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H. Lundbeck A — M&A Activity 2018
Mar 16, 2018
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Download source file-- Lundbeck will make an upfront payment of EUR 100 million and the deal terms
also include up to EUR 805 million in development, regulatory and sales
milestones
-- Foliglurax is a first-in-class treatment which entered clinical phase II
testing in Parkinson’s disease in July 2017
-- There remains a large unmet need for effective treatments for Parkinson’s
patients to sustain the utility of dopaminergic therapies
Valby, Denmark, Oss, The Netherlands, 16 March 2018 - H. Lundbeck A/S
(Lundbeck) and Prexton Therapeutics BV (Prexton) today announced signing of a
definitive agreement in which Lundbeck will acquire Prexton. Under terms of the
agreement, Lundbeck will pay EUR 100 million (approximately DKK 750 million)
upfront and is furthermore required to later pay up to EUR 805 million
(approximately DKK 6 billion) in development and sales milestones to the group
of current owners.
By acquiring Prexton, Lundbeck will obtain global rights of an attractive
compound (foliglurax) which currently is in clinical phase II testing for
symptomatic treatment of OFF-time reduction in Parkinson’s disease and
dyskinesia including Levodopa Induced Dyskinesia (LID). First data from the
ongoing clinical phase II programme is expected to be available during the
first half of 2019.
"By acquiring Prexton, Lundbeck will obtain global rights to foliglurax, an
exciting first-in-class compound, and gain full control of the asset," said
Anders Götzsche, interim CEO and CFO at Lundbeck. "Foliglurax addresses high
unmet needs with its potential indication in Parkinson’s fitting perfectly
within Lundbeck’s core areas and this treatment option also appears to be
highly interesting for patients, physicians and payors."
Foliglurax works by stimulating a specific glutamatergic target (mGluR4) which
activates a compensatory neuronal system in the brain which is largely
unaffected in Parkinson’s disease. Animal models have convincingly demonstrated
positive effects in models of Parkinson’s disease. The aim is to treat the
motor symptoms of Parkinson’s disease, such as resting tremor, muscle rigidity
and uncontrolled movements (dyskinesia).
Deal terms
Lundbeck will pay EUR 100 million upfront to the current investors of Prexton
Therapeutics BV. Furthermore, Lundbeck is required to pay up to EUR 805 million
in development, regulatory and sales milestones depending on successful outcome
of certain undisclosed milestones. More than half of the EUR 805 million is
connected to sales milestones.
Financial guidance
The content of this release will have no influence on Lundbeck's financial
guidance for 2018, which was provided on 7 February 2018. The upfront payment
will be capitalized in the balance sheet as an intangible asset and tested for
impairment annually or whenever there is indication of impairment.
About Prexton
Prexton is a biopharmaceutical company founded in 2012 by Francois Conquet and
M Ventures, the corporate venture arm of Merck KGaA, their entrepreneurial
partnership program, which supports the creation of spin-offs from Merck.
Prexton applies a new scientific approach that fully integrates molecular,
behavioral and chemistry technologies to address Parkinson’s disease and other
brain disorders. Prexton is based in Oss (The Netherlands) and in Geneva
(Switzerland). Other major investors include Forbion, Seroba Life Sciences,
Sunstone Capital and Ysios Capital.
About foliglurax
Foliglurax (PTX002331) is a small-molecule positive allosteric modulator of
group III metabotropic glutamate receptor 4 (mGluR4 PAM), for the potential
oral treatment of Parkinson's disease.
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 appears well-tolerated with a satisfactory
pharmacokinetic (how the drug is processed in the body) profile.
In July 2017, Prexton initiated a phase II clinical trial (NCT03162874) with
foliglurax. The trial will enroll around 165 Parkinson’s patients in sites
across six European countries (U.K., Germany, France, Austria, Spain, and
Italy). The double-blinded, randomized, placebo-controlled, parallel-arm study
will assess the effectiveness, safety, and tolerability of foliglurax in
reducing motor complications of levodopa therapy in patients experiencing
end-of-dose wearing-off and levodopa-induced dyskinesia.
Two groups will receive oral doses (10 mg and 30 mg) of the treatment over 28
days, in addition to their standard medication, incl. levodopa. A third group
will receive placebo. The primary outcome measure will be the change 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 treatment. The study is
expected to be completed in 2019.
About Parkinson’s disease
Parkinson’s is a devastating progressive neurological condition affecting
around 6 million people worldwide. The disease is caused by the degeneration of
dopaminergic brain cells. The main motor symptoms are resting tremor, muscle
rigidity, and slowed movement (bradykinesia). Uncontrolled movements
(dyskinesia) is a debilitating complication to levodopa use.
Current treatments aim to replace dopamine or to mimic its effects. Patients
are administered with the dopamine precursor levodopa. This treatment provides
adequate symptomatic relief initially, but over time, it loses efficacy as the
disease progresses and patients experience serious debilitating, complications,
such as increased OFF time and dyskinesia.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Vice President, Investor Relations Senior Director, Corp. Communication
[email protected] [email protected]
+45 30 83 24 26 +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 psychiatric and neurological disorders. For more than 70 years,
we have been at the forefront of research within neuroscience. Our key areas of
focus are Alzheimer's disease, depression, Parkinson's disease and
schizophrenia.
Our approximately 5,000 employees in 55 countries are engaged in the entire
value chain throughout research, development, manufacturing, marketing and
sales. Our pipeline consists of several late-stage development programmes and
our products are available in more than 100 countries. We have production
facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.2
billion in 2017 (EUR 2.3 billion; USD 2.6 billion).
For additional information, we encourage you to visit our corporate site
www.lundbeck.com and connect with us on Twitter at @Lundbeck.
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 taking into account 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.