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PARIS–(BUSINESS WIRE)–Regulatory news:
Disclaimer: For International Media and Investor Use Only
Ipsen (Euronext: IPN; ADR: IPSEY) reports that the U.S. Food and Drug Administration (FDA) today announced its decision to postpone the scheduled Endocrine and Metabolic Drug Advisory Committee meeting for investigational palovarotene to a later date to be confirmed. The initial advisory committee meeting was scheduled for October 31, 2022. The FDA informed Ipsen that the postponement is related to an FDA request for new information on clinical trial data on palovarotene and does not relate to the safety profile. palovarotene. The company is currently working to meet demand. We will work quickly with the FDA as we remain committed to bringing innovative treatment options to the fibrodysplasia ossificans progressiva community.
Ipsen is a mid-sized international biopharmaceutical company specializing in transformative medicines in oncology, rare diseases and neurosciences. With specialty medicine sales of €2.6 billion in fiscal year 2021, Ipsen sells medicines in more than 100 countries. Alongside its external innovation strategy, the Company’s research and development efforts focus on its innovative and differentiating technology platforms located at the heart of major biotechnology and life sciences hubs: Paris-Saclay, France; Oxford, UK; Cambridge, USA; Shanghai, China. Ipsen has approximately 5,000 employees worldwide and is listed in Paris (Euronext: IPN) and in the United States via a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com
Ipsen forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s current management strategy, beliefs and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial objectives, which have been set assuming reasonable macroeconomic conditions based on information available today. The use of the words “believes”, “anticipates” and “expects” and similar expressions is intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including filings and regulatory decisions. Furthermore, the objectives described in this document were established without taking into account assumptions of external growth and possible future acquisitions, which could modify these parameters. These objectives are based on data and assumptions considered reasonable by Ipsen. These objectives depend on conditions or facts likely to occur in the future, and not exclusively on historical data. Actual results may differ materially from these objectives due to the occurrence of certain risks and uncertainties, including that a promising drug in early development or clinical trial may never be brought to market. or achieve its business objectives, including for regulatory or competitive reasons. Ipsen faces or could face competition from generic drugs which could result in a loss of market share. Furthermore, the research and development process involves several stages, each of which carries a substantial risk that Ipsen will not be able to achieve its objectives and will be forced to abandon its efforts with respect to a drug in which it has invested. significant sums. Therefore, Ipsen cannot be certain that favorable results obtained in preclinical trials will be confirmed later in clinical trials, nor that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the drug concerned. There can be no guarantee that a drug will receive the necessary regulatory approvals or that the drug will prove to be a commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward health care cost containment; technological advances, new drugs and patents obtained by competitors; challenges inherent in the development of new drugs, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its drugs which could potentially generate substantial royalties; these partners could engage in behavior that could harm Ipsen’s business and financial results. Ipsen cannot be certain that its partners will fulfill their obligations. He might not be able to get any benefit from these deals. Failure of one of Ipsen’s partners could generate revenues below expectations. Such situations could have a negative impact on Ipsen’s business, financial situation or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, objectives or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which such statements are based, except if required by law. Ipsen’s business is subject to the risk factors described in its reference documents filed with the Autorité des Marchés Financiers. The risks and uncertainties presented are not exhaustive and the reader is invited to refer to Ipsen’s 2021 Universal Registration Document, available on ipsen.com
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