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 − If Approved, Maribavir Will Be the First and Only Treatment Indicated for Post-Transplant Cytomegalovirus (CMV) Infection in Those That Are Refractory, With or Without Resistance (R/R)

− Maribavir is Takeda’s Fourth New Molecular Entity Accepted for Regulatory Review in Six Months

Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir for the treatment of CMV infection in those that are refractory with or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.

This is an inflection year for Takeda’s pipeline with up to six regulatory submissions and four potential approvals anticipated by the end of fiscal year 2021. The maribavir NDA acceptance is Takeda’s fourth new molecular entity accepted for regulatory review in six months, following the FDA submissions of TAK-721 for the treatment of eosinophilic esophagitis, mobocertinib for the treatment of EGFR Exon20 insertion mutation positive metastatic non-small cell lung cancer, and the European Medicines Agency submission of the Company’s dengue vaccine candidate (TAK-003), which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60.

“CMV is one of the most common viral infections experienced by transplant recipients, and current antiviral treatment options are limited, and physicians have to engage in a careful balance of viral clearance and side effect management that can impact patient care and transplant outcomes,” said Obi Umeh, MD, Vice President and Maribavir Global Program Leader, Takeda. “If approved, maribavir has the potential to change the treatment landscape for post-transplant CMV, and the acceptance of this regulatory application is an important milestone on maribavir’s path forward.”

The application is based on the pivotal Phase 3 TAK-620-303 (SOLSTICE) trial, results of which were presented at the 2021 Transplantation & Cellular Therapy (TCT) Meetings Digital Experience, with subgroup analysis presented during the Presidential Symposium 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).

“CMV infection puts transplant recipients at an increased risk of disease, such as pneumonia or gastrointestinal disease. It can also increase the risk of graft rejection, opportunistic co-infections, and in some cases, even death,” said Michael Boeckh, M.D., Ph.D., Head, Infectious Disease Sciences Program at the Vaccine and Infectious Disease Division, Fred Hutch “The results of the SOLSTICE trial are promising and show that maribavir may help with post-transplant CMV viremia, including cases of drug-resistance for which there is an unmet need.”

Maribavir has been granted Orphan Drug Designation by the FDA for treatment of clinically significant CMV viremia and disease in at-risk patients. The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy. These designations do not guarantee that the FDA will approve maribavir for the treatment of CMV infections in transplant patients, and the timing of any such approval is uncertain.

About CMV
CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40%-100% of various adult populations.2 CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including hematopoietic cell transplant (HCT) or solid organ transplant (SOT).3,4 Out of the estimated 200,000 adult transplants per year, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16-56% in SOT recipients and 30-70% in HCT recipients.4–9

In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal.10,11 Existing therapies to treat posttransplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication.12–14 Additionally, existing therapies may require or prolong hospitalization due to administration.12,13

About Maribavir
Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HCT. Maribavir is an investigational treatment that has not been approved for use by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or any other regulatory authorities. Maribavir is the only CMV antiviral drug that targets and inhibits the UL97 protein kinase and its natural substrates.1,15–17

Maribavir has been granted Orphan Drug Designation by the European Commission as a treatment of CMV disease in patients with impaired cell mediated immunity and by the FDA for treatment of clinically significant CMV viremia and disease in at-risk patients. Orphan status is granted to certain investigational medicines intended for the treatment or prevention of a rare, life-threatening disease. The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy. Breakthrough Therapy Designation expedites the development and review of investigational treatments for serious conditions with preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy. These designations do not guarantee that the EMA or FDA will approve maribavir for the treatment of CMV infections in transplant patients, and the timing of any such approval is uncertain.

About Takeda’s SOLSTICE Trial
The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing treatment with either maribavir or investigator assigned treatment, IAT, (conventional antiviral therapy) in hematopoietic cell transplant and solid organ transplant recipients with CMV infection refractory, with or without resistance, to one or a combination of the conventional antiviral therapies: ganciclovir, valganciclovir, foscarnet or cidofovir. Patients underwent a 2-week screening period, followed by randomization 2:1 to maribavir (n=235) (400 mg) or IAT (n=117) for an 8-week treatment period, plus 12 weeks of follow-up.

The trial’s primary endpoint was defined as the proportion of patients who achieved confirmed CMV viremia clearance (plasma CMV DNA <137 IU/mL in two consecutive tests ≥5 days apart at central laboratory) compared to IAT at the end of Study Week 8. The key secondary endpoint was defined as achievement of CMV viremia clearance and symptom control at end of Study Week 8, maintained through Study Week 16.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

*The difference in proportion of responders between treatment groups was obtained using Cochran-Mantel-Haenszel (CMH) weighted average across all strata and tested using stratum-adjusted CMH method, with transplant type and baseline plasma CMV DNA concentration as two stratification factors

† Refractory defined as documented failure to achieve >1 log10 decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with IV ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir

‡ Resistant defined as refractory CMV and documentation of >1 CMV genetic mutations associated with resistance to ganciclovir, valganciclovir, foscarnet, and/or cidofovir

References

1.

Marty F. A Phase 3 Randomized Study of Maribavir (MBV) Versus Investigator-Assigned Antiviral Therapy (IAT) for the Treatment (Tx) of Refractory/Resistant (R/R) Cytomegalovirus (CMV) Infection in Hematopoietic Cell Transplant (HCT) or Solid Organ Transplant (SOT) Recipients. In: The 2021 TCT Meetings Digital Experience. ; 2021.

2.

Krech U. Complement-fixing antibodies against cytomegalovirus in different parts of the world. Bull WHO. 1973;49:103-106.

3.

de la Hoz R. Diagnosis and treatment approaches to CMV infections in adult patients. Journal of Clinical Virology. 2002;25:S1-S12.

4.

Azevedo L, Pierrotti L, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics. 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09

5.

World Health Organization. International Report on Organ Donation and Transplantation Activities- Executive Summary 2018.; 2020. Accessed December 2, 2020. http://www.transplant-observatory.org/wp-content/uploads/2020/10/glorep2018-2.pdf

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World Health Organization. Haematopoietic Stem Cell Transplantation HSCtx. Accessed December 2, 2020. https://www.who.int/transplantation/hsctx/en/

7.

