Viatris Inc.

ANI Pharmaceuticals is proud to support Sarcoidosis disease awareness BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq : ANIP) is proud to support the Foundation for Sarcoidosis Research’s (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April’s Sarcoidosis Awareness Month. During the month of April, members of the ANI organization are raising awareness of sarcoidosis by wearing “Say Sarcoidosis” pins offered through FSRs National Awareness Campaign, “Say Sarcoidosis.” In addition, ANI members will also be wearing purple on April 13th in honor of “World Sarcoidosis Awareness Day.” According to the FSR, sarcoidosis is a rare inflammatory disease characterized by the formation of granulomas predominately in the lungs and, to a lesser extent, in other organs of the body. Despite increasing advances in research, sarcoidosis remains difficult to diagnose with limited treatment options and no known cure. Approximately 175,000 people live with sarcoidosis in the United States. In addition, Black Americans in general have a higher incidence of sarcoidosis. ANI acknowledges FSR’s recently launched multi-prong initiative, Ignore No More , designed to address underrepresentation of Black Americans in clinical trials, and overall care of Black sarcoidosis patients and encourages more education on the disease to this population. “We applaud the Foundation for Sarcoidosis Research’s Awareness Campaign – “Say Sarcoidosis” and their ongoing education and support of people who live with sarcoidosis. We welcome the opportunity to partner with FSR to demonstrate our commitment to the sarcoidosis community as a Corporate Advisory Committee (CAC) Member,” said Nikhil Lalwani, President and Chief Executive Officer of ANI. “We are grateful for ANI Pharmaceuticals’ commitment to increasing awareness and education about those living with sarcoidosis,” said Mary McGowan, Chief Executive Officer of the FSR. “In the month of April and throughout the year, we are honored to work alongside committed partners like our Corporate Advisory Committee member, ANI Pharmaceuticals, to elevate the voice of all impacted by sarcoidosis.” Learn more about sarcoidosis, FSR, and how you can get involved . About ANI ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. The Company is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint. For more information, please visit our website Forward-Looking Statements To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: acquisitions and other investments could disrupt our business and harm our financial position and operating results; the limited number of suppliers for our active pharmaceutical ingredients could result in lengthy delays in production if we need to change suppliers; delays or failure in obtaining or maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA and other regulatory agencies, including drug recalls; acceptance of our products at levels that will allow us to achieve profitability; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; our dependence on single source suppliers of ingredients due to the time and cost to validate a second source of supply; our ability to develop, license or acquire, and commercialize new products; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; whether we experience difficulties closing a sale transaction with a buyer for the plant and property resulting from the closure of our Oakville, Ontario manufacturing plant; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict between Israel and Gaza, or conflicts relating to attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, such as COVID-19, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations: Lisa M. Wilson In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com Public Relations: Faith Pomeroy-Ward T: 817-807-8044 E: faith.pomeroyward@anipharmaceuticals.com

BAUDETTE, Minn., April 03, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, and Stephen Carey, Chief Financial Officer, will host investor meetings at the Piper Sandler Spring Biopharma Symposium on Wednesday, April 17, 2024, at the Encore Boston Harbor. To schedule a 1x1 meeting with the Company, please email corporateaccess@psc.com. About ANI ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. The Company is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint. For more information, please visit our website . Investor Relations: Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com Source: ANI Pharmaceuticals, Inc.

Johnson & Johnson originally sued Teva and Mylan—now part of Viatris—for alleged patent infringement over potential generics to Invega Sustenna in 2018 and 2019, respectively. After incurring a loss in New Jersey federal court in 2021, Teva and Viatris have successfully resurrected challenges to the last remaining U.S. patent on a lucrative Johnson & Johnson schizophrenia drug. On Monday, the U.S. Court of Appeals for the Federal Circuit sided with Teva and Viatris’ argument that the last FDA-registered patent on Invega Sustenna, dubbed the ‘906 patent, may be invalid. The appeals court’s decision will send the case back for consideration in New Jersey federal court, where U.S. District Judge Claire Cecchi in 2021 ruled that Teva failed to successfully challenge the patent’s validity. The ‘906 patent primarily concerns dosing regimens for Invega Sustenna, according to a recent court filing. Viatris, which is attempting to position its generic version of Invega Sustenna apart from Teva’s, agreed to follow Cecchi’s 2021 decision in the case, Reuters reports. J&J originally sued Teva and Mylan—now part of Viatris—for alleged patent infringement over potential generics to Invega Sustenna in 2018 and 2019, respectively, according to the news service. In the latest appeals ruling, the three-judge panel decided that the ‘906 patent could be invalid because Invega Sustenna’s dosing regimen may have been obvious to an average person in the field. A Teva spokesperson told Fierce Pharma Tuesday that the company is “pleased” by the latest decision, which will give it another shot to prove the invalidity of J&J’s patent. “We look forward to providing this important low-cost medication to patients as soon as possible,” she added. Naturally, J&J sees things differently. "Intellectual property protections enable us to continue the discovery and development of new life-changing therapies for patients, and J&J will continue defending the intellectual property of Invega Sustenna,” a J&J spokesperson said over email. Approved back in 2006, Invega Sustenna is a once-a-month long-acting schizophrenia drug that seeks to sidestep many of the adherence hurdles that accompany daily oral antipsychotics. Since Sustenna’s original nod, J&J has secured approvals for even longer-acting versions of the product, such as Invega Trinza, which can be taken every three months, and Invega Hafyera, which only needs to be administered twice a year. J&J has reaped blockbuster sales from its Invega franchise over the years, with the family of schizophrenia meds last year generating nearly $2.9 billion in the U.S. and $4.1 billion worldwide, according to J&J’s full-year 2023 earnings report. Meanwhile, J&J last May beat back a separate attempt by Viatris to deploy a copycat of the every-three-months schizophrenia treatment Invega Trinza. At the time, New Jersey District Judge Evelyn Padin wrote that Viatris’ proposed generics would “induce infringement” of a patent known as ‘693, adding that Viatris’ attempts to show the patent was invalid had fallen flat.