Newron Pharma....Billig ,Billiger am Billigsten (Seite 2168)

[Nivagl]

Valeo Pharma and Zambon form partnership for Parkinson’s disease treatment Xadago® (safinamide) in Canada

 

Milan, Italy, April 11, 2017 (World Parkinson’s Day*) – 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, that it has entered into a partnership with Valeo Pharma for the Canadian market to provide the 100,000 patients living with Parkinson’s access to Xadago® (safinamide). Canada represents one of the eight major markets.”

*World Parkinson's Day (WPD) is observed every year on April 11, the birthday of Dr. James Parkinson, the English physician who first described the symptoms of the disease, in 1817; thus, the 2017 WPD marks 200 years since publication of “An Essay on the Shaking Palsy”.

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

Valeo Pharma and Zambon form partnership for Parkinson’s Disease Treatment Xadago® (safinamide) in Canada

 

Valeo Pharma and Zambon announce a partnership in Canada which grants Valeo Pharma exclusive rights to commercialise Zambon’s Parkinson’s disease product, licensed from Newron
New treatment option for estimated 100,000 Canadians living with Parkinson's disease
Xadago® (safinamide) has been launched in the European Union, Switzerland, and it has recently been approved by the U.S. Food and Drug Administration in the U.S.A.
Valeo Pharma to be responsible for registering and launching Xadago® in Canada
 

April 11, 2017 –Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and Valeo Pharma Inc., a specialty pharmaceutical company dedicated to registering and launching innovative prescription products in Canada, today announced a strategic agreement to commercialize Xadago® (safinamide) for the treatment of Parkinson’s disease in Canada.

 

Under the terms of the agreement, Valeo Pharma will be responsible for all regulatory, sales and marketing, quality, and distribution activities in Canada. Valeo Pharma will pay Zambon upfront, regulatory and commercial milestone payments as well as royalties on product sales.

 

“On approval, Xadago® will be the first new oral treatment in almost 15 years to address this serious condition in Canada,” said Steve Saviuk, President of Valeo Pharma. “We look forward to bringing this important new treatment option to more than 100,000 Canadians living with Parkinson’s, and adding to our growing portfolio of prescription medications addressing major neurodegenerative diseases.”

 

Roberto Tascione, CEO of Zambon said “We are very pleased to have signed our agreement with Valeo Pharma, a company with an excellent track record in bringing innovative products to market. Entering Canada is an important step forward in the acceptance of safinamide for patients with PD already treated with L-dopa or other therapeutic combinations”.

Gut so, es geht weiter...irgendwann zieht dann auch der Kurs nach!
Habt geduld.

[Nivagl]

ZAMBON LAUNCHES XADAGO® (safinamide) IN PORTUGAL For patients With mid- to late-stage Parkinson’s Disease

 

Zambon today announces the availability of Xadago® (safinamide) in Portugal as an add-on to levodopa alone or in combination with other Parkinson’s disease (PD) medications in mid- to late-stage PD
Safinamide is a new chemical entity with a unique dopaminergic and non-dopaminergic mechanism of action, providing control of motor symptoms and motor complications both in the short and long term
Xadago® (safinamide) has now been launched in 11 European Union countries, Switzerland, and was recently approved by the US Food and Drug Administration
 

Milan – April 10, 2017 – Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and its partner 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, today announced the launch of Xadago® (safinamide) in Portugal for the treatment of mid- to late-stage Parkinson’s disease (PD).

Safinamide is a new chemical entity with a unique dopaminergic and non-dopaminergic mechanism of action (MoA), providing a balanced control of motor symptoms and motor complications. It is now available in Portugal as add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD therapies for mid- to late-stage fluctuating patients.

Prof. Joaquim Ferreira, ‎Professor of Neurology and Clinical Pharmacology at the Faculty of Medicine, University of Lisbon, commented: “Safinamide’s unique dual mechanism of action makes it a valuable treatment option for fluctuating PD patients”.

Roberto Tascione, CEO of Zambon, said: “Today's launch of Xadago® in Portugal is a great step forward for patients who urgently need a novel treatment option for Parkinson’s disease. Zambon is committed to paving the way for the development of innovative therapies for patients suffering from Parkinson’s disease and other diseases of the central nervous system, with the potential to raise the standard of care.”

With the addition of Portugal, Xadago® is now available in twelve European countries: Germany, Switzerland, Spain, Italy, Belgium, Denmark, Sweden, UK, Luxembourg, the Netherlands and Norway. In addition to launch in Europe, on March 21, 2017 the US Food and Drug Administration (FDA) approved the use of Xadago® for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa

[Forzza]

Antwort auf Beitrag Nr.: 54.684.206 von Swiss-Biotech am 05.04.17 19:56:11

@ Swiss Biotech

Du bist jetzt aber ein ganz Lustiger Kamerad! Du sprichst ein Sell-Off muss her, ja was hatten wir dann seit der Zulassung von Safinamide in den USA. Verkümmert jetzt das Wallstreet-Forum zur gleichen Scheisse wie das Cash-Forum? Aiaiai, da stehen einem ja die Haare am Nacken.

[mainforce]

Antwort auf Beitrag Nr.: 54.684.206 von Swiss-Biotech am 05.04.17 19:56:11

Träum weiter, der Zug ist abgefahren und vor den Sommerferien kommt noch der Entscheid der nächsten Entwicklungsstufe, sollte da ein potentioneller Partner verkündet werden, (von dem gehe ich aus) geht es schnell es eine Etage höher.
Auch der jetzige Kurs ist noch in keiner Weise angemessen, wiederspiegelt lediglich den Zuständ des Marktes "Schnäpchenjäger mit Null Risiko".
Bin mir sicher, Newron macht den Weg...

Gruss Mainforce

[Swiss-Biotech]

Guten Abend zusammen

FDA Zulassung! Längerfristig wird sich das auszahlen für Newron. Safinamide bietet ein gutes Fundament aber KGV naja.... Wenn ich mir das gesamte Zahlengerüst von Newron so anschaue, sieht das jedoch nichtmal so schlecht aus für ein F&E Unternehmen. Ich würde mir aber noch ein bisschen mehr Begeisterung und "Marketing" wünschen. Tatsächlich kommt für mich eine Beteiligung hier in Frage. Es ist einfach eine Frage des Preises. Die momentane Bewertung ist "fair", kann sich aber schnell ändern sollte Sarizotan positive Ergebnisse liefern. Starke Rückschläge aber "leider" auch jederzeit möglich, da wir hier im Biotech Bereich sind.

Bei Kursen zwischen 15-18 könnte ich mir hier einen beherzten Einstieg vorstellen. Eine 20% Korrektur liegt absolut noch drin zum jetzigen Zeitpunkt. Das klassische Sommerloch. Zuerst muss ein Sell-Off her. Das ist nichts schlimmes und gehört einfach dazu. Es sind zu viele nervöse Spekulanten am Werk.

Viel Erfolg weiterhin & Beste Grüsse
Swiss-Biotech

[deam85]

Meiji Seika and Eisai enter into a collaboration for the development and commercialization of safinamide in Parkinson’s disease for Japan and Asia


Milan, Italy, April 5, 2017 – 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 Meiji Seika Pharma Co., Ltd., that it has entered into a collaboration with Eisai Co., Ltd.

The full text of the announcement from Meiji Seika and Eisai is as follows:

EISAI AND MEIJI ENTER INTO LICENSING AGREEMENT CONCERNING PARKINSON’S DISEASE DRUG SAFINAMIDE IN JAPAN AND ASIA

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo; CEO: Daikichiro Kobayashi, “Meiji”) announced today that they have entered into a license agreement for the commercialization of safinamide (development code: ME2125) for the treatment of Parkinson’s disease in Japan and Asia. Safinamide is currently under clinical development by Meiji in Japan.

Under the agreement, Eisai will obtain exclusive rights to safinamide to market in Japan and to develop and market in Asia (seven countries*). Meiji will continue the clinical trials that it is currently conducting and submit a manufacturing and marketing authorization application for the drug in Japan. Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia. Meiji will manufacture and supply the product of safinamide to Eisai for Japan and Asia. Furthermore, Meiji will receive an upfront payment from Eisai, as well as developmental milestone and sales royalty payments under the agreement.

Parkinson's disease is a neurodegenerative disease which causes motor impairment, including shaking in the limbs, muscular rigidity and brachybasia. It is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain.

According to a survey by the Ministry of Health, Labour and Welfare, the number of patients suffering from Parkinson’s disease in Japan numbered 163,000 in 20141, with the number of patients increasing due to the aging of the population.2

Levodopa is widely used to treat Parkinson's disease by replenishing the brain’s supply of dopamine. However, as the disease progresses, levodopa’s duration of effect (“on” time) decreases, and there are cases of Parkinson’s disease symptoms returning before the next dose (“wearing-off” phenomenon). To prevent the “wearing-off” phenomenon, combination therapy with a drug that has a different mechanism of action to levodopa is administered.

Safinamide is a selective monoamine oxidase B (MAO-B) inhibitor, which reduces the degradation of excreted dopamine, helping to maintain the density of dopamine in the brain. Additionally, safinamide blocks sodium ion channels and inhibits glutamate release, and as such, has potential as a new Parkinson’s disease treatment which possesses both dopaminergic and non-dopaminergic mechanisms. Global clinical trials of safinamide in combination with levodopa for the treatment of mid- to late-stage Parkinson’s disease showed extended “on” time, and an improvement in motor function.3

Safinamide was discovered and developed by Newron Pharmaceuticals S.p.A. (Headquarters: Italy, Milan, “Newron”). In 2011, Newron entered into a licensing agreement with Meiji, granting Meiji exclusive rights to development, manufacture and commercialize the drug in Japan and Asia. Safinamide is marketed under the name “Xadago” in eleven countries in Europe, and on March 21, 2017, was approved by the U.S. Food and Drug Administration. In Japan, Meiji is currently conducting Phase II/III trials for safinamide in combination with levodopa.

Through this agreement, Eisai and Meiji will make further contributions to address the diversified needs of, and increase the benefits provided to, Parkinson’s disease patients and their families.

* South Korea, Taiwan, Brunei, Cambodia, Laos, Malaysia, and the Philippines

Notes to editors

1.About Eisai Co., Ltd.

Eisai Co., Ltd. defines its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com/.

2. About Meiji Seika Pharma

In order to protect and improve people’s health and lives, Meiji Seika Pharma, as a “Speciality and Generic Pharmaceuticals Company”, runs its pharmaceutical business in the two main fields, infectious disease and central nervous system disorders, as well as generic drugs. Meiji Seika Pharma strives to respond to diversified medical needs and contributes to the well-being of people worldwide.

For details, please visit its corporate website:

http://www.meiji.com/global/about-us/corporate-profile/meiji…

1 Patient Survey 2014 (Disease and Injury) by Statistics and Information Department, Minister's Secretariat, Ministry of Health, Labour and Welfare

2 Japan Intractable Diseases Information Center　http://www.nanbyou.or.jp/

3 Borgohain R et al. Randomized Trial of Safinamide Add-On to Levodopa in Parkinson's Disease With Motor Fluctuations. Mov Disord. 2014 Feb;29(2):229-37

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, with a subsidiary in Morristown, NJ, USA. Xadago® (safinamide) has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland and the USA, and is commercialized by Newron’s partner Zambon. US WorldMeds holds the commercialization rights in the USA. 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, including sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. www.newron.com.

[Gilbertus]

@ bierteufel

Dein Frust ist verständlich, aber einfach antizyklisch handeln dann gehörst du zu den Gewinnern.
Wenn Du von einer Firma überzeugt bist, lohnt sich dies doch sehr, bei rurückgekommenen Kursen kannst Du dich freuen anstatt aufzuregen dass Du die Shares jetzt günstiger bekommst.

Und nicht vergessen von Zeit zu Zeit Buchgewinne sichern. Bringt Cash zum günstigeren Wiedereinstieg.

Viel Glück.

[bierteufel]

Antwort auf Beitrag Nr.: 54.657.128 von STOER am 01.04.17 11:51:43

Zitat von STOER: Das Volumen hat zwar nachgegeben aber so wie ich das sehe hat der "Verkäufer" längst noch nicht fertig. Also wird das wohl noch nix mit steigenden Kursen....und sollte jetzt irgend eine positive Meldung kommen, steigt evtl. wieder das Volumen aber mehr auch nicht.
Es könnte ja auch mal ne kurze Info zur aktuellen (veränderten ?) Aktionärsstruktur geben. Zumindest sollte das einem CEO, dem das Wohl seiner Aktionäre am Herzen liegt, ein Bedürfnis sein.

Leider hat Weber ja auch keinen Plan und keine Ahnung wer da am verkaufen ist, jedenfalls meinte er das per Mail und wie so oft gibt es keine Beteiligungsmeldungen...

Zambon wird es wohl doch nicht sein, da kommen mir nur noch die Verschwörungstheorien in den Sinn, was aber nichts mit Übernahme zu tun haben wird...

Unglaublich was wir hier alles erleben und wie gesteuert und manipuliert wird... Unglaublich was hier abgeht, und niemand stört es oder greift ein. Krass

[bierteufel]

Antwort auf Beitrag Nr.: 54.657.872 von zitronenhamster am 01.04.17 15:42:34

Zitat von zitronenhamster: dass der Verkäufer "längst noch nicht fertig hat". ich habe das gleiche Gefühl, aber leider keine Grundlagen dafür, du schon? Oder auch nur Gefühl?

guckst Du OB und Kursverlauf...

[zitronenhamster]

und an was siehts du das?

dass der Verkäufer "längst noch nicht fertig hat". ich habe das gleiche Gefühl, aber leider keine Grundlagen dafür, du schon? Oder auch nur Gefühl?