Teva Pharmaceuticals USA, Inc.

Company Grants Teva a License to Market Generic Galafold® Beginning in January 2037PRINCETON, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that it has entered into a License Agreement (Agreement) with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). This Agreement resolves the patent litigation brought by Amicus in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of GALAFOLD® (migalastat) 123mg capsules prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD® in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD® patents pending in the U.S. District Court for the District of Delaware. The litigation will continue against Aurobindo1 as the remaining active party and the litigation stay remains in place for Lupin2. As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. About Amicus Therapeutics Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on X and LinkedIn. Forward Looking StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements concerning: the terms of the settlement agreement with Teva, expectations regarding the impact of the settlement agreement and submission of the settlement agreement for review to the United States Federal Trade Commission and the United States Department of Justice. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties, including the unfavorable outcome of other litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to GALAFOLD, which may lead to competition from generic drug manufacturers; the outcome of any review of the settlement agreement by the United States Federal Trade Commission and United States Department of Justice; the U.S. FDA may approve Teva's ANDA significantly in advance of the entry date; and those risks and uncertainties described under the heading "Risk Factors" in the company's most recent Annual Report on Form 10-K for the year ended December 31, 2023, and on Form 10-Q for the quarter ended June 30, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof. CONTACT: Investors:Amicus TherapeuticsAndrew FaughnanVice President, Investor Relationsafaughnan@amicusrx.com (609) 662-3809 Media:Amicus TherapeuticsDiana MooreHead of Global Corporate Affairs and Communicationsdmoore@amicusrx.com (609) 662-5079 FOLD–G 1 Aurobindo Pharma LTD and Aurobindo Pharma USA, Inc.2 Lupin LTD and Lupin Pharmaceuticals, Inc.

有些时候，看上去打着为患者解决药品经济负担的所谓“慈善基金会”，也会成为药企垄断提升药价的工具。 4年前，美国司法部对以色列Teva制药在美国的下辖子公司Teva Pharmaceuticals USA Inc .和Teva Neuroscience Inc.发起诉讼，指控他们通过“表面上独立的基金会”非法支付其多发性硬化症(MS)产品Copaxone的医疗保险付款。在这一过程中，Teva通过一系列的合谋抬价，以超过通货膨胀率19倍的速度提高其药物Copaxone的价格，最终让药品成本上涨了329%。 如今Teva为恶意抬价和非法回扣的指控支付了4.5亿美元和解费。 事件主角Copaxone Copaxone毫无疑问是一款1996年上市的老药，是一种人工合成的肽类制剂。由L-丙氨酸、L-赖氨酸、L-谷氨酸、L-酪氨酸四种氨基酸按一定比例（4.2:3.4:1.4:1）聚合而成的多肽混合物。这四种氨基酸在髓鞘碱性蛋白中常见，Copaxone在体内可以作为免疫系统的诱饵，从而减缓自身免疫作用，因此可以用于MS这一疾病。 自上市以来，这款药物一直是Teva的销量超级重磅炸弹，2014年销售额达到了42.4亿美元，按理来说，自2015年Copaxone基础专利期到期以后，这款药物的销量就该出现断崖式下滑了。 但是Teva显然不想要这款药物的利润从公司手心中溜走，为了确保销量的桂冠，这家公司可以说是无不用其极，从多个方面重拳出击。 重拳出击 在专利方面，Teva发起了十几项针对仿制药的专利诉讼，在基础专利到期后，该公司利用重叠专利让竞争对手陷入了旷日持久的专利战。 在法规方面，该公司试图通过美国药品监管法达成目的。因为Copaxone是一种多肽混合物，Teva试图将Copaxone认定为生物制品，被认定为生物制品那么原本所谓的仿制药就将成为生物类似物，而Copaxone作为处方的不可取代性也将更为稳固。 而这里，Teva的控价阴谋则涉及慈善基金会，药房，药商（其他竞争对手）。 从2007年到2015年间，Teva向两个慈善基金会——援助基金会(TAF)和慢性病基金会(CDF)支付款项，试图使用Teva的钱来支付服用Copaxone的患者的医疗保险共付额。在同一时期，Teva将Copaxone的价格就从每年约17000美元提高到每年73000美元以上。 不过这只是提价阴谋的一部分，药房供应商Advanced Care Scripts Inc. (ACS)也参与其中，Teva将几乎所有面临美国医保Medicare共同支付药物费用的Copaxone患者介绍给该药房。然后Teva再利用ACS、TAF和CDF的信息来计算支付给每个基金会多少钱，以维持每个基金会登记的Copaxone患者的医疗保险共付额的覆盖范围。 ACS与Teva协调将新处方的Copaxone患者转诊到TAF和CDF，在Teva向基金会付款的同时分批转诊患者，这确保Copaxone患者获得TAF和CDF用Teva的钱提供的绝大部分共付额援助。 考虑到美国医保常常是按照比例支付的，在价格提升的过程中，虽然一部分参与整个过程的患者可能支付的价格是相同的，但是医保要支付的钱却逐年上升，这一过程中可以说是薅了医保的羊毛。 而同时对于没有参与这一骗保链条的患者，则可能需要面临被提升了多倍的药价。 后续的药品操纵定价指控则表明，Teva早在2015年12月至2023年5月左右就参与了三次定价阴谋，该公司与其他药品制造商勾结，操纵仿制药价格，操纵投标和分配客户。结果，消费者可能被多收了至少3.5亿美元。 2023年8月，Teva达成了2.25亿美元的延期起诉协议，协议允许该公司避免被强制排除在联邦医疗保健计划之外——潜在的惩罚是Teva选择接受审判并被判有罪。根据协议，该公司将在2024年至2027年期间支付2250万美元，最终在2028年一次性支付1.35亿美元。 参考来源： https://www.justice.gov/opa/pr/drug-maker-teva-pharmaceuticals-agrees-pay-450m-false-claims-act-settlement-resolve-kickback https://www.biospace.com/policy/teva-to-pay-450m-in-settlement-with-doj-over-kickback-and-price-fixing-allegations

WASHINGTON, July 1, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. District Court for the District of Delaware (the "Court") denied the motions for judgment on the pleadings that were filed by Teva Pharmaceuticals USA, Inc. ("Teva") and Apotex Inc. and Apotex Corp. ("Apotex") and ordered that Vanda's HETLIOZ® patent lawsuit may proceed. Vanda brought this suit in December 2022, alleging patent infringement against Teva and Apotex (the "Defendants"). The Defendants moved for judgment on the pleadings in April 2023. On June 27, 2024, the Court denied the motions. The Court concluded that the issues of patentability were not the same as those resolved in prior patent-infringement litigation between the parties. It further concluded that the Defendants raised issues that require claim construction and fact development before the Court can resolve the case. Vanda intends to proceed with discovery in the case to continue pursuing its claims. Vanda will request relief from the Court that includes an order requiring the Defendants to discontinue marketing their generic versions of HETLIOZ® until the expiration of the patent-in-suit and enjoining them from the commercial manufacture, use, import, offer for sale and/or sale of these products. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. About HETLIOZ® For full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit . CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this press release, including, but not limited to statements regarding Vanda's intentions to proceed with discovery in pursuit of its claims and to request relief from the Court, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the results of Vanda's discovery and the Court's willingness to grant Vanda the relief that it seeks. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc.