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Taconic Biosciences Launches Alzheimer’s Disease Mouse Model

Proven Model Available Exclusively From Taconic Biosciences

RENSSELAER, N.Y., Nov. 04, 2019 (GLOBE NEWSWIRE) — Taconic Biosciences, a global leader in providing drug discovery animal model solutions, expands its robust neurodegeneration portfolio with the launch of a new  Alzheimer’s disease model, the ARTE10 mouse model.

Exclusively available from Taconic, the ARTE10 is a transgenic mouse model expressing mutant human APP and PS1 genes.  This combination manifests in early onset of amyloid plaques, with downstream cognitive deficits commonly associated with Alzheimer’s disease.  The plaques formed in the ARTE10 model are particularly suitable for PET imaging, making ARTE10 valuable for translational research.

Taconic offers this and other Alzheimer’s disease models under a simple use license without a license fee, making it easily available for commercial use, including contract research.  Many other Alzheimer’s models are available under restrictive terms for academic use only or require large license fees for commercial use.  The ARTE10 model is immediately available in typical study quantities.

“The ARTE10 mouse is a unique model.  It develops amyloid plaques as early as 3 months of age, which can greatly speed up the drug discovery timeline.  In many other Alzheimer’s mouse models, plaques don’t develop until 9-12 months of age, which can prolong the start of critical studies,” shared Dr. Michael Seiler, vice president of commercial products at Taconic.  “Offering such a key model through a simple use license, with no agreement to sign, no license fees and no third-party intellectual property licenses required underscores Taconic’s commitment to empowering drug discovery researchers.”

Alzheimer’s disease is a major area of focus for research due to its immense impact on society.  According to the Alzheimer’s Association, 1 out of 3 seniors die with Alzheimer’s or another form of dementia (www.alz.org).

To learn more about Taconic Biosciences’ ARTE10 model and the complete neuroscience portfolio, please contact Taconic at 1-888-TACONIC (888-822-6642) in the US, +45 70 23 04 05 in Europe, or email info@taconic.com.

About Taconic Biosciences, Inc.

Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. Founded in 1952, Taconic provides the best animal solutions so that customers can acquire, custom-generate, breed, precondition, test, and distribute valuable research models worldwide. Specialists in genetically engineered mouse and rat models, microbiome, immune-oncology mouse models, and integrated model design and breeding services, Taconic operates three service laboratories and six breeding facilities in the U.S. and Europe, maintains distributor relationships in Asia and has global shipping capabilities to provide animal models almost anywhere in the world.

Media Contact:

Kelly Owen Grover
Director of Marketing Communications
(518) 697-3824
kelly.grover@taconic.com

Indosat Ooredoo and Synchronoss partner for unified customer engagement and new digital economy ecosystem

Indosat Ooredoo will roll out the Synchronoss Digital Experience Platform to support its new digital ecosystem service model for consumer and enterprise customers

BRIDGEWATER, N.J., Nov. 04, 2019 (GLOBE NEWSWIRE) — Synchronoss Technologies, Inc. (NASDAQ: SNCR), a global leader and innovator of cloud, messaging, digital and IoT products, today announced that Indosat Ooredoo (IDX:ISAT), a leading telecoms service provider in Indonesia, has chosen the Synchronoss Digital Experience Platform (DXP) to deliver a unified, interconnected user experience for customers across all of its engagement channels. The Synchronoss platform will also support Indosat Ooredoo’s “future digital economy ecosystem” project, a nationwide initiative to encourage collaboration and develop new ideas, products and use cases involving IoT technology to help drive economic growth.

Synchronoss DXP allows operators, service providers and other companies to design and roll out a unified, interactive customer experience across mobile apps, call centers, in-store point-of-sale interactions and online. Indosat will use the Synchronoss platform across all of its business units, for both consumer and enterprise customers, to improve its operational agility and support new digital services and features, plus third-party partner offerings.

“The telecom services market in Indonesia is highly competitive. For an organization of our size, scale and reach, we must go beyond providing basic connectivity to pursue ongoing growth and long-term success,” said Arief Musta’in, Director & Chief Innovation & Regulatory Office at Indosat Ooredoo Indonesia. “We’re transforming our business operations and pursuing a new approach in which digital services, including those will be created via our future digital economy ecosystem initiative. The Synchronoss platform is a significant part of this process. By having new service model, effortless and intuitive technology platform with the agile process, we will be able to roll out new services more quickly, do adoption of new experience, and we will get closer to our customers as we interact with them more effectively across multiple channels according to their preferences and circumstances.”

Indosat Ooredoo chose Synchronoss DXP because of its scalability, flexibility and wide-ranging built-in functionality, which includes the following features:

  • Effortless integration with legacy customer relationship management and complex back-end systems,
  • Easy-to-use, intuitive drag-and-drop dashboard that allows staff without developer or coding experience to easily create, configure and launch end-to-end digital customer journeys across multiple engagement channels,
  • Ability to quickly develop, connect and integrate new digital services with minimal cost and disruption,
  • In-depth data mapping and analytics capabilities that aggregate and analyze customer data to create cross-selling opportunities through customized offers, and
  • Capacity to personalize customer care in real time based on individual preferences.

“Operators worldwide are transforming their business models and pursuing new digital features and services, in order to tackle the competitive threat from OTTs and other service providers,” said Glenn Lurie, President and CEO, Synchronoss.

“An essential part of this transformation trend is for operators to radically rethink their approach to customer engagement. By recognising and responding to customers more quickly and intuitively, operators can add value, retain subscribers for longer and open up new opportunities to cross-sell revenue-generating services as well,” he said.

Lurie added, “This agreement with Indosat Ooredoo demonstrates our continuing success in winning new operator customers and expanding our footprint into important international growth markets like Indonesia. Synchronoss looks forward to working with Indosat Ooredoo to help bring its new digital capabilities to market, and improve its customer engagement.”

To learn more about the Synchronoss Digital Experience Platform (DXP) and its capabilities, please visit: https://synchronoss.com/products/digital/dxp/.

About Synchronoss Technologies, Inc.
Synchronoss (NASDAQ: SNCR) transforms the way companies create new revenue, reduce costs and delight their subscribers with cloud, messaging, digital and IoT products and platforms supporting hundreds of millions of subscribers across the globe. Synchronoss’ secure, scalable and groundbreaking new technologies, trusted partnerships and talented people change the way TMT customers grow their businesses. For more information, visit us at www.synchronoss.com.

Investors:
Joe Crivelli
908-566-3131
investor@synchronoss.com

Media Contact:
Anais Merlin
CCgroup (International)
T: +44 20 3824 9200
E: synchronoss@ccgrouppr.com

Diane Rose
CCgroup (North America)
T: +1 727.238.7567
E: diane@ccgrouppr.com

Sinch AB (publ): Invitation to conference call and web presentation of Sinch Q3 2019 interim report

Stockholm, Sweden – Sinch AB (publ) – XSTO: SINCH

Sinch AB will publish its 2019 third quarter interim report on Friday, November 8, 2019, at 07:30 AM CET. You are invited to participate in a conference call at 09:00 AM CET on the same day. Oscar Werner, CEO, and Roshan Saldanha, CFO, will present the report and review the results.

Time for publication of the interim report
Friday November 8, 2019, at 07:30 AM CET

Time for conference call and web presentation
Friday November 8, 2019, at 09:00 AM CET

Dial-in numbers and access code
Please make sure you are connected to the phone conference by calling in and register a few minutes before the conference begins.

Sweden:              +46 (0) 8 566 426 51
UK:                     +44 (0) 333 300 08 04
US:                     +1 631 913 14 22

Access code:        774 225 45#

Web presentation and slide deck
The live webcast will be available at investors.sinch.com/webcast

The presentation and report will be available at investors.sinch.com after publication.

For further information, please contact

Thomas Heath
Chief Strategy Officer and Head of Investor Relations
Sinch AB (publ)
Mobile:            +46-722-45 50 55
E-mail:             thomas.heath@sinch.com

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CNH Industrial acquires Australian implement manufacturer K-Line Ag

London, November 4, 2019

CNH Industrial N.V. (NYSE: CNHI /MI: CNHI), today announced its agreement to acquire the Australian agricultural implement manufacturer K-Line Ag. This acquisition will add key tillage and residue management equipment, which is key to ensuring optimal seedbed preparation, fundamental for productive yields, and will further enhance the crop production portfolios of Case IH and New Holland Agriculture, the global agricultural equipment brands of CNH Industrial. K-Line has become the number one tillage manufacturer in Australia by designing robust and reliable products for some of the world’s harshest soil conditions.

CNH Industrial’s commitment to growing its global agricultural business focuses on placing technological advancements at the service of its brands’ global customer base and developing an advanced digital farming offering. These are core pillars of its Agricultural Segment’s growth strategy, and the integration of leading-edge tillage and residue management equipment is an important step in achieving this aim.

“The acquisition of K-Line Ag is further concrete expression of the Agricultural Segment’s stated aim of seeking both strategic acquisitions to enhance their respective agricultural offerings, as well as their role as industry consolidators,” stated Hubertus Mühlhäuser, Chief Executive Officer, CNH Industrial. “Our brands will now be able to even better serve their customers, thanks to K-Line Ag’s outstanding product portfolio and knowledgeable team who now join the CNH Industrial family.”

K-Line Ag, a pioneering leader and innovator in the agricultural implement business in Australia, founded in 1993, is headquartered in Cowra, New South Wales, Australia, and expanded into North America in 2013. K-Line products will be available in Case IH dealerships in North America and through the Case IH, New Holland, and K-Line networks in Australia and New Zealand.

CNH Industrial N.V. (NYSE: CNHI /MI: CNHI) is a global leader in the capital goods sector with established industrial experience, a wide range of products and a worldwide presence. Each of the individual brands belonging to the Company is a major international force in its specific industrial sector: Case IH, New Holland Agriculture and Steyr for tractors and agricultural machinery; Case and New Holland Construction for earth moving equipment; Iveco for commercial vehicles; Iveco Bus and Heuliez Bus for buses and coaches; Iveco Astra for quarry and construction vehicles; Magirus for firefighting vehicles; Iveco Defence Vehicles for defence and civil protection; and FPT Industrial for engines and transmissions. More information can be found on the corporate website: www.cnhindustrial.com

Sign up for corporate news alerts from the CNH Industrial Newsroom:
bit.ly/media-cnhindustrial-subscribe

Media contacts:
                       
Laura Overall
Corporate Communications Manager
CNH Industrial
Tel. +44 (0)2077 660 338                           
E-mail: mediarelations@cnhind.com

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AIR Worldwide Releases Multi-Peril Crop Insurance Model for India

Boston, Nov. 04, 2019 (GLOBE NEWSWIRE) — Catastrophe risk modeling firm AIR Worldwide (AIR) today announced that it has released a Multiple Peril Crop Insurance (MPCI) Model for India to help support probabilistic assessments of potential losses caused by yield shortfalls for 11 major crops across the two main Indian crop-growing seasons. AIR Worldwide is a Verisk (Nasdaq:VRSK) business.

The MPCI Model for India is an event-based model, with an event defined as an individual crop year made up of a kharif season (the “summer” period from late spring into autumn) and the following rabi season (the “winter” period from autumn into the following spring).

“One of the many challenges in developing and testing an MPCI model for Indian crops is the collation and evaluation—quality assuring—of the available historical data on planted areas and yields of insured crops, which comes from various, sometimes contradictory sources,” said Dr. Jeff Amthor, assistant vice president, AIR Worldwide. “Our team at AIR invested significant effort in gathering data and, just as important, in screening it for quality and consistency. As a result, we produced what may be the highest-quality single data set of India’s state and district crop production statistics currently available. We also carried out a significant effort to understand the causes and consequences of the sometimes significant differences among weather data sources.”

The model features a stochastic catalog of 10,000 simulated crop years, each containing a kharif season and the following rabi season, which describes the wide range of possible crop loss scenarios, both common and rare, in the two seasons. It also features a historical catalog of losses based on a recast of the years 1979 through 2017. Both the stochastic and historic recast yield and loss catalogs reflect current crop “technology” levels (for example, current crop genetics, farmer skill, availability of chemical inputs), insurable exposure by district, and PMFBY (Pradhan Mantri Fasal Bima Yojana) policy conditions as revised in late 2018.

Damage estimation accounts for the vulnerability of different crops to variations and extremes in environmental conditions that occur at specific periods during both the kharif and rabi growing seasons. A crop’s vulnerability to stressful environmental factors (such as local or regional heat waves, droughts, or floods) can differ with each crop’s developmental stage, and that is accounted for in the AIR MPCI Model for India. The model also accounts for the fact that irrigation lessens or eliminates negative effects of precipitation shortfall on crop yields.

The model uses a combination of quality-assured historical yield events and both historic and stochastic all-India gridded weather data sets composed of daily values of minimum air temperature, maximum air temperature, rainfall amount, and maximum wind speed to simulate a full range of crop insurance loss outcomes under the current terms of the PMFBY. Simulations of annual weather over the entire country reflect today’s climate. Probabilistic assessments of loss return periods for the10,000 scenario years are provided for individual crops in each insuring district and provide complete loss profiles by return period. Those results can be integrated to any level of aggregation desired to support evaluation of risk at the portfolio level.

“Despite the long and extensive history of agriculture in India, it is only recently that multiple-peril crop insurance has been widely available to farmers,” said Dr. Praveen Sandri, executive vice president and managing director, AIR Worldwide India. “One of the most valuable components of this model is that reinsurers in the India crop market can have their exposure data analyzed at the district level or aggregated to the cluster and/or state level for individual crops or all crops combined. Additionally, the model can provide guidance toward putting together a balanced book of business that considers geographic correlations in a complex agricultural market.”

The AIR MPCI Model for India is currently available in the Touchstone ReTM catastrophe risk management system.

About AIR Worldwide
AIR Worldwide (AIR) provides risk modeling solutions that make individuals, businesses, and society more resilient to extreme events. In 1987, AIR Worldwide founded the catastrophe modeling industry and today models the risk from natural catastrophes, terrorism, pandemics, casualty catastrophes, and cyber incidents. Insurance, reinsurance, financial, corporate, and government clients rely on AIR’s advanced science, software, and consulting services for catastrophe risk management, insurance-linked securities, longevity modeling, site-specific engineering analyses, and agricultural risk management. AIR Worldwide, a Verisk (Nasdaq:VRSK) business, is headquartered in Boston, with additional offices in North America, Europe, and Asia. For more information, please visit www.air-worldwide.com.

For more information, contact:
Kevin Long
AIR Worldwide
+1-617-267-6645
klong@air-worldwide.com

RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H. pylori in Adults

  • RedHill plans to launch Talicia®1 in the U.S. in Q1/2020 for the treatment of H. pylori infection in adults, targeting more than two million patients estimated to be treated for H. pylori infection annually
  • Talicia® is the first and only FDA approved rifabutin-based H. pylori therapy and is designed to address the high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy
  • H. pylori affects approximately 35% of U.S. adult population; it is classified as a Group I carcinogen and is the strongest risk factor for the development of peptic ulcer disease, gastritis and non-cardia gastric cancer
  • Talicia® is eligible for 8 years of U.S. market exclusivity under QIDP designation, in addition to patent protection extending until 2034
  • Debt-free balance sheet with approximately $59 million in cash and short-term investments following a recent strategic investment by Cosmo Pharmaceuticals
  • RedHill will host Investor and Analyst day and live webcast on November 22, 2019 to present its planned commercial launch of Talicia® and Aemcolo®

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of proprietary drugs for the treatment of gastrointestinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults. RedHill expects to launch Talicia in the U.S. in the first quarter of 2020 with its dedicated sales force.

Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies. It is estimated that H. pylori resistance to clarithromycin more than doubled between 2009-20132.

Professor David Y. Graham, MD, MACG, Professor of Medicine, Molecular Virology and Microbiology at Baylor College of Medicine, Houston and Lead Investigator of the Talicia Phase 3 studies, said: “Talicia offers patients a much-needed new treatment option for H. pylori with an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance. The clinical studies for Talicia demonstrated high efficacy in eradication of H. pylori. Studies with Talicia found zero resistance to rifabutin and showed 17% resistance to clarithromycin, a current standard-of-care macrolide antibiotic, consistent with current data showing that clarithromycin-containing therapies fail in approximately 25-40% of cases.”

Colin W. Howden, MD, AGAF, FACG, Hyman Professor of Medicine & Chief of the Division of Gastroenterology, University of Tennessee Health Science Center, added: H. pylori is a major cause of peptic ulcer and gastritis. It is also carcinogenic and is the leading cause of gastric cancer. Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade. Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”

“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We thank the patients, researchers and clinical staff who participated in the studies of Talicia and the RedHill team and vendors for this important milestone achieved by their commitment and hard work,” said Dror Ben-Asher, Chief Executive Officer of RedHill Biopharma. “We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.”

RedHill will host an Investor and Analyst day on November 22, 2019 in New York to review launch plans for Aemcolo® and Talicia® and provide an overview of the Company’s commercial operations. A live webcast of the event, including the slide presentation, will be available on the Company’s website: https://ir.redhillbio.com/events. Additional information will be made available on the Company’s website.

About Talicia®
Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Talicia is designed to address the increasing resistance of H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies and the imperative need for new treatments.5 Talicia’s approval is based, in part, on the results of two positive Phase 3 studies in the U.S. for the treatment of H. pylori-positive adult patients complaining of epigastric pain and/or discomfort. The confirmatory Phase 3 study of Talicia demonstrated 84% eradication of H. pylori infection with Talicia vs. 58% in the active comparator arm (p<0.0001). Further, in an analysis of data from this study, it was observed that subjects with measurable blood levels of drug at Day 13 had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm3. No resistance to rifabutin, a key component of Talicia, was detected in the study. Treatment discontinuation due to an adverse reaction occurred in 1% of patients (4/305) receiving Talicia. The adverse reactions leading to the patients’ discontinuation of Talicia were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, respectively. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation, in addition to patent protection extending until at least 2034.

About H. pylori
H. pylori bacterial infection affects over 50% of the population worldwide4 and approximately 35%, or over 100 million people, in the U.S., with an estimated 2.5 million patients treated annually in the U.S.5 H. pylori is classified as a Group I carcinogen by the International Agency for Research on Cancer. It is the strongest risk factor for the development of gastric cancer6 and a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma8, with infected persons having a 6-fold increased risk of developing non-cardia gastric cancer and MALT lymphoma9. Eradication of H. pylori is becoming increasingly difficult; current standard-of-care therapies fail in approximately 25-40% of patients who remain H. pylori positive due to growing resistance of H. pylori to clarithromycin and metronidazole, antibiotics commonly used in standard combination therapies10. Clarithromycin-resistant H. pylori was formally categorized by the World Health Organization (WHO) as a pathogen for which there is a high priority need to develop new treatments11.

INDICATION AND USAGE
TALICIA is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS

  • Known hypersensitivity to omeprazole, amoxicillin or any other beta-lactam antibacterial drugs, rifabutin or any other rifamycin, or any component of TALICIA.
  • Rilpivirine-containing products.
  • Delavirdine.
  • Voriconazole.

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of TALICIA. If hypersensitivity reactions occur, discontinue TALICIA and institute immediate therapy (e.g., anaphylaxis management).
  • Clostridioides difficile-Associated Diarrhea (CDAD): Evaluate if diarrhea occurs.
  • Reduction in the Efficacy of Hormonal Contraceptives: Additional non-hormonal highly effective methods of contraception should be used while taking TALICIA.
  • Acute Interstitial Nephritis (AIN): Observed in patients taking Proton Pump Inhibitors (PPIs) and penicillins. Discontinue TALICIA if AIN develops.
  • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue TALICIA and evaluate.

ADVERSE REACTIONS
Most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

DRUG INTERACTIONS
Components of TALICIA have the potential for clinically important drug interactions. See full prescribing information for important drug interactions with TALICIA.

USE IN SPECIFIC POPULATIONS

  • TALICIA may cause fetal harm.
  • Renal Impairment: Avoid use in severe renal impairment.
  • Hepatic Impairment: Avoid use.

To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please also see full Prescribing Information.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes several gastrointestinal products in the U.S., Donnatal®, EnteraGam® and Mytesi®, and is planning to launch Aemcolo® and Talicia® in the U.S.12 In November 2019, the FDA approved Talicia® for marketing in the U.S. for the treatment and of Helicobacter pylori (H. pylori) infection in adults. RedHill’s key clinical late-stage development programs include: (i) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) ABC294640 (Yeliva®), a firstinclass SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; (v) RHB106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks related to the timing of our launch of Talicia® and Aemcolo®, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its therapeutic candidates; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia®; (v) the Company’s ability to successfully commercialize and promote Talicia®, Aemcolo®, Donnatal®, EnteraGam® and Mytesi®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company’s Expanded Access Program; (xiv) competition from other companies and technologies within the Company’s industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 26, 2019, as amended on May 15, 2019. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact:
Adi Frish
Senior VP of Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Timothy McCarthy, CFA, MBA
Managing Director, Relationship Manager
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com

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1
Each delayed-release capsule contains omeprazole 10 mg (equivalent to 10.3 mg omeprazole magnesium), amoxicillin 250 mg, and rifabutin 12.5 mg.
2 Shiota S, Reddy R, Alsarraj A, et al. Antibiotic resistance of Helicobacter pylori among male United States veterans. Clin Gastroenterol Hepatol. 2015;13:1616-1624.
3 This PK population included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at Visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
4 Lamb A et al. Role of the Helicobacter pylori‐induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
5 Foster Rosenblatt market analysis, October 2018.
6 Lamb A et al. Role of the Helicobacter pylori‐induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
7 NIH – Helicobacter pylori and Cancer, September 2013.
8 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
9 NIH – Helicobacter pylori and Cancer, September 2013.
10 Fallone CA et al. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology 2016;151:51–69; Malfertheiner P. et al. Management of Helicobacter pylori infection – the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; Graham DY et al. New concepts of resistance in the treatment of Helicobacter pylori infections. Nat Clin Pract Gastroenterol Hepatol. 2008 Jun;5(6):321-31 and Graham DY et al. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut 2010;59:1143-1153.
11 World Health Organization, Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics, February 2017.
12 For full prescribing information see: Aemcolo®: www.Aemcolo.com; Mytesi®: www.Mytesi.com; EnteraGam® https://bit.ly/2N3q7DW; Talicia®: w.accessdata.fda.gov

MATRADEs mission to Egypt nets US$23.36 million in sales

KUALA LUMPUR, The recent week-long Export Acceleration Mission (EAM) in Cairo, Egypt organised by Malaysia External Trade Development Corporation (MATRADE) to promote Malaysian products and services has successfully generated sales amounting to US$23.36 million.

MATRADE Trade Commissioner in Jeddah Yusram Yusup who headed the mission said, more importantly, the EAM has achieved its aim of exploring business ventures as well as providing a platform for Malaysian companies to promote their Made in Malaysia brands in the region.

A total of 145 business meetings were arranged between Malaysian companies and potential Egyptian partners. We received lots of good feedback from Egyptian companies towards Malaysian products and services, he said in a statement made available to Bernama here today.

A total of 12 Malaysian companies from four sectors, namely palm oil and palm oil-based products, food and beverages, construction and renewable energy and chemical and chemical products took part in the EAM.

Apart from business meetings and networking session, the Malaysian and Egyptian companies also participated in a forum and seminar to provide the latest updates on trade and investment opportunities between both countries.

The meeting and networking session was organised by MATRADE in collaboration with local trade and business associations such as with Egyptian Businessmen’s Association (EBA), The ASIA-Egypt Business Association (AEBA), General Authority for Investment and Financial Regulatory Authority (GAFI) and Cairo Chamber of Commerce.

Malaysian companies also got the opportunity to visit local importers, distributors and retailers to get a better understanding of the product requirements and certifications, pricing structure and specific demand from local companies, said Yusram.

A participant, Bernard Lim, director of BCC Ban Chuan Sdn Bhd, said MATRADE has done an impressive job in acting as a gateway to introduce Malaysian companies to overseas market, adding that We managed to forge good contacts with some potential distributors in Egypt.

Managing director of Metal Dot Machinery Sdn Bhd M.K. Loganathan said he received some serious enquiries for his company’s metal products from local Egyptian companies interested to source the products from Malaysia and would further follow up as soon as the details were finalised.

Meanwhile, Pumar Marketing Sdn Bhd chief executive officer (CEO) Norazam Kamisan said his solar-based company sees the demand for solar technology is booming in Egypt and looking forward to having a long presence in the market.

Malaysian ambassador to Egypt Mohd Haniff Abd Rahman in his opening remarks during the business forum said EAM has certainly provided the market potential for Malaysian products and services due to the country’s huge domestic market.

Egypt he said, could become a gateway to the surrounding markets such as the European Union and Middle East and North African (MENA) countries which could open up a bigger market for Malaysian products and services.

Purity International Sdn Bhd CEO Mohd Zaidi Ismail said as a newcomer to the market, he needs to pay attention to the regulations and find the right partner, which he managed to do during the EAM.

Through the meetings and engagement with local companies, we were also able to identify some good prospects that are interested to collaborate with us, he added.

Malaysia’s total trade with Egypt from January until August this year amounted to RM1.58 billion with exports stood at RM1.30 billion while imports totalled RM284.3 million.

Source: BERNAMA (News Agency)