Razonable RR, Eid AJ. A Viral infections in transplant recipients. MINERVA MEDICA. 2009;100(6):23.

8.

Styczynski J. Who Is the Patient at Risk of CMV Recurrence: A Review of the Current Scientific Evidence with a Focus on Hematopoietic Cell Transplantation. Infect Dis Ther. 2018;7:1-16.

9.

Cho S-Y, Lee D-G, Kim H-J. Cytomegalovirus Infections after Hematopoietic Stem Cell Transplantation: Current Status and Future Immunotherapy. Int J Mol Sci. 2019;20(2666):1-17.

10.

Fishman JA. Infection in Organ Transplantation. American Journal of Transplantation. 2017;17:856-879.

11.

Kenyon M, Babic A, eds. The European Blood and Marrow Transplantation Textbook for Nurses. Springer International Publishing; 2018. doi:10.1007/978-3-319-50026-3

12.

Martín-Gandul C, Pérez-Romero P, González-Roncero FM, et al. Clinical impact of neutropenia related with the preemptive therapy of CMV infection in solid organ transplant recipients. Journal of Infection. 2014;69(5):500-506. doi:10.1016/j.jinf.2014.07.001

13.

Chemaly RF, Chou S, Einsele H, et al. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clinical Infectious Diseases. 2019;68(8):1420-1426. doi:10.1093/cid/ciy696

14.

Beyer K. Outpatient Foscarnet Administration Incorporating Home Infusions Is Feasible Greatly Enhancing the Care of Hematopoietic Stem Cell Transplant Recipients. Biol Blood Marrow Transplant. 2017;23:S18-S391.

15.

Hamirally S, Kamil JP, Ndassa-Colday YM, et al. Viral Mimicry of Cdc2/Cyclin-Dependent Kinase 1 Mediates Disruption of Nuclear Lamina during Human Cytomegalovirus Nuclear Egress. Nelson JA, ed. PLoS Pathog. 2009;5(1):e1000275. doi:10.1371/journal.ppat.1000275

16.

Krosky PM, Baek M-C, Coen DM. The Human Cytomegalovirus UL97 Protein Kinase, an Antiviral Drug Target, Is Required at the Stage of Nuclear Egress. JVI. 2003;77(2):905-914. doi:10.1128/JVI.77.2.905-914.2003

17.

Prichard MN. Function of human cytomegalovirus UL97 kinase in viral infection and its inhibition by maribavir: Human cytomegalovirus UL97 kinase. Rev Med Virol. 2009;19(4):215-229. doi:10.1002/rmv.615

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Business Wire India

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Merck, a leading science and technology company, today announced 40 abstracts, including seven oral presentations and seven poster discussions, from Company- and investigator-sponsored studies (ISS) and external collaborations, representing the Company’s innovative oncology portfolio will be presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8, 2021.

“Important new analyses from our pivotal studies in urothelial cancer and non-small cell lung cancer, which have led to recent regulatory approvals for BAVENCIO® (avelumab) and TEPMETKO® (tepotinib) in these tumor types, demonstrate how our research continues to drive forward new standards of care in certain cancers with high unmet medical need,” said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck. “These analyses, along with additional data informing the understanding of new and emerging mechanisms under investigation, are the latest examples of our dedication to advancing the science of cancer treatment to make a meaningful difference for patients.”

The Company’s research programs, focused on synergistic approaches in immuno-oncology, oncogenic pathways, and DNA damage response (DDR), aim to tackle some of the most challenging tumor types, including urothelial cancer (UC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colorectal cancer (CRC), and cervical cancer (CC).

Key Data Highlights at ASCO

BAVENCIO (avelumab)
Data across three approved indications for BAVENCIO (avelumab) provide further evidence of continued patient benefit:

Advanced urothelial cancer (presentations: 4520, 4525, 4527). New analyses from the Phase III JAVELIN Bladder 100 study demonstrated consistent survival benefit of BAVENCIO (avelumab) as first-line maintenance treatment across key subgroups including those defined by the treatment-free interval from the end of chemotherapy to the start of maintenance, disease stage, site of metastasis, or genomic subtype. These data further reinforce the role of BAVENCIO for patients with advanced UC that have not progressed on 1L platinum-containing chemotherapy.
Advanced renal cell carcinoma (aRCC) (presentations: 4514, 4574). Data from the extended follow-up of the Phase III JAVELIN Renal 101 study explored the effects of subsequent therapies on outcomes for patients with aRCC treated with BAVENCIO (avelumab) plus axitinib and confirmed the efficacy benefits of the combination across International Metastatic RCC Data Consortium (IMDC) risk groups including in the favorable risk group.
Metastatic Merkel cell carcinoma (mMCC) (presentation: 9517). In previously treated patients with metastatic MCC (mMCC), treatment with BAVENCIO (avelumab) provided meaningful long-term overall survival (OS), based on more than five years of follow-up in Part A of the Phase II JAVELIN Merkel 200 study with 48- and 60-month OS rates 30% (95% CI, 20%-40%) and 26% (95% CI, 17%-36%), respectively. These results further support the role of avelumab as a standard-of-care treatment for patients with mMCC.

TEPMETKO (tepotinib)
ASCO highlights for TEPMETKO (tepotinib) include new data from the Phase II VISION study:

METex14 NSCLC biomarker response detected in liquid biopsy (LBx) abstract (oral presentation: 9012). In this analysis, reduction in variant allele frequency following tepotinib treatment was related to an improved treatment outcome. Further, this investigation provides evidence that liquid biopsy may provide a reliable means for monitoring response to treatment, understanding resistance mechanisms, and improving patient outcomes and quality of life.
METex14 skipping NSCLC with brain metastases (presentation: 9084). Data demonstrated efficacy in patients with mesenchymal epithelial transition (MET) exon 14 (METex14) skipping NSCLC with brain metastases consistent with the overall treatment population, complemented by intracranial activity in an ad hoc retrospective analysis of brain lesions determined by CT/MRI. Brain metastases are reported in 20% to 40% of patients with METex14 skipping NSCLC and are associated with poor prognosis.
NSCLC with MET amplification (METamp) (presentation: 9021). Clinical activity observed in VISION Cohort B, the first study of a MET inhibitor in people with NSCLC with METamp prospectively detected by liquid biopsy, showed the potential of tepotinib to target METamp-driven disease, particularly in the treatment-naïve setting where there is high unmet need. MET amplification is a genetic alteration occurring in approximately 1% to 5% of patients with NSCLC and has no approved targeted therapies.

Tepotinib is also being investigated in two ongoing studies, which are currently recruiting patients: INSIGHT 2 (Presentation: TPS9136), assessing the combination of osimertinib and tepotinib in patients with epithelial growth factor receptor (EGFR)-mutant NSCLC that has developed resistance to first-line osimertinib treatment due to MET amplification; and PERSPECTIVE (Presentation: TPS3616), evaluating tepotinib in combination with cetuximab in mCRC having acquired resistance to anti-EGFR antibody-targeted therapy due to MET amplification.

ERBITUX® (cetuximab)
For the Company’s first biology-driven leader, ERBITUX (cetuximab), a number of ISS, and the PERSPECTIVE study in combination with TEPMETKO (tepotinib) continue to demonstrate its steady role across the continuum of care in metastatic colorectal cancer, and as a backbone of treatment in squamous cell carcinoma of the head and neck.

DEEPER “JACCRO CC-13” (oral presentation: 3501). Significant greater depth of response seen with cetuximab + triplet CT vs bevacizumab + triplet CT in 1L RAS wt mCRC
FIRE 4.5 “AIO KRK-0116” (oral presentation: 3502).Comparable efficacy shown between cetuximab and bevacizumab in 1L BRAF mt mCRC
TROG 12.01 and De-ESCALaTE (oral presentation: 109).This pooled analysis from two Phase III studies identifies a potential prognostic biomarker for patients treated with cetuximab + RT in HPV-positive oropharyngeal cancer (OPC) LA SCCHN

Bintrafusp alfa(M7824)
Data for bintrafusp alfa, an investigational bifunctional fusion protein, continue to shed light on the potential benefits of dual inhibition of the TGF-β and PD-L1 pathways:

Recurrent/metastatic cervical cancer (oral presentation: 5509). A pooled analysis of data from the Phase I INTR@PID Solid Tumor 001 study and a National Cancer Institute (NCI)-led Phase II study demonstrated that bintrafusp alfa monotherapy has a manageable safety profile and clinical activity in patients with platinum-pretreated, immune checkpoint inhibitor-naïve recurrent/metastatic cervical cancer.
HPV 16+ advanced malignancies (oral presentation: 2501). Data from this NCI-led Phase II clinical study of patients with advanced HPV 16+ cancers provided early evidence of the clinical activity of a triple combination of bintrafusp alfa, NHS-IL12 and PDS0101, with a manageable safety profile.

Merck is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer. Our oncology research efforts aim to leverage our synergistic portfolio in oncogenic pathways, immuno-oncology, and DNA Damage Response (DDR) to tackle challenging tumor types in gastrointestinal, genitourinary, and thoracic cancers. Our curiosity drives our pursuit of treatments for even the most complex cancers, as we work to illuminate a path to scientific breakthroughs that transform patient outcomes. Learn more at https://www.merckgrouponcology.com.

About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications
The European Commission (EC) has authorized the use of BAVENCIO as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized by the EC for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced RCC. Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients in 50 countries for at least one use.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)
The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.

About TEPMETKO® (tepotinib)
TEPMETKO is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck KGaA, Darmstadt, Germany, TEPMETKO has a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.

TEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020. TEPMETKO was approved in the United States in February 2021 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tepotinib is currently under clinical investigation and not yet approved in any markets outside of Japan and the United States.

About ERBITUX® (cetuximab)
ERBITUX® is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX® is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX® also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX® has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX®, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

About Bintrafusp Alfa
Bintrafusp alfa (M7824), discovered in-house at Merck, and currently in clinical development through a strategic alliance with GSK, is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF-β and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck
Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

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Business Wire India

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance® (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced.1

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“Heart failure is a progressive and debilitating condition affecting 60 million people worldwide.2 It is the leading cause of hospitalizations in Europe – not only impacting the quality of life considerably for those living with the condition but also putting significant pressure on healthcare systems,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “If Marketing Authorisation is granted by the European Commission, empagliflozin will provide an important additional treatment option for the millions of people in Europe already living with symptomatic chronic heart failure with reduced ejection fraction.”

The positive opinion is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk of cardiovascular death or hospitalization due to heart failure.3 The findings from the primary endpoint were consistent in subgroups with and without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.4

“We are delighted with the CHMP’s decision to recommend empagliflozin as a treatment for people living with symptomatic chronic heart failure with reduced ejection fraction,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Today’s decision marks our entrance into a new chapter of heart failure management, enabling us to help address the challenges heart failure patients are facing in the EU and beyond.”

“Later this year, we expect trial results from our study in people with heart failure with preserved ejection fraction, another serious form of the condition. Our ongoing research of empagliflozin underscores the continued needs of people with serious metabolic conditions, and our collective commitment to finding solutions,” continued Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly.

In Europe, heart failure is the leading cause of hospitalization in people over the age of 65.4 Heart failure is a very common and severe complication of a heart attack5,6 and occurs when the heart cannot pump sufficient blood to the rest of the body. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.7,8

The EMPEROR-Reduced trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.

+++

About the EMPEROR Heart Failure Studies9,10

The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care:

EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
Number of patients: 3,730
Completion: 2020
Link to lay summary
EMPEROR-Preserved[NCT03057951] investigates the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
Number of patients: approx. 5,989
Completion: 2021

About the EMPOWER program

The Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.11 Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of eight clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 400,000 adults studied worldwide in clinical studies, it is the broadest and most comprehensive clinical program for an SGLT2 inhibitor to date.

About Heart Failure

Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.6 It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes;12 however, approximately half of all people with heart failure do not have diabetes.3,13

About Cardio-Renal-Metabolic Conditions

Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.12

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.14,15

Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.16,17,18

Please click on the following link for ‘Notes to Editors’ and ‘References’ http://www.boehringer-ingelheim.com/press-release/emperor-reduced-chmp-positive-opinion

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Business Wire India 

Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today presented results from the pivotal Phase 3 PUNCH™ CD3 clinical trial, demonstrating superior efficacy and consistent safety of single-dose RBX2660 in reducing recurrence of Clostridioides difficileinfection (CDI) over placebo. RBX2660 is an investigational, potential first-in-class microbiota-based live biotherapeutic.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210521005335/en/

The trial, presented today at Digestive Disease Week® (DDW) 2021, successfully met its primary endpoint. RBX2660 demonstrated superior efficacy versus placebo (70.4% and 58.1%, respectively) at 8 weeks post treatment, with a comparable safety profile to placebo. RBX2660 results demonstrated statistical significance with a 98.6% posterior probability of superiority, which exceeded the 97.5% minimum threshold. In addition to these outcomes, RBX2660 provided a relative reduction of recurrence of 29.4% compared to placebo. The majority of treatment emergent adverse events (TEAEs) for RBX2660 were similar to placebo, and mild to moderate in nature. These data add to the large body of evidence showing consistent efficacy and safety in patients who have received RBX2660, which may help address the unmet need for patients who suffer from this debilitating and potentially deadly recurrent infection.

“C. difficile infection is a global public health threat that requires immediate action to halt the unrelenting cycle of recurrence. While necessary to treat initial infection, antibiotics are also a predominant risk factor for recurrence because they can disrupt the gut microbiome, leaving the current treatment paradigm for recurrent infection incomplete,” said Paul Feuerstadt, MD, FACG, AGAF, PACT Gastroenterology, Hamden, Conn., Assistant Clinical Professor of Medicine, Yale University School of Medicine, New Haven, Conn., and RBX2660 clinical trial investigator. “These Phase 3 RBX2660 results, as part of the overall clinical development program, show consistent efficacy as early as a first recurrence of C. difficile infection by delivering a broad consortium of live microbes to the area of active infection.”

“People who suffer from C. difficile infection are devastated when they experience recurrence. Patients have told me that they felt hopeless when the infection returned again and again despite multiple courses of antibiotic treatment. They believed that the infection would never go away,” said Christine Lee, MD, FRCPC, Clinical Professor, Department of Pathology and Laboratory Medicine, UBC Faculty of Medicine, Medical Microbiologist and Researcher, Island Health, Vancouver, and RBX2660 clinical trial investigator who presented the data at DDW. “The findings from this pivotal Phase 3 trial of RBX2660 are very encouraging to both patients and healthcare providers, providing hope this potential new treatment could make a meaningful difference in the lives of patients with recurrent C. difficile infection.”

The RBX2660 program is the largest and most robust clinical program ever conducted in the field of microbiome-based therapeutics. The decade-long development program consists of six trials with more than 1,000 patients enrolled; two of these trials are the only ones in the field to include two years of follow-up.

“These Phase 3 results are a testament to a decade of robust clinical research to help address a significant unmet patient need,” said Lee Jones, President and CEO of Rebiotix, a Ferring Company. We are deeply grateful to the patients and clinicians for their years of dedication to this program.”

“At Ferring, we are dedicated to helping people live better lives,” said Per Falk, President of Ferring Pharmaceuticals. “We look forward to sharing our data with the U.S. FDA as we believe, based on the totality of evidence, RBX2660 holds the potential to be an improvement over the standard of care alone for tens of thousands of patients affected every year by recurrent C. difficile infection.”

About the PUNCH™ CD3 Clinical Trial (Clinicaltrials.gov identifier: NCT03244644)

PUNCH™ CD3 is a Phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled clinical trial evaluating the efficacy and safety of RBX2660 vs. placebo in preventing rCDI. The study included adults ages 18 or older who had at least one recurrence after a primary episode of CDI. Participants were followed up to 8 weeks for the efficacy analysis, and up to six months for the safety analysis.

About RBX2660

RBX2660 is a potential first-in-class microbiota-based live biotherapeutic being studied to deliver a broad consortium of diverse microbes to the gut to reduce recurrent C. difficile infection. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). The pivotal Phase 3 program builds on nearly a decade of research with robust clinical and microbiome data collected over six controlled clinical trials with more than 1,000 participants.

About the microbiome and C. difficile infection

The microbiome is a highly-diverse microbial community that plays an essential role in human health. There is a growing body of evidence that shows when there is a disruption of the composition and/or diversity of the gut microbiome, there may be an associated risk for serious illnesses, such as C. difficile infection.

C. difficile is a bacterium that causes debilitating symptoms such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).1 Estimated to cause up to half a million illnesses and thousands of deaths annually in the U.S. alone every year, C. difficile infection is considered an urgent threat to public health by the CDC and can lead to severe complications, including hospitalization, surgery, sepsis and death.1,2C. difficile infection is often the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.3,4 The use of antibiotics has been shown to disrupt the ecology of the gut microbiome, and are a predominant risk factor for C. difficile recurrence – occurring in up to 35% of patients after initial C. difficile infection diagnosis.5,6,7 After the first recurrence, it has been estimated that up to 60% of patients may develop a subsequent recurrence.8

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection. With the 2018 acquisition of Rebiotix and several other alliances, Ferring is a world leader in microbiome research, developing novel microbiome-based therapeutics to address significant unmet needs and help people live better lives. Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn.

About Rebiotix

Rebiotix Inc, a Ferring Company, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The platform consists of investigational drug technologies designed to potentially rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com, or connect with us on Twitter, Facebook, LinkedIn and YouTube.

About DDW

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is a fully virtual meeting from May 21-23, 2021. The meeting showcases more than 2,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

References:

Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html.
Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.
Cornely OA, et al. Treatment of First Recurrence of Clostridium difficile Infection: Fidaxomicin Versus Vancomycin. Clinical Infectious Diseases. 2012;55(S2):S154–61.
Langdon A, Crook N, Dantas G. The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation. Genome Med. 2016;8(1):39.
Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.

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Business Wire India
In a recent ET article published on 19th May sources at the Finance Ministry confirmed that the Government wants to regulate cryptocurrencies and take a calibrated approach in the best interest of investors and the ecosystem. This comes like a relief to some extent in Indian Crypto Ecosystem where investors are worried about the future. In this Context the company had a chat with Some experts focused on blockchain and crypto assets reassuring the community that Cryptos are here to stay and how it will create a transparent, trusted, compliant and sustainable economy going forward.
 
 The COVID-19 pandemic and ensuing lockdowns have put lives, businesses, and the economy in general, into a downward spiral. India’s GDP is relied upon to have shrunk by almost shrunk significantly in this last one year. During these times, the government along with financial institutions have made intrepid efforts to stabilize the livelihoods of millions.
 
Notwithstanding these endeavors, there are yet enormous gaps in execution of various welfare schemes, implying that many are still being left out from relief opportunities. RBI sources demonstrate that credit lending to MSMEs — enterprises that need maximum liquidity — has shrunk by 7.6 percent this year. It has proven to be a complicated situation and only effective partnerships, synergies, and communication between the public, the private sector, and the government will ensure complete economic recovery. India’s GDP target by 2024 is Five Trillion USD. For the country to achieve this number, the company will have to incorporate unprecedented technology or systems.
 
With the Supreme Court lifting the ban on cryptocurrency, it seems like Crypto Currencies might be a solution to a lot of problems. Let us quickly see how it can add value to the economy.
 
“Cryptos are Best way to Hedge against global inflation”: With governments printing more money, reducing interest rates and interest rate going negative there is free money flow into the system which is causing global inflation to reach all time high world really needs an asset which is really rare, exchanged easily and globally hence Bitcoins could be one of the best ways to do that. Mining Bitcoins is like mining gold on the internet. It’s just that it’s more difficult and there is a really high cost of production since mining bitcoins is not like any other asset which is created out of debt. The last bitcoin will be mined in 2140 and there is no possible way one can extract all bitcoins at once unlike gold ( where miners & mediators like bank/traders/central bodies decide /control the value and supply of assets like gold, oil etc). Bitcoins to lot of extents are community driven, with more miners and people wanting to mine bitcoin more its value, scarcity increases a perfect required fundamental to be called as store of value says Rahul Agarwal, Co-founder of a leading Digital Assets Platform Coinsbit India.

“Cryptos and Blockchain provide access to Universal Financial Infrastructure”: Today, let’s look at places like Africa, Venezuela, Palestine, Zimbabwe and several other Countries Inflations everyday touch ATH practically destroying lives of several million people just because of lack of proper governance. To them, bitcoins and any cryptos are just saviour since they can get access to pool of global currencies since cryptos are traded and can be cashed out 24*7*365 days in any major currency like USD, GBP, EUR and tens of currencies easily. Today, in developed economies like the USA, UK, EU, Singapore, Japan, etc there are crypto debit cards and several merchants accept cryptos. Even for banks for example, in money /forex markets when they remit money rely on several intermediaries in getting quotes to hedge the risk arising out of fluctuations and people know that there are several scams with billions of dollars happening and still happening where best of the financial institutions are involved. The global daily trading volume of cryptos, perhaps liquidity globally, stands around $250B which is bigger than Indian Stock Exchange and several other exchanges combined together. Recently, in a latest dip in the market Elon Musk commented “Tesla bought Bitcoins to prove the liquidity of the crypto market” he is an avid supporter of cryptos and like everyone else still exploring space. Today with Cryptos, DeFi ( Decentralised Finance) anyone having as low as $10 can invest globally and can earn universal returns in a global market without any discrimination on basis of net worth. Blockchain, Smart Contracts and algo’s treat everyone equally, in a trusted, transparent and secured way adds Prashant Surana Jain Co-founder Snapper Future Tech, He also clarified that the volatility and speculation exists because certain influencers/decision makers try to drive sentiments/judgements about this market. Give it a free hand and then see wonders it can do. The company has seen ideas getting access to global capital through means of Coin offering resulting in Projects like Matic Polygon being born out of India and is now a fastest growing multi billion dollar crypto asset solving deep tech problems. Entrepreneurs with great ideas and spirit to do something awesome can now get access to universal global capital without any barriers and this could be proved with success stories of so many startups and communities raising capital through coin offering.

“Regulating Cryptos could provide new revenue/taxation streams to the government and create new job opportunities”: Sidharth Sogani, CEO CREBACO Global, a research and intelligence company focused on blockchain and crypto factually expresses that”Bitcoin is solving a great problem and has been operating for a decade now. The global growth of the crypto industry is surprisingly amazing, the Coinbase IPO which was valued at around 100Billion proves it. Crypto has over 65Lakh users in India with about 15 thousand crores or worth of assets in holding, and growing everyday. The industry can generate employment to at least 25000 young professionals if regulated, and can invite billions of dollars as FDI. The industry can generate a considerable amount of direct and indirect taxes as well.” According to Tatva Legal, Hyderabad, “The government of India has been very enthusiastic about the application of blockchain in the day-to-day administration of the country. The only exception is cryptocurrency. The government has been reluctant to regulate it due to its partial understanding of what cryptocurrency exactly is. It will not replace the Indian rupee but will only supplement it. India shall consider its benefits like accessibility, micro-payments and should consider not being left out by its global competitors like the US and Europe in the blockchain-enabled cyberspace. Bottomline is the earlier India regulates it, the earlier the country benefits.”

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Business Wire India

Schlumberger announced today a collaboration with Amazon Web Services (AWS) to deploy domain centric digital solutions, enabled by the DELFI* cognitive E&P environment, on the cloud with AWS. This collaboration will bring AWS customers to the DELFI Petrotechnical Suite, which provides access to AI-enhanced applications from Schlumberger and high-performance computing from AWS’s secure, extensive, and reliable global infrastructure.

“Our partnership with AWS complements our strategy to further expand access to the DELFI environment so that more customers can benefit from their subsurface data,” said Rajeev Sonthalia, president, Digital & Integration, Schlumberger. “By increasing access to digital solutions enabled by DELFI, our collaboration with AWS further unlocks opportunities for customers to continuously improve their productivity and performance.”

The collaboration enables more customers to use advanced digital solutions in the DELFI Petrotechnical Suite to draw deep insights from a large pool of data sources and apply those insights across their workflows for faster and better decision making.

“With AWS, Schlumberger can leverage the most comprehensive set of cloud services in the world, including AI and machine learning services that easily integrate with customer applications,” said Matt Garman senior vice president of sales & marketing at AWS. “Schlumberger’s cloud-based solutions paired with the high performance, scalability and security of AWS cloud, increase efficiencies so customers have more freedom to innovate—and this is just the beginning. By combining our expertise, we have the potential to accelerate innovation across the entire energy sector including new energies.”

By deploying digital solutions enabled by the DELFI environment and running on AWS, customers can run complex models, computer simulations, and analyses in a fraction of the time compared to traditional computing solutions.

For more information about the DELFI Petrotechnical Suite, click here.

About Schlumberger

Schlumberger (SLB: NYSE) is a technology company that partners with customers to access energy. Our people, representing over 160 nationalities, are providing leading digital solutions and deploying innovative technologies to enable performance and sustainability for the global energy industry. With expertise in more than 120 countries, we collaborate to create technology that unlocks access to energy for the benefit of all.

Find out more at www.slb.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws — that is, statements about the future, not about past events. Such statements often contain words such as “expect,” “may,” “believe,” “plan,” “can,” “estimate,” “intend,” “anticipate,” “should,” “could,” “will,” “likely,” “goal,” “potential,” “projected” and other similar words. Forward-looking statements address matters that are, to varying degrees, uncertain, such as forecasts or expectations regarding the deployment of, or anticipated benefits of, digital technologies. These statements are subject to risks and uncertainties, including, but not limited to, the inability to recognize intended benefits from digital strategies, initiatives or partnerships; and other risks and uncertainties detailed in our most recent Forms 10-K, 10-Q and 8-K filed with or furnished to the U.S. Securities and Exchange Commission. If one or more of these or other risks or uncertainties materialize (or the consequences of such a development changes), or should underlying assumptions prove incorrect, actual outcomes may vary materially from those reflected in our forward-looking statements. Statements in this press release are made as of the date of this release, and Schlumberger disclaims any intention or obligation to update publicly or revise such statements, whether as a result of new information, future events, or otherwise.

*Mark of Schlumberger

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Business Wire IndiaISS Confirms Underperformance and Concern of Entrenchment
Oasis Urges Shareholders to Vote on the GOLD Proxy Card for the Oasis Nominees 

Oasis Management Company Ltd. (“Oasis”) is manager to a fund that is a significant, long-term shareholder of Stratus Properties Inc. (NASDAQ: STRS) (the “Company” or “Stratus”) that beneficially owns over 13.5% of Stratus’ ordinary shares.

Oasis urges Stratus shareholders to vote on the GOLD proxy card for the highly qualified and independent Oasis director nominees.

While Institutional Shareholder Services (“ISS”), a leading independent proxy advisory firm, recommends shareholders “oppose the reelection of long-tenured incumbent James Leslie”, Oasis disagrees with ISS that the election of only one of Oasis’ nominees is sufficient change to the composition to the board.

In addition to Laurie Dotter, who ISS recognized should be elected to the board, Oasis encourages shareholders to elect Ella Benson and Jamie De la Garza, both highly qualified candidates with significant knowledge of financial markets and best governance practices as well as public company board experience, in stark contrast to the sole Stratus nominee supported by ISS.

In addition to recommending that shareholders withhold their vote from incumbent director James Leslie, ISS faulted the company’s board for its poor corporate governance noting that “…the company’s multiple takeover defense mechanisms – including a poison pill that does not warrant shareholder ratification – coupled with poor relative performance, raise the concern of potential board entrenchment.”

Oasis encourages its fellow shareholders to read its letters and presentation which can be viewed on the homepage of www.abetterstratus.com.

All shareholders are encouraged to contact Oasis at [email protected].

About Oasis Management Company Ltd.

Oasis Management Company Ltd. manages private investment funds focused on opportunities in a wide array of asset classes across countries and sectors. Oasis was founded in 2002 by Seth H. Fischer, who leads the firm as its Chief Investment Officer. More information about Oasis is available at https://oasiscm.com.

Important Information

Oasis Management Company Ltd., Seth Fischer, Ella Benson, Laurie L. Dotter and Jaime Eugenio De la Garza Diaz (collectively, the “Participants”) have filed with the Securities and Exchange Commission (the “SEC”) a definitive proxy statement and accompanying form of GOLD proxy card to be used in connection with the solicitation of proxies from the shareholders of Stratus Properties Inc. (the “Company”). All shareholders of the Company are advised to read the definitive proxy statement and other documents related to the solicitation of proxies by the Participants as they contain important information, including additional information related to the Participants. The definitive proxy statement and an accompanying GOLD proxy card will be furnished to some or all of the Company’s shareholders and is, along with other relevant documents, available at no charge on Oasis’ campaign website at https://www.abetterstratus.com/ and the SEC website at http://www.sec.gov/. Information about the Participants and a description of their direct or indirect interests by security holdings is contained in the definitive proxy statement filed by the Participants with the SEC on April 14, 2021. This document will be available free of charge from the source indicated above

Disclaimer

This material does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein in any state to any person. In addition, the discussions and opinions in this press release and the material contained herein are for general information only, and are not intended to provide investment advice. All statements contained in this press release that are not clearly historical in nature or that necessarily depend on future events are “forward-looking statements,” which are not guarantees of future performance or results, and the words “anticipate,” “believe,” “expect,” “potential,” “could,” “opportunity,” “estimate,” and similar expressions are generally intended to identify forward-looking statements. The projected results and statements contained in this press release and the material contained herein that are not historical facts are based on current expectations, speak only as of the date of this press release and involve risks that may cause the actual results to be materially different. Certain information included in this material is based on data obtained from sources considered to be reliable. No representation is made with respect to the accuracy or completeness of such data, and any analyses provided to assist the recipient of this material in evaluating the matters described herein may be based on subjective assessments and assumptions and may use one among alternative methodologies that produce different results. Accordingly, any analyses should also not be viewed as factual and also should not be relied upon as an accurate prediction of future results. All figures are unaudited estimates and subject to revision without notice. Oasis disclaims any obligation to update the information herein and reserves the right to change any of its opinions expressed herein at any time as it deems appropriate. Past performance is not indicative of future results. Oasis has neither sought nor obtained the consent from any third party to use any statements or information contained herein that have been obtained or derived from statements made or published by such third parties. Except as otherwise expressly stated herein, any such statements or information should not be viewed as indicating the support of such third parties for the views expressed herein.

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Business Wire India

What started out as a way for the style community to come together when the pandemic stopped the industry in its tracks has grown into one of the largest gatherings of the fashion industry worldwide. Now, with life opening back up in the US and abroad, Glamhive’s Digital Spring Style and Beauty Summit on May 22nd will be the final 100% digital summit. Glamhive will launch all future events as a hybrid physical-digital experience.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210520005908/en/

The Spring Summit will be the company’s fifth global digital experience and will once again bring together industry professionals and beauty and style enthusiasts to discuss spring style, skincare in the colder months, getting started in the fashion business and much more.

The all-day, ticketed event will feature 19 panels with 66-plus speakers. Below is an overview of the topics that will be covered by the all-star speaker line-up.

TOPICS:

Who Made This? How Sustainably Sourced Products Empower Women With Every Purchase
Style 411: Inside the World of Styling
Contemporary Costume Design: The Role, The Challenges, And It’s Influence On Fashion
The Red Carpet Report
“A Star Is Born” Exclusive Interview with Astrologist Susan Miller
Exclusive Interview with Bridgerton’s Costume Designer Ellen Mirojnick
How To Make A Great First Impression Every Time
Brand Building for Creatives & Entrepreneurs
 

During the Who Made This? How Sustainably Sourced Products Empower Women With Every Purchase panel, Chief Marketing Officer for Mary Kay Inc., Sheryl Adkins-Green, will host a discussion on the origin of the items inside each of our closets—and how we can better know the innovators behind the fashion styles. Panelists include Jane Mosbacher, Founder and CEO of TO THE MARKET; Matilda Payne Boakye-Ansah, Designer, Eco-Warrior, Social Entrepreneur, Founder of MH Couture and Co-Founder of Xtreme Upcycle; Christelle C. Paul, Founder and Director of Atelier Calla; and Tara Swennen, celebrity stylist.

“We have an opportunity every day to make choices that help protect our environment,” said Sheryl Adkins-Green, “and it’s important to know about the people and products that are making a difference.”

CO-HOSTS

Stephanie Sprangers – Founder & CEO, Glamhive

Johnny Wujek – Celebrity Stylist & Costume Designer to Katy Perry and Mariah Carey

Nicole Chavez – Celebrity Stylist to Kristen Bell and Jessica Simpson

Andrew Fitzsimons – Celebrity hairstylist to The Kardashians

Claire Sulmers – Founder + CEO of Fashion Bomb Daily

SPEAKERS:

Our speakers are celebrity stylists, makeup artists, and image-makers who work with the biggest names in Hollywood and beyond, including Kristen Stewart, Angelina Jolie, Matthew McConaughey, Emily Blunt, Gabrielle Union, Zendaya, Sophie Turner, Amanda Seyfried, Margot Robbie, Lupita Nyong’o, Emma Watson, Rosie Huntington-Whiteley, Claire Danes, Carmen Electra.

CELEBRITY STYLISTS:

Jen Rade, Tara Swennen, Jessica Paster, Nicole Chavez, Sonia Young, Dana Asher Levine, Mimi Lombardo, Joiee Thorpe, Franzy Staedter.

CELEBRITY MAKEUP ARTISTS + HAIRSTYLISTS:

Sheridan Ward, Matey Denno, Matin Maulawizada, Christian Wood, Halley Brisker, Larry Sims

MODERATORS:
Brian Underwood (Oprah Magazine), Brooke Jaffe, (Penske Media), Alexis Bennett (Vogue), Sarah Ball (PEOPLE Magazine), Flavia Nunez (Real Simple), Alana Peden (StyleCaster) and Sheryl Adkins-Green (Mary Kay Inc.)

Tickets to the conference are $149 for an all-day ticket. Presenting sponsor for the Glamhive Digital Spring Style and Beauty Summit is Mary Kay Inc. and its Mary Kay Global Design Studio.

For more information, visit https://www.glamhive.com/live

About Glamhive: Glamhive was founded by entrepreneur Stephanie Sprangers in 2017 with the vision to democratize personal styling and the premise that the confidence that comes with glamour should not be exclusive to the rich and famous.

The online styling experience offers anyone with a WiFi connection access to stylists who will provide them with the support they need to be the best version of themselves. For stylists, it is a seamless end-to-end platform to help them grow their network and their business, 100% virtually.

About Mary Kay
One of the original glass ceiling breakers, Mary Kay Ash founded her beauty company nearly 60 years ago with three goals: develop rewarding opportunities for women, offer irresistible products, and make the world a better place. That dream has blossomed into a multibillion-dollar company with millions of independent sales force members in nearly 40 countries. Mary Kay is dedicated to investing in the science behind beauty and manufacturing cutting-edge skin care, color cosmetics, nutritional supplements and fragrances. Mary Kay is committed to empowering women and their families by partnering with organizations from around the world, focusing on supporting cancer research, protecting survivors from domestic abuse, beautifying our communities, and encouraging children to follow their dreams. Mary Kay Ash’s original vision continues to shine—one lipstick at a time.

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Business Wire India

NTT today announced a $3M donation to support the humanitarian tragedy facing the people of India. This brings the total combined donation from NTT and its affiliates, including NTT DATA Services and NTT Ltd, to $10M in relief aid to India.

The donations will support local hospitals and healthcare providers, increase access and transportation to care and boost vaccination efforts to directly support team members as well as the general public.

“Since the beginning of the pandemic, we’ve focused on supporting our team members with safety-first policies, financial support and resources, but as the crisis continues to deepen in India, NTT is joining the global effort to broaden our impact,” said Abhijit Dubey, CEO, NTT Ltd.

Funds have been committed to provide oxygen, medical supplies, ambulances, hospital beds and equipment. The NTT Corporate Social Responsibility team has worked quickly to make an impact across rural and urban communities of India, partnering with local non-profits to distribute funding.

For NTT team members, the company will continue to enable remote work, support essential on-site workers, offer reimbursement for medical costs and family support, provide additional COVID-related paid sick leave, and provide free virtual health visits. As a resource for team members in India, NTT employees also created a COVID-19 command center to help teammates coordinate medical care, vaccine appointments, hospital beds and transportation.

“Together, we have more than 30,000 team members based in India who are a core part of the NTT family,” said Bob Pryor, CEO, NTT DATA Services. “The outpouring of support from our global teams, who have stepped up, leading assistance efforts without hesitation, has been encouraging during these difficult times and a shining example of our culture and belief that we are all stronger together.”

About NTT Ltd

NTT Ltd. is a leading, global technology services company. To help our clients achieve their digital transformation goals, we use our global capabilities, expertise, and full-stack technology services delivered through our integrated services platform. As their long-term strategic partner, we help them enhance customer and employee experience, transform their cloud strategy, modernize their networks and strengthen their cybersecurity. And across their transformation priorities, we automate their business processes and IT, drawing insights and analytics from their core business data. As a global ICT provider, we employ more than 50,000 people across 57 countries, trading in 73 countries and delivering services in over 200 countries and regions. Together we enable the connected future. Visit us at hello.global.ntt.

About NTT DATA Services

NTT DATA Services is a recognized leader in IT and business services including cloud, data and applications. A division of NTT DATA headquartered in Texas, the company leverages consulting and deep industry expertise to help clients accelerate and sustain value throughout their digital journeys. Visit nttdataservices.com or LinkedIn to learn more.

About NTT DATA

NTT DATA – a part of NTT Group – is a trusted global innovator of IT and business services headquartered in Tokyo. We help clients transform through consulting, industry solutions, business process services, digital & IT modernization and managed services. NTT DATA enables them, as well as society, to move confidently into the digital future. We are committed to our clients’ long-term success and combine global reach with local client attention to serve them in over 50 countries around the globe. Visit us at nttdata.com.

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Business Wire India
Senator, Dr. Rasha Kelej, CEO of Merck Foundation, the philanthropic arm of Merck KGaA Germany, together with H.E. Mrs. NEO JANE MASISI, The First Lady of Botswana and Ambassador of Merck More Than A Mother, announced the winners of “Stop GBV” Best Poster Contest during award ceremony. The Poster Contest was held with the aim to prevent Gender-Based Violence and child abuse in Botswana.
 
Prof. Dr. Frank Stangenberg-Haverkamp Chairman of both of Executive Board of E.Merck KG and Merck Foundation Board of Trustees was the Guest of Honor of the ceremony to support the program and advocate for ending Gender-Nased Violence in Botswana and rest of Africa as part of Merck Foundation More than a Mother campaign.

Senator, Dr. Rasha Kelej, CEO of Merck Foundation and President of Merck More Than A Mother, who joined the award ceremony virtually, emphasized “I am proud to announce the winners of “Stop GBV” Best Poster Contest together with my dear sister H.E. NEO JANE MASISI, The First Lady of Botswana and Ambassador of Merck More Than A Mother. We have worked with the jury committee to select the most creative and inspiring work advocating one of the key contest objectives. This initiative is part of Merck foundation more than a Mother campaign.

In 2020, I virtually joined the Botswana First Lady, during her cycling tour to STOP GBV and marked the International Day of Elimination of Violence against Women and Girls together. I salute my dear sister, The First Lady of Botswana, for her great efforts and innovative idea to stop Gender-Based Violence and encourage us to take a stand against GBV and child abuse.”
 
H.E. NEO JANE MASISI, The First Lady of Botswana and Ambassador of Merck More Than A Mother said, “We launched the “Stop GBV” Poster Contest together with Merck Foundation, so as to advocate against Gender-Based Violence in Botswana. I am very happy to award the winners, who have shared some brilliant work. We will continue our joint efforts to fight against GBV, protect humanity, especially the girls and women. The COVID pandemic gave rise to violence against girls, women and children. GBV has destroyed families and promoted disunity within communities, both at national and international level; and this initiative to demonstrate our effort to fight for this cause, and eradicate GBV from our societies.”
 
The “Stop GBV” Poster Contest was held across Botswana and the aim of the contest was to select the most creative and inspiring work. The contest objectives were: 1) Stop Gender-Based Violence, 2) Take a stand against GBV and child abuse, 3) Help people understand that GBV is unacceptable and evil, 4) Promote Zero tolerance of GBV, and 5) Demonstrate that GBV can be emotional, financial, physical, and sexual.
 
“I am looking forward to joining the next cycling tour and to launch the second edition of this poster contest in partnership with the First Lady of Botswana in 2021,” added Senator, Dr. Rasha Kelej.
 
Merck Foundation will also continue to build healthcare capacity by providing Merck Foundation scholarships of one year diploma and two year master degree in many Medical specialities with the aim to transform the healthcare landscape and improve patient care in Botswana, specially during coronavirus pandemic.
 
“We have provided till today scholarships to more than 39 Doctors in Botswana in different critical specialities such as: Oncology, Diabetes, Cardiovascular, Endocrinology, Respiratory Medicines, Acute Medicines and Sexual and Reproductive, which is also very important to advancing women health and reproductive health. It is very critical to empower girls and women against many challenges and specially against GBV. Access to health, awareness and education is an important key to stop gender-based violence,” explained Senator, Dr. Rasha Kelej.
 
Link to the Live Streaming of the award ceremony: https://fb.watch/5AK0UvEgoa/
 
The first three award winners of the “STOP GBV” Poster Contest are:
 
First Position: TAMUCHA TULU
Second Position: ELIJAH MAPHAKELA
Third Position: MOHUMAGADI MORUTI
 
Moreover, the below 10 winners were awarded with a special Award:
 
1.      TSOTLHE MORAKENYANE
2.      THANDIE SIBANDA
3.      THAPELO LETSHWITI
4.      SADE. S RABASHA
5.      THATAYAMODIMO THEKISO
6.      TRUDY BAKWENA
7.      MALEBOGO W. RANTLHOTSE
8.      KUMBULANI MACHOLA
9.      TSHEPANG MOGOTSI
10.    MAIKANO MOJIWA

Click on the link below to Download Merck Foundation App

https://play.google.com/store/apps/details?id=de.merck.foundation&hl=en

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Twitter: @Merckfoundation
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Website: www.merck-foundation.com

The post Merck Foundation CEO and Botswana First Lady Announce the Winners of “STOP GBV” Poster Contest appeared first on Maverick Times.