Nasdaq GlobeNewswire

RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines

Del
  • RIZAPORT® is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines
  • A Prescription Drug User Fee Act (PDUFA) date is expected to be set by the FDA for the first half of 2018, if the submission is deemed complete and permits a full review
  • RIZAPORT® (5mg and 10mg) was granted marketing authorization in Germany and Luxembourg under the European Decentralized Procedure (DCP) and a national Marketing Authorization Application (MAA) has been submitted in Spain
  • Commercialization agreements for RIZAPORT® were signed with Grupo JUSTE S.A.Q.F. for Spain and with Pharmatronic Co. for South Korea
  • RedHill and IntelGenx continue discussions with additional potential commercialization partners for RIZAPORT® in the U.S., Europe and other territories        

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 01, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm(TM) technology platform, today announced that they have resubmitted the 505(b)(2) New Drug Application (NDA) for RIZAPORT® 10mg to the U.S. Food and Drug Administration (FDA).

RIZAPORT® is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines. RIZAPORT® offers an innovative therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water, and neutral flavor.

Following a first NDA submission to the FDA in March 2013, RedHill and IntelGenx received a Complete Response Letter (CRL) from the FDA. The questions raised by the FDA, which triggered the current resubmission, primarily related to third party chemistry, manufacturing and controls (CMC) and to the packaging and labeling of the product. The FDA letter raised no questions or deficiencies relating to RIZAPORT®'s safety and bio-equivalence data and did not require additional clinical trials.

If the RIZAPORT® NDA resubmission is deemed complete and permits a full review by the FDA, a Prescription Drug User Fee Act (PDUFA) date is expected to be set by the FDA for the first half of 2018.

Reza Fathi, PhD, RedHill's Senior VP Research & Development, said: "We are very pleased with the resubmission of the U.S. NDA for RIZAPORT®, which follows the marketing authorization received for RIZAPORT® in Germany and Luxembourg under the European Decentralized Procedure. Our efforts are focused on commercializing RIZAPORT® through partners in the U.S., Europe and other territories in the near future, and we are continuing the dialogue with potential partners."

"This resubmission of the RIZAPORT® 505(b)(2) NDA is an important milestone for IntelGenx," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We look forward to continuing to work with the FDA as we seek to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."

RIZAPORT® was granted marketing authorization in Germany and in Luxembourg on the basis of the European Decentralized Procedure (DCP). A national Marketing Authorization Application (MAA) has been submitted for RIZAPORT® in Spain. Under the European DCP, marketing authorization approval of RIZAPORT® in additional European countries is subject to a separate procedure to obtain additional national marketing authorizations in each country. A first commercialization agreement for RIZAPORT®was signed with Grupo JUSTE S.A.Q.F. (now Exeltis Healthcare, S.L.) for Spain, and a second commercialization agreement for RIZAPORT® was signed with Pharmatronic Co. for South Korea.

About RIZAPORT ®  (RHB-103):    
RIZAPORT® is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. RIZAPORT® 5 mg and 10 mg were approved for marketing in Germany in October 2015 and in Luxembourg in April 2017 under the European Decentralized Procedure. A New Drug Application for RIZAPORT® was resubmitted to the U.S. FDA in October 2017. RedHill entered into licensing agreements to commercialize RIZAPORT® in Spain (with with Grupo JUSTE S.A.Q.F.) and in South Korea (with Pharmatronic Co.). Rizatriptan is considered to be one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms. RIZAPORT® is based on IntelGenx's proprietary VersaFilm (TM)technology. It dissolves rapidly and releases its active ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract. The administration method of the RIZAPORT®oral soluble film, which does not require the patient to swallow a pill or consume water, along with its pleasant flavor, presents a potentially attractive therapeutic alternative for migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population1 and patients suffering from dysphagia (difficulty swallowing)1.

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 promotes three gastrointestinal products in the U.S.: Donnatal® , a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, Esomeprazole Strontium  Delayed-Release Capsules 49.3 mg, a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions, and 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) TALICIA(TM) (RHB -105) - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory 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 a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA®  (RHB-102) - a once-daily oral pill formulation of ondansetron with successful top-line results from a Phase III study in acute gastroenteritis and gastritis and successful top-line results from a Phase II study in 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 inflammatory gastrointestinal diseases  and (vii) RIZAPORT® (RHB-103) - an oral thin-film formulation of rizatriptan for acute migraines, with a U.S. NDA resubmitted to 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.

About IntelGenx:
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical films based on its proprietary VersaFilm(TM)technology platform.

IntelGenx' highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx' state-of-the-art manufacturing facility, established for the VersaFilm(TM) technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about the company can be found at www.intelgenx.com.

1 Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.

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) the Company's Expanded Access Program, which allows patients with life-threatening diseases potential access, subject to regulatory and other approvals, to RedHill's investigational new drugs that have not yet received regulatory marketing approval, if a patient suffers an adverse experience using such investigative drug, potentially adversely affecting the clinical development program of that investigational product or the Company generally; (xiv) 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.

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 GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Virgin Pulse and RedBrick Health Joining Forces to Create World's Largest Digital Employee Wellbeing and Engagement Company21.5.2018 17:00Pressemelding

Merger Will Create First and Only One-Stop-Shop for Employee Health, Wellbeing and Benefits Engagement; Combined Company Will Have More Than 3,300 Customers Across 190 Countries PROVIDENCE, R.I., May 21, 2018 (GLOBE NEWSWIRE) -- Providence-based Virgin Pulse and Minneapolis-based RedBrick Health announced today that the industry pioneers will merge, creating the world's largest, most comprehensive digital health and engagement company. This powerful combination will deliver the industry's only fully integrated digital platform, with benefits navigation and live coaching to support global clients and members across the entire health, wellbeing and benefits lifecycle - from screening and assessment to activation, behavior change and the adoption of sustainable, healthy habits. "We are thrilled to join with RedBrick to set a new vision and standard for employee health, wellbeing and engagement," said David Osborne, Virgin Pulse CEO, who will serve as CEO of the combined company. "Bringing

Hotels.com App Wins 2018 MediaPost Appy Award in Travel & Tourism Category21.5.2018 16:00Pressemelding

Developed by EPAM, app is recognized for creativity and excellence in app design NEWTOWN, Pa., May 21, 2018 (GLOBE NEWSWIRE) -- Hotels.com® and EPAM Systems, Inc. (NYSE:EPAM) announced their triumphant win at the 2018 MediaPost Appy Awards in the Travel and Tourism category this week. The Hotels.com mobile app, developed in collaboration with EPAM Systems, Inc., a leading global provider of digital platform engineering and software development services, has been crowned the best app developed for airlines, hotels, travel search engines, destinations, cruises, travel advice or car rentals. With over 70 million downloads and a 4.5+ star rating from consumers on both iOS and Android app stores, the Hotels.com app has now been recognized by the industry leading Appy Awards, which honor creativity and excellence in app design. The app provides a simple, fast and secure way for users to plan, book and manage hotel reservations, and allows travelers to book hundreds of thousands of places to

Claroty Launches Channel Program and Announces New Industrial Cybersecurity Partnerships21.5.2018 15:00Pressemelding

Claroty Vision Program Expands Global Reach and Joint Solution Delivery with OT Leaders, Including Dimension Data/NTT Security, Optiv, and Kudelski Security NEW YORK, May 21, 2018 (GLOBE NEWSWIRE) -- Claroty, the leader in operational technology (OT) network security, today unveiled Claroty Vision, a new global channel partner program for integrated solution partners, managed service providers (MSPs), and resellers. The program is tailored to provide partners with the tools and resources they need to accelerate revenue in the fast-growing industrial cybersecurity market. The company also announced several new partnerships under the Claroty Vision banner, including the addition of Optiv and Kudelski Security. Comprised of four participation levels - Elite, Premier, Authorized, and Referral - the Claroty Vision program provides partners with a broad range of tools, benefits, and incentives such as increased margin, deal registration, an online demo environment, and co-marketing activitie

Wabtec and GE Transportation to Merge, Creating Global Leader for Rail Equipment, Services and Software21.5.2018 13:00Pressemelding

Strategic Combination Will Drive Shareholder Value Creation by Accelerating Innovation in Transportation and Logistics Following the transaction, Wabtec will have approximately $8 billion in revenues, a more diversified business mix, higher margins, and approximately 15 percent cash EPS accretion in year one. Both businesses are expected to benefit from the cyclical tailwinds they are experiencing as industry conditions improve. Complementary businesses and large global installed base will create additional opportunities for cross-selling, aftermarket services growth and new solutions in a rapidly evolving industry. GE Transportation is positioned for a substantial rebound, with estimated adjusted EBITDA growing from about $750 million in 2018 to between $900 million and $1 billion in 2019. Substantial annual run-rate synergies of $250 million and a net present value of approximately $1.1 billion of net tax benefit will accrue to the combined company. The transaction is valued at appro

Sciaky Receives Order for Multiple Electron Beam Additive Manufacturing (EBAM®) Systems to Strengthen America's Defense and Power Generation Programs21.5.2018 09:00Pressemelding

CHICAGO, May 21, 2018 (GLOBE NEWSWIRE) -- Sciaky, Inc., a subsidiary of Phillips Service Industries, Inc. (PSI) and leading provider of metal additive manufacturing (AM) solutions, announced today that it has received an order for multiple Electron Beam Additive Manufacturing (EBAM®) systems to bolster the nation's defense and power generation programs. Details of the project are confidential. "Sciaky has a long history of providing innovative solutions to America's military and power generation initiatives," said Scott Phillips, President and CEO of Sciaky, Inc. "Our EBAM process is the only industrial-grade metal 3D printing technology to produce large-scale parts for land, sea, air, and space applications." As the most widely scalable metal additive manufacturing solution in the industry (in terms of work envelope), Sciaky's EBAM systems can produce parts ranging from 8 inches (203 mm) to 19 feet (5.79 meters) in length. EBAM is also the fastest deposition process in the metal addit

INTA Selects Singapore for 142nd Annual Meeting Slated for April 202021.5.2018 02:10Pressemelding

SEATTLE, May 20, 2018 (GLOBE NEWSWIRE) -- The International Trademark Association (INTA) today announced that it will hold its 142nd Annual Meeting-the world's largest trademark event-in Singapore from April 25 to 29, 2020, at the Marina Bay Sands. This marks the second time INTA is bringing its Annual Meeting to Asia, and the first time that the organization will host the event in Southeast Asia. INTA CEO Etienne Sanz de Acedo made the highly anticipated announcement at the opening ceremonies of the Association's 140th Annual Meeting, taking place in Seattle, Washington, now through May 23. Nearly 11,000 trademark practitioners and other intellectual property (IP) professionals from 150+ countries are gathering for this event. The number of registrants has been increasing each year. In 2014, INTA held its first-ever Annual Meeting in Asia-the 136th Annual Meeting in Hong Kong SAR, China. After that successful event, INTA's Board of Directors approved a rotation strategy to host the An

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom