Rivastigmine Tartrate

VANCOUVER, British Columbia--( BUSINESS WIRE )--Alpha Cognition Inc. (Nasdaq: ACOG) (CSE: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies for debilitating neurodegenerative disorders, today announced the pricing of its upsized public offering of 8,695,653 common shares at a public offering price of $5.75 per share, for gross proceeds of approximately $50 million, before deducting underwriting discounts, commissions, and estimated offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 1,184,592 common shares to cover over-allotments at the public offering price, less the underwriting discount. All of the common shares are being offered by the Company. The offering is expected to close on November 13, 2024, subject to the satisfaction of customary closing conditions. The Company has received approval to list its common shares on the Nasdaq Capital Market under the symbol “ACOG” and is expected to begin trading on Nasdaq today, November 12, 2024. The Company intends to use the proceeds towards the commercialization and launch of ZUNVEYL TM in Alzheimer’s Disease, further research and development of its pipeline product candidates, continued commercial CMC activities (chemistry, manufacturing, and controls), and for working capital and general corporate purposes. “This offering serves as a tremendous milestone for Alpha Cognition, as we begin the commercialization of our FDA-approved drug, ZUNVEYL, for the treatment of mild-to-moderate Alzheimer’s Disease,” said Michael McFadden, Chief Executive Officer and Director of the Company. "This financing puts our balance sheet in a position of meaningful strength and provides the necessary foundation for a successful commercial launch, with ample runway to scale over the next few years. We are thrilled to welcome a number of new, high-quality investors to our Nasdaq listing, who also see the benefits of ZUNVEYL and the exciting opportunity for our platform.” Titan Partners Group, a division of American Capital Partners, is acting as Sole Bookrunner for the offering. The securities were sold pursuant to a registration statement on Form S-1 (File No. 333-280196) relating to these securities and a related registration statement on Form S-1 MEF that became effective upon its filing in accordance with Rule 462(b) under the Securities Act of 1933, as amended. The Offering is being made only by means of a prospectus. A copy of the final prospectus related to the Offering may be obtained, when available, from Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, or via email at prospectus@titanpartnersgrp.com or telephone at (929) 833-1246. In addition, a copy of the final prospectus, when available, relating to the Offering may be obtained via the SEC's website at www.sec.gov . This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor (AChEI) for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it improves the function of neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. Benzgalantamine is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential closing of the Offering, the use of proceeds of the Offering, receipt of regulatory and stock exchange approvals in connection with Offering and completion of the Nasdaq uplisting. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future.

全球百亿市场，国内无人仿制？ 前面我们详细讨论过了关于国内两大化药贴膏——氟比洛芬凝胶贴膏和洛索洛芬钠凝胶贴膏，前者28亿市场，后者13亿，两大品种加起来占据国内化药贴膏80%市场。然而偌大的市场却没几家能竞争，更甚者，氟比洛芬凝胶贴膏自21年起竟连续被毙13条，无企业通过。相关文章：连续13次被驳回，仿制这么难？ 顺着这两个产品，今天我们继续聊透皮贴剂。 聊聊透皮贴剂领域“真正的传奇”。 传奇！ 着眼于全球透皮贴剂市场，称得上“传奇”的，唯有一款。 芬太尼透皮贴，一款透过皮肤给药的阿片类镇痛产品。由ALZA公司生产，年销售额峰值达22亿美元（折合人民币约154亿元）。 这是全球唯一一个年销售额超20亿美元的透皮制剂，亦是全球透皮贴剂销量巅峰。 一念天使、一念魔鬼。对于癌症患者来说，芬太尼透皮贴72h缓释止痛疗效是巨大福祉，而作为一种类似吗啡的强效合成阿片类镇痛剂，监管不当又极易造成泛滥。 因此，芬太尼透皮贴的商业化进程，曲折异常。 早期的芬太尼透皮贴是储库型透皮贴剂，这类储库型贴剂有两个很大的通病：药物残留和药物泄漏。 药物残留，即储库型贴片内药物无法被100%吸收。 对于早期储库型芬太尼透皮贴来说，使用正确的情况下，贴片内大约会残留30%的药物，而一旦使用不当如贴片未紧贴皮肤等，药物残留量会大量增加，最高残留甚至可达84%。 药物泄漏，顾名思义，即贴片内药物泄漏。 这一问题在芬太尼透皮贴身上尤其突出。2004年，FDA紧急召回了美国上市的200万个芬太尼贴片，给出的理由是“其中少量贴片的背衬材料在制造过程中可能会出现折叠缺陷，从而导致药物从贴片的边缘泄漏”。泄漏的药物将会与皮肤直接接触，从而导致芬太尼过量摄入。 无意识的泄漏残留还不算可怕，更可怕的是人为恶意提取。由于贴片内的药物是流态的，因此很容易就可以提取出来使用。在过去数年，储库型芬太尼透皮贴剂被毒贩当成了毒品的原料，被制成粉末或药片在美国和加拿大等国迅速流行开来。 基于以上种种弊端，ALZA又开发出了骨架型芬太尼透皮贴剂，遗憾的是骨架型产品也无法解决芬太尼的滥用问题，甚至泛滥更加。 根据一份加拿大的调查报告显示，该国的阿片类药物滥用者更喜欢骨架型芬太尼透皮贴剂，原因是他们可以将该贴片切成所需要的大小，然后贴在口腔内，这样药物就可以通过颊膜迅速吸收。 综上，芬太尼透皮贴在海外地区的泛滥问题到现在都没得到很好解决。 国内呢？ 原研芬太尼透皮贴于2004年被批准国内上市，然而，国内的市场环境与国外天差地别。 海外市场的芬太尼透皮贴，早在2004年就能一举揽下22亿美元；而在国内，自上市以来，芬太尼透皮贴的销售额最高产也未能超过3亿人民币。 原因很简单：欧美对毒品的态度模糊，但在国内，芬太尼透皮贴是按照麻精毒放类药物进行强监管的，临床使用极其严苛。 图源：摩熵医药 23年，芬太尼透皮贴销售更是陡然下滑，首度降至2亿以下，猜测可能与美国和加拿大接连针对阿片类药物发布药物安全警讯有关。 在这种强监管形势下，芬太尼透皮贴这一全球市场如此大的产品，在国内连试图参与竞争的企业都几乎没有。 目前仅河南羚锐和常州四药两家国内企业仿制上市，宜昌人福一家申报了临床。 图源：摩熵医药 希望！ 从目前监管态势看来，芬太尼透皮贴在国内的销量是无法再现传奇了，那国内还有哪个产品有希望成为爆款么？ 利斯的明透皮贴剂，目前国内阿尔兹海默症透皮给药治疗的唯一产品。 AD市场仍旧是片蓝海。据首个国家级《中国阿尔茨海默病蓝皮书》数据，2019年，我国AD及其他痴呆总人数达1314万，约占全球AD患者总人数的四分之一，并且死亡率逐步上升，死因顺位从1990年第19位跃升为2019年第6位，已成为我国人群第六大死因。 由于AD的发病机制十分复杂，虽然全球科研工作者大力攻克该病症，但仍未有特效药出现，目前的药物治疗以减轻症状、延缓病情发展为主。 国内常用的治疗药物仅有几种，主要包括美金刚，多奈哌齐、卡巴拉汀、加兰他敏和石杉碱甲以及甘露特纳胶囊，但这些药物只能控制症状，并不改变疾病的进程。 图源：慧博资讯 而通过透皮给药治疗AD的仅有利斯的明透皮贴剂，在真实世界研究中，相较于胶囊和片剂，贴剂给药依从性更好 、更受患者青睐、可减轻照料者负担。 根据公开数据显示，2018 年欧美市场的利斯的明透皮贴剂产品品类的整体销售规模达到 4.52 亿美元。跟芬太尼透皮贴22亿美元比起来虽然不多，但其实据统计，历史上全球透皮贴剂销售额峰值曾超过1亿美元也才约仅有10个。 2017年，原研厂家诺华的产品（艾斯能®/Exelon®）于国内上市，到了2020年，绿叶集团德国子公司Luye Pharma AG 研发的利斯的明透皮贴剂获批在国内上市。 两家企业并未对国内市场进行深入布局，所以销售成果不佳。2023年，二者合计销售额仅267.66万，这个数额即使较国内芬太尼透皮贴3亿销售总额也相差甚远。 但也许，这样的格局会随着泰德获批而改变。 2024年9月25日，北京泰德的利斯的明透皮贴剂又名卡巴拉汀透皮贴剂获批，用于治疗阿尔茨海默症，这是首个获批上市的国产利斯的明透皮贴剂。 众所周知，北京泰德手上已有一款“爆款”贴膏，氟比洛芬凝胶贴膏，在透皮制剂领域是先行者角色，有成功商业化的先例经验，泰德成就下一个“爆款”的几率更大。 且随着泰德过评，紧随其后已有三家企业提交了一致性评价上市申请分别是：宜昌人福药业、江苏康倍得药业及韩国企业Dae Hwa Pharmaceutical。 利斯的明透皮贴剂，国内透皮贴剂的下一个“爆款”也许是它？ 投稿/内容沟通：华籍美人（Ww_150525） 近期精华文章