Newron

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avion65

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Credo che un entrata leggera non sia male a questo punto.... non credi? :D
 

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Pacifico
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Credo che un entrata leggera non sia male a questo punto.... non credi? :D

Non so spiegarmi il motivo del rialzo di oggi e dei giorni scorsi; siamo in ritardo sulla fase clinica III dell'evenamide e il titolo schizza in alto; davvero strano.
 

avion65

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A meno che non siano così in ritardo sulla fase III .....:cool:
 

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Pacifico
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Anche oggi vola; non so darmi spiegazioni in merito.
 

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Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients

Final study data intended to support the initiation of Newron’s planned phase III pivotal trial program for evenamide

Milan, Italy and Morristown, NJ, USA, January 21, 2021 - Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the completion of enrollment for its explanatory study 008 with evenamide in patients with schizophrenia.

Results from the four-week, randomized, double-blind placebo-controlled study are expected in March 2021. Explanatory study 008 is designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed doses of evenamide (7.5 mg and 15 mg BID) in outpatients with chronic schizophrenia receiving treatment with one of the leading second-generation atypical antipsychotics. Enrollment to the study has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India.

The US Food and Drug Administration (FDA) requested that Newron complete additional short-term explanatory studies in rats and humans to address concerns from a study of evenamide in rats, and CNS events observed following high-dose administration of evenamide in dogs.

The data from study 008 will be a key component in the package of information to be submitted to the FDA to support the approval of the initiation of Newron’s planned phase III pivotal trial program for evenamide. Preclinical results confirming absence of toxicity have already been submitted to the FDA to support this package.

The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment-resistant schizophrenia.

Newron is currently evaluating potential options for partnering/co-developing the further development of evenamide.
 

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Pacifico
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Direi che è un buon periodo per Newron; siamo quasi a 3 €.
 

avion65

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Si sta’ navigando intorno a 3 ..... credo che tra poco possa ripartire
 

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Newron and Zambon sign agreement for potentially pivotal study with safinamide in Parkinson’s disease patients

Global study to evaluate the reduction of levodopa-induced dyskinesia (PD LID)

Milan, Italy – March 15, 2021 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system and its partner, Zambon S.p.A. (“Zambon”), an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, today announced an agreement regarding a potentially pivotal study to evaluate the efficacy of safinamide in Parkinson’s disease patients with levodopa induced dyskinesia (PD LID).

Under the agreement, Newron will sponsor the study and be responsible for its development and execution, as well as leading on all related regulatory interactions. Newron and Zambon will evenly share the cost of the study.

The double-blind, placebo-controlled study is intended to be performed in the US, Europe and Asia/Australia, with the aim of a label extension for safinamide in key markets. Safinamide has previously been approved for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa experiencing “off” episodes in 20 markets including: the European Union, Switzerland, the United Kingdom, the United States, Canada, Australia, Latin America, Israel, the United Arab Emirates, Japan and South Korea. Safinamide is commercialized by Zambon as well as Meiji Seika/Eisai. Supernus Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of products for the treatment of CNS diseases, acquired the US commercialization rights for safinamide in 2020.

Ravi Anand, CMO of Newron, said: “Previous pre-clinical and clinical studies have provided preliminary evidence of the efficacy of safinamide in reducing dyskinesia. We will be working with international clinical experts and regulatory authorities to finalize the design of a global trial to demonstrate the benefits of safinamide on dyskinesia in patients with PD.”

Paola Castellani, CMO and R&D Head of Zambon, added: “Since 2015, thousands of Parkinson’s disease patients around the world have benefited from safinamide’s safe and efficacious profile and the subsequent improvement in their motor fluctuations. We look forward to working closely with Newron to potentially provide a new treatment option for those living with PD LID, an area of huge medical need.”

Parkinson’s disease affects an estimated seven to ten million patients worldwide. More than 40% of Parkinson patients experience PD LID, involuntary, non-rhythmic and often painful movements during waking hours that are purposeless and unpredictable. Dyskinesia can interfere with people's daily living, resulting in functional impairment and disability. People with Parkinson's disease often experience multiple fluctuating periods of OFF time and dyskinesia during any given day, which can impede their movement and daily function. Currently, only one drug has ever received marketing authorization for PD LID in the US.

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 and Levodopa (L-dopa) Induced Dyskinesia (LID)

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 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, more than 40% of patients experience L-dopa-Induced Dyskinesia, involuntary and non-rhythmic movements during waking hours that are purposeless and unpredictable. Dyskinesia can interfere with people's daily living, resulting in functional impairment and disability. People with Parkinson's disease often experience multiple fluctuating periods of OFF time and dyskinesia during any given day, which can impede their movement and daily function. 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, Vol 1, Chapter 14 & 15, 2011.

NICE PD guideline, 2006.

About 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 Safinamide globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize safinamide. The rights to develop and commercialize Safinamide in the USA have been acquired by Supernus Pharmaceuticals.
 

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Newron announces 2020 financial results and provides outlook for 2021

Milan, Italy, March 16, 2021 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the year ended December 31, 2020, and provided an outlook for 2021.

Highlights 2020:

Evenamide (Schizophrenia)

All evenamide pre-clinical studies requested by the US Food and Drug Administration (FDA) have been completed with no toxicity concerns identified
Despite the COVID-19 pandemic, the Company has successfully completed enrolment for explanatory study 008 with evenamide in patients with schizophrenia, with results expected by the end of March 2021
Newron remains on track to initiate its pivotal Phase III program in Q3 2021 and continues to evaluate potential options for partnering/co-developing evenamide
Xadago®/safinamide (Parkinson’s disease)

Newron noted that Supernus Pharmaceuticals acquired the CNS portfolio of US WorldMeds, including the US rights to Xadago®/safinamide, effective June 2020
Agreement signed with Zambon for potentially pivotal study with safinamide in patients suffering from Parkinson’s disease levodopa-induced dyskinesia (PD LID)
Corporate

Newron continues to evaluate opportunities to broaden its pipeline of treatments for central and peripheral nervous system diseases
The Company received third tranche of EUR 7.5 million out of a potential EUR 40 million total funding amount under its financing agreement with the European Investment Bank (EIB)
Cash (incl. Other current financial assets) as of December 31, 2020 is EUR 31.3 million
Stefan Weber, CEO of Newron, commented:

“The onset of the COVID-19 pandemic in 2020 presented enormous challenges for societies across the world. The healthcare industry, in particular, was challenged with identifying the resources to cope with the pandemic and with finding ways to fight it. We are proud of the way that Newron has adapted to this fast-evolving situation and of our ability to continue making operational progress, despite the pandemic and the difficulties it presents. 2020 has demonstrated that Newron’s business remains resilient, and we move into 2021 and beyond confident in our strategy for the future. In addition, we enter into this year assessing a number of exciting strategic opportunities and additional compounds to expand our pipeline of novel therapies, and we will update the market accordingly.”

Evenamide

Present treatments are unsatisfactory for most people suffering from schizophrenia and some 30% of patients with schizophrenia do not respond adequately to conventional therapy. Evenamide, as potentially the first add-on therapy to currently marketed antipsychotics, holds promise to change the treatment management paradigm: improving functioning and allowing patients to continue longer on their maintenance antipsychotic treatment. This would likely translate into lower rates of relapse, thus helping reduce the personal, societal, and economic burden to patients, their families, and society. In the reporting year, Newron made significant progress with evenamide for the treatment of patients with inadequately treated or clozapine treatment-resistant schizophrenia. The additional short-term pre-clinical explanatory studies with evenamide requested by the US FDA were successfully completed, and no toxicity concerns were identified.

Additionally, Newron has initiated explanatory study 008, a clinical study designed to evaluate the safety, tolerability, electroencephalography (EEG) effects and preliminary efficacy of two fixed doses of evenamide in outpatients suffering from chronic schizophrenia receiving treatment with a second-generation atypical antipsychotic. Despite anticipated delays associated with the COVID-19 pandemic, the study was ongoing during 2020 and in January 2021, Newron announced that enrolment has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the US and India. Results from this four-week, randomized, double-blind placebo-controlled study are expected by the end of March 2021.

Newron remains on track to initiate the Phase III studies with evenamide in Q3 2021, contingent on no delays due to COVID-19 restrictions. The proposed Phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis while on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. The latter represents an orphan-like indication with approximately 25,000 patients in the US (with similar numbers in the EU).

Xadago®/safinamide

Newron’s partner Zambon had previously held discussions with the US FDA on the design of a potentially pivotal study to evaluate the efficacy of the compound in Parkinson’s disease patients with levodopa induced dyskinesia (PD LID). The intention is to perform the study in centers in the US, Europe, and Asia/Australia, aiming at a label extension for PD LID in key global markets. Given Newron’s extensive experience in the development of Xadago®/safinamide, Newron and Zambon have agreed on Newron taking responsibility for conducting the study. Zambon will remain associated with the study; Newron and Zambon will share the cost of the study equally, and Newron will qualify for a one-time milestone payment and a greater share of royalties, should the outcome of the trial lead to a label extension. Newron is currently working on finalizing the design of the study with international clinical experts and regulatory authorities.

To date, safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the United Kingdom, the United States, Canada, Australia, countries in Latin America, Israel, the United Arab Emirates, Japan and South Korea. It is commercialized by Newron’s partner Zambon, their partners, and Meiji Seika and Eisai under the brand names Onstryv® in Canada, Equfina® in Japan and South Korea, and Xadago® in the rest of the world.

Financial Key takeaways 2020:

In 2020, Newron reported a net loss of EUR 21.0 million, compared to EUR 20.2 million in 2019
Cash used in operating activities has been reduced to EUR 15.6 million from EUR 22.0 million in 2019
Xadago® royalty income increased by 10% to EUR 5.2 million versus EUR 4.8 million in 2019, when a one-time milestone payment for approval in Japan of net EUR 2.0 million was incurred, on top
Newron’s net R&D expenses have seen a reduction to EUR 14.9 million from EUR 17.4 million in 2019, largely due to the termination of the development program in Rett syndrome.
Due to substantial changes of the regulations covering the Italian R&D tax credits, the Company could only accrue an additional EUR 1.4 million in 2020 versus EUR 5.0 million in 2019. The cumulated tax credits of EUR 15.9 million can be offset with future tax and social contribution payments by Newron
In 2020, G&A expenses have been reduced to EUR 8.1 million compared to EUR 9.9 million in 2019
Cash and Other current financial assets at December 31, 2020, were at EUR 31.3 million, compared to EUR 39.2 million at the beginning of the year.
 

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Newron announces results of explanatory studies with evenamide in healthy volunteers and patients with schizophrenia

Primary objective of safety of evenamide met on all safety variables for study 010 in healthy volunteers and study 008 in patients with schizophrenia

Additional safety and efficacy study 008A in therapeutic dose (30 mg BID) to start in April 2021

Milan, Italy and Morristown, NJ, USA, April 1, 2021 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced initial results from two short-term explanatory studies in evenamide: study 010 in healthy volunteers and study 008 in patients with schizophrenia.

Results from study 010, a four-week, single dose, cross-over Thorough QT (TQT) study in 56 healthy volunteers, designed to evaluate the effects of evenamide (30 mg and 60 mg) compared with placebo and moxifloxacin 400 mg on the QT segment specifically, and on the electrocardiogram (ECG) generally, was requested by the US Food and Drug Administration (FDA) and under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The results indicate that evenamide was devoid of any QTcF prolongation compared to placebo (indicating lack of any increased risk of arrythmia), while moxifloxacin was associated with a 17.3 ms median maximum increase suggestive of clinically significant risk of arrhythmia. These results strongly suggest that evenamide does not increase a patient’s risk of QTc prolongation and arrhythmias, a risk generally associated with antipsychotics.

Study 008, a four-week, randomized, double-blind placebo-controlled study was designed to primarily evaluate the safety, tolerability, and electroencephalogram (EEG) effects of two fixed doses of evenamide (7.5 mg and 15 mg BID). The study was requested by the FDA to address questions which arose from a study of evenamide in rats, and central nervous system (CNS) events observed following high-dose administration of evenamide in dogs. The study was performed in 138 outpatients with chronic schizophrenia, receiving treatment with a second-generation atypical antipsychotic at study centers in the United States and India.

Over 95% of the patients completed study 008. No patient on evenamide discontinued from the study due to adverse events, and there were no significant adverse events relating to evenamide. No symptoms were observed suggestive of severe CNS events, symptoms/signs of seizures, EEG diagnosis of seizure like activity, or cardiac events in patients with evenamide. There were no differences in laboratory, ECG or vital signs abnormalities between evenamide and placebo-treated patients. The most frequent adverse events observed were related to CNS, gastrointestinal disorders, psychiatric disorders, metabolism and nutrition disorders and laboratory investigations. The most frequent adverse events reported (greater than 5%) were headache and somnolence, which were equally distributed between evenamide and placebo.

