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Sabin Begins Marburg Vaccine Trial in U.S.

WASHINGTON, April 16, 2025 (GLOBE NEWSWIRE) — The Sabin Vaccine Institute has launched a multi–site Phase 2 clinical trial in the U.S. for its Marburg vaccine candidate, administering doses to the first participants in Melbourne, Florida. This trial builds on ongoing Phase 2 testing in Kenya and Uganda, with initial findings from that research expected in the coming months.

Sabin’s vaccine development efforts, including clinical trials, are becoming increasingly critical as Marburg outbreaks grow in frequency, underscoring the urgent need for vaccines to protect those at highest risk. Sabin supported an open–label Phase 2 clinical trial sponsored by the Rwanda Biomedical Centre (RBC) by supplying the investigational vaccine during Rwanda’s 2024 Marburg outbreak. More than 1,700 individuals — primarily frontline health care workers — were vaccinated, with first doses arriving within nine days of the outbreak being declared. Data from the RBC trial will be shared with Sabin to support the vaccine’s licensure.

Rwanda’s outbreak ended on December 20 with a case fatality rate of 23%, lower than the historical average of 50%. Fatality rates in outbreaks can vary due to multiple factors, including greater surveillance, prompt detection, supportive care, and the overall response effort. On January 20, Tanzania declared an outbreak of Marburg virus disease, which ended on March 13.

Currently, there are no approved vaccines for Marburg virus disease.

For the U.S. clinical trial that began this week, Sabin will recruit 200 volunteers aged 18 to 70 across four locations – in addition to Melbourne, the vaccine will be tested at sites in Dallas, Texas; Huntsville, Alabama; and Peoria, Illinois. The randomized, placebo–controlled, double–blind trial will continue to evaluate safety and immunogenicity, and will monitor vaccinated volunteers for a year.

“Recent outbreaks highlight the urgent need to strengthen our defenses against this deadly and unforgiving disease,” says Amy Finan, Sabin’s Chief Executive Officer. “Sabin’s Phase 2 clinical trials will generate essential data to move this vaccine closer to licensure — and offer a potentially life–saving tool where none exists.”

Marburg is a filovirus, in the same family as the virus that causes Ebola. Like Ebola, Marburg virus disease spreads via direct contact with the blood or other bodily fluids of infected individuals. It is highly virulent and causes hemorrhagic fever.

“Conducting clinical trials in Africa is key to evaluating the vaccine in regions where Marburg and other filoviruses are most common or endemic,” notes Kelly Warfield, Sabin’s President of Research & Development. “The U.S. trial will give us vital safety and immune response data for non–endemic populations, helping us better prepare for outbreaks and spread of this disease.”

Based on the cAd3 platform, Sabin’s single–dose investigational Marburg vaccine was found to be promising in Phase 1 clinical and non–clinical studies, with results showing it to be safe, while eliciting rapid and robust immune responses.

The Marburg vaccine trials are supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under multi–year contracts between the organizations.

BARDA and Sabin began working together in September 2019 to develop monovalent vaccine candidates for Marburg virus and Sudan virus diseases. To date, Sabin has received around $252 million in contract awards from BARDA for furthering vaccine research and development against these two disease threats.

A Phase 2 clinical trial for Sabin’s Sudan virus vaccine is underway in Uganda and Kenya. The cAd3 Sudan vaccine candidate will also be tested among adult volunteers in the U.S. later this year.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Center for the Biomedical Advanced Research and Development Authority (BARDA), under contract numbers 75A50119C00055 and 75A50123C00010.

For information about Sabin’s Phase 2 Marburg vaccine trials, visit:
Clinicaltrials.gov — NCT06620003 (U.S. trial)
Clinical.trials.gov — NCT05817422 (Uganda and Kenya trial)
Pan African Clinical Trials Registry — PACTR202306534727467 (Uganda and Kenya trial)

About the Sabin Vaccine Institute

The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non–profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X @SabinVaccine.

About Sabin’s Vaccine R&D and the cAd3 Platform

In August 2019, Sabin announced exclusive agreements with GSK for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Zaire ebolavirus, Sudan virus, and Marburg virus. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary cAd3 (Chimpanzee Adenovirus Type 3) platform, were further developed by GSK, including the Phase 2 development for the Zaire ebolavirus vaccine. Under the agreements between GSK and Sabin, Sabin exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines.

Media Contact:
Monika Guttman
Senior Media Relations Specialist
Sabin Vaccine Institute
+1 (202) 621–1691
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cdb8a6cd–2ff2–49bd–aeb4–43e859c1b44f


GLOBENEWSWIRE (Distribution ID 9423434)

Minovia Therapeutics Announces FDA Clearance of Second IND Application, for a Phase II Clinical Trial of Lead Product MNV-201 in Pearson Syndrome

MNV–201 is Minovia’s second generation mitochondrial cell therapy product composed of autologous hematopoietic stem cells enriched with allogeneic mitochondria

Rare Pediatric Designation granted

MNV–201 is also being studied in a Phase Ib for low–risk Myelodysplastic Syndrome; Preliminary clinical data demonstrate safety and efficacy

HAIFA, Israel, April 03, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd, a clinical stage biopharmaceutical company advancing mitochondrial therapies for primary and secondary mitochondrial diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its second Investigational New Drug (IND) application for MNV–201, an autologous hematopoietic stem cell product augmented with allogeneic mitochondria. The IND supports the initiation of a Phase II clinical trial of MNV–201 in pediatric patients with Pearson Syndrome, a primary mitochondrial disease.

Based on previous clinical experience from the 1st generation product, MNV–101 (autologous hematopoietic stem cell product augmented with syngeneic maternal mitochondria), Minovia designed this phase II study with change in growth (height SDS) as primary endpoint. According to the natural history study recently published by Dr. Rebecca Ganetzky from CHOP, all patients with Pearson Syndrome suffer from failure to thrive and do not respond to growth hormone. Natural history shows an annual reduction of 0.5 units in height SDS, while MNV–101 treated patients showed stabilization or improvement, with no decline of height SDS at the 6 and 12 month follow up time points in a comparable subset of patients. This change in growth correlated with an improved International Pediatric Mitochondrial Disease Scale (IPMDS), which measures how the patient feels and functions (R2=0.9; p=0.0036). Linear growth was also suggested as an objective and clinically meaningful endpoint for a pivotal trial in Pearson by the FDA in early interactions.

“The FDA’s clearance of our IND marks an important achievement for Minovia, allowing us to clinically evaluate our allogeneic mitochondrial cell therapy approach and proceed with the Phase II clinical program for this first–in–class allogeneic mitochondrial therapy for Pearson Syndrome patients,” said Natalie Yivgi Ohana, PhD, CEO of Minovia. “We are pleased to have safely dosed three Pearson patients enrolled in an ongoing study under the Israeli Ministry of Health. We look forward to treating additional patients under this IND, as well as to learning about the potential of MNV–201 to improve growth in this patient population.”

“We are pleased that our cumulative interactions with the FDA enabled alignment on requirements for the entire MNV–201 program, including preclinical, CMC, and clinical aspects,” said Noa Sher, PhD, CSO of Minovia. “Early clinical and regulatory experience with MNV–101 shaped the current program and enabled a successful IND submission.”

The Phase II clinical trial is an open–label, single dose study to evaluate the safety and efficacy of MNV–201 in pediatric subjects diagnosed with Pearson Syndrome. The trial will also enable assessment of efficacy in improving growth and quality of life. The study is expected to enroll three additional patients up to a total of 6 patients. For more information visit clinicaltirals.gov

About MNV–201
MNV–201 is an autologous hematopoietic stem cell product enriched with allogeneic mitochondria. MNV–201 aims to restore mitochondrial function in patient hematopoietic stem cells, resulting in improved differentiation and function. Preclinical research suggests the potential for safe dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for MNV–201 therapy.

