Evofem Biosciences, 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.

Your vote is important no matter how many votes you hold.Shareholders who have questions or need assistance with voting their shares should contact info@appilitherapeutics.com HALIFAX, Nova Scotia, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announces its special meeting of shareholder date. The notice of the special meeting of shareholders (the "Meeting") and management information circular (the "Circular") will be available on the Company's website at: appilitherapeutics.com/proxy-info/ as well as under Appili’s profile on SEDAR+ www.sedarplus.ca. Appili’s board of directors recommend that shareholders vote in favour of the resolution pursuant to which Aditxt Inc. (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc., agreed to acquire all of the issued and outstanding Class A common shares of the Company (“Appili Shares”) by way of a court-approved plan of arrangement (the “Arrangement”). Under the terms of the Arrangement, for each Appili Share, shareholders will receive (i) US$ 0.467 in cash and (ii) 0000686251 of a share of Adixt common stock (the “Aditxt Shares”) (representing a value of approximately US$0.00013 per Appili Share based on the closing price of the Aditxt Shares on October 3, 2024 (the date immediately preceding the date of the Circular)). This Amalgamation represents a significant premium to Appili’s recent trading price, and assuming the completion of the transaction, provides shareholders with immediate value. In addition to the diversifying Appili’s shareholders’ investments, the combined enterprise should enhance access to capital and accelerate the development of Appili’s programs. “Aditxt’s expertise in development operations and commercialization will significantly accelerate the advancement of Appili’s programs, including facilitating access to new U.S. non-dilutive funding sources, preparing ATI-1701 IND submission, and supporting manufacturing activities for ATI-1801. By leveraging Aditxt’s robust capabilities, we aim to work with partners to enhance the commercialization of LIKMEZ™ and capitalize on the strategic value of two potentially PRV eligible programs.” said Don Cilla, President and CEO of Appili. “Together, we are committed to delivering critical solutions to health challenges and accelerate innovation across early detection and healthcare delivery.” YOUR VOTE IS IMPORTANT. VOTE YOUR SHARES FOR THE ARRANGEMENT AS SOON AS POSSIBLE. The Company is in the process of mailing the Circular and related materials for the Meeting to Appili’s shareholders. Copies of the notice of the meeting, proxy form and Circular will be available on Appili’s investor relations website at appilitherapeutics.com/proxy-info/. Shareholder Meeting DetailsThe Company's Meeting will be held virtually via a live teleconference hosted through the facilities of Chorus Call at 11:00 a.m. (Toronto time), on November 6, 2024 (as more particularly described in the Circular). Shareholders are encouraged to read the Circular and vote their shares as soon as possible. The deadline for voting your shares is 11:00 a.m. (Eastern time) on November 4, 2024. Appili’s board of directors recommends that shareholders vote FOR the resolution approving the Arrangement (the “Arrangement Resolution”). Shareholders representing approximately 11.9% of the outstanding Appili Shares have entered into support and voting agreements to vote in favour of the Arrangement Resolution. It has also been communicated to the Company that shareholders holding an additional approximately 17.1% of the outstanding Appili Shares intend to vote in favour of the Arrangement Resolution. Recommendation of Appili’s Special Committee and Appili’s BoardThe special committee of the board of directors of Appili and the board of directors of Appili have recommended that shareholder vote in favour of the Arrangement Resolution. Aditxt ArrangementAditxt’s strategy is anchored in accelerating promising health innovations. With two subsidiaries in immune health and precision diagnostics already established, the proposed acquisitions of Evofem Biosciences, Inc., and Appili seek to further extend Aditxt’s presence into women’s health and public health, supporting its continued expansion. Support from Aditxt may enable Appili to accelerate clinical and commercial stage innovations and activate the strategic value of potentially PRV eligible products. LIKMEZ™ (ATI-1501), Expansion of FDA Approved Liquid Oral Reformulation of the Antibiotic MetronidazoleIn September 2023, Appili, together with its U.S. partner, Saptalis Pharmaceuticals LLC., announced the FDA approval of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ addresses the unmet need in both pediatric patients and elderly patients with dysphagia and mitigating risks associated with drug compounding and antimicrobial resistance. LIKMEZ, the first FDA-approved ready-made suspension of metronidazole with patent coverage through 2039, is expected to expand accessibility to patients in need. ATI-1701, Accelerate Development to IND SubmissionCollaboration within the Aditxt ecosystem has the potential to facilitate access to new U.S. non dilutive funding sources and accelerate the development of the program. Existing funding including the Company’s USAFA $14M awards, along with new non-dilutive funding sources facilitated by Aditxt are expected to advance Appili’s ATI-1701 biodefense program toward an Investigational New Drug submission to the U.S. FDA in 2025. ATI-1801, Advance Clinical Development of ParomomycinAditxt’s presence, established in public health and women’s health areas, is expected to accelerate the advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally. Appili also expects to capitalize on the strategic value of potentially PRV eligible ATI-1801, which, if confirmed, would make it the second PRV-eligible products at Appili, alongside ATI-1701, pending renewal of certain U.S. legislation. Additional Infectious Disease Development OpportunitiesAppili has partnered with other companies to explore additional infectious disease development opportunities in the fungal disease and viral disease space. By collaborating with these partners, the development programs benefit from prior work on the asset by the partner and leverage Appili’s government contracting expertise to solicit non-dilutive funding to fund the programs infectious disease development. This allows Appili the opportunity to lead in the development of new infectious disease assets. Through these partnerships, Appili can potentially access additional government funding, and potentially gain substantial benefit on commercialization. About AppiliAppili is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. Appili is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information about Appili Therapeutics Inc., visit www.AppiliTherapeutics.com. About AditxtAditxt, Inc.® is an innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress. Shareholder Questions Shareholders who have any questions or require assistance with voting may contact Appili Therapeutics info@appilitherapeutics.com. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSThis news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits. Forward-looking statements in this news release include, but are not limited to: statements with respect to the anticipated completion of the Arrangement, shareholders voting in favour or the Arrangement Resolution, anticipated effects of the Arrangement on Aditxt, the Company and the combined company’s strategy going forward and statements with respect to the anticipated benefits associated with the acquisition of Appili. Actual results and developments may differ materially from those contemplated by these statements. Such forward-looking statements are based on certain assumptions regarding Aditxt and Appili, including the successful completion of the Arrangement, anticipated benefits from the Arrangement, and expected growth, results of operations, performance, industry trends and growth opportunities. While Appili considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect. Among other things, there can be no assurance that the Arrangement will be completed or that the anticipated benefits from the Arrangement will be achieved. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information, including those set out in the Circular. Consequently, readers are cautioned not to place undue reliance on the forward-looking statements and information contained in this press release. The statements in this press release are made as of the date of this release. Appili disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws. No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, 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. Neither IIROC nor any stock exchange or other securities regulatory authority accepts responsibility for the adequacy or accuracy of this release. Media Contact: Jenna McNeil, Corporate Affairs and Communications ManagerAppili TherapeuticsE: JMcNeil@AppiliTherapeutics.com Investor Relations Contact: Don Cilla, Pharm.D. M.B.A.Appili TherapeuticsE: Info@AppiliTherapeutics.com

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.