Daily Archives: April 18, 2017

RedHill Biopharma Receives Notice of Allowance for Two Additional U.S. Patents Covering BEKINDA®

  • RedHill received Notices of Allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA® (RHB-102), expected to be valid until at least 2034, once granted
  • BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications
  • 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
  • A Phase II study with BEKINDA® 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) is ongoing, with top-line results expected in the third 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 18, 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 that it has received notices of allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA® (RHB-102)1. Once granted, the patents are expected to be valid until at least 2034.

Danielle Abramson, Ph.D., RedHill’s Director of Intellectual Property & Research said: “We are very pleased with the allowance of two additional U.S. patents for BEKINDA®. This is an important addition to RedHill’s strong IP portfolio, that will further enhance our protection of BEKINDA®. We are approaching significant milestones with BEKINDA® in the coming months, with top-line results from the Phase III study for gastroenteritis and gastritis expected in the second quarter of 2017 and top-line results from the Phase II for IBS-D expected in the third quarter of 2017.”

The patent applications, entitled ‘Antiemetic Extended Release Solid Dosage Forms’ and ‘Ondansetron Extended Release Solid Dosage Forms for Treating Either Nausea, Vomiting or Diarrhea Symptoms’, cover claims directed to ondansetron extended release tablets and methods of treating patients with ondansetron extended release solid dosage forms. In addition to the two new U.S. patent applications, the patent portfolio covering BEKINDA® includes one U.S. patent, two pending U.S. patent applications, 17 foreign patents, and over 35 pending foreign patent applications.

BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications. BEKINDA® is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet.

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.

A randomized, double-blind, placebo-controlled Phase II study with BEKINDA® 12 mg is currently ongoing for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). The Phase II study is evaluating the safety and efficacy of BEKINDA® 12 mg in adults over the age of 18 with IBS-D in 16 clinical sites in the U.S. Top-line results are expected in the third quarter of 2017.

The Phase III GUARD study and Phase II 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 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.

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]

New Study Published in PLOS ONE Advances Science Around VTS-270 for Treatment of Niemann-Pick Disease Type C1

ROCKVILLE, Md., April 18, 2017 (GLOBE NEWSWIRE) — Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global biopharmaceutical company, today announced the publication of a new study in an independent scientific journal that confirms the unique composition of VTS-270, a 2-Hydroxypropyl-beta-cyclodextrin (HPβCD) product under investigation as a novel treatment for Niemann-Pick Disease Type C1 (NPC-1).

NPC-1 is a rare, progressive and ultimately lethal genetic disorder affecting an estimated 2,000-3,000 patients globally. The results were published today in an article entitled, “Characterization of hydroxypropyl-beta-cyclodextrins used in the treatment of Niemann-Pick Disease type C1,” in PLOS ONE, the world’s first multidisciplinary, Open Access journal, and are available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0175478.

In this study, researchers demonstrated that VTS-270 has a low degree of consistently specific hydroxypropylation, or degree of substitution (DS), as well as a low level of doubly charged hetero-dimers as seen through an ion mobility false color representation, or heat map. The analysis was based on ion distribution and abundance profiles using mass spectrometry methodology as a means for assessing key molecular activity.

“We are continuing to advance the science around VTS-270 as a potential treatment for NPC,” said Peter Kiener, D. Phil, Chief Scientific Officer of Sucampo. “These study results further support the specific compositional fingerprint and purity of VTS-270 that distinguishes it from other HPßCD mixtures. The defined and reproducible fingerprint is likely inextricably linked to the specific potential clinical efficacy and safety of VTS-270.”

HPβCDs are complex mixtures of different species, and variations in production may lead to differences in composition including differing degrees of hydroxypropylation of the cyclodextrin ring, also known as degrees of substitution. The average degree of substitution is a critical characteristic of the complexity of HPβCDs mixtures, as it influences the ability to bind to other molecules, and affects the degree of aqueous solubility, both of which may ultimately influence the biological activity.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of specialized medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA, its lead product, and RESCULA – and a late-stage pipeline of product candidates in clinical development for orphan disease areas.  VTS-270 is a mixture of 2-hydroxypropyl-B-cyclodextrins with a specific compositional fingerprint that has been granted orphan designation in the U.S. and Europe and is in a pivotal Phase 2/3 clinical trial for the treatment of Niemann-Pick Disease Type C-1.  Sucampo has an option for the North American rights to CPP1-x/sulindac, which is in Phase 3 development for the treatment of familial adenomatous polyposis and has been granted orphan drug designation in the U.S.  A global company, Sucampo is headquartered in Rockville, Maryland, and has operations in Japan and Switzerland. For more information, please visit www.sucampo.com.

The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).
Twitter   LinkedIn

Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
[email protected]

New Study Published in PLOS ONE Advances Science Around VTS-270 for Treatment of Niemann-Pick Disease Type C1

ROCKVILLE, Md., April 18, 2017 (GLOBE NEWSWIRE) — Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global biopharmaceutical company, today announced the publication of a new study in an independent scientific journal that confirms the unique composition of VTS-270, a 2-Hydroxypropyl-beta-cyclodextrin (HPβCD) product under investigation as a novel treatment for Niemann-Pick Disease Type C1 (NPC-1).

NPC-1 is a rare, progressive and ultimately lethal genetic disorder affecting an estimated 2,000-3,000 patients globally. The results were published today in an article entitled, “Characterization of hydroxypropyl-beta-cyclodextrins used in the treatment of Niemann-Pick Disease type C1,” in PLOS ONE, the world’s first multidisciplinary, Open Access journal, and are available at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0175478.

In this study, researchers demonstrated that VTS-270 has a low degree of consistently specific hydroxypropylation, or degree of substitution (DS), as well as a low level of doubly charged hetero-dimers as seen through an ion mobility false color representation, or heat map. The analysis was based on ion distribution and abundance profiles using mass spectrometry methodology as a means for assessing key molecular activity.

“We are continuing to advance the science around VTS-270 as a potential treatment for NPC,” said Peter Kiener, D. Phil, Chief Scientific Officer of Sucampo. “These study results further support the specific compositional fingerprint and purity of VTS-270 that distinguishes it from other HPßCD mixtures. The defined and reproducible fingerprint is likely inextricably linked to the specific potential clinical efficacy and safety of VTS-270.”

HPβCDs are complex mixtures of different species, and variations in production may lead to differences in composition including differing degrees of hydroxypropylation of the cyclodextrin ring, also known as degrees of substitution. The average degree of substitution is a critical characteristic of the complexity of HPβCDs mixtures, as it influences the ability to bind to other molecules, and affects the degree of aqueous solubility, both of which may ultimately influence the biological activity.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of specialized medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA, its lead product, and RESCULA – and a late-stage pipeline of product candidates in clinical development for orphan disease areas.  VTS-270 is a mixture of 2-hydroxypropyl-B-cyclodextrins with a specific compositional fingerprint that has been granted orphan designation in the U.S. and Europe and is in a pivotal Phase 2/3 clinical trial for the treatment of Niemann-Pick Disease Type C-1.  Sucampo has an option for the North American rights to CPP1-x/sulindac, which is in Phase 3 development for the treatment of familial adenomatous polyposis and has been granted orphan drug designation in the U.S.  A global company, Sucampo is headquartered in Rockville, Maryland, and has operations in Japan and Switzerland. For more information, please visit www.sucampo.com.

The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.

Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).
Twitter   LinkedIn

Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
[email protected]

Thailand: Suspected Lao Drug Kingpin Pleads Not Guilty to Smuggling Charges

A Laotian man described as a major drug lord in Thailand and elsewhere in Southeast Asia pleaded not guilty Tuesday in a Bangkok court to charges that could carry the death penalty, including smuggling and possession.

Xaysana Keopimpha, 41, had been dubbed an ASEAN Drug Lord and Thai authorities said he headed a network that supplied caffeine-laced methamphetamine tablets known as yaba, which were produced in Myanmar, throughout the Mekong River region.

Xaysana's Thai lawyer, Vorakorn Pongthanakul on Tuesday promised a strong defense of his client that would include challenging an earlier confession. Vorakorn said his client confessed to a police investigator because while Thai and Lao are similar languages, Xaysana does not understand it or the country's laws.

The lawyer said his client was worried because he had never been convicted of any crime. As for possible bail, family members in Laos are going to decide whether to apply.

Now Xaysana is indicted and is becoming a defendant ... he and I, as his lawyer, agreed that he would plead innocent and we will fight all the charges, Vorakorn said following the arraignment in Bangkok North Criminal Court. I felt somewhat heavyhearted because the charges carry the death penalty.

The last execution in Thailand for any crime was in 2009.

Xaysana was arrested Jan. 19 at Bangkok's Suvahnbhumi Airport following a five-year investigation and a tip from Laos officials, according to Lt. Gen. Sommai Kongvisaisuk, who heads the Thai police's Narcotics Suppression Bureau.

A Malaysian suspect who was arrested by police in Malaysia in February, Kamarudin Bin Awang, was a trade partner of Xaysana, Thailand's counter-narcotics chief said back then, Sommai said at the time.

Assets seized

Xaysana led a flamboyant lifestyle prior to his arrest, hanging out with Thai celebrities and a soap opera star, according to reports. Lao authorities seized his assets including nine luxury vehicles, five houses and a 475-acre rubber plantation.

Following his January arrest, Sommaly Thammavong, the daughter-in-law of former Lao Prime Minister Thongsing Thammavong distanced herself from rumored ties, saying that a photo showing her and Thammavong's son with Xaysana was taken by accident.

The photo that circulated widely on Facebook shows only a casual social connection among the three, Sommaly Thammavong said at the time.

We have not done any business with him, and we didn't know what he was involved in, she said.

Arrest details

The Golden Triangle which straddles Thailand, Laos and Myanmar, was notorious for opium and heroin, but recently methamphetamine overtook production in the region, mostly in Myanmar and to a lesser degree in Laos. Police officials allege that Xaysana himself distributed the drug in Thailand and had a network of dealers peddling yaba in other countries.

Thai police in 2016 captured four members of Xaysana's alleged drug network, seizing more than 5 million yaba pills, officials told reporters on Jan. 20, the day after they captured the alleged kingpin. Police arrested Xaysana and three associates after they arrived in Bangkok following a visit to the southern Thai resort town of Phuket.

During that press conference, Sommai thanked Lao law-enforcement authorities for providing information that helped lead to the arrest.

Lao authorities said to us that if we couldn't arrest him here, they wouldn't be able to do anything in Laos, Sommai said.

Xaysana has enormous assets in Laos, he said, adding, I don't know what's going on over there.

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