Pramipexole Dihydrochloride

Pooled data analysis of efficacy and safety from Phase 2b and Phase 3 data sets in patients with early-stage Parkinson’s disease (PD) support P2B001 as a first line, once-daily treatment choice for early PD KIRYAT ONO, Israel, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Pharma Two B, a private, late-stage pharmaceutical company developing innovative combination drugs for neurological disorders, today announced a poster presentation of integrated safety and efficacy data on P2B001 from its Phase 2b and Phase 3 studies in early-stage Parkinson’s disease (PD) patients. P2B001 is a fixed, low-dose extended-release (ER) combination of pramipexole, 0.6 mg and rasagiline, 0.75 mg. The data are being presented today by Henry Moore, M.D., Associate Professor of Clinical Neurology, University of Miami, Miller School of Medicine, at the Parkinson’s Study Group (PSG) 33rd Annual Meeting in Nashville, TN. “The poster includes robust safety and efficacy data from two double-blind studies, which compared once-daily P2B001 to titrated pramipexole ER (PramiER) or placebo, over a 12-week period,” said Dr. Moore, Associate Professor of Clinical Neurology at the University of Miami and presenter of the study. “P2B001 consistently demonstrated a favorable risk-benefit profile in treating PD symptoms in early-stage patients, compared to the groups receiving other, commercially available therapies. It therefore could be a valuable potential first-line therapy for such patients who are often treated by general neurologists and primary care physicians.” The poster summarizes an integrated modified-ITT analysis of Unified Parkinson’s Disease Rating Scale (UPDRS) results in 196 early-stage PD patients, as follows: P2B001 had significantly greater effect on the UPDRS Part II (Activities of Daily Living, or ADL), Part III (Motor), and Total (Parts II and III) scores versus placebo.P2B001 had comparable efficacy to individually titrated PramiER.P2B001 had significantly less worsening in daytime-sleepiness compared to those treated with PramiER.P2B001 was well-tolerated with an adverse event profile that included fewer sleep-related and dopaminergic adverse events than titrated doses of PramiER. Dan Teleman, CEO of Pharma Two B, added, “These data provide further support for P2B001 as a first-line, once-daily combination pill treatment for people with early PD that requires no titration. Currently, we are focused on completing our merger with Hepion and thereafter look forward to moving P2B001 towards an NDA submission.” About the PSG Annual Conference The 2024 Annual Meeting of the Parkinson Study Group is being held December 5-8, 2024, in Nashville, TN. For over three decades, the PSG Annual Meeting has showcased the organization’s efforts in collaborative research and a commitment to education and mentorship. The meeting welcomes leading investigators, coordinators, trainees, advocates, and allied stakeholders to exchange the latest advances and practices in PD. About Pharma Two B Pharma Two B is a private, late-stage pharmaceutical company. Pharma Two B’s mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience. Pharma Two B’s lead product candidate is P2B001. For more information, please visit: www.pharma2b.com. Pharma Two B plans to go public via a merger transaction (the “Merger”) with Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) (“Hepion”) in conjunction with the closing of a concurrent private placement. The proposed merger transaction was initially announced on July 22, 2024, and on November 11, 2024, the U.S. Securities and Exchange Commission (“SEC”) declared effective the Company’s registration statement on Form F-4, as amended (the “Registration Statement”) relating to the Merger. The Merger, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol “PHTB” and other customary closing conditions. About P2B001 P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of PD (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with PD. Extended release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. In a Phase 3 clinical trial, P2B001 demonstrated that it provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep-related and dopaminergic side effects. Pharma Two B owns worldwide-granted patents for both pharmaceutical composition and method of treatment with P2B001. About Hepion Pharmaceuticals Hepion is a biopharmaceutical company headquartered in Edison, New Jersey, previously focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Hepion’s cyclophilin inhibitor, rencofilstat, was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. In December 2023, Hepion’s board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. Additionally, Hepion initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, Hepion announced that it has begun wind-down activities in its ASCEND- NASH clinical trial which wind-down activities have since been completed and the trial has been closed. Hepion is continuing efforts, to the extent that cash is available, to provide any value derived from rencofilstat to its shareholders. Forward-Looking Statements Certain statements in this press release may be considered “forward-looking statements”. Forward-looking statements generally relate to future events or Hepion’s or Pharma Two B’s future financial or operating performance. For example, express or implied statements regarding Hepion and Pharma Two B’s expectations with respect to the Merger, including the timing of the Special Meeting, listing Pharma Two B’s ordinary shares on Nasdaq, receipt of necessary shareholder approvals and the timing of closing of the Merger, and related matters, as well as all other statements other than statements of historical fact included in this press release, are forward-looking statements. When used in this press release, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions, as they relate to Hepion or Pharma Two B, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, Hepion’s and Pharma Two B’s management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in Hepion’s and Pharma Two B’s filings with the SEC. Most of these factors are outside the control of Hepion and/or Pharma Two B and are difficult to predict. In addition to factors disclosed in Hepion’s and Pharma Two B’s filings with the SEC, the following factors, among others, could cause actual results and the timing of events to differ materially from the anticipated results or other expectations expressed in the forward-looking statements: the risk that the Merger may not be completed in the fourth quarter of 2024 or at all; the inability to meet the closing conditions to the Merger, including the failure of Pharma Two B to meet Nasdaq initial listing standards in connection with the consummation of the Merger; costs related to the Merger and the failure to realize anticipated benefits of the Merger or to realize estimated pro forma results with respect thereto as well as other risks associated with biopharmaceutical companies generally, including the risks of filing an NDA, obtaining regulatory approval for any product candidates, commercialization of any approved product, including P2B001 for PD, as well as the total addressable market and potential for success of P2B001, the presentation of financial information in U.S. GAAP, completion of a PCAOB audit of U.S. GAAP financials, as well as other risks set forth in more detail in the Registration Statement. The forward-looking statements are based upon management’s beliefs and assumptions; and other risks and uncertainties identified in the Registration Statement, including those under “Risk Factors” therein, and in other filings with the SEC made by Hepion. Each of Hepion and Pharma Two B undertake no obligation to update these statements for revisions or changes after the date of press release, except as required by law. No Offer or Solicitation This press release does not constitute an offer to sell or a solicitation of an offer to buy, or the solicitation of any vote or approval in any jurisdiction in connection with the Merger or any related transactions, nor shall there be any sale, issuance or transfer of securities in any jurisdiction where, or to any person to whom, such offer, solicitation or sale may be unlawful. Any offering of securities or solicitation of votes regarding the proposed transaction will be made only by means of a proxy statement/prospectus that complies with applicable rules and regulations promulgated under the Securities Act, and the Securities Exchange Act of 1934, as amended, or pursuant to an exemption from the Securities Act or in a transaction not subject to the registration requirements of the Securities Act. Additional Information and Where to Find It In connection with the Merger, Pharma Two B filed the Registration Statement with the SEC, which includes a prospectus with respect to its securities to be issued in connection with the Merger, and a definitive proxy statement with respect to Hepion’s stockholder meeting at which Hepion’s stockholders will be asked to vote on the Merger and related matters. The Registration Statement has been declared effective by the SEC and Hepion is mailing a definitive proxy statement and prospectus to its shareholders. Each of Hepion and Pharma Two B urge investors, stockholders, and other interested persons to read, when available, the Registration Statement including the proxy statement/prospectus, any amendments thereto, and any other documents filed with the SEC, before making any voting or investment decision because these documents will contain important information about the Merger. Investors and security holders will be able to obtain free copies of the Registration Statement, the proxy statement prospectus and all other relevant documents filed or that will be filed with the SEC by Pharma Two B or Hepion through the website maintained by the SEC at www.sec.gov. Participants in the Solicitation Pharma Two B and Hepion and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Hepion’s stockholders in connection with the Merger. Information about Hepion’s directors and executive officers and their ownership of Hepion’s securities is set forth in Hepion’s filings with the SEC. To the extent that holdings of Hepion’s securities have changed since the amounts printed in Hepion’s Annual Report on Form 10-K/A, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. A list of the names of such directors and executive officers and information regarding their interests in the Merger is contained in the proxy statement/prospectus in the Registration Statement. You may obtain free copies of these documents as described in the preceding paragraph. Contact: Pharma Two BDan TelemanCEOPharma Two B Ltd.Cell: + 972-54-550-0804Email: dan@pharma2b.comwww.pharma2b.com U.S. investors Chuck PadalaLifeSci Advisors, LLC+1-917-741-7792chuck@lifesciadvisors.com

近期，又一家跨国药企将产品的中国商业化权益“外包”了出去。 11月27日，优时比宣布，将比奇珠单抗在中国的商业化权益交给博锐生物。优时比已经不是第一次卖中国产品权益。今年8月，优时比把中国的五款成熟产品业务连带珠海的生产基地一起打包，说卖就卖了。（详情见：再难躺平，跨国大药企连药带厂一起卖）。 这是继辉瑞、勃林殷格翰卖掉部分药物权益后，又一家选择在中国市场“后撤”的跨国药企。 值得注意的是，与此前将集采或成熟产品卖出不同，优时比此次“外包”出去的是一款潜力颇丰的创新药，靶向IL-17A/F，这是目前自免领域非常火热的靶点。优时比十分看好这一产品，预测其全球销售峰值有望超过40亿美元。这么一款重磅产品的权益都要外包出去，优时比是要撤退吗？ 接连撤退的跨国药企 刚开始卖中国产品时，不少人猜测，优时比并没有打算彻底退出中国市场。优时比也发声表示，计划将更多的精力集中在中国市场的创新药物开发上。 今年7月，优时比的比奇珠单抗成功在国内获批上市，用于治疗常规治疗疗效不佳或不耐受的活动性强直性脊柱炎成人患者；8月，治疗重症肌无力新药C5补体抑制剂泽勒普肽注射液也在国内获批上市。不少人预测，优时比可能依靠这些新产品在中国打个翻身仗。结果，优时比却选择了将比奇珠单抗的商业化权益授权给博锐生物。 事实上，这个选择不难理解。优时比公司体量不大，如果仅为了一款产品建立销售渠道，性价比太低了。更何况，国内围绕IL-17A靶点的竞争正在白热化，恒瑞医药、智翔金泰的同靶点产品都已经获批上市，优时比未必卖得过国内本土玩家。 而博锐生物在自免领域已经有5款药物上市，锻造了一支非常优秀自免的商业化团队，因此，优时比也就乐得选择“外包”，做个甩手掌柜。 最近一段时间，不少大型跨国药也都选择了将国内部分产品的商业化权益外包出去。 11月26日，辉瑞将四款药物的商业化运营交给了华润医药，其中三款都是在国内上市十多年的“肿瘤老药”。比如依西美坦片2008年上市，主要用于乳腺癌治疗；盐酸表柔比星1998年上市，主要用于乳腺癌、肺癌治疗；第一代alk抑制剂克唑替尼2013年上市。另一款哌柏西利胶囊，虽然2018年才上市，但在中国专利期已到，第十批国采竞争中，过评企业达14家，是最激烈的品种之一。 再早一些，勃林殷格翰也将旗下产品森福罗和泰毕全商业化交给国药控股。这两款抗帕金森领域和房颤抗凝领域产品，已进入中国市场十几年，也都已纳入集采。 这些品种的收益已经不足以支持外企自己组建销售团队，委托给上药、华润、国药这样的流通商来销售，是性价比更高的选择。 跨国药企们的战略转换 跨国药企们的战略调整并不意味着放弃中国市场。2025年中国创新药市场预计将突破万亿元规模，是绝不能放弃的庞大市场。 但是，跨国药企在中国市场的处境确实发生了变化。随着集采和医保谈判的推行，跨国药企的盈利空间被不断压缩，去年开始的控费、比价等一系列规则的出台，更让过专利期原研药的市场地位受到挑战。 如今，跨国药企的老产品已经无法躺平。但这些老药往往已经积累了规模可观的市场，直接全盘放弃显然太可惜。 在美国等成熟市场，跨国药企在品种专利到期后，也会选择交给代理商销售。不过在中国，过去原研药的价格长期居高不下，跨国药企有利可图，才保持自产自卖。如今随着集采开展越来越深入，大部分过专利期的原研药市场空间被极度压缩，有的选择像优时比一样打包出售产品，也有的像协和麒麟一样直接出售整个中国区业务，或像爱尔康一样与国内大企业合作。 在目前的国内市场，创新药拥有比老药更大的机会。中国创新药产业快速崛起，不少国内药企都展现出了不凡的实力，直接与进口药竞争，给跨国药企带来了不小的压力。在这样的情况下，跨国药企需要将资源更多地投入创新药研发领域，用实力在中国市场切到更大的蛋糕。 跨国药企有成熟的管线梯队，每年推出的新药物数量也不少，只有快速引进到中国，才能分享市场红利。辉瑞就新设了北京研发中心，开展国际多中心临床试验，推动临床试验全球同步；勃林格殷格翰也计划未来5年在华研发投资达40亿元。 跨国药企将产品交给国内企业销售，是平衡药物的成本投入与获益的一种手段，优时比绝不会是最后一个这样做的。 撰稿丨方涛之 编辑丨江芸 贾亭 运营｜廿十三 插图｜视觉中国 声明：健识局原创内容，未经许可请勿转载 一批创新药已开始大幅降价，一切为了2025医保谈判 “从来就没想过自体CAR-T能进医保” 新事丨72亿！又有国产ADC出海