Healthcare Industry News: S.A.
News Release - April 13, 2017
RedHill Biopharma and IntelGenx Announce Marketing Approval of RIZAPORT(R) for Migraines in Luxembourg
The national marketing approval in Luxembourg completes the current approval process of RIZAPORT® under the European Decentralized Procedure (DCP); RIZAPORT® iS.A.so approved for marketing in Germany and a national Marketing Authorization Application (MAA) has been submitted in S.A.nRIZAPORT® iS.A.proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines
Commercialization agreements for RIZAPORT® were signed with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for S.A.n and Pharmatronic Co. for South Korea
RedHill and IntelGenx currently expect to re-submit the RIZAPORT® 505(b)(2) U.S. New Drug Application (NDA) to the FDA in the third quarter of 2017
TEL-AVIV, IS.A.l, April 13, 2017 -- (Healthcare Sales & Marketing Network) -- RedHill Biopharma Ltd. (NAS.A.:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-S.A.e, proprietary, orally-administered, S.A.l molecule drugs for gastrointestinal and inflammatory diS.A.eS.A.d 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™ technology platform, today announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT® (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.
The national marketing authorization was granted in Luxembourg on the basis of the European Decentralized Procedure (DCP), in which Luxembourg served as the Concerned Member S.A.e. The approval in Luxembourg marks the completion of the current marketing approval process for RIZAPORT® under the European DCP. This process requires marketing approval in at least two European S.A.es, a Reference Member S.A.e and a Concerned Member S.A.e1. RIZAPORT® (5 mg and 10 mg) was previously approved for marketing in Germany, which served as the Reference Member S.A.e. 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.
RIZAPORT® offerS.A. innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nauS.A. due to its convenient dosing, facile intake due to the lack of need for water and pleasant flavor.
A first commercialization agreement for RIZAPORT® was signed with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for S.A.n and, subsequently, a national Marketing Authorization Application (MAA) for RIZAPORT® was submitted by Grupo JUSTE.
A second commercialization agreement for RIZAPORT® was recently signed with Pharmatronic Co. for South Korea.
RedHill and IntelGenx expect to re-submit the RIZAPORT® 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2017. The companieS.A.e continuing discussions with additional potential commercialization partners for RIZAPORT® in the United S.A.es., Europe and other territories.
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.A.so filed with the U.S. FDA in 2013 and a Complete Response Letter was received in 2014. RedHill has entered into licensing agreements to commercialize RIZAPORT® in S.A.n (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™ technology. It dissolves rapidly and releases itS.A.tive ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract. The administration method of the RIZAPORT® oral thin film, which does not require the patient to S.A.low 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 nauS.A. estimated to be approximately 80% of the total migraine patient population2 and patients suffering from dysphagia (difficulty S.A.lowing).
About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NAS.A.:RDHL) (Tel-Aviv Stock Exchange:RDHL) iS.A.specialty biopharmaceutical company headquartered in IS.A.l, primarily focused on the development and commercialization of late clinical-S.A.e, proprietary, orally-administered, S.A.l molecule drugs for the treatment of gastrointestinal and inflammatory diS.A.eS.A.d cancer. RedHill haS.A.U.S. co-promotion agreement with Concordia for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS.A.d acute enterocolitis, as well aS.A. 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-S.A.e 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 diS.A.e with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosiS.A.d QIDP S.A.us 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.A.d gastritiS.A.d 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-S.A.e, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-S.A.e first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumorS.A.d (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 Germany in October 2015. More information about the Company iS.A.ailable at: www.redhillbio.com.
About IntelGenx
IntelGenx iS.A.leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform. ES.A.lished in 2003, the Montreal-based company’s common S.A.eS.A.e listed on the TSX-V and OTCQX.
IntelGenx’ highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’ S.A.e-of-the art manufacturing facility, eS.A.lished for the VersaFilm™ technology platform, supports lab-S.A.e to pilot and commercial-S.A.e production, offering full service capabilities to its clients. More information iS.A.ailable about the company at: www.intelgenx.com.
1 European Commission Health and Food Safety Directorate-General, Volume 2A, Procedures for marketing authorization, Chapter 2.
2 Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013) Frequency and burden of headache-related nauS.A. results from the American Migraine Prevalence and Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.
This press release contains “forward-looking S.A.ements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such S.A.ements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking S.A.ementS.A.e based on certain assumptionS.A.d are subject to various known and unknown riskS.A.d 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 S.A.ements. Such riskS.A.d uncertainties include, without limitation, riskS.A.d uncertaintieS.A.sociated with (i) the initiation, timing, progresS.A.d results of the Company’s reS.A.ch, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’S.A.ility 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.A.d feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’S.A.ility to successfully market Donnatal® and EnteraGam®, (vi) the Company’S.A.ility to eS.A.lish and maintain corporate collaborations; (vii) the Company'S.A.ility to acquire productS.A.proved for marketing in the U.S. that achieve commercial succesS.A.d build its own marketing and commercialization capabilities; (viii) the interpretation of the propertieS.A.d characteristics of the Company’s therapeutic candidateS.A.d of the results obtained with its therapeutic candidates in reS.A.ch, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its businesS.A.d therapeutic candidates; (x) the scope of protection the Company iS.A.le to eS.A.lish and maintain for intellectual property rights covering its therapeutic candidateS.A.d itS.A.ility 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.A.d the Company’s needs for additional financing; (xiii) competitive companieS.A.d technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking S.A.ements is set forth in the Company's filings with the SecuritieS.A.d Exchange Commission (SEC), including the Company'S.A.nual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking S.A.ements 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 S.A.ement unless required by law.
Source: RedHill Biopharma
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