— Global Regulatory Filings including results from ongoing pivotal studies
SETTLE and MOTION on schedule —
Milan, Italy, October 21, 2011 – Newron Pharmaceuticals S.p.A. (“Newron”), a research
and development company focused on novel CNS and pain therapies, announced today
that Merck Serono, a division of Merck KGaA, Darmstadt Germany, is
returning global rights to safinamide to Newron effective in 180 days. The decision by
Merck Serono is due to strategic considerations and re-prioritization of its R&D pipeline,
and is not based on any new efficacy or safety findings with safinamide.
Based on the agreement signed in 2006, Merck Serono has confirmed that it will meet its
contractual and ethical commitments regarding the ongoing clinical development
program for safinamide until April 2012.
Based on the previously reported completion of enrolment of the Phase III MOTION and
SETTLE trials, these studies are scheduled to report results in first half of next year.
These two trials have been set up to complete the planned Phase III development of
safinamide as an adjunctive treatment for Parkinson’s disease that was the basis for the
registration programme agreed upon with health authorities in key world markets. Merck
Serono will work with Newron to execute an appropriate transfer of the program to
The collaboration of Merck Serono and Newron on pruvanserin and sarizotan continues.
Newron will now re-assess all the opportunities for safinamide including re-partnering the
compound at some stage. Ownership of global commercial rights for safinamide could
provide Newron the option to pursue marketing of this new chemical entity for
Parkinson’s disease in selected territories, as well.
On 27 September Newron announced its intention to merge with Biotie Therapeutics.
Both companies will evaluate this new opportunity.
Further announcements will be made in due course.
Safinamide is an alpha-aminoamide that is currently being developed by Merck Serono and
Newron as an add-on therapy to dopamine agonists or levodopa in patients with early or latestage
Parkinson’s disease. It is believed to have both dopaminergic and non-dopaminergic
activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity2
dependent sodium channel antagonism and inhibition of glutamate release in vitro. Studies are
ongoing to better understand safinamide’s actions in patients with Parkinson’s disease.
About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on
novel therapies for diseases of the Central Nervous System and pain. Newron is undertaking
phase III trials with safinamide for the treatment of Parkinson’s disease (PD) in conjunction with
its partner, Merck Serono, which has exclusive worldwide rights to develop, manufacture and
commercialize the compound in PD, Alzheimer’s disease, and other therapeutic applications.
Newron is currently evaluating the further clinical development of ralfinamide for pain and
psychiatric diseases. Newron’s additional projects are at various stages of preclinical and clinical
development, including HF0220 for neuroprotection and NW-3509 for the treatment of
schizophrenia. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at
SIX Swiss Exchange, trading symbol NWRN.
For more information, contact:
Media Investors and analysts
Luca Benatti – CEO
Phone: +39 02 6103 4 626
Phone: +44 (0) 20 7269 7187
Phone: +41 43 244 81 40
Stefan Weber – CFO
Phone: +39 02 6103 46 30