RedHill Biopharma and IntelGenx Announce Definitive Agreement for Commercialization of RIZAPORT™ for Migraines with Grupo JUSTE in Spain and Additional Potential Territories
RedHill and its co-development partner, IntelGenx, have signed a definitive agreement with Grupo JUSTE granting an exclusive license to commercialize their acute migraine drug RIZAPORT™ in Spain, and a right of first refusal for additional territories
Grupo JUSTE is a prominent private Spanish company with over 90 years of experience in the research, development and commercialization of proprietary pharmaceutical products, including migraine and other central nervous system (CNS) drugs in Europe, Latin America and other territories
- RIZAPORT™ was recently approved for marketing in Germany under the European Decentralized Procedure (DCP); RedHill and IntelGenx continue to work together to secure additional commercialization partners for RIZAPORT™ in the U.S., Europe and other territories
TEL-AVIV, Israel, July 05, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, together with IntelGenx Corp. (TSXV:IGX) (OTCQX:IGXT) (“IntelGenx”), a Canadian drug delivery company focused on oral drug delivery, today announced the signing of an exclusive license agreement with Grupo JUSTE S.A.Q.F (“Grupo JUSTE”), for the commercialization of RIZAPORT™ in Spain, and a right of first refusal for additional territories. RIZAPORT™ is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.
Grupo JUSTE is a prominent private Spanish company with over 90 years of experience in the research, development and commercialization of proprietary pharmaceutical products, including migraine and other central nervous system (CNS) drugs, in Europe, Latin America and other territories.
Under the terms of the agreement, RedHill granted Grupo JUSTE the exclusive rights to register and commercialize RIZAPORT™ in Spain and a right of first refusal for a predefined term for the territories of Belize, Carribean, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, the Middle East and Morocco. RedHill and IntelGenx are entitled to receive an upfront payment and additional milestone payments upon the achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. Financial terms of the agreement were not disclosed. The initial term of the agreement is for ten years from the date of the first commercial sale and shall automatically renew for an additional two-year term. Commercial launch in Spain is expected to take place in the second half of 2017.
“We are delighted to enter into this first commercialization agreement for RIZAPORT™ and look forward to building a long-term relationship with Grupo JUSTE in support of their efforts to introduce RIZAPORT™ in Spain and potentially other LATAM and Middle Eastern territories,” said Adi Frish, RedHill’s Senior VP Business Development & Licensing.“We believe that, thanks to the pleasant flavoring and convenient use of the rapidly dissolving thin-film, RIZAPORT™ could potentially become a preferred therapeutic option for migraine patients worldwide. We continue working diligently together with IntelGenx to bring this unique and advantageous drug to additional markets in the near future.”
Inés Juste, President of Grupo JUSTE, added: “We are extremely satisfied to announce the planned arrival of this new formulation of a leading treatment for migraine. Our partners, IntelGenx and RedHill possess a deep knowledge in the pharmaceutical industry including strong leadership in innovative formulations that improve the compliance and the administration pattern of gold standard drugs. This agreement should allow Grupo JUSTE to bring this new effective treatment to migraine patients in Spain and potentially some Latin American and Middle East countries and to reinforce its presence in Neurology.”
The Federal Institute for Drugs and Medical Devices of Germany (BfArM) recently granted marketing authorization for RIZAPORT™ 5 mg and 10 mg under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State for other European Union (EU) countries. This authorization was the first national marketing approval for RIZAPORT™.
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 under the European Decentralized Procedure. A New Drug Application for RIZAPORT™ was also filed with the U.S. FDA in 2013 and a CRL was received in 2014. 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. The worldwide annual sales of triptans were estimated to have exceeded $690 million in 20151. RIZAPORT™ is based on IntelGenx's proprietary VersaFilm™ 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 thin 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 population2 and patients suffering from dysphagia (difficulty swallowing).
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a 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 inflammatory and gastrointestinal diseases and cancer. RedHill’s current pipeline of proprietary products 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 and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA™ (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. 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 uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumors; (vii) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) 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; and (ix) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.
About Grupo JUSTE:
Grupo JUSTE is a Spanish corporate group with more than 90 years’ experience in research, development and distribution of drugs and active pharmaceutical ingredients. Its activity is aimed at improving the quality of life of patients, with the Central Nervous System therapies as one of its main areas of expertise since 1990 and a core strategic focus for the group.
Grupo JUSTE has two areas of activity: the Pharmaceutical Division, with broad experience in Central Nervous System, Radiology, Gynaecology and Primary Care; and Justesa Imagen, a fine-chemicals company committed to the research, development and production of active pharmaceutical ingredients, with substantial expertise in contrast media. The group has a significant presence in all the major world markets, directly or through partnerships with leading pharmaceutical companies. For more information, please visit:www.grupoJUSTE.com
IntelGenx is a leading drug delivery company focused on the development of innovative products based on its proprietary oral drug delivery technologies. Established in 2003, the Montreal-based company, listed on the TSX-V and OTC-QX, develops innovative oral drug delivery solutions based on its proprietary platform technologies, VersaFilm™, VersaTab™ and AdVersa™. IntelGenx has developed a broad and diverse product portfolio addressing unmet market needs and offering lifecycle management opportunities. Forfivo XL™, launched in 2012, is the first and only FDA approved once-daily bupropion HCl 450 mg dose in a single tablet for the treatment of major depressive disorder. IntelGenx’s highly skilled team provides comprehensive pharmaceutical services to pharmaceutical partners, including R&D, clinical monitoring, IP protection, analytical method development and regulatory services. IntelGenx’s state-of-the art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to our clients. For more information on IntelGenx, visit: www.intelgenx.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 establish and maintain corporate collaborations; (vi) 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; (vii) 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; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company's business. 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 25, 2016. 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 EvaluatePharma WW annual sales report.
2 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.
Senior VP Business Development &
IR contact (U.S.):
Senior Vice President
The Trout Group
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
Standard Lithium Announces Closing of $21.6 million Bought Deal Private Placement of Units16.2.2018 19:25 | Pressemelding
THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES. VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Standard Lithium Ltd. ("Standard Lithium" or the "Company") (TSX-V:SLL) (OTCQX:STLHF) (FRA:S5L) announced today that it has closed its previously announced bought deal private placement of 10,312,821 units of the Company (the "Units"), at a price of $2.10 per Unit, for aggregate gross proceeds to the Company of $21,656,924, including the issuance and sale of the Underwriters' (as defined below) option (the "Offering"). Each Unit consists of one common share of the Company and one-half of one common share purchase warrant (each whole common share purchase warrant, a "Warrant"). Each Warrant is exercisable to acquire one common share of the Company (a "Warrant Share") until February 16, 2020 at an exercise price of $2.60 per Warrant Share, subject to adjus
Cisco Offers Cloud-Based Endpoint Security Solutions for Managed Security Service Providers16.2.2018 14:00 | Pressemelding
Cisco's comprehensive cloud-based security endpoint portfolio provides advanced malware protection, internet security, and enterprise mobility management SAN JOSE, Calif., Feb. 16, 2018 (GLOBE NEWSWIRE) -- Cisco today is helping address the challenges of Managed Security Service Providers (MSSP) and their customers by offering MSSPs comprehensive security, visibility, and control of customer endpoints without added hardware or complexity. The Cisco endpoint security portfolio includes three industry-leading solutions-Cisco AMP for Endpoints, Cisco Umbrella, and Meraki Systems Manager to offer protection against advanced malware and threats. Security teams know the endpoints in their environments are being targeted by advanced threats, but often lack the security talent, tools, and budget to address those challenges. As a result, organizations of all sizes are choosing to augment their in-house IT security with managed security services. Nearly half of SMBs and enterprises in the US1 ar
Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family16.2.2018 14:00 | Pressemelding
Aurora Solar Technologies Inc. / Aurora Solar Adds Heterojunction Cell Characterization to Decima Gemini Family . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. NORTH VANCOUVER, British Columbia, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Aurora Solar Technologies Inc. ("Aurora") ("Company") (TSX.V:ACU) (OTCBB:AACTF) (FSE:A82) is pleased to provide an update on the further development of its Decima Gemini(TM) infrared measurement technology for applications in the rapidly developing heterojunction (HJT) cell manufacturing market. HJT is an ultra high-efficiency solar cell design pioneered by Japan's Panasonic Corp., who is now also partnered with Tesla Inc. for solar products. According to Solar Media Ltd., HJT production capacity is expected to increase by 20 percent this year. To produce the electrical structure of a HJT cell, it is necessary to apply thin layers of amorphous silicon on both sides of a crystallin
Nasdaq Cited as a Leader in Governance, Risk, and Compliance Platforms by Independent Research Firm16.2.2018 13:35 | Pressemelding
NEW YORK, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq:NDAQ) was among the select companies that Forrester invited to participate in its 2018 Forrester Wave(TM) evaluation, Governance, Risk, And Compliance (GRC) Platforms, Q1 2018. In this evaluation, Nasdaq was cited as a Leader in Governance, Risk, and Compliance Platforms and received the maximum score of 5 for the evaluation criteria "Risk & Control Management", "Audit Management", "Dashboard and Reporting" and "Integration capabilities" for its BWise solutions. "We feel the strong scores we obtained in important functional areas provide assurance to our clients that they have selected a robust and future-proof software platform," said Tom Passon, Head of Product Innovation & Global Standards, Nasdaq BWise. "We are proud of this recognition that encourages us to further execute on our strategy to provide user-friendly, pre-configured best practice solutions that combine our innovative GRC software platform with leading expertis
Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros(TM)16.2.2018 13:00 | Pressemelding
Company Evaluating Deficiencies and Potential Path Forward SAN DIEGO, Feb. 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for the New Drug Application ("NDA") of Vitaros(TM) (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control ("CMC") and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation. "We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response
SEMAFO: Positive Mana PFS and Reserve Additions at Mana and Boungou16.2.2018 03:36 | Pressemelding
5-Year Average Target of 413,000 Ounces of Annual Production, AISC $696 MONTREAL, Quebec, Feb. 15, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) today announced positive pre-feasibility study (PFS) results at Mana, the addition of 188,000 ounces of reserves, primarily at Siou underground, and an increase of 203,000 ounces of reserves at Boungou. As a result, the Corporation is providing the following consolidated five-year operational targets. Table 1 - Five-Year Operational Targets ---------------------------------------------------- 2019-2023 2019 2020 2021 2022 2023 Average ---------------------------------------------------- Production(1,2,3) Mana ('000 oz) 192 213 213 213 214 209 Boungou ('000 oz) 226 226 201 186 180 204 418 439 414 399 394 413 AISC(1,2,4,5) Mana ($/oz) 906 1,079 887 823 660 871 Boungou ($/oz) 419 405 527 606 626 516 643 733 712 721 643 696 Operating Cash Flow (at $1,300/oz) Total Revenue ($M) 543 571 539 518 512 2,683 AISC ($M) 268 321 295 287 253 1,42
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom