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Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, is pleased to note the news from its partner Zambon S.p.A., that it has entered into a long-term partnership with Seqirus covering Zambon’s Parkinson’s disease product (Xadago®) in Australia and New Zealand. Zambon will be responsible for product supply and Seqirus will undertake registration and commercialisation of the product.

The full text of the announcement from Zambon and Seqirus is as follows:

Seqirus and Zambon in partnership for Parkinson’s Disease product in Australia and New Zealand

• Seqirus and Zambon announce a partnership in Australia and New Zealand that grants Seqirus exclusive rights to commercialise Zambon’s Parkinson’s disease product, licensed from Newron
• Partnership reinforces Zambon commitment to developing and bringing innovative central nervous system (CNS) options to patients

Melbourne, Australia: Zambon and Seqirus today announced that they have entered into a long term partnership covering Zambon’s Parkinson’s Disease product, in Australia and New Zealand. Zambon will be responsible for product supply and Seqirus will undertake registration and commercialisation of the product.

Parkinson’s Disease is one of the most common neurological illnesses in Australia, with approximately 70,000 Australians living with Parkinson’s.¹ It is a chronic, progressive, incurable, complex and disabling neurological condition that affects people from all walks of life. Parkinson’s is categorised by clinicians as a “movement disorder” but in many cases it results in impaired speech and various mental health issues, such as depression and problems with memory and sleep.¹

The collaboration with Zambon consolidates Seqirus’ position of being a leading in-licensing partner in the Australian and New Zealand market.

“We recognise that access to more therapy options is very important to Australian healthcare professionals and Parkinson’s sufferers,” said Seqirus’ VP Commercial Operations, Dr Lorna Meldrum. “We are delighted to work with Zambon for the distribution, marketing and sales of Zambon’s Parkinson’s product which is an important addition to Seqirus’ growing product range and further strengthens our broad portfolio of in-licensed medicines in Australia,” she said.

Roberto Tascione, CEO of Zambon said “Expanding the reach of Zambon’s products by entering new growth markets is an important part of our strategy. Seqirus is an attractive partner being a large local pharmaceutical company in Australia with a prominent track record in neurology. Australia and New Zealand are markets with resilient economies, substantial disease prevalence and established Parkinson’s Disease markets.”

¹ Deloitte Access Economics, Living with Parkinson’s Disease, An updated economic analysis

About Parkinson’s disease (PD)

PD 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 PD is expected to grow in the next few 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 (slow movement). 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.

References:

BMC Oertel. European Handbook of Neurological Management, Vol1, Chapter 14 & 15, 2011.

NICE PD guideline, 2006.

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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 over 2 years. Results from 24 month 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. 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. The rights to develop and commercialize Xadago® in the USA have been granted to US WorldMeds, by Zambon.

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 Seqirus

Seqirus is a global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus also in-licenses a range of pharmaceutical products from partner companies to ensure a comprehensive range of products are available to meet the needs of many Australians. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity, and a commercial presence in approximately 20 countries.

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 woman 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. The Group is strongly working on the treatment of the chronic respiratory diseases as asthma and BPCO and on the CNS therapeutic area with Xadago® (safinamide) for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 19 countries with subsidiaries and almost 2,700 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 84 countries.

For details on Zambon please see: www.zambongroup.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. In addition to Xadago® for Parkinson’s disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development. For more information, please visit: www.newron.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements.

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