Chemo Research SL

SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film. The CRL includes a request for additional Pharmaceutical Quality information. The FDA confirmed that no additional inspection of IntelGenx’s facility is required at this time. “Our partner is committed to providing the FDA with a response to the CRL as soon as is practicable,” commented Dwight Gorham, IntelGenx’s CEO. Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm® technology in a novel formulation, is a generic version of Belbuca®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate. Approved by the FDA in 2015, Belbuca® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg. About IntelGenx IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm® and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit . Forward-Looking Information and Statements This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the SEC and available at , and also filed with Canadian securities regulatory authorities at . IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen Kilmer Investor Relations (647) 872-4849 stephen@kilmerlucas.com Or Andre Godin, CPA, CA President and CFO IntelGenx Corp. (514) 331-7440 ext 203 andre@intelgenx.com

SAINT LAURENT, Quebec, Nov. 09, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the third quarter ended September 30, 2023. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise. 2023 Third Quarter Financial Summary: Revenue was $318,000, compared to $142,000 in the 2022 third quarter.Net comprehensive loss was $2.5 million, compared to $3.0 million in Q3-2022.Adjusted EBITDA loss was $2.1 million, compared to $2.2 million in the 2022 third quarter. Third Quarter and Recent Developments: Received the first purchase order for RIZAFILM®1 from Gensco Pharma (Gensco®), the Company's U.S. commercialization partner, which triggered an upfront order deposit payment and a pre-specified milestone payment.Announced a further amendment to the November 2018 license, development and supply agreement with Tilray Brands Inc. ("Tilray") for the co-development and commercialization of cannabinoid-infused VersaFilm® products, and received an initial purchase order from Tilray for three SKUs (CBD20, THC10, THC10:CBD1), settling IntelGenx's arbitration claim against Tilray.Completed patient enrollment in the ongoing Phase 2a (“BUENA”) clinical trial of IntelGenx’s Montelukast VersaFilm® in patients with mild to moderate Alzheimer’s Disease (“AD”).Announced that, as part of a research collaboration with Karolinska University Hospital, Stockholm, and Per Svenningsson, MD, PhD, the manufacturing of both active and placebo films was underway for a planned clinical trial evaluating Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”).Announced that the U.S. Food and Drug Administration (“FDA” or the “Agency”) granted Xiromed LLC (“Xiromed”), the agent and affiliate of IntelGenx’s co-developer, Chemo Research SL, priority review of its amended abbreviated new drug application (ANDA) for Buprenorphine Buccal Film. Unless the Agency determines that an inspection is required, the Generic Drug User Fee Act (GDUFA) goal date is March 8, 2024.In the first major expansion of the Company’s CDMO business, entered into a binding term sheet agreement for the packaging of a pharmaceutical oral film product that its undisclosed CDMO customer is planning to commercialize in the United States.Closed the first tranche of a non-brokered private placement of units from atai Life Sciences AG (“atai”) for aggregate gross proceeds of approximately $3 million, including $750,000 to be received by the Company pursuant to a subsequent atai subscription, assuming shareholder approvals are obtained. “We have announced several positive developments over the past few months,” commented Mr. Gorham, CEO of IntelGenx. “We received from Gensco® their first RIZAFILM® purchase order, which triggered an upfront payment and a milestone payment that are both reflected in our third quarter financial results. We were also pleased with Xiromed’s successful request for the FDA’s priority review of the amended ANDA for Buprenorphine Buccal Film, and we are looking forward to the Agency’s decision. In addition, we completed patient enrollment in the ongoing Montelukast VeraFilm® Phase 2a BUENA clinical trial in AD; took another important step toward expanding our Montelukast VersaFilm® clinical program to include the treatment of PD in addition to AD; expanded our CDMO business to include oral thin film packaging services; and, earlier this week, settled our arbitration claim against Tilray, allowing the two companies to begin a new chapter of making innovative cannabinoid-infused VersaFilm® products available to consumers.” 1. RIZAFILM® (U.S. market name for RIZAPORT®) is a Registered Trademark of Gensco® Pharma Corporation Financial Results: Total revenues for the three-month period ended September 30, 2023 amounted to $318,000, an increase of 124% compared to $142,000 for the three-month period ended September 30, 2022. The change is mainly attributable to increases in R&D revenues of $128,000, R&D milestone revenues of $125,000 and royalties on product sales of $2,000; offset by a decrease in product revenues of $79,000. Operating costs and expenses were $2.7 million for the third quarter of 2023, versus $2.5 million for the corresponding three-month period of 2022. The change is mainly attributable to increases of $163,000 in R&D expenses, $134,000 in selling, general and administrative expenses, and $4,000 in depreciation of tangible assets, offset partially by a decrease of $146,000 in manufacturing expenses. For the third quarter of 2023, the Company had an operating loss of $2.4 million, consistent with the comparable period of 2022. Net comprehensive loss for the three-month period ended September 30, 2023 was $2.5 million, or $0.01 per basic and diluted share, compared to net comprehensive loss of $3.0 million, or $0.02 per basic and diluted share, for the comparable period of 2022. As at September 30, 2023, the Company's cash and short-term investments totalled $2.1 million. Conference Call Details: IntelGenx will host a conference call to discuss these third quarter 2023 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 545-0320 (Canada and the United States) or (973) 528-0002 (International), access code 356693. The call will also be webcast live and archived on the Company's website at www.intelgenx.com under "Webcasts" in the Investors section. About IntelGenx IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm® and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com. Forward-Looking Information and Statements This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen KilmerInvestor Relations(647) 872-4849stephen@kilmerlucas.com Or Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514) 331-7440 ext 203andre@intelgenx.com

荷兰的Pharming Technologies 和意大利Chiesi Farmaceutici最近在罕见病方面都取得了突破。前者的Joenja（leniolisib）今年3月份获得FDA监管审批通过，用于治疗 12 岁或以上成人和儿童患者的活化磷酸肌醇 3-激酶 δ（PI3Kδ）综合征；后者的 Lamzede® （Velmanase alfa）注射液也在今年2月份得到FDA的审批通过，用于治疗罕见病α-甘露糖苷贮积症的非中枢神经系统表现。相同的是，Pharming和Chiesi都获得了FDA的优先审评凭证（PRV, priority review voucher）。1优先审评（PR）和优先审评凭证（PRV）优先审评 (Priority review) 是FDA的一项计划，目的是为了加快那些“优等生”药物的审评过程。所谓的优等生药物，是指那些有可能对被忽略或者治疗效果不充分的疾病治疗产生重要影响的在研药物。为了擢拔优越，FDA有些像“举孝廉”那样为它们颁发优先审评凭证（PRV, priority review voucher），以激励赞助商开发针对盈利能力有限的适应症的治疗方法。制药公司可获得优先审评券，用于开发和批准治疗被忽视的热带病（NTD, Neglected Tropical Diseases）、罕见儿科疾病，以及针对恐怖主义的“医疗对策”药物。有意思的是，该PRV凭证可以保留而暂时不用，或者用于其它适应症的药物，但需要支付费用才能“僭越”该PRV (约 280 万美元)。手握PRV这份“丹书铁券”，开发商可以申请FDA的优先审查（priority review）。值得注意的是，PRV还可以买卖。根据目前的处方药使用者费用法案（Prescription Drug User Fee Act），FDA 的对于优先审查的审查期时限是6个月，而对常规的药物则为10个月。然而，实际的 FDA 审查时间表可能比目标 PDUFA 审查期限更长，尤其是对于以前没有被批准用于任何适应症的新产品。这种情况下，更加凸显了优先审查的宝贵。杜克大学的经济学家曾经做出评估，优先审评可以将 FDA 的审评过程从平均 18 个月缩短到 6 个月，为药物进入市场整整打通了一条提前一年的终南捷径。[1]享有PRV的公司也可以待价而沽，向其他制药公司以不同的价格出售PRV。迄今为止，PRV的售价为 6千多万-3.5 亿美元之间。尽管PRV的频繁流通也有可能产生“通货膨胀”的危险，但目前PRV的售价稳定在1亿美元左右。目前尚有十几个PRV未使用或出售。根据最新消息，礼来将为他们的肥胖症候选药物Mounjaro(tirzepatide)动用一张PRV，以将这款具有强劲吸金能力的药物提前打入市场。2FDA颁发的PRV[2]迄今为止，FDA已将PRV授予12个被忽视的热带病（NTD）治疗药物，33个罕见儿科疾病新药，以及6个物质威胁对策新疗法。3PRV售价PRV售价随年份波动见图1。其最高点为2015年的3.5亿美元。最低点为2014年的6750万美元。图1. PRV售价年度变化图。（数据来源：杜克大学；图片来源：Endpoints News）4PRV出售与自用状况前文提及，PRV即可自用，加速自家药物的审批过程，也可以存起来以备未来之需，也可以拿到市场上兑现。2009至2021年间FDA颁发的50个PRV使用模式见图2。这50个PRV中，有25个被开发商出售，25个自留。自留的25个中，还有19个尚未被使用。图2. 2009-2021年间PRV使用途径分布。（数据来源：杜克大学）5PRV使用明细1Novartis (6个)• Novartis靠自己的项目获得 4 个 PRV，这些 PRV 用于加快 Ilaris（未成功）、Cosentyx、Kesimpta 和 Beovu 的审查。• 除此之外，Novartis还购买了 2 个 PRV：2017 年以 1.25 亿美元从BioMarin购买了一个；同年以 1.3 亿美元从 Ultragenyx 购买了一个。2Gilead（5个）• 2014 年以 1.25 亿美元从 Knight Therapeutics 购买了一个 PRV。• 2016 年以 2.9 亿美元的价格从 PaxVax 买一个 PRV。• 2017 年以 1.25 亿美元的价格从 Sarepta Therapeutics 购买了第三个 PRV。• 2018 年以约 8060 万美元的价格从 Ultragenyx 购买了第四个 PRV，用于加速 filgotinib 的审评，被 FDA 拒绝。• Gilead自己从 FDA获得一个 PRV，但未售出，也未使用。3Alexion，现属于阿斯利康（4个）• 一个用于加速 Ultomiris 的批准。• 另外两个仍未使用也未售出。• 2021 年以 1 亿美元的价格从 Rhythm 购买1个PRV。4Sarepta Therapeutics (3个)• 2017 年以 1.25 亿美元的价格卖给了 Gilead。• 2020 年以大约 1.08 亿美元的价格卖给了 Vifor Pharma。• 第三个在 2021 年以 1.02 亿美元的价格卖给了一个未知的买家。5阿斯利康（3个）• Wellstat 于 2015 年将一个PRV转让给 AZ。• AZ 于 2019 年以 9500 万美元从 Sobi 购买了一个PRV。• 第三个（通过Koselugo® selumetinib获得）仍未使用或出售。6BioMarin (3个)• 一个在 2014 年以 6750 万美元的价格卖给了再生元/赛诺菲。• 第二个在 2017 年以 1.25 亿美元的价格卖给了诺华。• 第三个在 2022 年以 1.1 亿美元的价格卖给了未公开的买家。7赛诺菲（3个）未知8Vertex (2个) 未知9Ultragenyx (2个)• 一个以 1.3 亿美元的价格卖给了Novartis。• 另一个以 8060 万美元的价格卖给了Gilead。10Regeneron（2个）• 2014 年以 6750 万美元从 BioMarin 购买了一个。• 另一个（针对埃博拉病毒的Inmazeb）自获PRV仍未售出。11GlaxoSmithKline（2个）• 2017 年以 1.3 亿美元的价格从未公开的卖方购买了一个 PRV，以加快对当年获得批准的 HIV 维持疗法 Juluca 的审查；• 自获PRV（tafenoquine）尚未售出。12Novo Nordisk (2个)• 从 Chemo Research SL 购买了一个 PRV，价格未知。• 从 Medicines Development for Global Health 购买了一个 PRV，价格未知。• Novo 在 2020 年底使用了其中一种 PRV ，来加快 FDA 对其肥胖症semaglutide的审查。13Bluebird bio (2个)• Bluebird bio凭借其新批准的，用于治疗 β-地中海贫血，以及减缓早期活动性脑肾上腺脑白质营养不良 (CALD) 进展的基因疗法赢得了两项 PRV。• 2022 年 11 月以 1.02 亿美元的价格将一个PRV 卖给了 agrenx。• 另一个PRV于 2023 年 1 月以 9500 万美元的价格卖给了 Bristol Myers Squibb。14United Therapeutics (2个)• 一个 PRV在 2015 年以 3.5 亿美元的价格卖给了 AbbVie。AbbVie 使用该 PRV 加快了对其类风湿性关节炎药物 Rinvoq 的新适应症的审查。• 2020 年以 1.05 亿美元的价格从 Y-mAbs Therapeutics 购买了一个 PRV，应用于 Tyvaso DPI 的 NDA，Tyvaso DPI在 2022 年 5 月获得批准。6批评声音有业内人事对于PRV是否真正激励了赞助商开发NTD，罕见儿科病等适应症展开针轮。还是PRV成为了对那些即便没有这些政策也会去开发这些产品的开发商一种额外的“代金券”奖励。其他专家，包括被忽视疾病药物倡议 (DNDi) 的 Rachel Cohen，已经指出PRV系统实际上并不要求公司销售药物。公司可能会寻求监管部门批准在美国境外销售的热带病药物，以期获得PRV。PRV计划的创始人之一David Ridley表示，这种投机取巧的行为应该被禁止。除此之外，PRV制度没有关注患者对于药物的可负担性和承受能力。归根结底，人们纠缠的心结是，如果没有PRV政策，那些赞助商是否仍然会去开发这些罕见病药物？就好比说，如果没有那些优惠政策，去西部支教的人是否仍然会做出这个决定？人们目前各执一词，对这个问题尚未有明确的答案。参考文献：[1] Ridley, D. B. et al. Developing drugs for developing countries. Health Aff (Millwood). 2006, 25, 313–324.[2] Priority review. Wikipedia. https://en.wikipedia.org/wiki/Priority_review[3] Mezher, M. et al. Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers. Regulatory Focus. 25, 02, 2020.[4] Brennan, Z. Priority review voucher updates: Who's won PRVs, who's bought them, and how much they're selling for. Endpoints News. 21, 04, 2023.