공시 • May 22
Ani Pharmaceuticals Announces Initiation of Phase 4 Clinical Trial of Purified Cortrophin Gel for the Treatment of Acute Gout Flares
ANI Pharmaceuticals, Inc. announced the initiation of a Phase 4 clinical trial at Massachusetts General Hospital to compare the safety and efficacy of two dose levels (40 USP units and 80 USP units) of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) for the treatment of acute gout flares. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow then to achieve profitability; ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of their cash flow as a result of the indebtedness and liabilities incurred from the acquisition of Alimera; the risks that their acquisitions and investments, including the acquisitions and investments, including the acquired of Alimera, could disrupt their business and harm their financial position and operating results; delays and disruptions in production of their approved products, increased costs and potential loss of revenues if they need to change suppliers due to the limited number of suppliers for their raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production the approved products as a result of the reliance on single source third party contract manufacturing supply for certain of their key products, including Cortrophin gel, ILUVIEN andYUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug calls, regulatory approvals, facility inspections and potential enforcement actions; risks that they 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 their products from both domestic and overseas sources due to supply chain disruptions or for any other reason, including increased costs due to tariffs; the ability of manufacturing partners to meet product demands and timelines; the impact of changes or fluctuations in exchange rates; ability to develop, license or acquire, and commercialize new products; obligations in agreements under which they license, develop or commercialize rights to products or technology from third parties and ability to maintain such licenses; the level of competition they face and the legal, regulatory and/or legislative strategies employed by the competitors to prevent or delay competition from generic alternatives to branded products; ability to protect intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which are, or may become, a party; ability, and that of suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; ability, and that of their suppliers, development partners, and Manufacturing partners, to comply with laws and standards that govern or affect The pharmaceutical and biotechnology industries; the ability to maintain the services of their key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies. 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 the Company's filings with the securities and Exchange Commission.