NicOx.... in attesa di.....

[PIZZODIGINO]

Nicox Enters Research Collaboration with Re-Vana Therapeutics on its Next Generation of Stand-alone NO-donors in a Novel Sustained Release Ophthalmic Formulation

20 October 2017

Sophia Antipolis, France and Belfast, Northern Ireland

Nicox SA (Euronext Paris: FR0013018124, COX), the international ophthalmic company, and Re-Vana Therapeutics Ltd, ocular pharmaceutical and drug delivery company, today announced that they have entered into a research collaboration to explore combining Nicox’s next generation of stand-alone nitric oxide (NO)-donors with Re-Vana’s EyeLief™ long-acting photo-crosslinked biodegradable drug delivery platform for the reduction of intraocular pressure (IOP), a key risk factor for the development and progression of glaucoma.

Michael Bergamini, Nicox’s Executive Vice President and Chief Scientific Officer, stated, “Re-Vana’s technology offers us additional opportunities, alongside our recently announced collaboration with pSivida, to explore the potential for sustained-release delivery of our novel, next generation of stand-alone NO-donors. EyeLief™ technology has a number of unique properties that have shown promise in the delivery of drugs for the reduction of IOP. We look forward to working with Re-Vana on this innovative research endeavor.“

“The Nicox team has built a strong dataset demonstrating the role of nitric oxide in the reduction of IOP,” commented Michael O’Rourke, President & CEO of Re-Vana Therapeutics. “We believe that our biodegradable photo-crosslinked sustained delivery technology, EyeLief™, in combination with Nicox’s novel technology, has the potential to serve as an effective therapeutic approach to lowering IOP to prevent the progression and development of glaucoma.”

The non-exclusive collaboration will focus on the development of the EyeLief™ drug delivery platform for sustained release of certain of Nicox’s next generation of stand-alone NO-donors. EyeLief™ is a novel sustained-release, photo-crosslinked, preformed, biodegradable implant technology intended to release therapeutics over an extended period of time after insertion in the eye.

Under the terms of the agreement, Re-Vana will be responsible for the development and characterization of EyeLief™ implants containing Nicox’s NO-donors, and subsequently for initial in vitro evaluation of the implants’ sustained-release characteristics over a number of months. New jointly-developed intellectual property from the collaboration relating to these sustained-release formulations will be jointly owned. Depending on the outcome of the research collaboration under this agreement, Nicox and Re-Vana may then enter into discussions regarding the further development of other product candidates. Payments by Nicox associated with this agreement are not considered material to Nicox’s financial statements at this time.

 

[PIZZODIGINO]

Guly....hai venduto ?

Caro Viralic, c'è poco da scherzare; la situazione è tragica. Io sono disperato.

 

[viralic]

Caro Viralic, c'è poco da scherzare; la situazione è tragica. Io sono disperato.

Pizzo------o so , pare tutto contro di noi, ma entro l'anno spero che questa approvazione arriverà,

 

[viralic]

Nicox : Un analyste toujours positif
Aujourd'hui à 12:45


(Tradingsat.com) - Gilbert Dupont a réitéré vendredi sa recommandation d' "Achat" et son objectif de cours de 12 euros sur Nicox après que la société spécialisée en ophtalmologie a annoncé avoir conclu un accord de recherche avec Re-Vana Therapeutics Ltd, société britannique de

Cette collaboration vise à explorer l`association des composés donneurs d`oxyde nitrique (NO) purs de nouvelle génération de Nicox avec EyeLief(TM), plateforme d`administration biodégradable, photoréticulée, à longue durée d`action, de Re-Vana visant à réduire la pression intraoculaire (PIO), un facteur de risque majeur pour le développement et la progression du glaucome.

Pour Gilbert Dupont, le principal sujet d'intérêt à court/moyen terme concernant Nicox à court/moyen terme reste la réponse de la FDA quant à la mise sur le marché du produit Vyzulta, une solution pour patients atteints d'hypertension oculaire et de glaucome.

Pour rappel, Bausch & Lomb, partenaire de Nicox, a reçu en août dernier une lettre de réponse de la Food and Drug Administration (FDA) concernant les Bonnes Pratiques de Fabrication du produit. Le dossier a donc dû être soumis une deuxième fois. "La resoumission du dossier a eu lieu il y a deux mois environ et le délai de réponse est de 6 mois au maximum", note Gilbert Dupont.

 

[PIZZODIGINO]

Pizzo------o so , pare tutto contro di noi, ma entro l'anno spero che questa approvazione arriverà,

Ciao Viralic, hai ragione, è proprio tutto contro di noi. Io però temo che dovremo aspettare sino al 17 febbraio per avere il verdetto della FDA.
Mi domando poi come mai quando esce un report negativo l'azione subito precipita, mentre quando esce un report positivo l'azione non sale ?
Tante volte penso che Guly non abbia poi tutti i torti; lui è troppo negativo, ma non sempre sbaglia.

