Lupin Pharmaceuticals, 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.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The Coalition for Epidemic Preparedness Innovations (CEPI) is partnering with and funding a research project for Afrigen Biologics to investigate if the use of synthetic DNA can speed up mRNA vaccine development. The synthetic DNA will be manufactured and supplied by the CDMO Syngoi. The research project will develop a vaccine for Rift Valley fever, according to a Tuesday press release. Bora Pharmaceuticals is gaining a 30.5% share in Tanvex Biopharma in a new partnership that will combine their manufacturing services. Bora will provide its 10 global manufacturing sites and Tanvex will provide its commercial facility in San Diego, CA. No financial details were given. Bharat Biotech is launching an oral cholera vaccine, dubbed Hillchol, to address cholera vaccine shortages. The company will manufacture this out of its facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses, the company said on Tuesday. John Kosolcharoen, CEO of two stem cell manufacturing companies, pleaded guilty on Monday for marketing products linked to patient hospitalizations. Since 2016, the two companies, called Liveyon LLC and Genetech Inc. have been making and shipping unapproved injectable stem cell products manufactured from human umbilical cord blood. Kosolcharoen lied to the FDA stating these were being sold for research purposes only, as per a DOJ press release on Tuesday. AstraZeneca’s manufacturing facility in Södertälje, Sweden, has achieved a 98% reduction in greenhouse gas emissions since 2015, the company said on Thursday. ScaleReady has awarded a $20 million grant to Stanford Medicine Laboratory for Cell and Gene Medicine to help the development of its CAR-T cell therapy manufacturing platform. The funding will be used to investigate the manufacturing tech in a Phase 1 clinical trial for Glypican 2 pediatric neuroblastoma and medulloblastoma, the company said on Tuesday. Trinity Capital is investing $35 million into drug delivery device manufacturer ApiJect Systems. The funding will be used to expand ApiJect’s manufacturing footprint with a new facility, according to a press release on Tuesday. Molecular Assemblies has received $4 million in funding from the Defense Advanced Research Projects Agency (DARPA) to further develop its DNA synthetic technology. The funding will be used for future tech transfers and to develop other software like gene synthesis, the company said on Wednesday. Injectable CDMO Simtra Biopharma Solutions has tapped Lonza’s VP of Biologics, Lidia Serina, as its new head of development services. Prior to working at Lonza, Serina held positions at GSK, Sanofi and CureVac. CDMO Huateng Pharma is expanding its services to include manufacturing pharmaceutical and veterinary APIs, chemicals and cosmetic ingredients, according to a press release on Wednesday. Lupin Pharmaceuticals is voluntarily recalling 4554 bottles of its cefixime oral suspension from the US due to an out-of-specification result. The class 2 recall started on Aug. 21, according to a FDA report published on Monday. Dr. Reddy’s Laboratories is also voluntarily recalling 103,298 bottles of 800 mg ibuprofen tablets after a specification study showed some levels of impurities. The bottles are being recalled from the US and Puerto Rico, and the process is ongoing. The FDA classified this as a class 2-level recall.

EAST WINDSOR, N.J., July 23, 2024 /PRNewswire/ -- ForDoz Pharma Corp., a private specialty pharmaceutical company focused on product development, manufacturing and commercialization of complex injectables, like liposomes, microspheres, nano-suspensions, etc., today announced the ANDA approval of DOXOrubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) from the United States Food and Drug Administration (US FDA). DOXOrubicin Hydrochloride Liposome Injection is indicated for the treatment of patients with ovarian cancer and AIDS-related Kaposi's sarcoma. Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma. "The approval of DOXOrubicin Hydrochloride Liposome Injection marks a major milestone for ForDoz Pharma as our 1st liposomal injectable pharmaceutical product to enter the US market. It will be distributed by Lupin Pharmaceuticals, Inc.," said James He, Founder and CEO of ForDoz Pharma. About ForDoz Pharma Corp. ForDoz Pharma Corporation is a privately-owned specialty pharmaceutical company focusing on development, manufacturing, and commercialization of value-added sterile and complex injectable products. Based on its proprietary technology platform and unique cGMP sterile manufacturing facility, the company's corporate strategy is to accelerate the development and manufacturing of complex injectables for its own and help others through CDMO service. Please visit for more information LinkedIn: Media Contact: James He, CEO 609-469-5949 SOURCE ForDoz Pharma Corp.