Lifitegrast, if approved, would be the first and only new class treatment to address the signs and symptoms of dry eye disease in adults in Europe
ZUG, 16-Aug-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure (DCP). If approved, lifitegrast would be the first and only treatment in a new class of drugs (LFA-1 antagonist) to address the signs and symptoms of dry eye disease in adults in Europe. The disease is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, and fluctuating blurry vision1. Dry eye disease may significantly affect quality of life and may impact activities such as reading and using computers2. It is one of the most common conditions seen by ophthalmologists and eye care practitioners worldwide.3
“This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person’s vision-related quality of life, affecting daily activities such as reading and using computers,” said Howard Mayer, M.D., Head of Clinical Development, R&D. “Shire is committed to continued innovation in ophthalmics, where there are opportunities to address unmet need and improve the lives of patients.”
Shire’s MAA for lifitegrast is supported by the largest development program to date for an investigational-stage dry eye disease candidate, consisting of five clinical trials with more than 2,500 patients.4,5,6,7,8 In these studies, the signs of dry eye disease were measured using corneal staining and the symptoms by using patient reported eye dryness score (EDS).4-8
About the lifitegrast Marketing Authorization Application
The lifitegrast MAA was submitted via the Decentralized Procedure (DCP) to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece. The UK is the Reference Member State.
About Dry Eye Disease
The prevalence of dry eye disease, with and without symptoms, ranges from 5 to 50% in adults globally9. An eye care professional can diagnose dry eye disease based on signs and symptoms and determine management options, which could include the use of a prescription treatment. Dry eye disease is a multifactorial disease of the ocular surface that is often chronic and may be progressive1. The disease is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, or fluctuating blurry vision.1 Dry eye disease may significantly affect quality of life and may impact activities such as reading and using computers.2
Ophthalmologists and eye care professionals can diagnose dry eye disease based on patient reported symptoms as well as signs which can be objectively evaluated through various tests.9
Management options may include the use of non-prescription and prescription treatments.10
Aging and gender are recognized as traditional risk factors of chronic dry eye disease, while modern risk factors include prolonged digital/computer screen time, contact lens wear and cataract or refractive surgery.11,12 Dry eye is a common complaint to ophthalmologists and eye care professionals.3
About lifitegrast
Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist, the first medication in a new class of drugs. Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1), which plays a prominent role in ocular surface inflammation.6ICAM-1 may be over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to formation of an immunological synapse resulting in T-cell activation and migration to target tissues. 13 In vitro studies have shown that lifitegrast may inhibit the recruitment of previously activated T cells, the activation of newly recruited T cells, and the release of pro-inflammatory cytokines—interrupting the perpetual cycle of inflammation.14,15
About lifitegrast in the U.S.A.
The U.S. Food and Drug Administration approved lifitegrast under the brand name Xiidra®(lifitegrast ophthalmic solution) 5% for the treatment of signs and symptoms of dry eye disease in July 2016.16 For more information on the U.S. prescribing information, click here.
About lifitegrast clinical studies
Shire’s MAA for lifitegrast is supported by the largest development program to date for an investigational-stage dry eye disease candidate, consisting of five clinical trials with more than 2,500 patients.4-8 In four safety and efficacy studies, lifitegrast improved symptoms as measured by patient reported eye dryness score (EDS), and in three of the four studies improved the objective signs of dry eye disease (measured using corneal staining). A statistically significant reduction in EDS favoring lifitegrast was seen in all four studies at week six and week 12 (the week six analysis was a post-hoc analysis in three studies). In two clinical trials, symptom improvement was noted at two, six and 12 weeks.4-8 A long-term safety study randomized to either lifitegrast (n=220) or placebo (n=111) over 360 days found lifitegrast to be generally well-tolerated with no serious treatment-emergent ocular adverse events.
The most common adverse reactions reported in 5 to 25 percent of patients were instillation site irritation, altered taste sensation (dysgeusia) and reduced visual acuity.4-8
Shire’s commitment to ophthalmology
Shire officially entered into ophthalmology with the acquisition of SARcode Bioscience in 2013. Shire’s multi-faceted approach to discovery, development, and delivery in rare diseases and specialty conditions includes our efforts to address unmet needs in eye care.
Shire’s ophthalmology franchise has been driven by a combination of strategic acquisitions and organic growth, and is focused on continuing to expand the portfolio to include treatment options for anterior and posterior segment eye conditions. In close to four years, acquisitions including SARcode followed by Foresight Biotherapeutics helped bolster Shire’s early-, mid- and late-stage ophthalmology pipeline. As a result of a collaborative license agreement with Parion Sciences Inc., Shire is developing SHP-659 (formerly P-321), another investigational candidate for the treatment of dry eye disease in adults. Shire’s ophthalmology pipeline also includes investigational candidates in infectious conjunctivitis and glaucoma.
For further information please contact:
Investor Relations | ||
Ian Karp | ikarp@shire.com | +1 781 482 9018 |
Robert Coates | rcoates@shire.com | +44 1256 894874 |
Media | ||
Gwen Fisher | gfisher@shire.com | +1 781 482 9649 |
Clotilde Houzé | chouze0@shire.com | +1 781 266 3567 |
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company focused on serving people with rare diseases. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Forward-Looking Statements
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
- Shire’s products may not be a commercial success;
- increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
- the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
- Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
- the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
- Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
- adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the Company’s revenues, financial condition or results of operations;
- inability to successfully compete for highly qualified personnel from other companies and organizations;
- failure to achieve the strategic objectives, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire’s acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated may adversely affect Shire’s financial condition and results of operations;
- Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
- a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
- failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to Shire’s reputation, the withdrawal of the product and legal action against Shire;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
- Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
- Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs may decrease its business flexibility; and a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.
- Gayton, J. (2009). “Etiology, prevalence, and treatment of dry eye disease”. Clinical Ophthalmology. 3: 405–412.
- Miljanovic, B. et al. (2007). “Impact of Dry Eye Syndrome on Vision-Related Quality of Life”. American Journal of Ophthalmology. 143(3): 409-415.
- O’Brien PD, Collum LM. (2004). “Dry eye: diagnosis and current treatment strategies”. Curr Allergy Asthma Rep. 4:314-319. Available at: https://www.ncbi.nlm.nih.gov/pubmed/15175147 [Last accessed August 2017]
- Holland E J, Whitely WO, Sall Ke et al. (2016). “Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials”. Current Medical Research and Opinion. 32(10): 1759-1765.
- Sheppard JD, Torkildsen GL, Lonsdale JD et al. (2014). “Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study”. Ophthalmology. 121(2): 475-83.
- Tauber J, Karpecki P, Latkany R et al. (2015). “Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study”. Ophthalmology. 122(12): 2423–2431.
- Holland E, Luchs J, Karpecki P et al. (2017). “Lifitegrast for the Treatment of Dry Eye Disease Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3)”. Ophthalmology. 124(1): 53-60.
- Donnenfeld E, Karpecki PM, Majmudar PA et al. (2016). “Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients with Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study”. Cornea. 35: 741–748.
- Nelson, J. Daniel et al. (2017). “TFOS DEWS II Introduction”. The Ocular Surface. 15(3): 269-275.
- Vickers LA, Preeya PK. The Future of Dry Eye Treatment: A Glance into the Therapeutic Pipeline Ophthalmol Ther 2015 4:69–78
- Uchino M et al. (2013). “Dry Eye Disease: Impact on Quality of Life and Vision”. Curr Ophthalmol Rep. June; 1(2):51-57.
- Hovanesian JA, Shah SS, et al. (2001). “Symptoms of dry eye and recurrent erosion syndrome after refractive surgery”. J Cataract Refract Surg. 27:577-84.
- Pflugfelder, S. et al. (2017). “LFA-1/ICAM-1 Interaction as a Therapeutic Target in Dry Eye Disease”. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240001/. [Last accessed July 2017].
- Shire. (2016). “HIGHLIGHTS OF PRESCRIBING INFORMATION”. Available at: http://www.shirecontent.com/PI/PDFs/Xiidra_USA_ENG.pdf.[Last accessed July 2017].
- DEWS Research Subcommittee. Research in dry eye: report of the Research Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5(2):179-193.
- U.S. Food & Drug Administration. (2016). “FDA approves new medication for dry eye disease”. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm510720.htm. [Last accessed July 2017].
SOURCE: SHIRE
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- Smart exosomes from an Australian technology leader
- Bucharest Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Transmetrics AI is Applied by DB Schenker to Improve Land Transport Network in Bulgaria
- Digi Communications N.V.: Announces repayment of an aggregate amount of approx. EUR 272 million of the Group’s financial debt
- El Liceo Europeo vence el Premio Zayed a la Sustentabilidad 2022 en Europa y Asia Central
- Framework rebrands to daappa, heralding a new phase in fintech solutions designed for private markets
- Digi Communications N.V. Announces the publishing of the Financial Calendar for 2022
- Manufacturing giant Haizol expands their offices in China
- Patients and R&D Leaders Jointly Present at EU Conference on Progress with Patient-Input to Transform Medicine Development
- Seminário Bíblico sobre “O Cumprimento da Palavra de Jesus no Mundo de Hoje”
- 'I Love fruit & veg from Europe': Weihnachten in der Schweiz ist gesund und voller Aromen
- Fidupar Now Live on Framework’s Core Solution
- Maya Miranda Ambarsari launches InterconnectDATA information platform for authentic data
- Digi Communications N.V. Announces that the offer of the Company’s Romanian subsidiary was designated winner of the auction organised for the allocation of certain radio frecquency entitlements
- New dating site aimed at people with mental health problems launches in Switzerland
- BITSCore Tests Satellite Cyber-Security and Ride-Share Algorithms on Australian Rocket
- StatusMatch.com ed Emirates collaborano per aiutare i frequenti viaggiatori italiani a tornare in volo
- StatusMatch.com and Emirates partner up to help Italian frequent flyers get back in the air
- MinDCet drivers and FTEX powertrain solutions enable EV GaN applications
- Digi Communications NV announces the release of the Q3 2021 Financial Results
- Origami and citoQualis Team up for Startups
- Digi Communications NV announces Investors Call for the Q3 Financial Results presentation
- Digi Communications N.V. announces the extraordinary general meeting’s resolution from 4 November 2021, approving the appointment of KPMG N.V. as the Company’s statutory auditor for the 2021 financial year
- Digi Communications N.V. announces The solution reached by the Bucharest Court of Appeal regarding the investigation conducted by the Romanian National Anticorruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V. Announces the results of the auction organised by the Portuguese Authority for Telecommunications
- Haizol expands its capabilities to include component assembly and product development
- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
- Rockegitarist-Sensasjon Rocky Kramer Har Fått Hovedrollen I Mutt Productions Filmen Rockin’ In Time
- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP