Ipsen Statement on Updated Timeline for Palovarotene FDA Advisory Committee Meeting

Rhea-AI Summary

Ipsen (ADR: IPSEY) announces the FDA's postponement of the advisory committee meeting for its investigational drug palovarotene, originally scheduled for October 31, 2022. The FDA seeks additional information regarding clinical trial data but assures that the delay does not relate to the drug's safety profile. Ipsen is collaborating with the FDA to provide the requested data. The company remains committed to developing innovative treatments for Fibrodysplasia Ossificans Progressiva.

Positive

• Collaboration with the FDA reflects a commitment to regulatory compliance.
• Ongoing efforts to provide additional clinical trial data indicate proactive engagement.

Negative

• Delay in the advisory committee meeting may postpone potential approval timelines.
• Request for new information suggests possible concerns regarding existing clinical trial data.

PARIS--(BUSINESS WIRE)-- Regulatory News:

Disclaimer: Intended for international media and investor audiences only

Ipsen (Euronext: IPN; ADR: IPSEY) reports that the U.S. Food and Drug Administration (FDA) has today announced its decision to postpone the planned Endocrinologic and Metabolic Drugs Advisory Committee meeting for investigational palovarotene until a later date to be confirmed. The original advisory committee meeting was scheduled for 31 October 2022. The FDA informed Ipsen that the postponement relates to an FDA request for new information on palovarotene clinical trial data and does not relate to the safety profile of palovarotene. The company is currently working to fulfil the request. We will work expediently with the FDA as we remain committed to bringing innovative treatment options to the Fibrodysplasia Ossificans Progressiva community.

ENDS

About Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,000 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com

Ipsen’s Forward-Looking Statements

The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views 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 targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. 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 healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, 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 the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s 2021 Universal Registration Document, available on ipsen.com

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For further information:

Investors

Craig Marks

Vice President, Investor Relations

+44 (0)7584 349 193

Adrien Dupin de Saint-Cyr

Investor Relations Manager

+33 6 64 26 17 49

Media

Anna Gibbins

Global Head of Franchise Communications, Rare Disease

+44 7717801900

Rachel Reiff

U.S. Head of Franchise Communications

+1 908 616 1680

Source: Ipsen

FAQ

What is the latest news regarding Ipsen's drug palovarotene?

The FDA has postponed the advisory committee meeting for palovarotene to request new clinical trial data.

When was the advisory committee meeting for palovarotene originally scheduled?

The meeting was originally scheduled for October 31, 2022.

How does the FDA's request impact Ipsen's drug development timeline?

The FDA's request for additional data could delay the approval process for palovarotene.

What is the stock symbol for Ipsen?

Ipsen's stock symbol is IPSEY.

Is the FDA concerned about the safety of palovarotene?

The FDA has stated that the postponement does not relate to the safety profile of palovarotene.