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

  • Ipsen obtains the exclusive worldwide rights to develop and commercialize the investigational treatment mesdopetam which is based on a novel mechanism of action
  • Mesdopetam, an oral dopamine D3-receptor antagonist, has completed Phase Ib and IIa clinical programs which showed promising improvements for people living with Parkinson’s disease experiencing levodopa-induced dyskinesia (LID) in clinically relevant endpoints
  • IRLAB will continue to be responsible for the ongoing Phase IIb trial.1 Ipsen will initiate Phase III preparatory activities, and is responsible for all remaining clinical development and worldwide commercialization
  • IRLAB is eligible to receive up to $363m, including a $28m upfront payment and up to $335m in potential development, regulatory and sales-based milestones, plus tiered low double-digit royalties on worldwide net sales

PARIS, France & GOTHENBURG, Sweden I July 15, 2021 I 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.

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.

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

SOURCE: Ipsen

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