RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines
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.
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.
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.
Senior VP Business Development & Licensing
IR contact (U.S.):
Senior Vice President
The Trout Group
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
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
Ondot’s Mobile Card Controls Provide Protection to Thousands of Banks from ATM Heist Threat17.8.2018 22:47 | Pressemelding
-Card controls counter threat of FBI’s warning on unlimited ATM cash out crime - Santa Clara, Calif., Aug. 17, 2018 (GLOBE NEWSWIRE) -- US mainstream media is reporting on a FBI warning to banks of an impending cybercrime wave targeting ATMs in which thieves seek to steal millions of dollars by using cloned cards for fraudulent withdrawals. Ondot, the global leader in mobile payments services, provides consumers a simple protection with mobile-based card controls that can restrict ATM transactions without completely shutting off the card for legitimate needs. Ondot’s mobile controls can give consumers the ability to restrict transactions specifically for ATMs while leaving their cards active for in-person purchases, eCommerce, and other purchases. By locking the account’s use at an ATM, consumers can work with their financial institution to ensure other security best practices are in place while knowing that even a spoofed card will be unable to withdraw cash. If emergency cash is need
SEMAFO: Armed Incident in Bobo Area17.8.2018 15:48 | Pressemelding
MONTREAL, Aug. 17, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) regrets to report that a bus transporting employees from the town of Bobo-Dioulasso to the Mana Mine in Burkina Faso was shot at by armed bandits this morning. In the exchange of fire between the policemen and bandits, one SEMAFO national employee and one sub-contractor employee lost their lives. Operations at the Mana Mine, located 80 kilometers from the incident, are not affected. Early analysis suggests that this incident and the armed incident that occurred in the Est region six days ago are unrelated. However, the Corporation will be increasing its security measures at Mana and take appropriate steps to ensure the safety of the mine and of its employees. The Corporation would like to express its sincere sympathy to families of the victims. About SEMAFO SEMAFO is a Canadian-based mining company with gold production and exploration activities in West Africa. The Corporation operates the Mana Mine in Burkina
ThalesNano Energy Introduces H-Genie™: Revolutionary Compact, High Pressure Hydrogen Gas Generation Platform for Chemists17.8.2018 11:00 | Pressemelding
Improves safety, expands chemistry, saves lives. BUDAPEST, Hungary and BOSTON, Aug. 17, 2018 (GLOBE NEWSWIRE) -- ThalesNano Energy LLC today announced, at the 256th ACS conference (booth: 1615), the launch of the first in the series of revolutionary new gas generators, the H-Genie™. The H-Genie™ is a compact high pressure hydrogen generator designed to be used in any laboratory as a safer and simpler alternative to hydrogen cylinders. Capable of generating hydrogen at up to 1 NL/min and 100 bar (1450 psi), the system can help expand chemists’ limited hydrogenation chemistry capability by providing high purity hydrogen gas, on demand from water, to batch and flow reactors. Neal Langerman, Principal Scientist at Advanced Chemical Safety, comments: “The presence of cylinders of hydrogen raises the risk level of a lab. While the explosion or fire hazard can be mitigated with a gas cylinder cabinet, this takes precious floor space and does not eliminate the 1300 liters of flammable gas from
PayByPhone Supports Additional Languages16.8.2018 19:47 | Pressemelding
Drivers can now use the app in Spanish and Chinese VANCOUVER, British Columbia, Aug. 16, 2018 (GLOBE NEWSWIRE) -- Drivers who pay for their parking with the PayByPhone app can now use the app in Spanish, Traditional Chinese, and Simplified Chinese. Later this year, the leading mobile parking payment service will also be available in Punjabi. The support of multiple languages increases PayByPhone’s usability for its diverse consumer base, who are located across North America, Europe, and Australia. To gain access to the newly supported languages within PayByPhone, drivers can simply download the latest version of the app and set their iOS or Android device to their preferred language. “We’re excited to have expanded our language offerings beyond English and French,” said Barrie Arnold, Chief Commercial Officer, PayByPhone North America. “PayByPhone is available in many multicultural cities worldwide, and this update improves the app’s accessibility. PayByPhone has gained a global presen
Global Dairy Platform Announces Dairy Farmers of America CEO Rick Smith as New Board Chair16.8.2018 17:52 | Pressemelding
ROSEMONT, Ill., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Global Dairy Platform (GDP), a pre-competitive collaboration of dairy sector organizations focused on encouraging the appropriate intake of nutrient-rich dairy foods and demonstrating the sector’s role in sustainable agriculture, today announced the appointment of Rick Smith, President and Chief Executive Officer of Dairy Farmers of America as Chair of the Board of Directors. “It is truly an honor to serve as Chair of GDP’s Board of Directors,” noted Mr. Smith. “We are facing global food and health challenges that need short and long-term solutions. The work of GDP creates an avenue for collaborative action that demonstrates dairy’s valuable contribution to global food systems, healthy diets and sustainable livelihoods.” Mr. Smith will serve on the board along with Fonterra Co-operative Group Chief Executive Officer Mr. Miles Hurrell; China Mengniu Dairy Company Executive Director and Chief Executive Officer Mr. Minfang (Jeffery) Lu; Ro
GridGain Systems Named to Inc. 500 List of America’s Fastest-Growing Private Companies for Second Consecutive Year16.8.2018 09:00 | Pressemelding
GridGain Ranks 17th among Software Companies, 13th in San Francisco Metro Area FOSTER CITY, Calif., Aug. 16, 2018 (GLOBE NEWSWIRE) -- GridGain Systems, provider of enterprise-grade in-memory computing solutions based on Apache® Ignite™, today announced it has been named to the 37th annual Inc. 500 list, a highly regarded ranking of the nation’s fastest-growing private companies. This is the second year in a row GridGain has been named to the list. GridGain’s rank of 158 on this year’s Inc. 500 list is up from number 187 last year. The company is ranked 17th among software companies, 13th in the San Francisco metro area, and 37th in the state of California. The Inc. 500 represents a unique look at the most successful companies within the American economy’s most dynamic segment – its independent small and midsized businesses. GridGain provides an in-memory computing platform that delivers speed, scale and high availability to data-intensive applications. Built on a memory-centric archite
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom