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RedHill Biopharma Announces Enrollment of Last Patient in the BEKINDA® Phase II Study for IBS-D

  • op-line results are expected in the third quarter of 2017 
  • The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® (RHB-102) 12 mg in 127 U.S. patients with diarrhea-predominant irritable bowel syndrome (IBS-D)
  • IBS is one of the most common gastrointestinal disorders; it is estimated that at least 30 million Americans suffer from IBS, of which over 40% are cases of IBS-D
  • If approved, BEKINDA® 12 mg has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D, targeting a U.S. potential market estimated to exceed $1 billion by 2022
  • Top-line results from a Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017
  • RedHill will host an R&D Day and live webcast on BEKINDA® on Thursday, April 27, 2017 in NYC, discussing the product, indications, potential markets and the ongoing Phase III and II studies for acute gastroenteritis and IBS-D, respectively

TEL-AVIV, Israel, April 24, 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 and inflammatory diseases and cancer, today announced enrollment of the last patient in the Phase II study with BEKINDA® (RHB-102)1 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications.

The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® 12 mg in adults over the age of 18 with IBS-D. The study enrolled 127 subjects in 16 U.S. clinical sites. Top-line results are expected in the third quarter of 2017.

Subjects enrolled in the Phase II IBS-D study were randomized 60:40 to receive either BEKINDA® 12 mg or a placebo, once daily, for a period of eight weeks. The primary endpoint for the study is the proportion of patients in each treatment group with response in stool consistency as compared to baseline, per FDA guidance definition. Secondary endpoints include the proportion of patients in each treatment group who are pain responders and the proportion of patients in each treatment group who are responders to the combined endpoints of stool consistency and pain, per FDA guidance definition.

IBS is one of the most common gastrointestinal disorders2. It is estimated that at least 30 million Americans suffer from IBS3, of which over 40% are cases of IBS-D4. The U.S. potential market for IBS-D treatments is estimated to exceed $1 billion by 20225.

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA®, have been shown to slow intestinal transit time in humans6. Alosetron (Lotronex®), a 5-HT3 antagonist of the same class of drugs as ondansetron, has been approved by the FDA for the treatment of women with severe chronic IBS-D, but is under a restricted prescribing (REMS) program due to potential severe side effects7. Ondansetron, approved by the FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies8 and, in light of its safety profile, RedHill believes that BEKINDA®, if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D.

Top-line results from the Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017. In February 2017, RedHill announced that the last patient had completed the treatment course and observation period in the randomized, double-blind, placebo-controlled GUARD study, which treated 320 adults and children over the age of 12 in 29 U.S. clinical sites.

The Phase II study and the Phase III GUARD study with BEKINDA® are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

About BEKINDA® (RHB-102):
BEKINDA® is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents. A Phase III clinical study of BEKINDA® 24 mg formulation for acute gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with patient treatment course and observation period completed and top-line results expected in the second quarter of 2017. A Phase II study with BEKINDA® 12 mg formulation is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with patient enrollment completed and top-line results expected in the third quarter of 2017.

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 two EU member states under the European Decentralized Procedure (DCP). 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 BEKINDA® is an investigational new drug, not available for commercial distribution.

2 GlobalData PharmaPoint: Irritable Bowel Syndrome – Global Drug Forecast and Market Analysis to 2023.

3 Lovell RM, Ford AC, Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis, Clin Gastroenterol Hepatol (2012), 10(7)712-721; Saito YA et al, The epidemiology of irritable bowel syndrome in North America: a systemic review, Am J Gastroenterol (2002), 97(8): 1910-5.

4 GlobalData PharmaPoint: Irritable Bowel Syndrome – Global Drug Forecast and Market Analysis to 2023.

5 EvaluatePharma – Irritable bowel syndrome Indication Profile.

6 Garsed K. et al, A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea, Gut (2014), 63(10): 1617-25.

7 www.fda.gov, post market drug safety information for patients and providers.

8 Steadman CJ et al, Selective 5-hydroxytryptamine type 3 receptor antagonism with ondansetron as treatment for diarrhea-predominant irritable bowel syndrome: a pilot study, Mayo Clin Proc (1992), 67(8):732-8; Clayton NM et al, The pharmacological properties of the novel selective 5-HT3 receptor antagonist, alosetron, and its effects on normal and perturbed small intestinal transit in the fasted rat, Neurogastroenterol (1999), 11: 207-217; Garsed K. et al, A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea, Gut (2014), 63(10): 1617-25.

Company contact:
Adi Frish
Senior VP Business Development & 
Licensing 
RedHill Biopharma
+972-54-6543-112
[email protected]

IR contact (U.S.): 
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
[email protected]

TGS announces Crean 3D multi-client project in Ireland

ASKER, Norway, April 24, 2017 (GLOBE NEWSWIRE) — TGS announces new multi-client acquisition project, Crean 3D on the Irish Atlantic Margin.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/325303aa-b36f-4de5-a678-60be534ae895

Crean 3D (CRN 3D) is a multi-client survey of more than 5,400 km2 located in the South Porcupine Basin between the Porcupine High and the Irish Mainland Platform. Multi-level targets exist, such as Paleocene and Mesozoic channel/fan systems overlying tilted fault blocks. Exploration success on the Newfoundland Labrador conjugate margin coupled with historical exploration in Atlantic Ireland has resulted in significant acreage being licensed. TGS will acquire new 3D data to provide the higher spatial resolution required to delineate multiple plays at multiple levels. Acquisition is expected to commence in June 2017. Data processing will be performed by TGS using its Clari-FiTM broadband technology.

“Crean 3D will expand TGS’ modern 3D coverage in the underexplored Porcupine Basin. With the successful Atlantic Ireland license round in 2016, we see that activity across the Porcupine Basin is continuing to increase, creating exciting new opportunities. The Crean 3D survey further adds to our Atlantic Margins library which also includes data and new acquisition in the Norwegian Sea, North West Africa and Newfoundland Labrador,” commented Kristian Johansen, CEO for TGS.

This survey is supported by industry funding.

Company Summary

TGS-NOPEC Geophysical Company (TGS) provides multi-client geoscience data to oil and gas Exploration and Production companies worldwide.  In addition to extensive global geophysical and geological data libraries that include multi-client seismic data, magnetic and gravity data, digital well logs, production data and directional surveys, TGS also offers advanced processing and imaging services, interpretation products, and data integration solutions.

For more information visit TGS online at www.tgs.com.

Forward-looking statements and contact information

All statements in this press release other than statements of historical fact are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. These factors include TGS’ reliance on a cyclical industry and principle customers, TGS’ ability to continue to expand markets for licensing of data, and TGS’ ability to acquire and process data products at costs commensurate with profitability. Actual results may differ materially from those expected or projected in the forward-looking statements. TGS undertakes no responsibility or obligation to update or alter forward-looking statements for any reason.

TGS-NOPEC Geophysical Company ASA is listed on the Oslo Stock Exchange (OSLO:TGS).

TGS sponsored American Depositary Shares trade on the U.S. over-the-counter market under the symbol “TGSGY”.

For additional information about this press release please contact:

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Sven Børre Larsen
Chief Financial Officer
Tel: +47 90 94 36 73
Email: [email protected]

Will Ashby
VP HR & Communication
Tel: +1 713 860 2184 
Email: [email protected]

Arkansas Scheduled Double Execution is Heinous and Shameful

Arkansas executed Jack Jones today, the second of four prisoners scheduled to be executed before the state's supply of lethal injections expires at the end of the month. Jones was sentenced to death despite the fact that the jury was not told of his serious mental disabilities. The execution of Marcel Williams, also scheduled for tonight, remained under appeal at the time of Jones' death.

Tonight Arkansas continues its shameful backslide against prevailing trends away from the death penalty," said James Clark, senior campaigner with Amnesty International USA. "The sentences of Jack Jones and Marcel Williams are another heinous example of how the death penalty is applied to people with severe mental impairments and history of abuse. This conveyer belt of death must stop immediately by commuting the remaining sentences, and abolishing the death penalty once and for all.

A report released earlier this month by Amnesty International showed that for the first time since 2006, and only the second time since 1991, the U.S. is not among the world's five biggest executioners. The number of executions (20) in 2016 reached the lowest level recorded in any year since 1991. The number of executions has fallen every year since 2009, (except 2012, when it stayed the same).

Source: Amnesty International USA

Myanmar Police Arrest Married Couple in Murder of Yangon Publisher

Myanmar police on Friday said they have arrested two suspects in the murder of a news magazine publisher, saying the crime was in retaliation for a romantic affair, rather than for his critical coverage of the military, as many observers in the country had feared.

The body of Wai Yan Heinn, the 27-year-old publisher and editor of Iron Rose, was found slumped in a chair with 15 stab wounds in his in his chest and abdomen on April 16, after neighbors reported a strong odor coming from his first-floor office in Pazundaung township in the commercial capital Yangon.

Aung Ko Ko, a cargo ship officer and the husband of a woman with whom Wai Yan Heinn allegedly had an affair, has been charged with murdering the publisher, the Myanmar Police Force said in a post on its Facebook page.

Yangon police arrested both Aung Ko Ko and his wife on Wednesday, and they have formed a special team to investigate this case.

Police said Wai Yan Heinn and Aung Ko Ko's wife Al Ni had been in contact on Facebook for the past eight months, according to a report by the online journal The Irrawaddy.

A friend informed Aung Ko Ko that the two were having an affair, so he allegedly locked his wife and son in his home in Yangon's Mingalar Taung Nyunt township on April 11, prompting Al Ni to call Wai Yan Heinn for help, the report said.

Wai Yan Heinn broke the lock on the door and took Al Ni and her son to a hotel in Lanmadaw township on the same day, said police, it said.

Aung Ko Ko then reportedly phoned Wai Yan Heinn before going to the journalist's office on April 14, where he is suspected of killing him and taking his iPhone, the report said. He picked up his wife and son from the hotel and fled to Pyin Oo Lwin in Mandalay region the next day.

Journalism groups weigh in

Before news of the love triangle emerged, journalism rights groups spoke out on the murder, urging the Myanmar government to quickly resolve the crime and bring Wai Yan Heinn's killer to justice.

The groups believed that his murder was in retaliation for recent reports on Myanmar's former ruling military generals and their business associates, as well as his reference to the country's de facto leader Aung San Suu Kyi as a drone president.

Authorities should leave no stone unturned in identifying and apprehending Wai Yen Heinn's killer, said Shawn Crispin, senior Southeast Asia representative of the Committee to Protect Journalists in a statement issued on Thursday.

Myanmar is fast emerging as a country where media murders go unpunished, he said. The cycle of impunity and deadly violence should be broken now by promptly bringing Wai Yen Heinn's murderer to justice.

Reporters Without Borders (RSF) on Wednesday echoed the CPJ's also called for a swift investigation of Wai Yan Heinn's murder.

We offer our condolences to Wai Yan Heinn's family and colleagues, and we urge the authorities to allocate enough resources to the investigation so that it can be carried out quickly and thoroughly, and does not ignore the possible links to the victim's work as a journalist, said Benjamin Ismail, head of RSF's Asia-Pacific desk, in a statement.

Killings of other journalists

Last December, Soe Moe Tun, an investigative reporter for Myanmar's Eleven Media Group was found beaten to death on the side of a road in the town of Monywa in northwestern Myanmar's Sagaing region.

Soe Moe Tun, whose death marked the fifth killing of a journalist in Myanmar since 1999, had been reporting on sensitive topics, such as illegal logging and a controversial mining project, before he was murdered.

As of January, police had arrested three suspects, but no additional progress has been made in solving the case, according to local media reports.

The family of Soe Moe Tun, a journalist murdered more than four months ago, is still awaiting significant progress in that investigation, so any attempt to stint on the resources assigned to this latest investigation would send a very negative message to journalists and would foster an unacceptable climate of impunity, Ismail said.

In October 2014, freelance journalist Aung Kyaw Naing, also known as Par Gyi, was shot and killed in military custody in Kyaikmayaw township in southeastern Myanmar's Mon state, after he was arrested while covering fighting between the government army and ethnic Karen rebels.

The following month, a military court acquitted two soldiers of his death, and police stopped investigating the case in April 2016 although another court ruled in a separate civil case that Par Gyi had died of unnatural causes, according to media reports at the time.

Despite a series of reforms to push Myanmar towards democracy, including laws enshrining media freedom, enacted by the former administration of Thein Sein, authorities continue to use various means to intimidate media and restrict freedom of expression.

Myanmar remains in the bottom quarter of RSF's 2016 World Press Freedom Index, ranked 143rd of 180 countries.

Copyright (copyright) 1998-2016, RFA. Used with the permission of Radio Free Asia, 2025 M St. NW, Suite 300, Washington DC 20036

China to Try Political Refugee Forcibly Repatriated by Thailand For Subversion

Authorities in the central Chinese province of Henan are preparing to try an activist on subversion charges after he was forcibly repatriated by Thailand despite having been granted political refugee status by the United Nations.

Activists Dong Guangping and Jiang Yefei were handed back to Chinese authorities in November 2015, in a move that drew strong criticism from the U.N. High Commission for Refugees and human rights groups.

They have since been held in a detention center in the southwestern city of Chongqing, while their families have been resettled in Canada.

Dong's Canada-based wife Gu Shuhua said she is very concerned for his well-being, and that he also faces charges relating to his illegal crossing of the border with neighboring Myanmar during his flight to Thailand.

"Dong Guangping is facing two charges, one of 'illegally crossing a border,' and the other is 'incitement to subvert state power,'" she said on Thursday. "I strongly condemn these charges that have been brought by the Chinese government against Dong Guangping."

"Dong Guangping is a good man who fought to enable a better life for ordinary Chinese people," Gu said. "He wanted constitutional government one day for China. He was unarmed, with no vested interests and without ties to any organizations, so how could he have incited people to bring down the regime?"

Gu said she fears her husband will receive a heavy jail term. "Dong Guangping has been framed, and he could be sent away for a long time," she said.

Denied permission

Dong's lawyer Chang Boguang told RFA that he has been repeatedly denied permission to meet with his client, and he wasn't notified that the authorities are now preparing a trial.

"I heard that the case was moving to trial, but I haven't had any official communication," Chang said. "His wife instructed me to act in his defense, but I have been to Chongqing four times and haven't been allowed to see him in spite of lodging all the right paperwork with the court."

"The court has said it won't allow me to act for Dong Guangping, saying that he already has a lawyer, one that has been allocated for him by the authorities in Chongqing."

Sources said that Jiang Yefei is facing the same charges as Dong, and was formally arrested on May 13, 2016. Jiang's family have also been informed that he has "changed lawyers."

Dong Guangping fled China with his family in September after serving a three-year jail term for subversion from 2001-2004, and being disappeared and held for eight months in secret detention in 2014.

Political cartoonist Jiang Yefei had been in Thailand since fleeing China in 2008, where he was detained and tortured after he criticized the ruling Chinese Communist Party's handling of the devastating Sichuan earthquake, and was granted refugee status last April by the U.N. High Commission for Refugees (UNHCR).

Chinese officials told his brother that Beijing would be seeking his extradition on suspicion of "incitement to subvert state power" after he published a number of satirical cartoons targeting President Xi Jinping.

Both Jiang and Dong have "confessed" to the charges against them, their relatives have told RFA.

Thailand isn't a signatory to the United Nations covenant on refugees, and doesn't recognize the concept of political asylum. However, Chinese refugees, once approved by UNHCR, have the option of resettlement in more than 50 countries if they can evade detention by the country's immigration police.

Copyright (copyright) 1998-2016, RFA. Used with the permission of Radio Free Asia, 2025 M St. NW, Suite 300, Washington DC 20036