NASDAQ OMX

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

18.4.2017 14:00 | NASDAQ OMX

Dela
  • 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
adi@redhillbio.com

IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: RedHill Biopharma Ltd. via Globenewswire

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.

Senaste pressmeddelandena från NASDAQ OMX

Promethean Opens New Global Headquarters in Seattle18.8.2017 18:38Pressmeddelande

Seattle, Wash., Aug. 18, 2017 (GLOBE NEWSWIRE) -- PrometheanTM, a global education technology company, announced today the opening of its new global headquarters in Seattle, Wash. Promethean's office in Atlanta, Ga. will continue to serve as the hub for the Americas markets, and the Blackburn, U.K. office will continue to carry on as the hub for the EMEA markets and parts of Asia.  Promethean is one of the leading brands in the international education technology market with more than 20 years of experience in the K-12 classroom. Its solutions are in more than 50,000 schools and institutions in 154 countries. "As traditional pedagogy continues to move towards immersive learning, it's important for Promethean to lead innovation in education with the latest technology," said Vin Riera, CEO of Promethean. "Seattle is a global technology hub, and establishing Promethean's global headquarters there increases opportunities for new business models, concepts

Hminers Disrupts the Cryptocurrency Market with Powerful, Multi-Algorithm Mining Rigs18.8.2017 11:00Pressmeddelande

Hminers continues to hit the headlines in the rapidly expanding global market for cryptocurrency. The Miami-based company has recently introduced three extremely powerful, multi-algorithm mining rigs that have been designed to provide maximum hash rate with minimum power consumption. MIAMI, Aug. 18, 2017 (GLOBE NEWSWIRE) -- In their relentless efforts to deliver state-of-the-art products related to cryptocurrency, Hminers has recently launched three brilliantly designed bitcoin mining rigs. The unique features and capabilities of the company's new H2U Miner, H4U Miner, and Rack Equipped with 5 x H4U have already grabbed the attention of the cryptocurrency enthusiasts and experts around the world. An organization with a rich tradition, Hminers (www.hminers.com) is recognized in the industry as the creator of the first ever 10 nm ASIC Chip in the world. Cryptocurrency mining is the process of generating new cryptocurrency that requires a pot

Nasdaq Welcomes I-AM Capital Acquisition Company (Nasdaq: IAMXU) to The Nasdaq Stock Market17.8.2017 18:50Pressmeddelande

NEW YORK, Aug. 17, 2017 (GLOBE NEWSWIRE) -- I-AM Capital Acquisition Company (Nasdaq:IAMXU), a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses, celebrated its initial public offering (IPO) on The Nasdaq Stock Market.  I-AM Capital's founders, Chief Executive Officer F. Jacob Cherian and Chief Financial Officer Suhel Kanuga, have been focused on investing into India over the last decade, with the distinction of completing the first listed-SPAC investment in India. "Through our keen focus and unique accomplishments in India over the last decade, we have seen our investment thesis bear fruit: India's prominence and rise on the world stage, its distinction as being one of the fastest growing major economies of the world, and its strong vibrant consumer demographics. We believe these factors are aligning well now,

Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency17.8.2017 14:30Pressmeddelande

WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug- resistant (MDR) infections, today announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit. "The MAA filing represents a significant milestone for Tetraphase as it is our

RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules17.8.2017 13:00Pressmeddelande

RedHill was granted the exclusive rights to promote Esomeprazole Strontium Delayed-Release (DR) Capsules to gastroenterologists in certain U.S. territories Esomeprazole Strontium DR Capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor (PPI), indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions   RedHill expects to initiate the U.S. promotion of Esomeprazole Strontium  DR Capsules 49.3 mg  in the coming weeks   Esomeprazole Strontium  DR Capsules 49.3 mg  will be the third commercial GI product to be promoted by RedHill in the U.S.    RedHill's GI-focused sales force currently promotes two GI s

Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40Pressmeddelande

Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum