Rizafilm (rizatriptan oral film) / IntelGenx, Gensco Lab, Orivas, Insud Pharma - LARVOL DELTA

Gensco Pharma Acquires Global Rights and IP for RizaFilm and RizaPort (PRNewswire) - "Gensco Laboratories LLC d/b/a Gensco Pharma...proudly announces the acquisition of the global rights and intellectual property for the first and only rizatriptan Oral Dissolvable Film (ODF), which was co-developed under the trade names RizaFilm in the U.S. and both RizaFilm and RizaPort globally...With this acquisition, Gensco Pharma is advancing its strategic initiatives by bringing innovative migraine treatment solutions to patients worldwide....With the FDA and EMA approvals already secured, the Company is ramping up manufacturing and actively preparing for a U.S. launch of RizaFilm in Q4 2025."

Commercial • Launch US • Migraine • Pain

Gensco Pharma Announces RizaFilm Commercialization Update in the United States (PRNewswire) - "Gensco® Pharma...in partnership with IntelGenx is announcing the anticipated launch of RizaFilm® for Q1-2024. RizaFilm® is based on IntelGenx's proprietary VersaFilm® technology and is patent protected until 2034. As the NDA holder, Gensco® will begin commercialization of the 10mg Film and will continue to fund the expanded indications for the 5mg Pediatric dose.... A patient survey indicated that 69% of respondents said they would discuss switching their current migraine therapy to RizaFilm® with their doctor. Patients are encouraged to discuss the benefits of switching to RizaFilm® with their healthcare provider."

Clinical • Commercial • Launch US • CNS Disorders • Migraine • Pain

IntelGenx Provides RIZAFILM U.S. Commercialization Update (GlobeNewswire) - "IntelGenx Corp...today announced that it has received the first purchase order ('PO') for RIZAFILM from its commercial partner in the United States, Gensco Pharma ('Gensco®'). The PO triggers an upfront order deposit payment. A pre-specified milestone payment to IntelGenx from Gensco® is also payable upon transfer of NDA. Both payments will be reflected in the Company’s Q3-2023 financial results. IntelGenx expects to ship the ordered RIZAFILM® product to Gensco® in Q1-2024 for immediate launch."

Commercial • CNS Disorders • Migraine • Pain

IntelGenx Announces FDA Approval of RIZAFILM for the Treatment of Acute Migraine (GlobeNewswire) - "IntelGenx Corp...announced that the U.S. Food and Drug Administration ('FDA') has approved the Company’s RIZAFILM® VersaFilm® 505(b)(2) new drug application (NDA) for the treatment of acute migraine."

NDA • CNS Disorders • Migraine • Pain

"IntelGenx Announces FDA Approval of RIZAFILM® for the Treatment of Acute Migraine @BioStocks" (@UncoverMalawi)

FDA event • CNS Disorders • Migraine

IntelGenx and Arwan Enter into a Supply Agreement for RIZAPORT in MENA Countries (GlobeNewswire) - "IntelGenx Corp...announced today that it has entered into an exclusive supply agreement (the 'Agreement') for RIZAPORT®...with ARWAN Pharmaceuticals Industries Lebanon s.a.l. ('ARWAN') in various countries in the Middle East and North Africa ('MENA') region, including Lebanon, Kuwait, Saudi Arabia, United Arab Emirates, Jordan, Iraq, , Libya, Oman, Yemen, Qatar, Bahrain, Egypt, Sudan, Kenya, Nigeria, Mauritius, Cameroon, Afghanistan, Tajikistan, Kazakhstan, Turkmenistan, and Uzbekistan (the 'Territory')....Under the terms of the Agreement, IntelGenx will supply the Product to ARWAN, which will have the exclusive right to register and commercialize it in the Territory."

Licensing / partnership • CNS Disorders • Migraine • Pain

IntelGenx Receives FDA PDUFA Date for RIZAFILM (GlobeNewswire) - "IntelGenx Corp...announced that the U.S. Food and Drug Administration ('FDA') has accepted for review its Class 2 response to the 2020 Complete Response Letter for its 505(b)(2) New Drug Application ('NDA') for RIZAFILM® VersaFilm®. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the review of the RIZAFILM® NDA."

PDUFA date • CNS Disorders • Migraine • Pain

IntelGenx Submits Response to CRL from FDA for RIZAPORT VersaFilm (GlobeNewswire) - "IntelGenx...today announced that it has responded to the Complete Response Letter ('CRL') for its 505(b)(2) New Drug Application (NDA) for RIZAPORT® VersaFilm® received from the U.S. Food and Drug Administration ('FDA') in March 2020. 'We have been encouraged by our interactions with the FDA and are pleased to submit our response to the CRL,'..."

FDA event • CNS Disorders • Migraine • Pain

IntelGenx Announces Market Launch of RIZAPORT in Spain (GlobeNewswire) - "IntelGenx Corp...announced that Exeltis Healthcare S.L...its commercialization partner in the European Union ('EU') for RIZAPORT®, a unique for the treatment of acute migraines, has launched the product in Spain."

Launch Europe • CNS Disorders • Migraine

"$IGXT IntelGenx Announces Market Launch of RIZAPORT® in Spain https://t.co/1saG98qpsS" (@otcdynamics)

IntelGenx and Exeltis Healthcare S.L. Expand RIZAPORT Commercialization Agreement to Include the European Union (GlobeNewswire) - "IntelGenx Corp....today announced that it has granted Exeltis Healthcare, S.L. ('Exeltis') an exclusive license to manufacture and commercialize RIZAPORT®, a unique oral thin film for the treatment of acute migraines, in the European Union....Exeltis will pay IntelGenx prespecified royalties on net RIZAPORT® sales in the EU. In addition, IntelGenx has a right of first refusal to manufacture the Product for the EU market....'We are looking forward to continued collaboration with IntelGenx, and to launching RIZAPORT® in at least one major market early next year.'"

Launch Europe • Licensing / partnership • CNS Disorders • Migraine • Pain

IntelGenx provides update on Rizaport VersaFilm NDA resubmission process following type A meeting with the FDA (GlobeNewswire) - "At the meeting, IntelGenx obtained clarity from the Agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA....'We are looking forward to completing the work required to resubmit our RIZAPORT® VersaFilm® NDA and remain committed to making this innovative new oral film product available to people suffering from migraines.'"

FDA event • CNS Disorders • Migraine • Pain

IntelGenx Confirms Type A Meeting with the FDA Regarding Rizaport VersaFilm (GlobeNewswire, IntelGenx Corp.) - "IntelGenx Corp....today announced that the U.S. Food & Drug Administration (FDA) has granted the Company’s request for a Type A meeting related to its RIZAPORT® VersaFilm® program. This meeting has been scheduled for June 10, 2020....Dr. Horst G. Zerbe, CEO of IntelGenx, said, 'We are looking forward to meeting with the FDA to obtain clarification on its concerns regarding our resubmitted RIZAPORT® VersaFilm® NDA, so we can provide them with the additional information they require and determine the remaining steps required to obtain approval.'"

FDA event • CNS Disorders • Migraine • Pain

RedHill Biopharma and IntelGenx submit response to FDA CRL for RHB-103 migraine oral-film (The Wall Street Journal) - "RedHill Biopharma...announced, together with IntelGenx Corp....that they submitted a response to the Complete Response Letter ("CRL") of the U.S. Food and Drug Administration ("FDA") for the New Drug Application ("NDA") for RHB-103, an oral thin-film rizatriptan for the treatment of acute migraines."

FDA event • Migraine

RedHill Biopharma provides update on development pipeline and expected timing for RHB-105 phase III top-line results (GlobeNewswire) - "RIZAPORT™ (RHB-103) - for acute migraines: Regulatory feedback regarding the MAA submitted in October 2014 is expected either in the fourth quarter of 2015 or the first quarter of 2016...The existing source of raw material for RIZAPORT™ has been successfully audited in recent months by non-U.S. regulatory agencies, as well as an independent auditor on behalf of RedHill, and is currently awaiting another FDA inspection, after which, and subject to a successful audit, a new FDA PDUFA date is expected"

Anticipated EU regulatory • Anticipated PDUFA date • Migraine

IntelGenx announces USPTO has granted patent protecting Rizaport oral film for migraines (MarketWired) - "IntelGenx...announced the USPTO...has granted a patent protecting Rizaport™, an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines....The patent application, entitled 'Instantly Wettable Oral Film Dosage Form Without Surfactant or Polyalcohol' covers rapidly disintegrating film oral dosage forms and is expected to be valid until 2034 once granted."

Patent • Migraine

RedHill Biopharma announces closing of public offering of its American Depository Shares (Nasdaq) - "RedHill Biopharma...is today announcing the closing of its previously announced underwritten public offering of 2,462,000 American Depository Shares ('ADSs'), each representing 10 of its ordinary shares, at an offering price of $16.25 per ADS ('Offering Price'). RedHill has also granted the underwriters a 30-day option to purchase up to 369,300 additional ADSs, at the Offering Price, to cover over-allotments, if any."

Stock price • Migraine

RedHill Biopharma reports results for the third quarter of 2013 (RedHill Press Release) - "Net Cash Used from Investment Activities for the quarter ended September 30, 2013 was  approximately $0.2 million...The decrease was mainly due to a $0.2 million development milestone payment for RHB-103 in the  quarter ended September 30, 2013....Mr. Shilo added: "Looking ahead, we are excited by the prospective milestones for 2014, including the PDUFA date for our migraine drug RHB-103, expected in February 3, 2013(sic)."

Commercial • PDUFA date • Migraine

IntelGenx Announces Adjusted VersaFilm Business Strategy, Next Steps for RIZAPORT VersaFilm Program (GlobeNewswire, IntelGenx Corp.) - "'The decision by the FDA to issue a CRL for our RIZAPORT® NDA significantly reduces our internal revenue expectations for 2020'....Board and Management of the Company have decided to launch an aggressive performance improvement program that focusses on...undertaking steps to accelerate the launch of RIZAPORT® in Spain and, subsequently, in other European countries....IntelGenx plans to request a meeting with the FDA to discuss the CRL comments....It is now, together with Exeltis Healthcare, in advanced discussions with the originally listed contract manufacturing organization, which the Spanish marketing authorization lists as the approved manufacturer of the product, to leave the commercial production at its site."

Commercial • FDA event • Launch Europe

IntelGenx reports fourth quarter and full-year 2019 financial results (Market Screener) - "Received a No Objection Letter from Health Canada in response to IntelGenx’s amended Clinical Trial Application for the ongoing Montelukast VersaFilm® Phase 2a ('BUENA') clinical trial in patients with mild to moderate Alzheimer’s Disease; Signed a binding term sheet with Orivas for the commercialization of RIZAPORT® pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT® in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or the Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway)."

Canadian regulatory • Commercial

Intelgenx to report fourth quarter and full-year 2019 financial results on March 26; Conference call to follow on March 27 (GlobeNewswire, IntelGenx Corp.) - "As previously announced, the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020 for completion of its review of IntelGenx’s 505(b)(2) New Drug Application ('NDA') for RIZAPORT® VersaFilm® for the treatment of acute migraines. In order to facilitate a discussion on both the financial results and the FDA’s anticipated decision on the RIZAPORT® NDA, a conference call has been scheduled for Friday, March 27."

PDUFA date

IntelGenx Receives Complete Response Letter from FDA for RIZAPORT® NDA (GlobeNewswire, IntelGenx Corp.) - "IntelGenx Technologies Corp....today announced that it has received a Complete Response Letter ('CRL') from the U.S. Food and Drug Administration ('FDA') regarding its resubmitted 505(b)(2) New Drug Application ('NDA') for RIZAPORT® VersaFilm® for the treatment of acute migraines. The CRL states that the FDA cannot approve the application in its present form. The Agency requested additional information, but no new bioequivalence study."

FDA event

IntelGenx provides commercial update on its two lead VersaFilm product candidates, cannabis-infused oral film and Rizaport (Yahoo Finance) - "IntelGenx also announced the signing of a binding term sheet with Orivas for the commercialization of RIZAPORT...pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT® in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or Republic of Ukraine, as well as any of the Scandinavian countries...IntelGenx Continues to Make Preparations Ahead of RIZAPORT® PDUFA Goal Date of March 26, 2020."

Licensing / partnership • PDUFA date

IntelGenx reports third quarter 2019 financial results (GlobeNewswire) - "IntelGenx Technologies Corp....today reported financial results for the third quarter ended September 30, 2019....Announced that its 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm® for the treatment of acute migraines was accepted for review by the U.S. Food and Drug Administration (“FDA”) and that the FDA assigned a March 26, 2020, Prescription Drug User Fee Act (“PDUFA”) goal date for completion of the review."

NDA • PDUFA date

"$IGXT Announces FDA’s Acceptance of Resubmitted RIZAPORT NDA. PDUFA 03/26/20" (@BioStocks)

NDA • PDUFA date