Ampio Pharmaceuticals to Present at the 2021 International Society for Pharmaceutical Engineers Annual Meeting and Expo
The Company's work amid the COVID-19 pandemic will be showcased to pharmaceutical and biopharmaceutical professionals working in drug manufacturing, supply chain, devices, equipment and services, and global regulatory agencies
ISPE's 2021 Annual Meeting and Expo will include an educational agenda focused on the latest innovative developments in supply chain, operations, facilities, equipment, information systems, product development, production systems, quality systems and regulatory guidance.
Ampio's presentation, entitled "Pivoting From One to Multiple Production Platforms to Treat COVID," is scheduled for Tuesday November 2, 2021, from 10:30 am to 12:00 pm ET and will take place during the Agile Innovation in Lifesciences Development and Manufacturing session track.
The presentation highlights Ampio's innovative work which has significantly and rapidly expanded the capabilities of its wholly owned, automated drug manufacturing facility that was initially focused on producing 4 cc vials of its platform immunomodulatory drug Ampion™ for intra-articular injections into patients with osteoarthritis of the knee. In less than 4 months, the manufacturing facility was reprogrammed to manufacture Ampion products packaged to be clinically administered in doses more than ten times larger, either intravenously (IV) to, or inhaled by, patients suffering from acute respiratory distress due to COVID-19.
During the presentation, changes in the manufacturing process as well as modifications to the filling process will be further detailed. In addition, the presentation will also discuss the path that ultimately led to Ampio's state-of-the-art manufacturing facility's ability to support multiple configurations of Ampion drug delivery (interarticular injection, IV, inhalation) using modular cleanrooms, minimal fixed equipment, and flexible manufacturing arrangements utilizing single-use closed systems in the original design.
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).
Forward Looking Statements
Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.