About Pearson Syndrome
Pearson Syndrome is a multisystem progressive pediatric mitochondrial disease caused by single large–scale mitochondrial deletions (SLSMDS) of mitochondrial DNA (mtDNA), with consequent defects in the mitochondrial respiratory chain function. Pearson Syndrome classically presents in the first year of life with bone marrow failure and exocrine pancreatic dysfunction. Patients have macrocytic sideroblastic anemia that is frequently transfusion–dependent and may be accompanied by thrombocytopenia and neutropenia. Pancreatic dysfunction occurs secondary to fibrosis and leads to chronic diarrhea, malabsorption, and failure to thrive. Pearson Syndrome is marked by accumulating organ system involvement and worsening disease: variable other organ involvement can occur, including renal tubulopathy, liver cholestasis and/or fibrosis, adrenal insufficiency, diabetes mellitus, cardiomegaly, and/or cardiac conduction defects. Pearson Syndrome is universally fatal and since there is no effective therapy, the diagnosis of Pearson Syndrome is one of the worst diagnoses that a caregiver must deliver to parents of an affected infant. MNV–201 aims to reduce disease–associated symptoms and the risk of disease progression and death, thereby improving both lifespan and quality of life.

About Minovia Therapeutics
Minovia Therapeutics Ltd. is a clinical stage biotechnology company advancing mitochondrial therapies for primary–genetic and age–related mitochondrial diseases. Minovia's clinical stage product candidate, MNV–201, is composed of mobilized peripheral blood, autologous CD34+ cells enriched with allogeneic, cryopreserved placental derived mitochondria, produced by Minovia's proprietary Mitochondrial Augmentation Technology (MAT). The enrichment of hematopoietic stem cells with healthy and functional mitochondria aims to restore stem cells function of patients suffering mitochondrial dysfunction, caused both by mtDNA mutations or deletions in pediatric patients suffering from primary mitochondrial diseases, or in adults with age–related diseases. MNV–201 is currently in clinical studies for pediatric patients with single–large scale mtDNA deletion syndromes (Pearson Syndrome and Kearn Sayre Syndrome) with five patients successfully dosed; and in Low Risk Myelodysplastic Syndrome. For more information, please visit www.minoviatx.com or follow the Company LinkedIn.

Contact Information: Natalie Yivgi Ohana, Co–Founder and CEO

Phone: +972–74–7039954

Email: [email protected]


GLOBENEWSWIRE (Distribution ID 9416391)

Entera Bio Announces Full Year 2024 Financial Results and Provides Business Updates

JERUSALEM, March 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today reported financial results and key business achievements for the year ended December 31, 2024.

 “2024 was a truly transformational year for Entera. We delivered key data read–outs and advanced each of our oral peptide PTH(1–34), GLP1/Glucagon and GLP2 tablet programs, significantly increased our stockholder value, and efficiently strengthened our balance sheet. To our core team with whom I started this journey in late 2022 as a board member, and to our rapidly expanding ecosystem of premier global advisors, I thank you for your commitment and dedication. To our existing and new shareholders, we are grateful for your belief and support of our thesis. To our collaborators, especially, the formidable team at OPKO Health, Inc., we are grateful for your partnership and the opportunity to expand our N–Tab™ platform to additional high value peptides,” said Miranda Toledano, Chief Executive Officer of Entera.

 “To our potential patient base for whom we are developing EB613: the majority of the estimated 200 million women with osteoporosis who wish to preserve their bone health, who remain underserved with current treatments and who have not been able to access a new therapy since 2019, our dedication to you is firm and unwavering. Osteoporosis is one of the foremost underserved health issues globally which disproportionally afflicts women. Most women experience menopause between the ages of 45 and 55 years. One in three women over age 50 will develop osteoporosis, and one in two of those women will develop an osteoporosis–related fracture. The morbidity and mortality risk of osteoporosis fractures to women outpaces that of breast cancer, stroke and heart attack combined. Nevertheless, most patients remain untreated. Furthermore, existing regulatory guidelines requiring fracture outcomes have curtailed innovation in this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE (Study to Advance Bone Mineral Density as a Regulatory Endpoint), based on a statistical meta–analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip BMD to fracture outcomes, is undergoing review at FDA. This is analogous to prior initiatives that qualified LDL cholesterol as a surrogate marker for CV outcomes and HBA1C as a surrogate for the risk of future diabetes complications, both of which enabled the advancement of many important new therapies for those conditions. We look forward to potential updates from FDA and SABRE on this important ruling and to potentially initiating our pivotal Phase 3 study of EB613 promptly thereafter. Our EB613, the first oral PTH(1–34) peptide treatment candidate is being developed to close the treatment gap in osteoporosis with a validated anabolic mechanism of action in tablet form. We plan to continue our mission to add value to Entera in 2025, with humility and a focus on execution,” said Miranda Toledano, Chief Executive Officer of Entera.

2024 Key Achievements:

EB613: First Oral PTH(1–34), teriparatide Anabolic Tablet Treatment Candidate for Women with Osteoporosis

  • In March 2024, the ASBMR announced that the FDA had communicated to the SABRE project team that a ruling to qualify the treatment–related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs would be provided within 10 months 
  • In April 2024, Entera announced that the Journal of Bone and Mineral Research (JBMR) published EB613 placebo controlled Phase 2 Trial results, highlighting its dual mechanism of action and rapid increases in BMD at trabecular and cortical skeletal sites
  • In June 2024, an independent editorial was published by the JBMR “A Novel Oral PTH(1–34) [EB613] Unveils the Promise of Modeling–Based Anabolism with No Increase in Bone Remodeling”
  • In September 2024, Entera presented new comparative pharmacological data for EB613 vs. Forteo® at the ASBMR September 2024 Annual Meeting in Toronto. The abstract was previewed by Dr. Serge Ferrari of Geneva University Hospital in Switzerland in his sneak–peak highlights of cutting–edge clinical abstracts on osteoporosis therapy at ASBMR2024

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity

  • In September 2024, Entera and OPKO Health jointly announced topline pharmacokinetic/pharmacodynamic (PK/PD) results for the oral oxyntomodulin (OXM) tablet program
  • The program is focused on developing the first oral dual agonist GLP–1/glucagon peptide as a potential once–daily treatment for patients with obesity and metabolic disorders combining OPKO’s proprietary long–acting oxyntomodulin analog (OPK–88006) and Entera’s proprietary N–Tab™ platform
  • Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half–life for semaglutide (Rybelsus®), the only approved oral GLP–1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo
  • In March 2025, we entered into a collaboration and license agreement with OPKO relating to the preclinical and clinical development of the Oral OXM program. Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro–rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. The companies expect to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year

First GLP–2 Peptide Tablets for Short Bowel Syndrome

  • During 2024, Entera and OPKO completed a proof of concept (PoC) single dose pharmacokinetic study in rodents. Oral GLP–2 tablets exhibited significant systemic exposure. Furthermore, plasma levels achieved with the oral tablet form of the GLP–2 analogue were about 10–fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex®)
  • The pharmacokinetic analysis of the data obtained following the IV injections of the GLP–2 peptide showed the plasma half–life in rats to be about six times longer than the half–life reported for teduglutide in the same animal model. This data is consistent with previously reported PK data relating to OPKO’s GLP–2 peptide’s long–acting profile, which had initially been developed as a weekly subcutaneous injection
  • Given the challenging compliance rates attributed to injectable GLP–2 therapy and heterogeneity of short bowel syndrome (SBS) patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives. OPKO and Entera are determining next steps for this program

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets Candidate for Hypoparathyroidism

  • In June 2024, Entera presented Phase 1 clinical data for EB612, which is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for patients with hypoparathyroidism, at the Endocrine Society ENDO 2024 Annual Meeting. This Phase 1 data supports potentially moving the BID tablet dose to Phase 2 development in patients with hypoparathyroidism
  • Entera continues to collaborate productively with a third party on the oral tablet development of another PTH replacement treatment for hypoparathyroidism

Financial Results for the Year Ended December 31, 2024

As of December 31, 2024, Entera had cash and cash equivalents of $8.7 million. As of March 28, 2025, Entera had cash and cash equivalents of $21 million, largely attributable to at–market direct investments from existing and new institutional shareholders and our partner, OPKO. The cash is expected to be sufficient to fund our operations into the third quarter of 2026, including ongoing work related to the planned EB613 phase 3 study, regulatory expenses, research and development, patent prosecution, the completion of an additional Phase 1 PK study related to our new generation platform and our share of projected oral GLP1/Glucagon tablet Phase 1 study expenses in collaboration with OPKO.

  • Research and development expenses for the years ended December 31, 2024 and December 31, 2023 were each $4.5 million. There was a decrease of $0.8 million related to the completion of the first cohorts of a Phase 1 PK study, which occurred in 2023. The decrease was offset by an increase of $0.8 million in 2024 related to optimization related to the preparation of the EB613 phase 3 study
  • General and administrative expenses for the year ended December 31, 2024 were $5.1 million, compared to $4.4 million for the year ended December 31, 2023. The increase of $0.7 million was mainly attributable to expanding our intellectual property position and advisor compensation. The increase was partially offset by a decrease of $0.2 million in D&O insurance costs and other costs
  • Operating expenses for the year ended December 31, 2024 were $9.6 million, as compared to $8.9 million for the year ended December 31, 2023

Net loss was $9.5 million, or $0.25 per ordinary share (basic and diluted), for the year ended December 31, 2024, as compared to 8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
       
  December 31,   December 31,
  2024   2023
  (Unaudited)   (Audited)
   
Cash and cash equivalents 8,660   11,019
Accounts receivable and other current assets 312   238
Property and equipment, net 57   100
Other assets, net 361   408
Total assets 9,390   11,765
     
     
Accounts payable and other current liabilities 1,176   1,091
Total non–current liabilities 134   288
Total liabilities 1,310   1,379
Total shareholders' equity 8,080   10,386
       
Total liabilities and shareholders' equity 9,390   11,765

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
  Year Ended
December 31,
  2024   2023
REVENUES 181   –
COST OF REVENUES 172   –
GROSS PROFIT 9   –
OPERATING EXPENSES:    
Research and development 4,499   4,510
General and administrative 5,095   4,430
Other income –   (49)
TOTAL OPERATING EXPENSES 9,594   8,891
OPERATING LOSS 9,585   8,891
FINANCIAL INCOME, NET (58)   (31)
INCOME TAX 14   29
NET LOSS 9,541   8,889
     
LOSS PER SHARE BASIC AND DILUTED 0.25   0.31
WEIGHTED AVERAGE NUMBER OF SHARES      
OUTSTANDING USED IN COMPUTATION OF      
BASIC AND DILUTED LOSS PER SHARE  37,650,179    29,007,794 


GLOBENEWSWIRE (Distribution ID 9412734)

Curia Anuncia Expansão da Rede Global de Locais de Processamento Final Estéril

ALBANY, N.Y., March 17, 2025 (GLOBE NEWSWIRE) — A Curia Global, Inc. (Curia), uma organização líder em contratos de pesquisa, desenvolvimento e fabricação, anunciou hoje planos de expansão de suas instalações em Glasgow, Reino Unido, e forneceu atualizações sobre a expansão em andamento em Albuquerque, NM.

A instalação de processamento final estéril da Curia em Glasgow adicionará uma linha de processamento final de frascos integrada e baseada em isolador e um liofilizador adequado para uma ampla gama de medicamentos, incluindo recursos altamente potentes, mais do que dobrando o tamanho atual do lote de GMP. Já conhecida por seus conjugados anticorpo–droga (ADCs), nanopartículas lipídicas (LNPs), desenvolvimento de liofilização, formulação e desenvolvimento complexos, e experiência de fabricação clínica, a expansão em Glasgow fortalecerá ainda mais a oferta da Curia de desenvolvimento de produtos injetáveis estéreis desde a pré–formulação, passando pelas fases clínicas e de fabricação comercial.

Além de aumentar o tamanho dos lotes em até 20.000 frascos, a nova capacidade contará com tecnologia de processamento final robótica e sem perdas situada dentro de um isolador para permitir velocidades de processamento final cinco vezes mais rápidas do que as capacidades atuais. O liofilizador adicional também fornecerá aos clientes em estágio clínico mais escalabilidade no caminho para a comercialização e criará uma oportunidade para futuros processamentos finais comerciais de pequeno volume em Glasgow. A instalação continuará atendendo clientes com operações normais durante a expansão.

“Nosso investimento em Glasgow ressalta o compromisso da Curia de ser um parceiro completo”, disse Philip Macnabb, CEO da Curia. “Existe muita inovação nos estágios iniciais do desenvolvimento clínico, e a Curia está pronta para atender à crescente demanda de maior capacidade para nossos clientes em estágio clínico.”

A expansão de Glasgow se soma a um investimento de US $ 200 milhões em um projeto de expansão plurianual em andamento nas instalações da Curia em Albuquerque. Duas linhas de processamento final isoladas adicionarão mais de 70.000 pés quadrados ao espaço de fabricação de mais de 200.000 pés quadrados de Albuquerque e criarão uma capacidade clínica e comercial significativa de fase III para seus clientes. Uma Linha VarioSys™ Flex, adequada para produtos biológicos de pequena escala e pequenas moléculas não potentes, pode acomodar seringas, cartuchos e frascos. Esta linha está passando por comissionamento. Além disso, a nova linha de frascos de alta velocidade da Curia começará a ser comissionada no terceiro trimestre de 2025. A nova linha de frascos de alta velocidade inclui dois liofilizadores automáticos, inspeção automatizada de frascos e rotulagem/embalagem para frascos de 2R a 30R.

“O aumento da demanda por agonistas de GLP–1, novos medicamentos biológicos, juntamente com as avaliações contínuas da cadeia de suprimentos por nossos clientes, tornam este o momento ideal para que essa capacidade em Albuquerque seja disponibilizada”, disse Macnabb. “A Curia é ideal para ajudar nossos clientes a enfrentar todos esses desafios com nossas várias instalações de fabricação nos EUA, experiência na cadeia de suprimentos e capacidade prontamente disponível.”

A rede global de instalações de processamento final estéril da Curia também inclui capacidades de desenvolvimento clínico e fabricação em Camarillo e Thousand Oaks, CA e capacidades de fabricação comercial e clínica em Burlington, MA.

Sobre a Curia
A Curia é uma Organização de Desenvolvimento e Fabricação por Contratos (CDMO) com mais de 30 anos de experiência, uma rede integrada de mais de 20 locais em todo o mundo e 3.100 funcionários em parcerias com clientes biofarmacêuticos para lançamento no mercado terapias que mudam a vida. Nossas ofertas de pequenas moléculas, APIs genéricos e produtos biológicos resultam em descobertas através da comercialização, com integridade regulatória, de capacidade analítica e processamento final estéril. Nossos especialistas científicos e de processos, juntamente com nossas instalações em conformidade regulatórias, oferecem a melhor experiência em fabricação de medicamentos e produtos farmacêuticos. Da curiosidade à cura, proporcionamos todas as etapas necessárias para acelerar sua pesquisa e melhorar a vida dos pacientes. Visite–nos em curiaglobal.com.

Contato Corporativo:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9394930)

Curia kündigt Erweiterung des globalen Netzwerks steriler Abfüllanlagen an

ALBANY, N.Y., March 17, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), ein führendes Unternehmen für Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen, gab heute Expansionspläne für seinen Standort in Glasgow, Großbritannien, bekannt und informierte über den aktuellen Stand der laufenden Expansion in Albuquerque, New Mexico.

Die sterile Abfüllanlage von Curia in Glasgow wird um eine integrierte, isolatorbasierte Abfülllinie für Ampullen und einen Gefriertrockner erweitert, der für eine breite Palette von Arzneimitteln geeignet ist, einschließlich hochwirksamer Produkte, wodurch die derzeitige GMP–Chargengröße mehr als verdoppelt wird. Curia ist bereits für seine Antikörper–Wirkstoff–Konjugate (ADCs), Lipidnanopartikel (LNPs), die Entwicklung von Gefriertrocknung, komplexe Formulierungen und Entwicklung sowie seine Erfahrung in der klinischen Fertigung bekannt. Durch die Erweiterung in Glasgow wird das Angebot von Curia im Bereich der Entwicklung steriler injizierbarer Produkte von der Vorformulierung über die klinischen Phasen bis hin zur kommerziellen Fertigung weiter gestärkt.

Zusätzlich zur Erhöhung der Chargengröße auf bis zu 20.000 Phiolen wird die neue Anlage mit einer robotergestützten, verlustfreien Abfülltechnologie ausgestattet sein, die sich in einem Isolator befindet und Abfüllgeschwindigkeiten ermöglicht, die fünfmal schneller sind als die derzeitigen Möglichkeiten. Der zusätzliche Gefriertrockner bietet Kunden im klinischen Stadium auch mehr Skalierbarkeit auf dem Weg zur Vermarktung und schafft die Möglichkeit für zukünftige kommerzielle Abfüllungen in kleinen Mengen in Glasgow. Die Einrichtung wird während der Erweiterung Kunden wie gehabt bedienen.

„Unsere Investition in Glasgow unterstreicht das Engagement von Curia, ein umfassender Partner zu sein“, so Philip Macnabb, CEO von Curia. „In den frühen Phasen der klinischen Entwicklung gibt es so viel Innovation, und Curia ist bestrebt, die wachsende Nachfrage nach mehr Kapazität für unsere Kunden in der klinischen Phase zu decken.“

Die Erweiterung in Glasgow erfolgt zusätzlich zu einer Investition von 200 Millionen US–Dollar in ein laufendes, mehrjähriges Erweiterungsprojekt in der Curia–Einrichtung in Albuquerque. Zwei isolierte Abfüllanlagen werden die über 200.000 Quadratmeter große Produktionsfläche von Albuquerque um über 70.000 Quadratmeter erweitern und eine bedeutende klinische und kommerzielle Phase–III–Kapazität für seine Kunden schaffen. Eine VarioSysTM Flex–Anlage, die für kleine Mengen an Biologika und nicht potenten kleinen Molekülen geeignet ist, kann Spritzen, Kartuschen und Phiolen aufnehmen. Diese Anlage wird derzeit in Betrieb genommen. Darüber hinaus wird die neue Hochgeschwindigkeits–Phiolenanlage von Curia im 3. Quartal 2025 in Betrieb genommen. Die neue Hochgeschwindigkeits–Phiolenanlage umfasst zwei automatisch beladene Gefriertrockner, eine automatische Phioleninspektion und eine Etikettier–/Verpackungsanlage für 2R– bis 30R–Phiolen.

„Die erhöhte Nachfrage nach GLP–1–Agonisten und neuen biologischen Arzneimitteln in Verbindung mit den laufenden Überprüfungen der Lieferkette durch unsere Kunden machen dies zu einem idealen Zeitpunkt, um diese Kapazität in Albuquerque in Betrieb zu nehmen“, fuhr Macnabb fort. „Curia ist ideal aufgestellt, um unseren Kunden bei all diesen Herausforderungen mit unseren zahlreichen Produktionsstätten in den USA, unserer Expertise in der Lieferkette und unserer sofort verfügbaren Kapazität zu helfen.“

Das weltweite Netzwerk steriler Abfüllanlagen von Curia umfasst auch klinische Entwicklungs– und Fertigungskapazitäten in Camarillo und Thousand Oaks, Kalifornien, sowie kommerzielle und klinische Fertigungskapazitäten in Burlington, Massachusetts.

Über Curia
Curia ist ein Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen (CDMO) mit über 30 Jahren Erfahrung, einem integrierten Netzwerk von über 20 Standorten weltweit und 3.100 Mitarbeitern, die mit biopharmazeutischen Kunden zusammenarbeiten, um lebensverändernde Therapien auf den Markt zu bringen. Unser Angebot an niedermolekularen, generischen Wirkstoffen und Biologika reicht von der Entdeckung bis zur Vermarktung und umfasst integrierte regulatorische, analytische und sterile Abfüll– und Veredelungskapazitäten. Unsere wissenschaftlichen und technischen Experten bieten zusammen mit unseren regulatorisch konformen Einrichtungen erstklassige Erfahrung in der Herstellung von Arzneimitteln und Produkten. Von der Neugier bis zur Heilung – wir unterstützen Sie bei jedem Schritt, um Ihre Forschung zu beschleunigen und das Leben von Patienten zu verbessern. Besuchen Sie uns unter curiaglobal.com.

Firmenkontakt:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9394930)

Curia Announces Expansions to Global Network of Sterile Fill-Finish Sites

ALBANY, N.Y., March 17, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), a leading contract research, development and manufacturing organization, today announced expansion plans to its Glasgow, UK facility and provided updates on the ongoing expansion in Albuquerque, NM.

Curia’s sterile fill–finish facility in Glasgow will add an integrated, isolator–based vial filling line and lyophilizer suitable for a broad range of drug product including highly potent capabilities, more than doubling current GMP batch size. Already known for its antibody drug conjugates (ADCs), lipid nanoparticles (LNPs), lyophilization development, complex formulation and development, and clinical manufacturing experience, the Glasgow expansion will further strengthen Curia’s offering of sterile injectable product development from pre–formulation, through the clinical phases and commercial manufacturing.

In addition to increasing batch sizes up to 20,000 vials, the new capacity will feature robotic, lossless filling technology situated within an isolator to allow filling speeds five times faster than current capabilities. The additional lyophilizer will also provide clinical–stage clients more scalability on the path to commercialization and creates an opportunity for future small–volume commercial fills in Glasgow. The facility will continue serving clients with normal operations during the expansion.

“Our investment in Glasgow underscores Curia’s commitment to being an end–to–end partner,” said Philip Macnabb, CEO of Curia. “So much innovation exists in the early stages of clinical development, and Curia is eager to meet the growing demand for increased capacity for our clinical–stage clients.”

The Glasgow expansion is in addition to a $200 million investment in an ongoing, multi–year expansion project at Curia’s Albuquerque facility. Two isolated filling lines will add over 70,000 square feet to Albuquerque’s over 200,000–square–foot manufacturing space and will create significant phase III clinical and commercial capacity for its clients. A VarioSysTM Flex Line, suitable for small–scale biologics and non–potent small molecules can accommodate syringes, cartridges and vials. This line is currently undergoing commissioning. Additionally, Curia’s new high–speed vial line will begin commissioning in Q3 2025. The new high–speed vial line includes two autoloaded freeze driers, automated vial inspection and labeling/packaging for 2R to 30R vials.

“Increased demand for GLP–1 agonists, new biologic drugs, coupled with on–going supply chain reviews by our customers make this an ideal time for this capacity In Albuquerque to come on–line,” Macnabb went on to say. “Curia is ideally suited to help our clients meet all of these challenges with our multiple U.S. manufacturing facilities, supply chain expertise and readily available capacity.”

Curia’s global network of sterile fill–finish facilities also includes clinical development and manufacturing capabilities in Camarillo and Thousand Oaks, CA and commercial and clinical manufacturing capabilities in Burlington, MA.

About Curia
Curia is a contract research, development and manufacturing organization (CDMO) with over 30 years of experience, an integrated network of 20+ global sites and 3,100 employees partnering with biopharmaceutical customers to bring life–changing therapies to market. Our offerings in small molecule, generic APIs and biologics span discovery through commercialization, with integrated regulatory, analytical and sterile fill–finish capabilities. Our scientific and process experts, along with our regulatory compliant facilities, provide a best–in–class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate your research and improve patients’ lives. Visit us at curiaglobal.com.

Corporate Contact:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9394930)

Curia annonce l’extension de son réseau mondial de sites de remplissage et de finition stériles

ALBANY, État de New York, 17 mars 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), une organisation leader du domaine de la recherche, du développement et de la fabrication sous contrat, dévoile ce jour les projets d’agrandissement de son site de Glasgow, au Royaume–Uni, et fait le point sur le développement de celui d’Albuquerque, au Nouveau–Mexique.

Le site de remplissage et de finition stériles situé à Glasgow apporte à Curia une nouvelle ligne de remplissage de flacons intégrée à base d’isolateurs et un lyophilisateur adapté à une large gamme de produits pharmaceutiques, y compris des capacités de production extrêmement élevées, ce qui fera plus que doubler la taille des lots certifiés BPF actuels. Déjà connue pour ses conjugués anticorps–médicaments (ou ADC, pour antibody drug conjugates), ses nanoparticules lipidiques (ou LNP, de l’anglais lipid nanoparticles), son développement de la lyophilisation, sa formulation et son développement complexes, ainsi que pour son expérience en termes de fabrication clinique, l’unité de fabrication de Glasgow permettra, dans ses nouvelles dimensions, de consolider l’offre de Curia en matière de développement de produits injectables stériles, depuis la préformulation jusqu’à la fabrication commerciale, sans oublier les phases cliniques.

Outre l’augmentation de la taille des lots à concurrence de 20 000 flacons, la nouvelle usine sera dotée d’une technologie de remplissage robotisé sans perte située dans un isolateur pour atteindre des vitesses de remplissage cinq fois supérieures aux capacités actuelles. Le lyophilisateur supplémentaire permettra également aux clients en phase clinique de gagner en évolutivité sur la voie de la commercialisation et concrétise l’opportunité de proposer de futurs remplissages commerciaux de petits volumes à Glasgow. L’installation continuera à fonctionner normalement pendant les travaux d’agrandissement.

« Notre investissement à Glasgow vient souligner l’engagement de Curia en tant que partenaire de bout en bout », indique Philip Macnabb, PDG de la société. « Il existe une multitude d’innovations dans les premiers stades du développement clinique. Curia souhaite ardemment répondre à la demande croissante d’augmentation des capacités pour ses clients en phase clinique. »

L’agrandissement du site de Glasgow vient s’ajouter à un investissement de 200 millions de dollars visant un projet d’agrandissement pluriannuel en cours sur le site d’Albuquerque. Deux lignes de remplissage isolées viendront compléter l’espace de fabrication d’Albuquerque de plus de 70 000 pieds carrés (soit un peu plus de 6 500 mètres carrés), à noter que son périmètre actuel en représente plus de 200 000 (soit environ 18 580 mètres carrés). Elles permettront de mettre en place une importante capacité clinique et commerciale de phase III pour ses clients. Une ligne VarioSysTM Flex, adaptée aux produits biologiques de petite taille et aux petites molécules non puissantes, peut fabriquer des seringues, des cartouches et des flacons. La mise en service de cette ligne est actuellement en cours. Par ailleurs, la nouvelle ligne de flacons à grande vitesse de Curia démarrera au troisième trimestre 2025. La nouvelle ligne de flacons à grande vitesse comprend deux lyophilisateurs à chargement automatique, une inspection automatisée des flacons et un étiquetage/conditionnement de flacons de 2 à 30 ml.

« L’augmentation de la demande d’agonistes du GLP–1 et de nouveaux médicaments biologiques, associée à l’évaluation continue de la chaîne d’approvisionnement par nos clients, fait de cet instant l’occasion idéale pour mettre en service cette capacité sur le site d’Albuquerque », poursuit M. Macnabb. « À l’appui de ses multiples sites de production aux États–Unis, son expertise en matière de chaîne d’approvisionnement et sa capacité de production facilement disponible, Curia est parfaitement en mesure d’aider ses clients à relever tous ces enjeux. »

Le réseau mondial de sites de remplissage et de finition stériles de Curia comprend également des capacités de développement clinique et de fabrication à Camarillo et Thousand Oaks, dans l’État de Californie, ainsi que des unités de fabrication commerciale et clinique à Burlington, dans l’État du Massachusetts.

À propos de Curia
Curia est une organisation de recherche, de développement et de fabrication sous contrat (ou CDMO pour Contract Development and Manufacturing Organization) forte de plus de 30 ans d’expérience à son actif. Elle exploite un réseau intégré de plus de 20 sites à travers le monde et emploie quelque 3 100 collaborateurs travaillant en partenariat avec des clients biopharmaceutiques pour mettre sur le marché des traitements qui changent véritablement la vie des gens. Nos offres en matière de petites molécules, d’API génériques et de produits biologiques couvrent le cycle complet de la découverte à la commercialisation, et intègrent des capacités réglementaires, analytiques et de remplissage et finition stériles. Nos scientifiques, nos experts en processus et nos installations conformes aux réglementations en vigueur apportent une expérience de premier ordre dans la fabrication de substances et de produits pharmaceutiques. De la curiosité au traitement, nous réalisons toutes les étapes permettant d’accélérer vos recherches et d’améliorer la vie des patients. Consultez notre site à l’adresse curiaglobal.com.

Contact de l’entreprise :
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9394930)

OPKO Health and Entera Bio Enter into Collaboration Agreement to Advance Oral GLP-1/Glucagon Tablet Candidate into the Clinic to Treat Obesity and Metabolic Disorders

MIAMI and JERUSALEM, March 17, 2025 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, entered into a collaboration and license agreement to advance into the clinic the first oral dual agonist GLP–1/glucagon peptide as a once–daily tablet treatment for patients with obesity, metabolic and fibrotic disorders. The program combines OPKO’s proprietary long–acting oxyntomodulin analog (OPK–88006) and Entera’s proprietary N–Tab™ technology. Favorable pharmacodynamic, pharmacokinetic and bioavailability data in vivo were reported in September 2024. The companies expect to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year.

Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro–rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. In connection with the execution of the agreement, OPKO purchased 3,685,226 ordinary shares of Entera for a purchase price equal to $2.17 per share. Entera has agreed to utilize the proceeds from the sale of the shares to fund its 40% share of costs through Phase 1 of the development program. Following the completion of the Phase 1 stage, Entera has the option to continue to fund its 40% share to maintain its pro–rata ownership interest of the program. Should Entera opt–out, Entera will retain a 15% ownership interest in the Oral OXM program, while OPKO will retain 85% and be responsible for ongoing development activities and funding of the program.

“We are pleased to continue working with Entera on this promising program to develop the first oral GLP–1/Glucagon dual agonist in addition to our subcutaneous injectable dual agonist GLP–1/Glucagon program. Our goal with this franchise is to provide additional options for patients with obesity, metabolic and fibrotic diseases,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.

“We have enjoyed our synergistic partnership with OPKO. This expanded collaboration on the GLP–1/Glucagon program reinforces our shared vision to develop first in class differentiated oral peptide treatments for patients to better manage their health,” said Miranda Toledano, Entera Chief Executive Officer.

Oxyntomodulin is a naturally occurring GLP–1/Glucagon dual agonist peptide hormone found in the small intestine that acts to suppress appetite, induce weight loss and has additional cardioprotective and anti–fibrotic attributes. OPK–88006 is a GLP–1/glucagon dual agonist peptide that has been modified to maintain its long–acting profile while increasing its potential potency. Currently, there are no approved dual GLP–1/Glucagon agonists available.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

About OPKO Health

OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry–leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release, including those regarding our prospects, plans, financial position, business strategy and expected financial and operational results, may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s and OPKO’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, whether by Entera, OPKO or their respective collaboration and laboratory partners; impacts to research and development or clinical activities that Entera or OPKO may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing our product candidates; the parties’ reliance on third parties to conduct clinical trials; Entera’s and OPKO’s expectations regarding licensing, business transactions, including OPKO’s development efforts should Entera opt–out, and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s and OPKO’s intellectual property positions and their ability to protect their respective intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of each of Entera’s and OPKO’s most recent Annual Reports on Form 10–K filed with the SEC, as well as the companies’ respective subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward–looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9395480)

VIVUS تطلق عقار QSYMIA® في الإمارات العربية المتحدة

– علاج جديد في مجال التحكم بالوزن أصبح متاحاً الآن
– دولة الإمارات العربية المتحدة هي الدولة الأولى التي تطرح دواء QSYMIA في منطقة الشرق الأوسط
– ارتفاع معدلات السمنة يكلّف الإمارات العربية المتحدة ما يقرب من 12 مليار دولار سنويًا

كامبيل، كاليفورنيا, March 11, 2025 (GLOBE NEWSWIRE) —  أعلنت VIVUS LLC، وهي شركة متخصصة في صناعة الأدوية والمستحضرات الصيدلانية الحيوية والملتزمة بتطوير وتسويق العلاجات المبتكرة التي تركز على علاج المرضى الذين يعانون من احتياجات طبية حرجة غير ملباة، عن حصول عقار QSYMIA® (وهو عبارة عن كبسولات أدوية فينتيرمين وتوبيرامات ممتدة المفعول) CIV على موافقة السوق في دولة الإمارات العربية المتحدة لعلاج الوزن الزائد والسمنة لدى البالغين والمرضى الأطفال من سن 12 عامًا فما فوق. وتعدّ دولة الإمارات العربية المتحدة الدولة الأولى في منطقة الشرق الأوسط التي توافق على عقار QSYMIA وتطرحه في الأسواق. وتمثل هذه الخطوة إنجازاً هاماً للمرضى الذين يعانون من السمنة والأطباء الذين يقومون بعلاجهم.

هذا وتعتزم شركة VIVUS التعاون مع شركة PharmaAccess، شريكها التسويقي في منطقة الشرق الأوسط وشمال أفريقيا، لتزويد مقدمي الرعاية الصحية بالمزيد من الخيارات لمعالجة هذا الوباء، بما يتماشى مع رؤية الإمارات العربية المتحدة المعنية بمكافحة السمنة. تجدر الإشارة إلى أنّ Alphamed Drug Store هو الموزع الحصري لعقار QSYMIA في الإمارات العربية المتحدة.

وفي هذا الصدد، قال John Amos، الرئيس التنفيذي لشركة VIVUS LLC: “تلتزم VIVUS تحقيق مهمتها المتمثلة في معالجة أزمة السمنة بشكل فوري”. وأضاف: “بالتزامن مع طرح علاج QSYMIA في دولة الإمارات العربية المتحدة، لا تقتصر مهمتنا على توسيع نطاق وصول المرضى إلى العلاج فحسب، بل نؤكد التزامنا برعايتهم وتطوير العلاجات في جميع أنحاء العالم. كما نعرب عن حماسنا إزاء قدرتنا على إحراز تقدم ملموس لمكافحة هذه المشكلة الصحية العامة الملحة، وإحداث تأثير إيجابي في المجتمعات في جميع أنحاء العالم“.

هذا وتشير تقديرات الاتحاد العالمي للسمنة World Obesity Federation إلى أنه بحلول العام 2035، سيعاني ما يقرب من 7.5 مليون شخص من البالغين والأطفال والمراهقين في الإمارات العربية المتحدة من زيادة الوزن أو من السمنة. وتؤكد هذه الإحصائية على مدى خطورة أزمة السمنة في دولة الإمارات العربية المتحدة، وتكشف عن الآثار الضارة المحتملة لهذه الآفة على صحة الأفراد المصابين واقتصاد الدولة، في الوقت الحالي وفي المستقبل المنظور.

ومن جهته، قال الطبيب Santosh T. Varghese، رئيس قسم VIVUS للتطوير الدوائي العالمي والرئيس التنفيذي للشؤون الطبية في VIVUS LLC: “بفضل تزويد المرضى بإمكانية الوصول إلى دواء QSYMIA، ستتمكن دولة الإمارات العربية المتحدة من إحداث فرق في حياة مرضى السمنة، ومعالجة تحديات هذه الحالة متعددة الأوجه والتخفيف من تداعياتها الاقتصادية“. وأضاف: “تتمثل مهمتنا في شركة VIVUS في تزويد المرضى من جميع أنحاء العالم بعلاج مستدام يخوّلهم التحكم الدائم في وزنهم. ويمثل هذا الإنجاز خطوة مهمة في مسار تعزيز الجهود المبذولة لمكافحة مرض السمنة”.

هذا ومن المتوقع أن تؤثر السمنة على مليار شخص على مستوى العالم بحلول العام 2030، أي ما يقرب من ضعف العدد المسجّل في عام 2020. وللتخفيف من الأعباء الصحية والاقتصادية الهائلة لوباء السمنة، تعمل شركة VIVUS على توسيع نطاق وصول المرضى في العديد من البلدان الأوروبية إلى دواء QSYMIA، والذي سيتم بيعه تحت الاسم التجاري QSIVA® (فينتيرمين وتوبيراميت معدل المفعول). كما تعتزم VIVUS تزويد أكثر من مليار شخص في العالم بعقار QSYMIA بحلول أواخر العام 2025.

وقد ثبت أن تناول دواء QSYMIA، بالاقتران مع إتباع نظام غذائي منخفض السعرات الحرارية وممارسة الرياضة، يساعد البالغين والأطفال الذين تتراوح أعمارهم بين 12 و17 عامًا على إنقاص وزنهم والحفاظ على وزن مستدام. تجدر الإشارة إلى أن عقار QSYMIA موصى للاستخدام على المدى الطويل.

لمحة عن VIVUS
VIVUS هي شركة لتصنيع الأدوية والمستحضرات الصيدلانية الحيوية تلتزم بتطوير وتسويق العلاجات المبتكرة التي تركز على علاج المرضى الذين يعانون من احتياجات طبية حرجة غير ملباة. للمزيد من المعلومات عن الشركة، يرجى زيارة الموقع الإلكتروني التالي: http://www.vivus.com.

لمحة عن PharmaAccess
تتعاون PharmaAccess مع شركات الأدوية والتكنولوجيا الحيوية التي تتطلع إلى دخول سوق دول مجلس التعاون الخليجي لتستحوذ على مكانة مرموقة بين الشركات الأفضل أداءً في المنطقة. وتعمل شركة PharmaAccess على تزويد شركائها بحلول متكاملة من خلال تنفيذ مجموعة من الوظائف التجارية.

لمحة عن QSYMIA
يوصى دواء QSYMIA بالاقتران مع نظام غذائي منخفض السعرات الحرارية وممارسة للرياضة للمرضى البالغين والأطفال الذين تبلغ أعمارهم 12 عاماً فأكثر ويعانون من السمنة المفرطة، ما يتيح لهم إنقاص وزنهم الزائد والحفاظ على وزن مستدام على المدى الطويل، ومعالجة البالغين الذين يعانون من زيادة الوزن بسبب حالة مرضية مصاحبة واحدة على الأقل مرتبطة بالوزن.

لم يتم حتى الآن إثبات تأثير دواء QSYMIA على ارتفاع حالات اعتلال القلب والأوعية الدموية ونسبة الوفيات. كما أنه لم يتم إثبات سلامة وفعالية استخدام QSYMIA إلى جانب المنتجات الأخرى المخصصة لإنقاص الوزن، بما في ذلك الأدوية التي تُصرف بموجب وصفة طبية والأدوية التي لا تستلزم وصفة طبية والمستحضرات العشبية.

للمزيد من المعلومات عن دواء QSYMIA، يُرجى زيارة الرابط الإلكتروني التالي: https://QSYMIA.com/.

لمحة عن QSIVA
حصل عقار QSIVA (الاسم التجاري الأوروبي لعقار QSYMIA) على الموافقة للاستخدام في السويد والدنمارك وفنلندا وأيسلندا والنرويج وبولندا. ويوصى QSIVA للمرضى البالغين الذين يبلغ مؤشر كتلة الجسم الأولي لديهم 30 كيلوغرام/م2 أو أكثر (مرضى السمنة) أو 27 كيلوغرام/م2 أو أكثر (يعانون من زيادة الوزن) أو في حال وجود حالة طبية واحدة على الأقل مرتبطة بالوزن مثل ارتفاع ضغط الدم أو السكري من النوع الثاني أو ارتفاع الكوليسترول. ويعمل هذا العقار، بالاقتران مع نظام غذائي منخفض السعرات الحرارية وممارسة الرياضة، على التحكم بارتفاع الوزن المزمن. حتى الآن، لم يتم إثبات تأثير QSIVA على ارتفاع حالات اعتلال القلب والأوعية الدموية ونسبة الوفيات. كما أنه لم يتم إثبات سلامة وفعالية استخدام QSYMIA مع المنتجات الأخرى المخصصة لإنقاص الوزن، بما في ذلك الأدوية التي تُصرف بموجب وصفة طبية والأدوية التي لا تستلزم وصفة طبية والمستحضرات العشبية. للمزيد من المعلومات عن QSIVA، يُرجى زيارة الموقع الإلكتروني التالي: www.QSIVA.eu.

معلومات مهمة تتعلق بسلامة دواء QSYMIA
لا تتناولي QSYMIA إذا كنتِ حاملاً أو تخططين للحمل أو إذا أصبحتِ حاملاً أثناء تناول علاج QSYMIA؛ أو إذا كنت مصاباً بالجلوكوما؛ أو بمشاكل في الغدة الدرقية (فرط نشاط الغدة الدرقية)؛ أو إذا كنت تتناول أدوية معينة تُعرف بمثبطات الأوكسيداز أحادي الأمين (MAOIs) أو إذا تناولت مثبطات الأوكسيداز أحادي الأمين خلال الـ 14 يوماً الماضية؛ أو إذا كنت مصاباً بحساسية تجاه دواء توبيرامات، أو الأمينات المحاكية للأعصاب الوديّة مثل فينتيرمين أو أي من مكونات QSYMIA.

تشمل الآثار الجانبية الشائعة لدواء QSYMIA لدى البالغين الخدر (التنميل) أو الوخز في اليدين أو الذراعين أو القدمين أو الوجه (الخدران)، والدوخة، وتغيرات في مذاق الطعام أو فقدان حاسة التذوّق (خلل التذوق)، ومشاكل النوم (الأرق)، والإمساك، وجفاف الفم. وتشمل الآثار الجانبية الشائعة لدواء QSYMIA لدى الأطفال الذين تبلغ أعمارهم 12 عاماً فأكثر الاكتئاب والدوار وآلام المفاصل والحمى والإنفلونزا والتواء الكاحل.

كما يمكن أن ينتج عن دواء QSYMIA آثارًا جانبية خطيرة، بما في ذلك العيوب الخلقية (الشفة المشقوقة/الحنك المشقوق)، وزيادة معدل ضربات القلب، ومشاكل في الرؤية (تختلف عن ارتفاع ضغط العين)، والأفكار أو الأفعال الانتحارية، ومشاكل خطيرة في العين، وطفح جلدي شديد مع ظهور بثور وتقشير الجلد. وقد يؤدي QSYMIA إلى إبطاء زيادة الطول لدى الأطفال بعمر 12 عاماً فأكثر.

معلومات مهمة تتعلق بسلامة دواء QSIVA
يمنع استخدام كبسولات QSIVA الصلبة (فينتيرمين وتوبيرامات معدلة المفعول) من قبل النساء الحوامل والنساء القادرات على الإنجاب اللاتي لا يستخدمن وسائل فعالة لمنع الحمل، أو المرضى الذين يعانون من الجلوكوما، أو فرط نشاط الغدة الدرقية، أو المرضى الذين يتلقون العلاج بمثبطات أوكسيداز أحادي الأمين أو بعد 14 يوماً من تلقي العلاج، أو المرضى الذين يعانون من فرط الحساسية تجاه المحاكيات الوديّة أو التوبيرامات أو أي من مكونات QSIVA غير النشطة.

كذلك، قد يسبب تناول دواء QSIVA ضررًا للجنين. ويُستحسن أن تخضع المريضة التي من المحتمل أن تصبح حاملاً لاختبار يثبت أنها غير حامل قبل بدء العلاج بعقار QSIVA، وإجراء اختبار الحمل شهرياً، واستخدام وسائل منع الحمل الفعالة أثناء تناول دواء QSIVA. إذا أصبحت المريضة حاملاً أثناء تناول عقار QSIVA، يجب عليها إيقاف العلاج فوراً، كما ينبغي إبلاغها بالخطر المحتمل على الجنين.

وتشمل الآثار الجانبية الأكثر شيوعاً لدى البالغين الخدران والدوار وتغير أو ضعف حاسة التذوق والأرق والإمساك وجفاف الفم.

البيانات التطلعية
معلومات مهمة وملاحظة تحذيرية بشأن البيانات التطلعية

إن بعض البيانات الواردة في هذا البيان الصحفي هي بيانات تطلعية بالمعنى المقصود في قانون إصلاح التقاضي الخاص بالأوراق المالية لعام 1995، بصيغته المعدلة، و/أو المشمولة بمبدأ ”التحذير من مخاطر توقعات الأداء“ الذي تطبقه المحاكم بموجب أحكام مكافحة الاحتيال في قوانين الأوراق المالية الفيدرالية، وغيرها من الأحكام المعمول بها في قوانين الأوراق المالية الفيدرالية. وتستند مثل هذه البيانات التطلعية إلى التوقعات الحالية والمعتقدات وبعض الافتراضات التي وضعتها إدارة الشركة. ويمكن تحديد هذه البيانات من خلال استخدام كلمات تطلعية مثل، ”سوف“، ”يجب“، ”قد“، ”نعتقد“، ”نتوقع“، ”نتنبأ“، ”نعتزم“، ”نستبق“، ”نترقب“، ”ينبغي“، ”نخطط“، ”من المحتمل“، ”فرصة“، ”مقدّرة“، ”محتملة“، و/أو الاستخدام السلبي لهذه الكلمات أو كلمات أخرى مشابهة. تستند جميع البيانات التطلعية الواردة في هذا المستند إلى توقعاتنا الحالية، ولا تتحمل الشركة أي التزام بتحديث أي من هذه البيانات التطلعية إلا بالقدر الذي يقتضيه القانون.

تنطوي المعلومات التطلعية حول عقار QSYMIA، بما في ذلك فوائده المحتملة، والموافقات التي حصل عليها في الأسواق المحتملة خارج الولايات المتحدة والتوافر المتوقع للمنتج، على مخاطر وشكوك كبيرة قد تؤدي إلى اختلاف النتائج الفعلية مادياً عن تلك المعبر عنها أو المضمنة في هذا البيان الصحفي. وتشمل المخاطر والشكوك، من بين أمور أخرى، الشكوك الكامنة في نتائج البحث والتطوير، بما في ذلك القدرة على تلبية نقاط النهاية السريرية المتوقعة، وتواريخ بدء و/أو استكمال تجاربنا السريرية، وتواريخ تقديم طلبات الدواء التنظيمية، وتواريخ الموافقة التنظيمية على المنتج و/أو تواريخ إطلاقه، بالإضافة إلى إمكانية وجود بيانات سريرية جديدة غير مواتية وتحليلات أخرى للبيانات السريرية الحالية؛ ومخاطر من خضوع بيانات التجارب السريرية لتفسيرات وتقييمات مختلفة من قبل السلطات التنظيمية; وما إذا كانت السلطات التنظيمية ستكون راضية عن تصميم دراساتنا السريرية ونتائجها؛ وما إذا كان سيتم تقديم طلبات الأدوية في أي أسواق أخرى أو الموافقة عليها ومتى سيتم ذلك، وما إذا كان دواء QSYMIA سينجح تجاريًا؛ والقرارات التي تتخذها السلطات التنظيمية والتي تؤثر على عملية وضع الملصقات على المنتج وعمليات التصنيع والسلامة و/أو غيرها من المسائل التي يمكن أن تؤثر على توافر دواء QSYMIA أو إمكاناته التجارية؛ والشكوك المتعلقة بتأثير جائحة كوفيد–19 على أعمالنا وعملياتنا ونتائجنا المالية؛ والتطورات التي تشهدها المنافسة في هذا المجال.

