NASDAQ OMX

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

Dela
  • 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 OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

LeoVegas applies for gambling licence in Sweden20.8.2018 12:05Pressmeddelande

On January 1, 2019, Sweden becomes a licensed gaming market and LeoVegas has now submitted its application to obtain a licence for casino and sports betting. This is in line with LeoVegas' expansion strategy and is one of the steps towards achieving the financial targets for the year 2020, which are to reach at least EUR 600 m in revenue and EBITDA of at least EUR 100 m. "While it has been known for some time that Sweden is introducing a local licence system, it is very exciting to formally submit an application and is something we have been looking forward to for a long time. Sweden's becoming a locally regulated market is a milestone for Sweden, the industry and LeoVegas. Now, for the first time, everyone can compete on equal terms in a regulated environment, where responsible gaming is a very important part. We believe we have great opportunities to continue gaining market shares in the Swedish market. LeoVegas is a company that operates on several regulated markets and thus has the

LeoVegas ansöker om spellicens i Sverige20.8.2018 12:05Pressmeddelande

Den 1:a Januari 2019 blir Sverige en licensierad spelmarknad och LeoVegas har nu lämnat in sin licensansökan för casino och sportspel. Detta ligger i linje med LeoVegas expansionsstrategi och är ett av stegen för att uppnå de finansiella målen år 2020 om minst 600 MEUR i intäkter och minst 100 MEUR i EBITDA. "Att Sverige inför ett lokalt licenssystem har varit känt en längre tid men att formellt lämna in ansökan känns oerhört bra och någonting vi sett fram emot länge. Att Sverige äntligen blir en reglerad marknad är en milstolpe för Sverige, branschen och LeoVegas. Nu kan alla för första gången konkurrera på lika villkor i en reglerad miljö, där ansvarsfullt spelande är en väldigt viktig del. Vi anser oss ha stora möjligheter att fortsätta ta marknadsandelar på den svenska marknaden. LeoVegas är ett bolag som opererar på flera reglerade marknader och har därmed de rätta verktygen och kunskapen för att skapa en hållbar och stark tillväxt.", säger Gustaf Hagman, Group CEO. Reglerade mark

Stillfront Group AB: Stillfront Group rekryterar IR- och kommunikationschef20.8.2018 08:30Pressmeddelande

PRESSMEDDELANDE 2018-08-20 Stillfront Group rekryterar IR- och kommunikationschef Sofia Wretman har utsetts till IR- och kommunikationschef för Stillfront Group och kommer att ingå i koncernledningen. Befattningen är ny och omfattar intern och extern kommunikation samt investor relations. Sofia Wretman har mer än 15 års erfarenhet av att arbeta strategiskt med kommunikations- och IR-frågor inom olika branscher. Tidigare positioner inkluderar bland annat IR- och kommunikationschef på Alimak Group, seniorkonsult på Hallvarsson & Halvarsson och kommunikationsansvarig på SAS Institute. "Vi är glada att välkomna Sofia till Stillfronts ledning. Sofia blir ansvarig för koncernens kommunikation, internt och externt samt investor relations. Rekryteringen av Sofia och tillsättningen av denna tjänst, som är ny, är ett led i bolagets planerade listbyte till Nasdaq Stockholms huvudlista. Denna satsning är också viktig då gruppen sedan noteringen på First North 2015 har vuxit med flera stora förvärv

Stillfront Group AB: Stillfront Group announces Head of IR & Communications20.8.2018 08:30Pressmeddelande

PRESS RELEASE 2018-08-20 Stillfront Group announces Head of IR & Communications Sofia Wretman has been appointed as Head of IR & Communications and will be part of the Group's management team. The position is new and covers both internal and external communications as well as investor relations. Sofia Wretman has more than fifteen years of experience of strategic communication and investor relations from a range of industries. Former positions include Head of IR & Communications at Alimak Group, Senior Consultant at Hallvarsson & Halvarsson and Communications manager at SAS Institute. "We are pleased to welcome Sofia as member of the management team. Sofia will be responsible for internal and external communications as well as investor relations. The recruitment of Sofia and the appointment of this new role is part of the Group's planned move to the main market of Nasdaq Stockholm. The recruitment is also important as the Group since its listing at First North in 2015, has grown rapidl

BIMobject AB: Kallelse till extra bolagsstämma den 5 september 2018. Patrick Söderlund och Hjalmar Winbladh föreslås som nya styrelseledamöter i BIMobject AB. Split 2:1 föreslås.15.8.2018 15:30Pressmeddelande

Aktieägare representerande cirka 49 procent av rösterna i BIMobject AB har meddelat att de föreslår att Hjalmar Winbladh och Patrick Söderlund väljs till nya styrelseledamöter vid en extra bolagsstämma onsdagen den 5 september 2018. Ben O'Donnell lämnar sitt uppdrag som styrelseledamot i samband med den extra bolagsstämman. Styrelsen kommer därefter att bestå av Stefan Larsson (VD), Anders Wilhjelm (ordförande), Johannes Reischböck, Philippe Butty, Hjalmar Winbladh och Patrick Söderlund. Vidare föreslås ändrad ersättning till styrelsen. Nytt arvode utgår med 800 000 kronor, fördelat mellan styrelseordförande och Söderlund om 400 000 kronor vardera. Styrelsen föreslår även att stämman beslutar om aktieuppdelning av befintliga utestående aktier i förhållande 2:1. Patrick Söderlund, född 1973 och svensk medborgare, är Chief Design Officer samt Executive Vice President på Electronic Arts. I denna roll leder han utvecklingen av bolagets tekniska innovationer och bolagets marknadsföringsteam

BIMobject AB: Notice to attend Extraordinary General Meeting on September 5, 2018. Patrick Söderlund and Hjalmar Winbladh proposed as new Board Members in BIMobject AB. A split 2:1 is proposed.15.8.2018 15:30Pressmeddelande

Shareholders representing approximately 49 percent of the votes in BIMobject AB have announced that they propose that Hjalmar Winbladh and Patrick Söderlund are appointed new Board Members at an Extraordinary General Meeting to be held on Wednesday September 5, 2018. Ben O'Donnell resigns as Board Member in connection with the Extraordinary General Meeting. The Board will thereafter be composed of Stefan Larsson (CEO), Anders Wilhjelm (Chairman), Johannes Reischböck, Philippe Butty, Hjalmar Winbladh and Patrick Söderlund. Furthermore, a change in remuneration to the Board is proposed. The new Board fee totals SEK 800,000 and is to be divided between the Chairman and Söderlund with SEK 400,000 each. The board also proposes that the General Meeting resolves to split the company's shares 2:1. Patrick Söderlund, born in 1973 and a Swedish citizen, is Chief Design Officer and Executive Vice President at Electronic Arts. In his present role he manages the development of technology innovation

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

Besök vårt pressrum