Zambon and US Worldmeds partner to bring Newron Pharmaceuticals’ Parkinson’s disease treatment Xadago® (safinamide) to the U.S.

  • Xadago® (safinamide) is already approved in the EU and Switzerland, under review by the U.S. Food and Drug Administration
  • Drug candidate has potential to assist the more than one million Americans living with Parkinson's

Milan, Italy – March 17, 2016 – Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, today announced a strategic agreement with US WorldMeds to commercialize Newron’s lead compound, Xadago® (safinamide), for the treatment of Parkinson’s disease in the U.S.

Zambon S.p.A. holds the global marketing rights for safinamide with the exception of Japan/Asia and has recently begun the commercialization of safinamide under the trade name Xadago® in the EU and Switzerland. The New Drug Application (NDA) for safinamide has been accepted for review by the U.S. Food and Drug Administration (FDA).

We are really pleased to have signed this agreement for Xadago® with US WorldMeds” said Maurizio Castorina, CEO of Zambon S.p.A “It will help Zambon to fulfill the promise of bringing Xadago to patients with Parkinson’s disease in the United States and highlights once again our commitment to the CNS therapeutic area”.

Under the terms of the U.S. sub-licensing agreement, US WorldMeds will pay Zambon upfront, regulatory and commercial milestone payments as well as royalties on product sales. Newron Pharmaceuticals will receive from Zambon a milestone payment upon FDA approval and a share of upfront, milestones and royalty payments made by US WorldMeds to Zambon. Newron has been the sponsor of the clinical development for safinamide in all major countries of the world excluding Japan. US WorldMeds plans to focus more than 60 sales representatives launching Xadago in the U.S.

US WorldMeds is thrilled to partner with Zambon and looks forward to introducing Xadago® in the U.S.” said P. Breckinridge (“Breck”) Jones, CEO of US WorldMeds. “Parkinson’s disease has been a significant area of focus for our company for many years, and we look forward to leveraging our expertise in helping bring an exciting, new treatment option to the more than one million Americans with this condition.

Marketing authorization in the EU for safinamide was granted by the EU Commission in February 2015, and by Swissmedic in November 2015. Xadago® has been launched by Zambon in Germany, Spain and Italy, as well as in Switzerland. The New Drug Application (NDA) for safinamide has been accepted for review by the FDA with a PDUFA date of March 29, 2016.

With US WorldMeds’ focus on and knowledge of Parkinson’s disease, we are confident that patients in the U.S. will have access to another innovative treatment option rapidly once Xadago® is approved” said Stefan Weber, CEO of Newron Pharmaceuticals.

About Xadago® (safinamide)

Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect also in the long term (over 2 years). Results from long-term (24 months) double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways.
Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. The New Drug Application (NDA) forXadago® to the US FDA was accepted for filing by the US FDA, PDUFA date is March 29, 2016. Zambon has the rights to develop and commercialize Xadago® globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and commercialize the compound.

References:

  • Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. Borgohain, Rupam; Szasz, Jozsef; Stanzione, Paolo; Meshram, Chandrashekhar; Bhatt, Mohit H et al. (2014)
  • Movement disorders : official journal of the Movement Disorder Society vol. 29 (10) p. 1273-80.
  • Anand R: Safinamide is associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa (SETTLE). 17th International Congress of Parkinson’s Disease and Movement Disorders, Sydney, Australia, June 16-20, 2013.

About Parkinson’s disease

Parkinson’s disease is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals aged ≥ 65 years worldwide. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. The diagnosis of PD is mainly based on observational criteria of muscular rigidity, resting tremor, or postural instability in combination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on L-dopa. L-dopa remains as the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitating motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, many patients experience involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the disease progresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symptoms while managing LID and the “off-time” effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopaminergic transmission that leads to amelioration of motor symptoms. There is a growing belief that targeting non-dopaminergic systems may lead to improvements in PD symptoms such as dyskinesia that are not improved by current dopaminergic therapies.

References:

  • BMC Oertel. European Handbook of Neurological Management, Vol1, Chapter 14 & 15, 2011.
  • NICE PD guideline, 2006.

About Zambon

Zambon is a leading Italian pharmaceutical and fine-chemical multinational company that has earned a strong reputation over the years for high quality products and services. Zambon is well-established in 3 therapeutic areas: respiratory, pain and women’s care, and is very strongly committed to its entry into the CNS space. Zambon S.p.A produces high quality products thanks to the management of the whole production chain which involves Zach (Zambon chemical), a privileged partner for API, custom synthesis and generic products. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 15 countries with subsidiaries and more than 2,600 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 73 countries.

For details on Zambon please see: www.zambongroup.com

About US WorldMeds

US WorldMeds is a specialty pharmaceutical company dedicated to developing, licensing and commercializing unique and significant specialty pharmaceuticals that address unmet medical needs or overcome limitations of existing products. Through sound science and targeted commercialization, the Kentucky-based company continually strives to identify specialty and orphan products for diseases with limited patient populations. US WorldMeds’ portfolio includes Revonto® (dantrolene sodium for injection) for the treatment of malignant hyperthermia, MYOBLOC® (rimabotulinumtoxinB) Injection for the treatment of cervical dystonia in adults and APOKYN® (apomorphine hydrochloride injection) for the acute, intermittent treatment of hypomobility, "off" episodes associated with advancing Parkinson's disease. In addition, US WorldMeds is working on the development of a non-narcotic drug product (Lofexidine) for the treatment of opiate withdrawal symptoms. For more information about US WorldMeds, visit www.usworldmeds.com.

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. Marketing authorization in the EU for Xadago® (safinamide) for the treatment of Parkinson’s disease was granted by the EU Commission in February 2015, followed by Swissmedic’s marketing authorization for Switzerland in November 2015. The drug has been launched by Newron’s partner Zambon in the first key EU countries Germany, Spain and Italy, as well as in Switzerland. The New Drug Application (NDA) has been accepted for review by the FDA, PDUFA date March 29, 2016. Zambon has the rights to develop and commercialize safinamide globally, excluding Japan and other key Asian territories, where Meiji Seika has the rights to develop and commercialize the compound. Newron’s additional projects are based on highly promising treatments for rare disease patients and are at various stages of clinical development. They include Sarizotan for patients with Rett Syndrome, for which Newron received Orphan Drug Designation in both the US and the EU, ralfinamide for patients with specific rare pain indications, and NW-3509 as potentially the first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

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Media
Investors and Analysts

Zambon
Luca Primavera - CCO
Phone: +39 02 66524491
Mobile: +39 335 7247417
Email: luca.primavera@zambongroup.com

Italy
Milva Naguib
Phone: +39 02 66524095
Mobile: +39 3459215675
Email: milva.naguib@zambongroup.com

US WorldMeds
P. Breckinridge Jones – CEO
Phone: +1 502.815.8101
Email: pbj@usworldmeds.com

Newron
Stefan Weber - CEO
Phone: +39 02 6103 46 30
E-mail: ir@newron.com

UK/Europe
Julia Phillips
FTI Consulting
Phone: +44 (0)20 3727 1000

Switzerland
Martin Meier-Pfister
IRF Communications
Phone: +41 43 244 81 40

Germany
Anne Hennecke
MC Services AG
Phone: +49 211 52925222
E-mail: anne.hennecke@mc-services.eu

U.S.
Alison Chen
LaVoieHealthScience
Phone: +1 617 374 8800, Ext. 104
E-mail: achen@lavoiehealthscience.com

Newron
Stefan Weber - CEO
Phone: +39 02 6103 46 30
E-mail: ir@newron.com