Milan, Italy – 5 April 2011 - Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, announces its financial results for the year ended 31 December 2010.
- Top-line results of a long-term study of safinamide as add-on treatment to levodopa in advanced Parkinson’s disease were announced by Newron and Merck Serono.
- CHF 3.5 million (EUR 2.7 million) were raised through a private placement to Great Point Partners, LLC, a leading US institutional investor.
- Positive outcome was reported from meetings held with the FDA and MHRA to determine the development of Newron’s novel ion channel compound, NW-3509 as an add-on to antipsychotics in patients with schizophrenia, a major psychiatric disorder which is inadequately served.
- Together with its partner, Merck Serono, Newron presented new results on safinamide at the 14th Annual meeting of the Movement Disorder Society (MDS), in Buenos Aires.
- The results seen with ralfinamide in the SERENA phase IIb/III study were reviewed by an independent US advisory Board that recommended its evaluation in other pain conditions.
- Restructuring/downsizing of operations was executed by July 1. 2010
- Scope of collaboration with Merck Serono was broadened. Two compounds were licensed to Newron for further evaluation ahead of new phase II studies.
- Newron received EUR 3.7 million as part of a EUR 5 million grant for innovative R&D by the Italian government.
Luca Benatti, CEO of Newron, said: “We are committed to the successful development and commercialization of our pipeline. Despite the setback with ralfinamide during 2010, we have much to look forward to in 2011 as our lead compound moves towards the final stages of clinical development. We have held discussions with a number of potential partners and licensors and we continue to look for opportunities to create value in the business through partnering and M&A.”
Newron is working closely with its global partner Merck Serono to conclude the clinical development of safinamide, an adjunctive treatment for Parkinson’s disease, which is in phase III trials. In November 2010, Newron and Merck Serono reported top-line results for the 18 month extension study (study 018) of a previously completed and reported six month phase III study (study 016), which confirmed the safety profile of safinamide and its effect on motor function. Although the trial did not meet the primary efficacy endpoint measuring dyskinesia after 24 months of treatment, results of the exploratory analysis of the pre-specified secondary endpoints were consistent with the effects observed in study 016. The placebo-controlled two-year study 018 showed that safinamide improved nominal motor fluctuations, parkinsonism, activities of daily living, depressive symptoms and quality of life without worsening dyskinesia.
The long-term safety data provided by the extension study 018 are part of the clinical development programme of safinamide, together with completed studies 015, 016 and 017, as well as the ongoing MOTION and SETTLE studies. This clinical programme is designed to support an application for marketing authorization of safinamide as an add-on therapy of dopamine agonist therapy in patients with early Parkinson’s disease and as an add-on to levodopa therapy in patients with advanced Parkinson’s disease. New proof-of-concept studies sponsored and conducted by Merck Serono have been initiated to evaluate the efficacy of safinamide in improving cognition in PD and reducing levodopa-induced dyskinesia.
After announcing the results of the SERENA trial, Newron’s US Advisory Board met to review all preclinical and clinical data on ralfinamide. The Board concluded that the development of ralfinamide in pain should continue based on the exciting pharmacology, the evidence of efficacy in the phase II placebo-controlled study, and the excellent safety profile seen in the SERENA trial. The Board recommended that its efficacy be evaluated in neuropathic pain conditions, especially those with a central component. Therefore, the Company has decided to keep the long term preclinical studies ongoing, which are required for a potential filing of the compound at a later point in time. Newron is currently evaluating the further development of ralfinamide in pain and psychiatric diseases.
In 2010, Newron reported the positive outcome from its Pre-IND and CTA meetings with the US FDA and the UK MHRA for NW-3509. The meetings indicated their acceptance of the pharmacological, toxicological and pharmaceutical information collected in IND enabling studies to date, as well as the proposed clinical development plan for phases I and II. Newron is close to finalising the IND application, which is expected to be filed in QII/2011.
In 2010, a significant amount of additional pharmacological work was performed, to evaluate the potential of HF0220 in ameliorating cognitive deficits in various neurodegenerative diseases. In 2011, Newron plans to perform further studies to confirm the benefits in models of stroke/trauma-induced cognitive impairment. These models are predictive of efficacy in post-stroke patients with cognitive deficits. Should these experiments confirm the efficacy of HF0220, a PoC trial could be started in 2012, conditional on sufficient funding or partnering of the compound.
Trident Pharmaceuticals, Newron’s 17% financial holding, has continued progress on completion of the necessary preclinical studies for HF1020, under development for inflammatory diseases, required for a CTA filing in the UK. Assuming acceptance of the CTA filing by the UK MHRA regulatory authority, Trident expects to start phase I safety testing in man during 2011.
Broader collaboration with Merck Serono: pruvanserin and sarizotan
In March 2011, Merck KGaA, the parent company of Merck Serono, granted a license to Newron for the development of pruvanserin and sarizotan. Pruvanserin and sarizotan are highly selective compounds for specific serotonin or dopamine receptors and modulate the activity of these neurotransmitters in the brain. Both compounds exhibit pharmacological properties and have clinical data that support further evaluation and development. Newron will assess the potential of these compounds in additional preclinical experiments prior to initiating proof of concept studies in central nervous systems (CNS) diseases.
Licence income in 2010 was EUR 0.6 million (2009: EUR 0.9 million). Research and development expenses decreased to EUR 15.9 million (2009: EUR 18,5 million), mostly as a result of the termination of the ralfinamide SERENA extension trials. This amount is net of (i) safinamide development costs of EUR 4.3 million (2009: EUR 5.2 million) incurred by Newron and fully reimbursed by Merck Serono (ii) R&D costs of EUR 0.6 million (2009: EUR 2.1 million) covered by ongoing R&D grant programmes and tax credits. The net loss was reduced to EUR 20.5 million from EUR 23.5 million in 2009, mostly due to lower R&D costs as well as a reduction of G&A costs. By restructuring the Company, the net cash used in operating actiivities has been strongly reduced to EUR 6.4 million for the second half year of 2010, excl. certain one-time restructuring payments.
In December the Company raised CHF 3.5 million (EUR 2.7 million) through a private placement to Great Point Partners, LLC, a leading US institutional investor. Cash, cash equivalents and other short term financial assets were at EUR 8.1 million at year end. In February 2011, Newron received a further EUR 3.7 million under the Italian government R&D support programme.
- Newron’s top priority is to work with Merck Serono on the successful conclusion of safinamide’s clinical trials to allow regulatory filing of safinamide in PD.
- Newron is close to finalising the IND application for NW-3509 which is expected to be filed early in QII/2011. This will be followed by the start of clinical development in man, conditional on sufficient funding or partnering of the compound.
- In 2011 Newron plans to perform further studies with HF0220 to confirm the benefits in models of stroke/trauma-induced cognitive impairment predictive of possible efficacy in post-stroke patients with cognitive deficits.
- Product development is the key goal overall in parallel with the strategy to pursue partnering and appropriate M&A opportunities. Newron is working hard on all fronts to regain value lost through the unsuccessful SERENA study.
- Newron’s financial position, with EUR 8.1 million in cash by start of 2011, EUR 3.7 million received early in 2011 from government grants, and new funds to be received from Merck Serono within short, makes us well funded through most of 2012, excluding any potential revenues from license agreements. Furthermore, Newron has access to further funds (max. CHF 27.5 million) under the equity line agreement with Yorkville Global.
Media/analyst conference call on 5 April, 11.00-12.00am CET
Luca Benatti, CEO, Ravi Anand, CMO, and Stefan Weber, CFO, will present the full year results and provide an update on the development of Newron’s R&D pipeline during a media/analyst conference call on 5 April 2011, 11.00-12.00 am CET. The conference call can be accessed via the following dial-in numbers:
Continental Europe: +41 (0) 91 610 56 00
UK: +44 (0) 203 0595 862
USA: +1 (1) 866 291 41 66
The presentation and the Annual Report, including the IFRS Consolidated Financial Statements, as well as the Italian statutory financial statements are available for download at: http://www.newron.com/presentationandfactsheet.asp.
A replay of the conference call will be available on the Company’s website (http://www.newron.com/presentationandfactsheet.asp) by April 6.
Annual Shareholders' meeting Milan, 27 April 2011 (first call)
Half year report 2011 9 September 2011
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. Phase III trials with safinamide are currently ongoing for the treatment of Parkinson’s disease (PD). As per the agreement signed with Newron in 2006, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, 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.
Luca Benatti - CEO
Phone: +39 02 6103 4 626
Phone: +44 (0) 20 7269 7187
Phone: +41 43 244 81 40
Investors and analysts
Stefan Weber - CFO
Phone: +39 02 6103 46 30
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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