Business Wire

Ipsen and IRLAB Enter Exclusive Worldwide Licensing Agreement Aimed to Improve the Lives of People Living with Parkinson’s Disease

Share

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210715005854/en/

Disclaimer: Intended for international media and investor audiences only

Ipsen (Euronext: IPN; ADR: IPSEY) and IRLAB (Nasdaq Stockholm; IRLAB A) today announced the signing of a licensing agreement, providing Ipsen exclusive worldwide development and commercial rights to mesdopetam, a novel dopamine D3-receptor antagonist. Mesdopetam is being assessed in Phase IIb clinical trials as a potential treatment option for people living with Parkinson’s disease (PD) experiencing levodopa-induced dyskinesia (LID). It is estimated that approximately 40-50 percent of people living with PD will experience LID after five years of initiating dopamine replacement therapy. LID currently has limited treatment options.2,3,4 Mesdopetam is also in early development for Parkinson’s Disease Psychosis (PDP), which is a common symptom of PD; around 50 percent of people with PD eventually develop such symptoms over the course of their disease.5

PD is a common, progressive neurodegenerative condition affecting more than 10 million people worldwide.6 PD affects nerve cells in the brain that control movement and affects patients differently; the most common motor symptoms however are tremor, muscle rigidity and slowness of movement. People living with PD also experience other problems not related to movement including anxiety, pain and depression.7 Symptoms of PD are most commonly managed by medicines, such as levodopa that aim to compensate for the loss of dopaminergic neurons. A common side effect of levodopa is dyskinesia, involuntary and erratic movements of the face, arms, legs or trunk.8 For many people, dyskinesias can be so severe that they interfere with normal functioning.9 Mesdopetam has also shown antipsychotic properties in preclinical studies.

Dr Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen, said “We are excited to enter this licensing agreement with IRLAB. By working in partnership, we aim to bring investigational mesdopetam to people living with Parkinson’s disease experiencing levodopa-induced dyskinesia. We are delighted to strengthen our pipeline and deepen our commitment to the neuroscience community around the world, including to patients living with this debilitating neurodegenerative disorder.”

Dr Nicholas Waters, CEO of IRLAB, said “We believe in the potential of investigational mesdopetam for people with Parkinson’s disease experiencing dyskinesia or psychosis. We have purposefully worked to find a partner to pursue the late-stage clinical development of mesdopetam to commercialization and launch on a global market. Ipsen shares the broad vision for mesdopetam and the commitment to people with neurological disorders. We are very excited to enter the final steps of the journey to market in collaboration with Ipsen. Additionally, we are proud of the accomplishment this important collaboration represents. The agreement and partnership with Ipsen is a validation of our proprietary discovery platform, ISP, and our drug development efforts. This deal is one of the larger deals struck in the Swedish biotech space in decades, which is a merit for all of us at IRLAB and to those who have supported the mesdopetam project to reach this milestone.”

Under the terms of the agreement, IRLAB will be eligible to receive up to $363m, including an upfront cash payment of $28m and up to $335m in development, regulatory and commercial milestones. IRLAB is also eligible to receive tiered low double-digit royalties on worldwide net sales of mesdopetam. The transaction does not impact Ipsen’s financial guidance for 2021.

This information is information that IRLAB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 15 July 2021, 17:45 CET.

ENDS

About mesdopetam
Mesdopetam (IRL790) is a dopamine D3-receptor antagonist being developed to prevent and treat levodopa-induced dyskinesias (LIDs), a severe form of troublesome involuntary movements commonly occurring in Parkinson’s disease (PD). Mesdopetam is also in development for the treatment of psychosis in Parkinson’s (PDP). In clinical studies, mesdopetam reduces time spent with troublesome dyskinesia and thereby increases daily ‘good ON-time’ in patients with Parkinson’s. Preclinical studies show that mesdopetam is a potent and efficacious antidyskinetic, and that mesdopetam also has the potential to prevent the development of dyskinesia. In addition, mesdopetam has shown antipsychotic properties in preclinical studies.

About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience; it also has a well-established Consumer Healthcare business. With Total Sales of over €2.5bn in FY 2020, Ipsen sells more than 20 medicines in over 115 countries, with a direct commercial presence in more than 30 countries. 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 c.5,700 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.

About IRLAB
IRLAB is a Swedish research and development company that focuses on developing novel treatments in Parkinson’s disease. The company's most advanced candidates, mesdopetam (IRL790) and pirepemat (IRL752), have completed Phase IIa studies and are designed to treat some of the most difficult symptoms related to Parkinson's disease: involuntary movements (PD-LIDs), psychosis (PDP) and symptoms linked to cognitive decline such as impaired balance and increased risk of falls (PD-Falls). Through the proprietary research platform, ISP (the Integrative Screening Process), IRLAB discovers and develops unique drug candidates for central nervous system (CNS)-related disorders where large and growing medical needs exist. In addition to the clinical candidates, the ISP platform has also generated several CNS programs that are now in preclinical phase. IRLAB is listed on Nasdaq Stockholm Main Market. More information on www.irlab.se.

Ipsen’s Forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on the Group’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 the Group’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 the Group’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 the Group. 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 product 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. The Group must face or might face competition from generic products 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 the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical 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 product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product 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 health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group'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 the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group 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 the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group 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. The Group’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 the Group’s 2020 Registration Document, available on ipsen.com.

References

1 NCT04435431 https://clinicaltrials.gov/ct2/show/NCT04435431
2 Ahlskog JE, & Muenter MD (2001) Frequency of levodopa- related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord, 16, 448-458
3 Holloway RG, Shoulson I, Fahn S, Kieburtz K, Lang A, Marek K, McDermott M, Seibyl J, Weiner W, Musch B, Kamp C, Welsh M, Shinaman A, Pahwa R, Barclay L, Hubble J, LeWitt P, Miyasaki J, Suchowersky O, Stacy M, Russell DS, Ford B, Hammerstad J, Riley D, Standaert D, Wooten F, Factor S, Jankovic J, Atassi F, Kurlan R, Panisset M, Rajput A, Rodnitzky R, Shults C, Petsinger G, Waters C, Pfeiffer R, Biglan K, Borchert L, Montgomery A, Suther- land L, Weeks C, DeAngelis M, Sime E, Wood S, Pantella C, Harrigan M, Fussell B, Dillon S, Alexander-Brown B, Rainey P, Tennis M, Rost-Ruffner E, Brown D, Evans S, Berry D, Hall J, Shirley T, Dobson J, Fontaine D, Pfeiffer B, Brocht A, Bennett S, Daigneault S, Hodgeman K, O’Connell C, Ross T, Richard K, & Watts A (2004) Pramipexole vs levodopa as initial treatment for Parkinson disease: A 4- year randomized controlled trial. Arch Neurol, 61, 1044- 1053.
4 Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, & Lang AE (2000) A five-year study of the incidence of dyskinesia in patients with early Parkinson’s disease who were treated with ropinirole or levodopa. 056 Study Group. N Engl J Med, 342, 1484-1491.
5 Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. A 12-year population-based study of psychosis in Parkinson’s disease. Arch Neurol. 2010;67:996-1001
6 Marras, C., Beck, J. C., Bower, J. H., Roberts, E., Ritz, B., Ross, G. W., Abbott, R. D., Savica, R., Van Den Eeden, S. K., Willis, A. W., Tanner, CM, on behalf of the Parkinson’s Foundation P4 Group (2018). Prevalence of Parkinson’s disease across North America. Npj Parkinson's Disease, 4(1), 1–7
7 The European Parkinson’s Disease Association (EPDA). About Parkinson’s Disease. https://www.epda.eu.com/about-parkinsons/what-is-parkinsons/
8 American Parkinson’s Disease Association. What is Dyskinesia. https://www.apdaparkinson.org/what-is-parkinsons/treatment-medication/medication/dyskinesia/
9 Parkinson’s Foundation. Understanding Parkinson’s, Movement Disorders, Dyskinesia. https://www.parkinson.org/Understanding-Parkinsons/Symptoms/Movement-Symptoms/Dyskinesia

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Ipsen’s
Investors
Craig Marks
Vice President, Investor Relations
+44 7584 349 193

Media
Jess Smith
Senior Director, Global Communications, R&D and Business Development
+44 7557 267 634

Adrien Dupin de Saint-Cyr
Investor Relations Manager
+33 6 64 26 17 49

IRLAB’s contacts
Nicholas Waters
Chief Executive Officer
+46 730 75 77 01

Viktor Siewertz
Chief Financial Officer
+46 727 10 70 70

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Blackstone and Hudson Pacific Properties Announce Plans for New World-Class Film and TV Studios in the UK2.8.2021 09:00:00 CEST | Press release

Blackstone (NYSE: BX) and Hudson Pacific Properties (NYSE: HPP) plan to create a major new centre for film, TV and digital production in Broxbourne, Hertfordshire. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210802005278/en/ Artist Impression No. 1 (Photo: Business Wire) Funds managed by Blackstone Real Estate Partners and Hudson Pacific Properties acquired a 91-acre site, 17 miles north of central London, through a joint venture for £120 million. The acquisition, with an expected total investment of over £700 million, will be the partners’ first expansion of their Sunset Studios platform outside of the US. The proposed development, which is subject to planning permission, would transform the site into one of the largest world-class film and television studio campuses. The project is expected to create over 4,500 permanent jobs for Broxbourne and the surrounding community and contribute more than £300 million annually int

AMICOGEN Inc. and Lysando AG Bring Partnership to the Next Level With Ownership Participations in Each Other’s Companies2.8.2021 08:00:00 CEST | Press release

South Korean KOSDAQ listed AMICOGEN Inc. will become the latest shareholder in Lysando AG. The transaction includes an acquisition of shares, a cash contribution to Lysando and a share package to Lysando into AMICOGEN. The deal means an 8% participation of AMICOGEN into Lysando and 2.69% in shares for Lysando into AMICOGEN. The transactions were negotiated with a 300 Mio. Euro evaluation of Lysando. Other shareholders of Lysando continue to be majority owner and Chairman of the Board Markus Graf Matuschka von Greiffenclau, Bangkok based SCG, and Lysando’s employees. The companies have already a productive partnership in place, based on Lysando´s leading platform Artilysin®. It is a globally patented, sustainable and highly effective technology, fighting resistance of microbes, as an alternative to antibiotics and other antimicrobial treatments. „I am very happy and proud to welcome AMICOGEN as a new shareholder of Lysando. AMICOGEN being such a strong and successfully operating CDMO, A

Leicester’s Hospitals Awards Deenova a Unit Dose Pharmacy Automation 15 Year Contract2.8.2021 08:00:00 CEST | Press release

Deenova reported today it signed its first ever contract in the United Kingdom, and established operations in Europe’s second largest GDP health care market, with the NHS being the eight largest employer in the world. Deenova was selected by University Hospitals of Leicester NHS Trust as the best solution amongst 8 of Deenova's competitors in United Kingdom and the United States of America. Claire Ellwood, chief pharmacist at University Hospitals of Leicester NHS Trust, said: “We’re proud to be working with Deenova to deploy the first unit dose closed loop medicines management system in the UK. Every year, we administer millions of medication doses so it’s vital our processes are as safe and efficient as possible. The partnership with Deenova will increase automation within our medication processes helping to reduce errors and wastage as well as freeing up staff time for other care and tasks. After a successful pilot, we are pleased to start planning the roll out across our three hospi

Ipsen and Exicure Enter Into Exclusive Collaboration Targeting Rare Neurodegenerative Disorders2.8.2021 07:00:00 CEST | Press release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210801005028/en/ Disclaimer: Intended for international media and investor audiences only Ipsen (Euronext: IPN; ADR: IPSEY) and Exicure Inc. (NASDAQ: XCUR) have signed an exclusive collaboration agreement to research, develop, and commercialize novel Spherical Nucleic Acids (SNAs) as potential investigational treatments for Huntington’s disease and Angelman syndrome. Oligonucleotides are synthetic structures of nucleic acids that can be used to modulate gene expression via a range of processes, including gene activation, inhibition, and splice-modulation. These molecules have demonstrated potential in many different therapeutic areas.1 Achieving efficient oligonucleotide delivery to target organs and tissues, including the brain, remains a major limitation to their use.1,2 Exicure’s SNAs provide distinct chemical and biochemical properties to oligonucleotides. I

Arqit Releases QuantumCloud™ to Deliver Stronger, Simpler Encryption2.8.2021 06:20:00 CEST | Press release

Arqit Limited (“Arqit”), a leader in quantum encryption technology announces the release of the first version of its service, QuantumCloud™ 1.0. This Platform‑as‑a‑Service software enables customers to secure the communications channels and data of any cloud, edge or end-point device. The service combines transformational and unique advances in both quantum and classical cryptography. The release of QuantumCloud™ 1.0 allows customers to secure devices globally by providing a strong device authentication capability, over which is layered the agreement of symmetric keys between authenticated and authorised devices. Importantly, since there are no asymmetric cryptographic primitives used within the trustless key agreement protocol, the keys can be regarded as safe against future attack using Shor’s algorithm running on a quantum computer. A range of other features will be added in future quarters, culminating in the launch of Arqit’s proprietary quantum satellites, which is targeted for 2

Arqit Registration Statement Related to Business Combination With Centricus Acquisition Corp. Declared Effective By SEC2.8.2021 06:04:00 CEST | Press release

Arqit Limited (“Arqit”), a leader in quantum encryption technology today announced the Registration Statement on Form F-4 in connection with the previously announced business combination (the “Business Combination”) with Centricus Acquisition Corp. (“Centricus”) (Nasdaq: CENHU, CENH, CENHUW), a publicly-listed special purpose acquisition company, has been declared effective by the Securities and Exchange Commission (the “SEC”). Upon closing, the ordinary shares and warrants of Arqit Quantum Inc., a company formed for purposes of completing the Business Combination, will be listed on NASDAQ under the new ticker symbols “ARQQ” and “ARQQW.” The boards of directors of Arqit and Centricus have unanimously approved the Business Combination, and Centricus has set 9:00 a.m. ET on August 31, 2021 as the time and date for an extraordinary general meeting of shareholders to approve the proposals associated with the Business Combination. The proxy statement/prospectus contains important informatio

Takeda Receives Decision by the Irish Tax Appeals Commission Relating to Tax Assessment on Break Fee Shire Received from AbbVie2.8.2021 01:30:00 CEST | Press release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the receipt of a decision by the Irish Tax Appeals Commission on July 30, 2021 (IST) to uphold the Irish Revenue Commissioners’ position related to the treatment of a break fee received by Shire plc (“Shire”) in October 2014 from AbbVie Inc. (“AbbVie”). Shire was acquired by Takeda in January 2019. Takeda intends to challenge this outcome through all available legal means including appealing the decision to the Irish courts. On November 28, 2018, Shire received a tax assessment from the Irish Revenue Commissioners for 398 million EUR. This assessment sought to tax a 1,635 million USD break fee Shire received from AbbVie in connection with the terminated offer to acquire Shire made by AbbVie in 2014. Takeda appealed this assessment, and in late 2020 a hearing took place before the Irish Tax Appeals Commission. While Takeda is continuing to assess the substance of the decision, the company will record a

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom