Daily Archives: April 5, 2017
LONDON, April 05, 2017 (GLOBE NEWSWIRE) — XM Group (Trading Point Group), a leading Forex and CFD broker and the official trading partner of the Fastest Man in the World “Usain Bolt”, has been recognized as Best Forex Service Provider for 2017 during the City of London Wealth and Management Awards which were hosted on the 30th of March at The Guildhall in the City of London.
The City of London Wealth and Management Awards are hosted once a year and the winners of each category are determined by an online public vote.
During the event Stephen Pinner, MD of Goodacre UK the company managing the Awards said, “The Wealth Management sector is working hard to meet a wide range of challenges and it is very re-assuring to see the increasing interest from the investing public. In addition to ensuring that they meet a significant amount of new regulatory requirements, many firms strive to deliver services of the highest quality and these Awards acknowledge and reward the very best companies in the market.”
Notes for Editors
The purpose of the City of London Wealth and Management Awards is to recognize and promote quality of service from Wealth Management companies and individuals. Winners are determined by a public online vote which took place over a two-week period. The poll was reviewed by an independent panel of judges.
About XM Group
XM the official trading partner of the Fastest Man in the World “Usain Bolt” is an award-winning Forex and CFD Broker serving over 1,00,000 clients.
XM is a brand name of Trading Point Holdings Ltd which wholly owns Trading Point of Financial Instruments UK Ltd (XM UK), Trading Point of Financial Instruments Pty Ltd (XM Australia) and Trading Point of Financial Instruments Ltd (XM Cyprus).
XM UK is authorized and regulated by the Financial Conduct Authority (Reference number: 705428), XM Australia is licensed by the Australian Securities and Investment Commission (Reference number: 443670) and XM Cyprus is regulated by the Cyprus Securities and Exchange Commission (Reference number: 120/10).
For more information visit -> http://www.xm.com/
Forex and CFD Trading Involve a significant risk to your invested capital. Please ensure you fully understand the risks and take care to manage your exposure.
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For information contact: Chris A. Zacharia – Marketing Director XM Group firstname.lastname@example.org
RedHill Biopharma Announces Exclusive U.S. License from Entera Health for Commercial GI Product EnteraGam®
- RedHill expects to initiate U.S. promotion of its two commercially-available gastrointestinal specialty products, Donnatal®1 and EnteraGam®2, in mid-2017
- Under the terms of the agreement, RedHill will pay Entera Health royalties on net sales generated from the sale of EnteraGam® by RedHill
TEL-AVIV, Israel, April 05, 2017 (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 late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal (GI) and inflammatory diseases and cancer, today announced the signing of an exclusive license agreement with Entera Health Inc. (“Entera Health”), a privately held U.S. company focused on the research, manufacturing, and commercialization of value-added proteins and protein co-products, granting RedHill the exclusive U.S. rights to EnteraGam®2.
EnteraGam® is a commercially-available medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. 2016 net sales of EnteraGam® in the U.S. were over $5 million. EnteraGam® is a serum-derived bovine immunoglobulin/protein isolate (SBI) with a unique mechanism of action intended to restore gut balance. EnteraGam® has been studied for various uses, such as diarrhea-predominant irritable bowel syndrome (IBS-D), inflammatory bowel disease (IBD) and human immunodeficiency virus (HIV)-associated enteropathy3.
Guy Goldberg, RedHill’s Chief Business Officer, said: “We look forward to initiating the promotion of Donnatal®4 and EnteraGam® in mid-2017. We are currently in advanced stages of building RedHill’s commercial operations in the U.S. and are excited to complement our product portfolio with a second commercial product geared towards gastroenterologists. We would like to thank our new partners at Entera Health and look forward to a successful long-term partnership.”
Adi Frish, RedHill’s Senior VP, Business Development and Licensing, said: “This is another important step in implementing our strategic plan of becoming a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S. We continue to pursue additional commercial product opportunities in the specialty GI area to further expand our commercial operations. In parallel, we continue to advance the development of our three Phase III GI products, which, if approved by the FDA, we intend to commercialize in the U.S.”
Aage Lauridsen, Entera Health’s CEO, said: “We are very pleased to partner with RedHill to secure the continued marketing of EnteraGam® in the U.S. and are confident that RedHill’s sales team will continue to grow the value of this unique product.”
Under the terms of the agreement, RedHill licensed the exclusive U.S. rights to EnteraGam® for all indications for human use. RedHill will pay Entera Health tiered royalties on net sales generated from the sale of EnteraGam® by RedHill, and is not required to make any upfront or milestone payments. Under the terms of the agreement, Entera Health will also grant RedHill certain U.S. rights to its FDA-approved dicyclomine hydrochloride5 oral solution USP (10 mg/5 ml), an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome.
Numerous publications of clinical studies and retrospective chart reviews support the use of SBI in the dietary management of chronic diarrhea and loose stools4. The combined effect of SBI is intended to fulfill a distinctive nutritional requirement associated with various gastrointestinal conditions, where chronic diarrhea or loose stools are present and normal dietary proteins alone are insufficient. SBI has been shown in clinical studies to reduce loose stools and improve stool consistency as well as other symptoms, such as abdominal pain, bloating and urgency, in patients with chronic diarrhea and loose stools4. Several studies in patients suffering from inflammatory bowel diseases, such as ulcerative colitis and Crohn’s disease, suggest that SBI improves clinical symptomatic management of patients who are not fully managed on traditional therapies4. SBI has also been studied in patients with fecal incontinence with chronic diarrhea, in patients with celiac and non-celiac gluten sensitivity with chronic diarrhea and in additional gastrointestinal indications4.
No significant interactions of EnteraGam® with commonly prescribed medications or therapies have been reported. According to Entera Health, it is estimated that since EnteraGam® was introduced in 2013, nearly 3 million doses of EnteraGam® have been administered to patients in the U.S., with an overall adverse events rate of less than 0.2%, with no serious adverse events attributed to EnteraGam® during post-marketing surveillance.
In January 2017, RedHill announced an exclusive co-promotion agreement with a subsidiary6 of Concordia International Corp., granting RedHill certain promotional rights in the U.S. for Donnatal®, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel).
EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision. EnteraGam® binds microbial components7, such as toxic substances released by bacteria, that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools in people who have specific intestinal disorders8 9.
EnteraGam® contains beef protein; therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.
EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free and soy-free.
Please see full Product Information.
To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast-acting liquid.
Important Safety Information:
Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.
Further information, including prescribing information, can be found on www.donnatal.com.
Please see the following website for complete important safety information about Donnatal®: http://www.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, as well as an exclusive license agreement with Entera Health for EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) RHB-105 – an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 – an oral combination therapy for the treatment of Crohn’s disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) – a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 – an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) – a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON – a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) – an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015. 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 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; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number 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; (v) the Company’s ability to successfully market Donnatal® and EnteraGam®, (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 of 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; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
1 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. For more information, please see the prescribing information: http://www.donnatal.com/wp-
2 EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a commercially-available medical food, intended for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, which must be administered under medical supervision.
3 See full list of publications at: http://enteragam.com/assets/
4 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. For more information, please see the prescribing information: http://www.donnatal.com/wp-
5 For more information, please see the prescribing information: https://www.accessdata.fda.
6 Concordia Pharmaceuticals Inc.
7 Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein isolate binds to pathogen-associated molecular patterns. Poster presented at: Federation of American Societies for Experimental Biology; April 26-30, 2014; San Diego, CA.
8 Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.
9 Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights into the pathophysiology of IBS: intestinal microflora, gas production and gut motility. Eur Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.
Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 email@example.com IR contact (U.S.): Marcy Nanus Senior Vice President The Trout Group +1-646-378-2927 Mnanus@troutgroup.com
MAHWAH, N.J., April 05, 2017 (GLOBE NEWSWIRE) — Radware® (NASDAQ:RDWR), a leading provider of cybersecurity and application delivery solutions, announced that its Alteon NG Application Delivery Controller (ADC) Virtual Appliance (VA) is available on Microsoft Azure to enterprises that need to incorporate an application delivery solutions in their cloud deployment. It now comes with integrated migration tools that make cloud migration simple and easy to execute.
Radware’s Alteon NG VA for Azure enables organizations to run applications across private and public cloud infrastructures, while improving overall quality of experience (QoE) for users accessing business applications through its load balancing and traffic management capabilities.
Radware’s Alteon VA provides outstanding agility, a superior footprint-to-performance ratio, and next-generation ADC functionality, which allows IT administrators to fully use their application deployment on Azure. Alteon NG VA for Azure supports the complex functional requirements of enterprise applications, from Layer 7 rewrites to SSL offloading to web application security.
Organizations can now move ADC services back and forth between their private data center and the cloud in a few clicks. Using Radware’s vDirect automation suite, IT administrators can automate transition calls, regardless of where the ADC resides—their private data center, Azure, or another cloud solution—and easily transfer them back and forth from one environment to another.
“The integrated migration tool adds to the value of cloud based ADC,” said Daniel Lakier, vice president of ADC at Radware. “Alteon NG VA for Microsoft Azure supplements the enterprise application lifecycle, enabling organizations to grow and shrink their application infrastructure capacity on demand. Working under a pay-as-you-go structure helps organizations optimize their initial investment and their ongoing operational costs.”
In addition, Alteon NG VA for Azure monitors the application performance and user experience, enabling full control over application delivery service level assurances (SLAs) that cloud deployments provide. Its embedded web application firewall (WAF) and state-of-the-art application acceleration ensure that the application remains fast and secure on Azure.
“We’re pleased to make Radware’s Alteon NG Virtual Appliance available in the Microsoft Azure Marketplace to help customers improve performance for business applications,” said Andrea Carl, director, Commercial Communications at Microsoft Corp. “The ability to easily transfer ADC services between datacenter and the cloud makes it easier than ever for organizations to outfit their cloud environment with solutions that meet their business needs.”
Radware’s solution maintains agility across private data centers and different cloud environments by combining functional parity across all of its ADC form factors together with automation tools. Through automation, organizations gain instant ADC service portability across environments and can simplify all ADC lifecycle management tasks down to the click of a button.
Alteon NG VA for Azure is available via a bring-your-own-license (BYOL) model using a simple activation process in the Azure Marketplace.
For more information, visit Alteon NG VA for Azure.
Radware® (NASDAQ:RDWR), is a global leader of application delivery and cyber security solutions for virtual, cloud and software defined data centers. Its award-winning solutions portfolio delivers service level assurance for business-critical applications, while maximizing IT efficiency. Radware’s solutions empower more than 10,000 enterprise and carrier customers worldwide to adapt to market challenges quickly, maintain business continuity and achieve maximum productivity while keeping costs down. For more information, please visit www.radware.com.
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Two cleaners of the City Hall were slightly injured in an explosion in a garbage bin on Ratchadamnoen Avenue Wednesday night.
The two cleaners later told Chana Songkhram police that the garbage bin exploded when they poured litter into the bin near the former headquarter of the Government Lottery Office.
Pol Lt-Gen Sanit Mahathavorn, metropolitan police commissioner, said that it could not be determined for the time being that the explosion was caused by a bomb.
Source: Thai Public Broadcasting Service (Thai PBS)
The military court in Surat Thani on Wednesday issued warrants for the arrest of nine former soldiers suspected of involvement in the fatal assault of a conscript who died at the provincial hospital on April 1.
Surat Thani police team in charge of investigating the case, led by Pol Col Wichob Kerdkliang, the provincial deputy commander, sought the arrest of ten soldiers, but the court approved only nine after three hours of deliberation of the police request.
Of the nine soldiers facing arrest, eight of them are prisoners incarcerated at the army prison in the province with the ninth out of the prison. They were identified as Yanyong Samleemuang, Sanong Khamseetha, Surachet Prommat, Chalermpong Nilsuwan, Paramet Temyod, Sakiravuth Ponrak, Chakrapan Khiewsawat, Parkpoom Suebmat and Puvadet Thanayutthapoom.
The nine suspects were charged by the police with assault causing death to the other people.
The victim's mother has been informed by the military of the arrest of the nine suspects.
Source: Thai Public Broadcasting Service (Thai PBS)
Less than one day after police started enforcing seat belt regulation which includes a ban against pickup trucks carrying passengers in the cab and on the back of the vehicles, the Royal Thai Police Office and the Land Transport Department decided to take a step back by postponing the enforcement of the regulation until after Songkran festival.
The assistant police chief Pol Lt-Gen Wittaya Prayongpant said on Wednesday that many owners of pickup trucks were unable to adjust to the regulation because they were given just a short notice.
He said both the Royal Thai Police and the LTD agreed that enforcement of the seat belt regulation should be postponed until after Songkran.
Pol Lt-Gen Wittaya said Prime Minister Prayut Chan-ocha had been informed about the joint decision. He added that the prime minister agreed with the decision as he didn't want to unnecessarily cause trouble to the people and suggested both the police and the LTD to adopt other means to reduce road carnage during Songkran festival.
The enforcement of the seat belt regulation which started on Wednesday has provoked widespread criticism among drivers of pickup trucks and other public transports.
Source: Thai Public Broadcasting Service (Thai PBS)