Study 008 was designed to primarily assess safety and was not powered to demonstrate efficacy. The results, as expected, indicated that the 7.5 mg BID was a “no-effect” dose, which will not be investigated further. The 15 mg BID dose produced a higher magnitude response on the total PANSS than 7.5 mg BID, but this was not statistically significant when compared to placebo.The safety of the 30 mg BID (designated as the therapeutic dose) will be assessed in a planned additional study 008A in patients with schizophrenia, which is required in order to fully comply with the FDA’s original request prior to starting the planned phase III program. Study 008A will be initiated in the next days, with results expected in the second half of 2021.

Ravi Anand, MD, Newron’s CMO, commented: “The results of study 010 are of far-reaching importance as they indicate that evenamide, even at doses of 60 mg (twice the therapeutic dose), is devoid of any arrhythmic effect and thus can be safely added to any other antipsychotic. Furthermore, the safety data, specifically, the lack of any systemic pattern of adverse effects relating to the CNS (including EEG) indicate that the drug is safe at the doses investigated. We will now evaluate the safety of the 30 mg (BID) dose, the expected therapeutic dose, in patients with schizophrenia, in study 008A and plan for the initiating of our phase III program shortly after.”

The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment-resistant schizophrenia. The program will commence once study 008A results are available.

Newron is currently evaluating potential options for partnering/co-developing the further development of evenamide.

About evenamide
Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. The compound is an orally available New Chemical Entity that specifically targets voltage-gated sodium channels for the treatment of schizophrenia. Evenamide originates from Newron’s ion channel program and has a unique mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. It normalizes glutamate release induced by aberrant sodium channel activity. In a Phase IIa clinical study, Newron demonstrated evenamide’s evidence of efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. The study also indicated that evenamide is devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics.
 

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Da quando è uscita la notizia sull'Evenamide, in pochi giorni siamo passati da 2,90 a 2,50; davvero un cattivo segno per il futuro della molecola.
 

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E siamo a 2,33 chf; a quanto pare anche l'Evenamide non funziona.
 

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Pacifico
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Ora siamo a 2,50 chf. Ma questo Evenamide verrà mai portato in fase clinica III e se si ha delle possibilità di essere approvato ?
 

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Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that it received a Paragraph IV Notice Letter regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents.

Newron is reviewing the details of this Notice Letter and will respond as appropriate to protect its intellectual property rights relating to Xadago® (safinamide) tablets.

Xadago® (safinamide) tablets are currently protected by three patents listed in the FDA’s Approved Drugs Product List (Orange Book) that expire no earlier than 2026.
 

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Newron avvia il primo studio potenzialmente registrativo con evenamide in pazienti con schizofrenia
06. set 2021
Annuncio ad hoc ai sensi dell'articolo 53 del Regolamento di quotazione SEI


Evenamide ha il potenziale per essere la prima terapia aggiuntiva per i pazienti con sintomi positivi di schizofrenia

Studio di quattro settimane, in doppio cieco, controllato con placebo per valutare la sicurezza e l'efficacia della dose terapeutica (30 mg BID)

Minimo di 200 pazienti da arruolare presso centri studi in Europa, Asia e America Latina

Il meccanismo d'azione di inibizione glutamatergica di Evenamide offre un'opzione terapeutica innovativa ai pazienti che non beneficiano degli attuali trattamenti antipsicotici



Milano, Italia e Morristown, NJ, USA, 6 settembre 2021, ore 07:00 CEST – Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), azienda biofarmaceutica focalizzata sullo sviluppo di nuove terapie per pazienti con patologie del sistema nervoso centrale e periferico, ha annunciato oggi l'avvio dello Studio 008A, il primo studio potenzialmente registrativo con evenamide in pazienti con schizofrenia.

Lo studio 008A, uno studio internazionale di quattro settimane, randomizzato, in doppio cieco controllato con placebo, è progettato per valutare l'efficacia, la tollerabilità e la sicurezza (compresi gli effetti sull'elettroencefalogramma (EEG)) della dose terapeutica BID da 30 mg di evenamide in pazienti con schizofrenia cronica, attualmente in trattamento con un antipsicotico di seconda generazione. Newron prevede di randomizzare almeno 200 pazienti nei centri di studio in Europa, Asia e America Latina. I risultati dello studio sono attesi entro il Q4 2022.

Questo studio fa parte del programma di sperimentazione clinica di fase III dell'evenamide di Newron che si rivolge a pazienti con schizofrenia che sperimentano un peggioramento della psicosi su dosi terapeutiche di antipsicotici atipici, nonché a pazienti resistenti al trattamento.

Ravi Anand, MD, CMO di Newron, ha commentato: "Evenamide ha dimostrato di essere sicura negli studi che hanno trattato più di 300 volontari e pazienti sani a dosi fino a 60 mg. Lo studio 008A valuterà ora l'efficacia, la tollerabilità e la sicurezza della dose terapeutica di 30 mg BID. In caso di successo, Newron ritiene che lo studio si qualificherebbe come il primo studio (pivotal) adeguato e ben controllato con evenamide in pazienti con schizofrenia che sono responder inadeguati agli antipsicotici. Evenamide sarebbe attualmente la prima terapia aggiuntiva approvata per il trattamento di pazienti con sintomi positivi di schizofrenia, e il suo meccanismo d'azione unico di inibizione glutamatergica offre un'opzione terapeutica veramente innovativa a quei pazienti che non stanno beneficiando dei loro attuali antipsicotici".

Newron sta attualmente valutando potenziali opzioni per collaborare/co-sviluppare l'ulteriore sviluppo di evenamide.
 

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Newron Receives Fourth Tranche from Financing Agreement with European Investment Bank (EIB)



Milan, Italy – September 6, 2021, 5.45 pm CEST – Newron Pharmaceutical S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announces that it has received Tranche 4 under its financing agreement with the European Investment Bank (EIB) that was signed in October 2018 and comprises up to EUR 40 million, subject to achieving a set of agreed performance criteria. The EIB loan is backed by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe. Tranche 4 consists of EUR 7.5 million and will primarily be used to support the Company’s development programs in diseases of the central nervous system. The first three tranches of the loan totaling EUR 25 million were received by Newron in 2019 and 2020.

In connection with Tranche 4, EIB has received warrants entitling it to purchase up to 151,344 ordinary shares of Newron at an exercise price of EUR 9.25 per share.
 

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Newron announces Half-Year 2021 results
Sep 16 2021
Ad hoc announcement pursuant to Art. 53 LR

Milan, Italy, September 16, 2021, 07:00 am CEST – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its operational highlights and financial results for the half-year ended June 30, 2021.

Highlights:

Evenamide (Schizophrenia)

-The primary objective of two short-term explanatory studies of evenamide was met on all safety variables: study 010, in healthy volunteers, and study 008, in patients with schizophrenia
-Post-period, Newron initiated study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia, results from which are expected by Q4 2022
-Newron continues to evaluate strategic commercial and development partnering options for evenamide
Xadago®/safinamide (Parkinson’s disease)

-Newron signed an agreement with its partner Zambon to commence a potentially pivotal study with safinamide in Parkinson’s disease patients with levodopa-induced dyskinesia (PD LID)
-Newron is currently working on finalizing the design of the study with international clinical experts and regulatory authorities and intends to initiate the study in Q1 2022
-Newron and its partners Zambon and Supernus are responding appropriately to protect the intellectual property rights relating to Xadago®/safinamide in the US, following some Paragraph IV Notice Letters regarding Abbreviated New Drug Applications that have been submitted by generic manufacturers
Corporate

-Newron is in the process of conducting value assessments on several potential opportunities to broaden its pipeline of treatments for central and peripheral nervous system diseases
-Post-period, Newron received a fourth tranche of EUR 7.5 million under its financing agreement with the European Investment Bank (EIB)
Stefan Weber, CEO of Newron, commented:

“As we move forward into the remainder of 2021, we are pleased with the progress we are making with our innovative products. In particular, we look forward to advancing our potentially pivotal studies with evenamide in patients with schizophrenia and with safinamide in PD LID. We are evaluating opportunities to broaden our pipeline of treatments for central and peripheral nervous system diseases, as well as exploring opportunities to partner, where appropriate. Newron’s total available cash resources, including the EIB funds not yet drawn down, in addition to its royalty income and Italian R&D tax credits, will fund our planned development programs and operations well into 2023.”

Evenamide

In April, Newron announced encouraging results from two short-term explanatory studies in evenamide: study 010 in 56 healthy volunteers, and study 008 in 138 outpatients with chronic schizophrenia, receiving treatment with a second-generation atypical antipsychotic. These promising results showed that evenamide is devoid of any arrhythmic effect, a risk generally associated with antipsychotics, even at twice the therapeutic dose, and can be safely added to any other antipsychotic. The results also demonstrated that the drug is safe at all doses investigated, due to the lack of any systemic pattern of adverse effects relating to the central nervous system.

Based on this encouraging data and supported by the pre-clinical results published last year confirming the absence of toxicity, Newron, on September 6, 2021, initiated study 008A, the first potentially pivotal study with evenamide in patients with chronic schizophrenia. Study 008A, a four-week, randomized, double-blind placebo-controlled international study, is designed to evaluate the efficacy, tolerability, and safety – including electroencephalography (EEG) effects – of the 30mg BID therapeutic dose of evenamide in patients with chronic schizophrenia, currently being treated with a second-generation antipsychotic.

Results from the study are expected by Q4 2022. Newron believes that positive results from this study would qualify the trial as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.

Xadago®/safinamide

For the continued clinical development of its marketed product Xadago®/safinamide, Newron has signed an agreement with its partner Zambon to commence a potentially pivotal study with safinamide in PD LID. This double-blind, placebo-controlled study is intended to be performed in the US, Europe and Asia/Australia, with a potential label extension for safinamide in key markets. Newron currently expects to initiate the study in Q1 2022.

In May, Newron received some Paragraph IV Notice Letters regarding the submission by generic manufacturers of an Abbreviated New Drug Application to the US FDA, seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before the expiration of certain US patents. Newron and its partners Zambon and Supernus have responded in filing an infringement suit against the generic manufacturers to secure a 30-month stay of the ANDAs approval, and thus to protect its intellectual property rights relating to Xadago®/safinamide tablets. The compound is currently protected by three patents listed in the FDA’s Approved Drugs Product List (Orange Book) that expire no earlier than 2027.

Financial Key Takeaways:

-For the first six months of 2021, Newron reported a net loss of EUR 9.1 million, compared to EUR 10.5 million in the same period in 2020
-Cash used in operating activities has increased to EUR 8.8 million from EUR 7.0 million in H1 2020
-Xadago® revenues received from Zambon slightly increased from EUR 2.5 million in H1 2020 to EUR 2.7 million in the reporting period
-Newron’s R&D expenses have fallen to EUR 6.8 million from EUR 7.8 million in H1 2020
-G&A expenses were EUR 3.7 million in the first six months of 2021 versus EUR 4.4 million in the same period in 2020
-Cash and Other current financial assets at June 30, 2021 were at EUR 21.9 million, compared to EUR 31.3 million at the beginning of the year
-Post-period, on September 6, Newron received the fourth tranche of funds under its financing agreement with the EIB that was announced in 2018 and comprised of funding up to EUR 40 million. Tranche 4 consisted of EUR 7.5 million and will primarily be used to support the Company’s development programs in CNS diseases
Financial Summary (IFRS):

In thousand EUR (except per share information)


H1 2021

H1 2020

Licence income/Royalties

2,671

2,509

Research and development expenses

(6,783)

(7,777)

General and administrative expenses

(3,747)

(4,374)

Net profit/loss

(9,063)

(10,503)

Profit/loss per share

(0.51)

(0.59)

Cash used in operating activities

(8,750)

(7,039)


As of June 30, 2021

As of Dec. 31, 2020

Cash and Other current financial assets

21,906

31,250

Total assets
 

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Pacifico
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Dunque Newron capitalizza 37.000.000 Frs; fattura 5.900.000 Frs; alla luce di questi dati, forse, sarebbe più conveniente per gli azionisti fermare tutte le attività, azzerando i costi e distribuire agli azionisti un dividendo derivante dalle royalties dello Xadago.
 

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Pacifico
Registrato
24/10/07
Messaggi
7.968
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218
Ora ondeggiamo attorno ai 2 franchi; la domanda è sempre valida: non è forse meglio fermare la dispendiosa fase clinica dell'evenamide e distribuire i dividendi derivanti dallo Xadago ?