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H. Lundbeck A/S. (3/27/20). "Press Release: Lundbeck Reports Headline Results from Phase IIa AMBLED study of Foliglurax in Parkinson’s Disease". Valby.

Organisations Organisation H. Lundbeck A/S
  Group Lundbeck (Group)
  Organisation 2 Prexton Therapeutics B.V.
  Group Lundbeck (Group)
Products Product foliglurax (PXT002331)
  Product 2 phase 2 study
Index term Index term Prexton Therapeutics–Lundbeck: investment, 201803– acquisition €100m upfront + €805m developm + sales milestones ANNOUNCED
Persons Person Olesen, Palle Holm (Lundbeck 201309 Head of Investor Relations)
  Person 2 Kronborg, Mads (Lundbeck 201309 Media Relations Manager)
     


> The AMBLED study did not show a statistically significant reduction in OFF time (primary endpoint) nor an improvement of dyskinesia (secondary endpoint)

> The development programme of foliglurax will be terminated

> The termination of the project will, as announced on 6 February 2020, impact the financial guidance for reported EBIT, which has been changed from a range of DKK 2.2 – 2.7 billion to a range of DKK 1.4 – 1.9 billion


H. Lundbeck A/S (Lundbeck) today announced that the phase IIa study (AMBLED) of its novel selective positive allosteric modulator of the glutamate 4 receptor (mGlu4 PAM), foliglurax, for the treatment of Parkinson's disease did not meet the primary study endpoint. There was no statistically significant difference in change from baseline in OFF time versus placebo after a 4-week treatment period. The difference in change from baseline versus placebo was 0.27h and 0.44h for the 10 and 30 mg doses (twice daily) respectively, as assessed by the Hauser diary. Neither of the foliglurax doses separated from placebo on dyskinesia (secondary endpoint). The study showed an acceptable clinical safety and tolerability profile in patients with Parkinson’s disease.

The AMBLED study is a phase IIa randomized, double-blind placebo-controlled study involving 157 subjects diagnosed with idiopathic Parkinson’s disease for at least three years, being treated with a stable regimen of levodopa-based therapy and experiencing OFF time (end-of-dose wearing off) and dyskinesia. They received either 10 mg or 30 mg foliglurax twice daily as an adjunct to levodopa for a 28-day treatment period. The primary endpoint of the study was the change from baseline in the daily awake OFF time based on subject Hauser diary entries, while dyskinesia was assessed by the change from baseline in the UDysRS score as a secondary endpoint.

Dr. Johan Luthman, EVP and head of R&D at Lundbeck said:

“We are disappointed that foliglurax did not demonstrate sufficient efficacy for patients living with Parkinson’s disease. We have made the difficult decision to discontinue the development of the foliglurax program to focus our resources on more promising programmes.”

Lundbeck is conducting additional analyses to understand the totality of the foliglurax data. The results from the study will be published in the near future following international publication guidelines.


Financial guidance

Following the negative outcome of the AMBLED study, Lundbeck has decided to write-down the full value of foliglurax of EUR 100 million (approximately DKK 750 million). The write-down will have no impact on the financial guidance for revenue, EBITDA, core EBIT or cash flow. However, the reported EBIT guidance will be changed from a range of DKK 2.2 – 2.7 billion to a range of DKK 1.4 – 1.9 billion. The write-down will be recognized through R&D costs.

Financial guidance

DKK
Previous FY 2020 guidance Revised FY 2020 guidance
Revenue 17.4 – 18.0 billion 17.4 – 18.0 billion
EBITDA 3.9 – 4.4 billion 3.9 – 4.4 billion
Core EBIT 3.5 – 4.0 billion 3.5 – 4.0 billion
Profit from operation (EBIT) 2.2 ­– 2.7 billion 1.4 – 1.9 billion


About foliglurax

Foliglurax (PTX002331/Lu AF99757) is a small molecule acting as a selective positive allosteric modulator of the metabotropic glutamate 4 receptor (mGlu4 PAM) and may restore the glutamatergic/dopaminergic dysfunctions thought to underlie motor complications in patients living with PD.

A single- and multiple-ascending oral dose phase I trial (NCT02639221) in healthy volunteers with foliglurax was successfully completed in 2016. The results showed that foliglurax appeared safe and well tolerated with a satisfactory pharmacokinetic (how the drug is processed in the body) profile.

In July 2017, Prexton (acquired in March 2018) initiated a phase IIa clinical trial (NCT03162874) with foliglurax. The trial enrolled 157 patients with Parkinson’s disease for at least 3 years, in 46 sites across six European countries (Germany, France, Austria, Spain, Italy and UK).

AMBLED was a double-blind, randomized, placebo-controlled, parallel-arm study assessed the efficacy, safety, and tolerability of foliglurax as an adjunct to levodopa-based therapy in reducing motor fluctuations in patients experiencing OFF time and dyskinesia. They received foliglurax either 10mg or 30mg twice daily for 28-day treatment period, followed by 14-day follow up period.

The primary outcome measure was the change from baseline in the daily awake OFF time (i.e. time where the treatment does not work) based on patient diary entries between the start and end of the treatment period (28 days) while dyskinesia was assessed by the change from baseline in the UDysRS score as a secondary endpoint.


About Parkinson’s disease

Parkinson’s disease is a devastating neurodegenerative disorder that leads to progressive deterioration of motor function, affecting around 6 million people worldwide with approximately 60% of patients exhibiting motor fluctuations that generally start 2–5 years after treatment initiation.

Parkinson’s disease is diagnosed upon the occurrence of the cardinal motor symptoms resting tremor, muscle rigidity (stiffness) and slowed movement (bradykinesia). The disease is characterized by the progressive degeneration (loss) of dopaminergic brain cells as well as dysfunctions (or imbalance) in other neurotransmitters systems such as the glutamatergic pathway. Current therapies, mainly aiming at replacing or mimicking dopaminergic effect, gradually loose efficacy and results in debilitating complications such as OFF time (re-emergence of PD symptoms) or uncontrolled movement (dyskinesia).


Lundbeck contacts

Investors:
Palle Holm Olesen
Vice President, Investor Relations
PALO@lundbeck.com
+45 30 83 24 26

Media:
Mads Kronborg
Senior Director, Corporate Communication
MAVK@lundbeck.com
+45 36 43 40 00


About H. Lundbeck A/S

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.


Safe Harbor/Forward-Looking Statements

The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance.

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.

Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made considering past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.


H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Denmark
+45 3630 1311
info@lundbeck.com

   
Record changed: 2020-04-01

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