interest. Not surprised the company is in hiding and never has any positive news.
RedHill Biopharma Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency
https://finance.yahoo.com/news/redhill-biopharma-announces-receipt-nasdaq-110000036.html
TEL AVIV, Israel & RALEIGH, N.C., Oct. 18, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announces that on October 12, 2022, it received a letter from the Listings Qualifications Department of the Nasdaq Stock Market LLC ("Nasdaq") indicating that, for the last thirty consecutive business days, the bid price for the Company's American Depositary Shares ("ADSs") had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5550(a)(2). The Nasdaq letter is only a notification of deficiency and has no immediate effect on the listing or trading of the Company's ADSs.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until April 10, 2023, to regain compliance. The letter states that the Nasdaq staff will provide written notification that the Company has achieved compliance with Rule 5550(a)(2) if at any time before April 10, 2023, the bid price of the Company's ADSs closes at $1.00 per share or more for a minimum of ten consecutive business days.
RedHill's ADSs will continue to trade on the Nasdaq Global Market, and the Company's operations are not affected by the receipt of the Notice. RedHill intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance by April 10, 2023, the Company may be eligible for an additional 180 calendar day period to regain compliance, provided that the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the deficiency during the second compliance period.
Well, it's a start; or should I say a renewed start. Still a ways to go...
Reassessing The Changing Outlook For RedHill Biopharma Ltd. (RDHL)
https://www.lifetelegraph.com/2022/10/10/reassessing-the-changing-outlook-for-redhill-biopharma-ltd-rdhl/
October 10, 2022 in Industry
ARK Investment Management LLC recently announced the acquisition of new stake in RedHill Biopharma Ltd. (NASDAQ:RDHL). The institutional investor has increased its shareholding in the Healthcare company by 21.26% to 1.05 million shares with purchase of 0.18 million shares. This fresh investment now brings its stake to 1.79% valued currently at $0.94 million. In addition, Apo Asset Management GmbH raised its holdings by 0.2 million to 0.63 million shares. And Gagnon Securities LLC has lifted its position by 2.18% or 8000.0 shares – to 0.38 million shares.
With over 0.98 million RedHill Biopharma Ltd. (RDHL) shares trading Friday and a closing price of $0.55 on the day, the dollar volume was approximately $0.54 million. The shares have shown a positive weekly performance of 8.86% and its price on 10/07/22 lost nearly -10.81%. Currently, there are 52.52M common shares owned by the public and among those 34.99M shares have been available to trade.
Midas,
Thanks for the update!
RedHill's Oral Broad-Acting Antivirals, Opaganib and RHB-107, Inhibit Dominant Omicron Sub-Variant BA.5
https://finance.yahoo.com/news/redhills-oral-broad-acting-antivirals-110000773.html
Novel, oral, host-targeted, broad-acting antivirals, once-daily RHB-107 (upamostat) and twice-daily opaganib, demonstrated in vitro inhibition of the COVID-19-causing SARS-Cov-2 Omicron BA.5 sub-variant in testing conducted by University of Tennessee Health Sciences Center
Results add to previous variant-agnostic efficacy data for both investigational drugs against COVID-19 disease and several other viral diseases, highlighting their promising profile as broad acting, host-directed candidate therapies for pandemic preparedness
Development of both opaganib for hospitalized patients and RHB-107 for non-hospitalized patients is ongoing, including ongoing and planned pandemic preparedness research collaborations with US governmental agencies, pivotal Phase 3 trial design and regulatory clearances, and securing of external non-dilutive funding
TEL AVIV, Israel and RALEIGH, N.C., Oct. 3, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced study results showing in vitro efficacy against the currently dominant Omicron COVID-19 sub-variant BA.5, by both of RedHill's novel, oral, host-directed and broad-acting investigational antivirals, once-daily RHB-107 (upamostat)1 and twice-daily opaganib2. These results build on previously reported data on the inhibition of COVID-19, variants of concern and other viruses, and further support their broad-acting, host-directed mechanisms of action.
The study was done in collaboration with renowned virologist, Dr. Colleen B. Jonsson, Harriet Van Vleet Professor of Virology, Director of the Regional Biocontainment Laboratory (RBL), and Director of the Institute for the Study of Host-Pathogen Systems at the University of Tennessee Health Sciences Center (UTHSC), who remarked: "We tested RHB-107 and opaganib using a primary human nasal epithelial cell culture model of Omicron BA.5, which was specifically selected due to the high level of SARS-CoV-2 entry factor expression in these cells. The results of our work show that both RHB-107 and opaganib inhibit Omicron sub-variant BA.5 viral replication, which is indicative of antiviral activity. Of further interest is the hypothesis that, compared to Delta, Omicron replication is increased as compared to primary epithelial lung cell cultures - hinting at a different possible mechanism of cell entry via membrane fusion and the endocytic pathway. Although we may be potentially dealing with different methods of viral cell entry, these new data suggest that it does not prevent either RHB-107 or opaganib from exerting their viral inhibition capabilities."
"Almost three years after SARS-CoV-2 hit the headlines, we have seen extensive mutation and the emergence of many variants and sub-variants. Consequently, these results, showing viral inhibition of Omicron sub-variant BA.5 by both RHB-107 and opaganib, are especially encouraging. They add to the weight of data in support of their variant-agnostic capabilities, and further support their potential as easily administered, low-pill burden, oral options for treating non-hospitalized and hospitalized patients with COVID-19," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "There has been a recent shift in international and governmental policy, research, and funding focus to address the urgent need to develop broad-spectrum antivirals to prevent future viral pandemics. The ideal drugs would likely be broad-acting, with activity against a range of viruses, that target the host-pathways and cellular proteins used by such viruses to infect and replicate. RedHill's two novel, broad-acting, host-directed antivirals, opaganib and RHB-107, have both shown, despite three years of continual viral mutation, encouraging signs of their potential against the COVID-19-causing SARS-CoV-2 variants, as well as there being additional data suggesting their potential against various other viruses including influenza A."
RHB-107 recently reported positive results from the Phase 2 part of Phase 2/3 study in symptomatic non-hospitalized COVID-19, successfully meeting the study's primary endpoint showing good safety and tolerability and highly promising efficacy results including faster recovery from severe COVID-19 symptoms and reduced rates of hospitalization (NCT04723527).
Opaganib has previously demonstrated a 70% reduction in mortality in key hospitalized patient sub-populations, as well as improved viral RNA clearance and faster time to recovery, in its Phase 3 study in hospitalized patients with moderate to severe COVID-19 (NCT04467840). Opaganib's suggested host-directed mechanism of action was recently described in a manuscript entitled "Recent Progress in the Development of Opaganib for the Treatment of COVID-19" published in the journal Drug Design, Development and Therapy in July 2022. The paper outlines opaganib's multi-faceted potential to: inhibit multiple pathways, induce autophagy and apoptosis, and disrupt the viral RTC (replication-transcription complex) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS). These mechanisms support the hypothesis of broad antiviral effect and attenuation of multi-organ dysfunction in COVID-19 patients. Moreover, because of its host-directed targeting, opaganib is unlikely to encounter viral resistance due to mutation, which may be a problem for direct-acting antivirals.
Late-stage development of both opaganib and RHB-107 is ongoing pending Phase 3 trial design regulatory approvals and securing of external funding.
The ongoing clinical studies with RHB-107 and opaganib 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.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, investigational sphingosine kinase-2 (SK2) selective inhibitor, with suggested dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and, based on data accumulated to date, is expected to maintain effect against emerging viral variants, having already shown in vitro inhibition against variants of concern, including Omicron and Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
In prespecified analyses of Phase 2/3 clinical data, oral opaganib has demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, published in Open Forum Infectious Diseases.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in the prostate cancer study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally-administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein.
Top-line results from Part A of the Phase 2/3 study (NCT04723527) evaluating treatment with RHB-107 in non-hospitalized patients with symptomatic COVID-19 early in the course of the disease, showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm. The study also showed an approx. 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only one patient in the RHB-107 treated group 2.4%, (1/41) versus 20% (4/20) of patients in the placebo-controlled arm. Further analysis showed faster recovery from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat vs. 8 days with placebo.
In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients.
RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults3, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4, and Aemcolo® for the treatment of travelers' diarrhea in adults5. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for hospitalized COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a Phase 3-stage study as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that RHB-107 and opaganib will not be shown to be broad acting, host-directed candidate therapies for pandemic preparedness, the risk that a pivotal Phase 3 trial for RHB-107 and/or opaganib will not be initiated or that such trial be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 17, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: R&D
1 RHB-107 is an investigational new drug, not available for commercial distribution.
2 Opaganib is an investigational new drug, not available for commercial distribution.
3 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com
4 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
5 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
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View original content:https://www.prnewswire.com/news-releases/redhills-oral-broad-acting-antivirals-opaganib-and-rhb-107-inhibit-dominant-omicron-sub-variant-ba5-301638740.html
SOURCE RedHill Biopharma Ltd
From bad to worse, from worse to worst:
On September 13, 2022, RedHill Biopharma Ltd. (the “Company”) and its wholly-owned subsidiary RedHill Biopharma Inc. (“RedHill US”) received a notice of events of default and reservation of rights letter (the “Notice”) from HCR Collateral Management, LLC (“HCR”), as administrative agent, under the credit agreement, dated as of February 23, 2020 (as amended, the “Credit Agreement”), by and among the Company, RedHill US, HCR and the lenders from time to time party thereto. The Notice asserts that certain events of default occurred as a result of alleged breaches by the Company of its representations and warranties and financial covenants under the Credit Agreement. As a result of the alleged events of default, the Notice provides that the outstanding obligations under the Credit Agreement now bear interest at the default rate prescribed therein and that the lenders may accelerate the obligations under the Credit Agreement.
While not asserted in the Notice, the Company acknowledges that it has not satisfied its obligation to deliver to HCR its condensed consolidated interim financial statements as of June 30, 2022 within 60 days after the end of the Company’s fiscal quarter, and that it anticipates releasing such financial statements publicly on or before September 23, 2022.
The Company disagrees with the assertions made by HCR as the basis for the Notice and, accordingly, the validity of the Notice. Moreover, the Company disputes the alleged events of default asserted by HCR and, on September 15, 2022, the Company sent a response letter to HCR to this effect. Nonetheless, the Company is engaged with HCR in good faith in order to establish a consensual business resolution to this dispute. RedHill US continues operating its business as usual while also concurrently evaluating strategic alternatives to satisfy its outstanding obligations under the Credit Agreement, including a potential strategic transaction with respect to Movantik®. The Company has engaged Cravath, Swaine & Moore LLP as its legal advisor and has also engaged financial advisors in connection with the foregoing efforts.
Good weekend to you at RedHill. I like RedHill $RDHL stock because of the name and the reputation online. As far as I know RedHill is a "buy" stock. I don't know a lot about medicine because I'm not a doctor, but I went to college and can imagine. I've been holding my stock for a while and I still need to buy more. I need until next year at least before a good run.
I know that's crazy to ask but this stock might out perform if it runs any time soon. I'm looking forward to a good run; I'm holding a few shares that could be valuable enough.
“With more than 70% of American adults being overweight or obese, it is important to understand the influence of patient BMI on #Hpylori eradication and treatment success.” #RDHL data published in @GastroHep presented today at World Gastro 2022 https://t.co/fzoWZ7dRYH
— RedHill Biopharma (@RedHillBio) August 17, 2022
RedHill Biopharma Announces EU Orphan Drug Designation for RHB-204 for NTM Infections
https://finance.yahoo.com/news/redhill-biopharma-announces-eu-orphan-120000611.html
Developed as the first stand-alone standard of care first-line therapy for NTM disease caused by Mycobacterium avium complex (MAC) infection, RHB-204 is currently undergoing a Phase 3 study in the U.S.
EMA Orphan Drug Designation provides eligibility for 10 years post-approval EU market exclusivity. U.S. FDA Fast Track, Orphan and QIDP priority designations, previously granted to RHB-204, extend U.S. post-approval market exclusivity to a total of 12 years
The Company is advancing discussions with prospective partners for RHB-204 across multiple territories
TEL AVIV, Israel and RALEIGH, N.C., Aug. 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the European Commission has granted Orphan Drug Designation to RHB-2041 for the treatment of nontuberculous mycobacteria (NTM) disease, following a positive opinion recommendation by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP).
The EMA grants Orphan status to treatments of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in 10,000 people in the European Union)2. Orphan Designation provides for free protocol assistance (scientific advice from the EMA), potential reductions in fees, and eligibility for 10 years post-launch market exclusivity.
"NTM infections are increasing across the world and they are notoriously difficult to treat. There are no approved first-line stand-alone therapies in the U.S, EU, and Japan, highlighting the significant need for new options to treat this challenging and debilitating infectious disease," said Patricia Anderson, RedHill's SVP Regulatory Affairs. "The granting of EU Orphan Designation is important and brings significant developmental benefits, in addition to the provision for a potential 10 years of EU post-approval market exclusivity, which adds to the strong exclusivity secured in the U.S."
A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium complex (MAC) infection (NCT04616924). The study protocol provides for 6 months co-primary endpoint of sputum culture conversion (SCC) and clinical outcome (patient-reported outcomes - PRO) in a randomized placebo-controlled design, followed by open label active treatment with RHB-204 for 12 months from conversion.
The Company is advancing discussions with prospective partners for RHB-204 across multiple territories.
About Pulmonary Nontuberculous Mycobacteria (NTM) Infections
Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria, found in soil as well as natural and engineered water systems. The most common NTM symptoms include persistent cough, fever, weight loss, chest pain, and blood in sputum3. NTM infections can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure4. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world5. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 20176 and an estimated 28,000 in the EU. Pulmonary manifestations account for 80-90% of all NTM-associated diseases7, and approximately 80% of pulmonary NTM infections are caused by Mycobacterium avium complex (MAC)8.
Treatment of NTM infection can be difficult with guidelines recommending that MAC infection be treated with a multi-drug regimen for treatment, with at least three antimicrobials, for at least 12 months9. There is no FDA- or EMA-approved first-line standard-of-care combination therapy. Many patients fail current therapy, and more than half will have either recurring disease or a new infection after completing treatment10. Thus, new treatment options for NTM are needed.
About RHB-204
RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC). RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults11, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults12. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for hospitalized COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a Phase 3-stage study as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company will not initiate the Phase 3 clinical study in all or part of the sites in the U.S. or will be delayed; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, Movantik® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 17, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
1 RHB-204 is an investigational new drug, not available for commercial distribution.
2 https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview
3 Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome Am J Respir Crit Care Med. 2008; 178(10):1066–74.
4 The American Lung Association, 2020.
5 Winthrop KL, et al. Incidence and Prevalence of Nontuberculous Mycobacterial Lung Disease in a Large U.S. Managed Care Health Plan, 2008-2015. Ann Am Thorac Soc. 2020 Feb;17(2):178-185.
6 Foster|Rosenblatt, 2017
7 Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416.
8 Prevots DR et al. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med 2010; 182: 977-82
9 Daley CL, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. Ciaa241, https://doi.org/10.1093/cid/ciaa241.
10 Henkle E, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84.
11 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.
12 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
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View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-eu-orphan-drug-designation-for-rhb-204-for-ntm-infections-301607522.html
SOURCE RedHill Biopharma Ltd.
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Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
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http://www.redhillbio.com
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