من الصعب التنبؤ بالعوامل والمخاطر والشكوك المذكورة أعلاه، وهي تنطوي على شكوك قد تؤثر بشكل جوهري على النتائج الفعلية وقد تكون خارجة عن سيطرة الشركة. تظهر عوامل ومخاطر وشكوك جديدة من وقت لآخر، ولا يمكن للإدارة التنبؤ بجميع هذه العوامل والمخاطر والشكوك. على الرغم من أن الشركة تعتقد أن الافتراضات التي تستند إليها البيانات التطلعية الواردة في هذه الوثيقة معقولة، إلا أن أياً من الافتراضات قد تكون غير دقيقة، وبالتالي قد يثبت أن أياً من هذه البيانات غير دقيقة أيضاً. في ضوء الشكوك العديدة الكامنة في البيانات التطلعية الواردة في هذه الوثيقة، لا ينبغي اعتبار إدراج مثل هذه المعلومات بمثابة إقرار أو ضمان من الشركة أو أي شخص آخر بأن أهداف الشركة وخططها سوف تتحقق. لا تعتبر هذه البيانات التطلعية صالحة إلا اعتبارًا من تاريخ إصدار هذه البيانات أو في أي تاريخ سابق مشار إليه، ولا تتعهد الشركة بأي التزام بتحديث أو مراجعة أي بيانات تطلعية، سواء كان ذلك نتيجة لمعلومات جديدة أو أحداث مستقبلية أو تغييرات في الافتراضات الأساسية أو غير ذلك، ما لم ينص القانون على خلاف ذلك.

جهات الاتصال:

VIVUS LLC  
T: +1 (650) 934–5200

Media – FINN Partners  
Glenn Silver  
[email protected] 
T: +1 973–818–8198


GLOBENEWSWIRE (Distribution ID 9392618)

VIVUS Launches QSYMIA® in the United Arab Emirates

 –  A new path in weight management is now available

–  UAE is the first country in the Middle East to have QSYMIA® available

–  Rising obesity rates cost UAE nearly $12 billion annually

CAMPBELL, Calif., March 10, 2025 (GLOBE NEWSWIRE) — VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, announced the market approval of QSYMIA® (phentermine and topiramate extended–release capsules) CIV in the United Arab Emirates (UAE) for treatment of overweight and obesity in adults and pediatric patients, age 12 and older. The UAE is the first country in the Middle East region to approve QSYMIA and have it available in market. This marks an important milestone for patients challenged by obesity and the physicians who treat them.

VIVUS, in collaboration with PharmaAccess, its marketing partner in the Middle East North African (MENA) region, intends to provide healthcare providers with more treatment options to combat this epidemic in line with the UAE vision to address obesity. Alphamed Drug Store is the exclusive distributor of QSYMIA in the UAE.

“VIVUS remains steadfast in its mission to tackle the obesity crisis head–on,” said John Amos, Chief Executive Officer at VIVUS LLC. “With the availability of QSYMIA in the UAE, we're not only expanding treatment access but also reaffirming our commitment to advancing patient care on a global scale. We are enthusiastic about our continued progress in combatting this urgent public health concern, making a meaningful impact in communities worldwide.”

The World Obesity Federation estimates that by 2035, approximately 7.5 million adults, children, and adolescents in the UAE will be overweight or living with obesity. This statistic underscores the severity of the obesity challenge in the UAE, revealing potential detrimental effects on the health of affected individuals and the nation's economy, now and in the foreseeable future.

“By providing access to QSYMIA, the UAE can make a difference in the lives of those impacted by obesity, addressing the challenges of this multifaceted condition and mitigating its economic repercussions,” said Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “At VIVUS, our mission is to provide patients worldwide with a sustainable path to lasting weight management. This milestone marks a significant step forward in advancing those efforts.”

Obesity is forecasted to affect one billion individuals globally by 2030, nearly double that in 2020. In response to the substantial health and economic burdens of the obesity epidemic, VIVUS is expanding access to QSYMIA to patients in multiple European countries, which will be sold under the trade name QSIVA® (phentermine and topiramate modified–release). VIVUS plans to provide access to QSYMIA to over one billion individuals worldwide by the end of 2025.

QSYMIA, in combination with a reduced–calorie diet and exercise, has been proven to help adults and children ages 12 – 17 lose weight and maintain the loss. It is indicated for long–term use.

About VIVUS
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit http://www.vivus.com.

About PharmaAccess
PharmaAccess partners with pharmaceutical and biotech companies that are willing to enter the GCC market and be positioned among the top–performing companies in the region. It offers its partners fully integrated solutions by executing a range of commercial functions.

About QSYMIA
QSYMIA is indicated in combination with a reduced–calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight–related comorbid condition.

The effect of QSYMIA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription drugs, over–the–counter drugs, and herbal preparations, have not been established.

For more information on QSYMIA, please visit https://QSYMIA.com/

About QSIVA
QSIVA (the European brand name for QSYMIA) is approved in Sweden, Denmark, Finland, Iceland, Norway, and Poland. QSIVA is indicated as an adjunct to a reduced–calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight–related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The effect of QSIVA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSIVA in combination with other products intended for weight loss, including prescription and over–the–counter drugs and herbal preparations, have not been established. For more information on QSIVA, please visit www.QSIVA.eu.

Important Safety Information for QSYMIA
Do not take QSYMIA if you are pregnant, planning to become pregnant, or become pregnant during QSYMIA treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in QSYMIA.

Common side effects of QSYMIA in adults include numbness or tingling in the hands, arms, feet, or face (paraesthesia), dizziness, changes in the way foods taste or loss of taste (dysgeusia), trouble sleeping (insomnia), constipation, and dry mouth. Common side effects of QSYMIA in children aged 12 years and older include depression, dizziness, joint pain, fever, flu, and ankle sprain.

QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), increases in heart rate, visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, serious eye problems, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older.

Important Safety Information for QSIVA
QSIVA (phentermine and topiramate modified–release) hard capsules is contraindicated in pregnancy and in women of childbearing potential who are not using effective methods of contraception; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in QSIVA.

QSIVA can cause fetal harm. It is recommended that patients who can become pregnant obtain a negative pregnancy test result before starting QSIVA treatment, perform monthly pregnancy testing, and use effective contraception while taking QSIVA. If a patient becomes pregnant while taking QSIVA, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

The most common adverse reactions in adults are paraesthesia, dizziness, an altered or impaired sense of taste, insomnia, constipation, and dry mouth.

Forward–Looking Statements

Important Information and Cautionary Note Regarding Forward–Looking Statements

Certain statements in this press release are forward–looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the “Bespeaks Caution” doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward–looking statements are based on current expectations, management’s beliefs and certain assumptions made by the Company’s management. These statements may be identified by the use of forward–looking words such as “will,” “shall,” “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” and/or the negative use of these words or other similar words. All forward–looking statements included in this document are based on our current expectations, and the Company assumes no obligation to update any such forward–looking statements except to the extent otherwise required by law.

Forward–looking information about QSYMIA, including its potential benefits, approvals in potential markets outside the U.S. and anticipated product availability, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other markets or approved, whether QSYMIA will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSYMIA; uncertainties regarding the impact of COVID–19 on our business, operations, and financial results; and competitive developments.

The above factors, risks and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results and may be beyond the Company’s control. New factors, risks and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks and uncertainties. Although the Company believes that the assumptions underlying the forward–looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward–looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company’s objectives and plans will be achieved. These forward–looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward–looking statements, whether as a result of new information, future events, changes in underlying assumptions or otherwise, unless otherwise required by law.

Contacts

VIVUS LLC
T: +1 (650) 934–5200

Media – FINN Partners
Glenn Silver
[email protected] 
T: +1 973–818–8198


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