 

[viralic]

Ciao Viralic, hai ragione, è proprio tutto contro di noi. Io però temo che dovremo aspettare sino al 17 febbraio per avere il verdetto della FDA.
Mi domando poi come mai quando esce un report negativo l'azione subito precipita, mentre quando esce un report positivo l'azione non sale ?
Tante volte penso che Guly non abbia poi tutti i torti; lui è troppo negativo, ma non sempre sbaglia.

Nicox alla borsa di Parigi è bruciata. L'unica speculazione che fanno è quella in negativo. Rimane il fatto che quando il Vyzulta sarà approvato vorra' dire che Nicox diventerà l'unica società francese ad oggi ad aver fatto approvare un farmaco dalla FDA. Spero che quindi quando Nicox approderà al Nasdaq verra' valutata come merita, con buona pace del nostro amico Guly.

 

[PIZZODIGINO]

Nicox alla borsa di Parigi è bruciata. L'unica speculazione che fanno è quella in negativo. Rimane il fatto che quando il Vyzulta sarà approvato vorra' dire che Nicox diventerà l'unica società francese ad oggi ad aver fatto approvare un farmaco dalla FDA. Spero che quindi quando Nicox approderà al Nasdaq verra' valutata come merita, con buona pace del nostro amico Guly.

Io aspetto che per il Vyzulta venga presentata la domanda anche all'EMA; credo che aspettino ad avere il via libera della FDA e poi procederanno con l'iter per l'approvazione anche in Europa. Un mercato molto grande quello europeo, anche se i prezzi di vendita che si spuntano negli USA sono molto più interessanti e sostanziosi. Chissà quando finirà questa storia infinita ?

 

[PIZZODIGINO]

Nicox Provides Third Quarter 2017 Business Update and Cash Position

24 October 2017

• ZERVIATETM1 U.S. Rights Licensed to Eyevance Pharmaceuticals – Launch Expected Late 2018
• Two New Collaborations in Place for Development of Ophthalmic Sustained Release Pipeline Assets
• Cash Balance of €47.1 Million as of September 30, 2017

Sophia Antipolis, France

Nicox S.A. (Euronext Paris: FR0013018124, COX), international ophthalmic company, today provided an update on its activities and cash balance as of September 30, 2017.

“We continued to execute on our strategy in the third quarter with a partnership for the U.S. commercialization of ZERVIATETM, licensing the rights to Eyevance Pharmaceuticals. Eyevance is a newly created ophthalmic specialty pharmaceutical company backed by an investment group with a long track record of success in the creation and growth of U.S. specialty pharma companies. Eyevance is led by a seasoned, entrepreneurial leadership team with specific expertise in the commercialization of products in the U.S. ophthalmic market. We believe that the launch, planned for late 2018, will be a success for both Eyevance and Nicox.” commented Michele Garufi, Chairman and Chief Executive Officer of Nicox.

“Our two mid-stage products, NCX 470 for IOP lowering and NCX 4251 for blepharitis, are progressing toward their IND submissions in H1 and H2 2018 respectively to enter directly into Phase 2. Moreover, we continue to pursue additional opportunities within our pipeline of early stage next generation stand-alone NO-donors through the recently announced research collaborations with pSivida and Re-Vana Therapeutics to evaluate the potential for sustained release delivery of our promising new compounds. We continue to focus on our strategy of becoming a fully-integrated pharmaceutical company focused on the discovery, development and commercialization of novel ophthalmic therapeutics and believe we are in a position to rapidly advance our clinical programs and realize the value of VYZULTATM and ZERVIATETM through our partnerships with Bausch + Lomb and Eyevance respectively.”

Third Quarter 2017 and Recent Business Development Highlights

• Earlier this month Nicox entered into two collaborations to explore the potential for sustained release formulations of Nicox’s next generation of stand-alone nitric oxide (NO)-donors for the reduction of intraocular pressure (IOP), with Re-Vana Therapeutics concerning their EyeLief™ long-acting photo-crosslinked biodegradable drug delivery platform and with pSivida Corp concerning their bioerodible sustained release drug delivery system.
• In September, Nicox entered into an exclusive licensing agreement with Eyevance Pharmaceuticals LLC, for the commercialization of ZERVIATETM (cetirizine ophthalmic solution) 0.24%, in the US and received a non-refundable upfront payment of $6 million.
• In September, Nicox and VISUfarma amended certain elements of their agreement relating to the August 2016 transfer of Nicox’s European and International commercial operations to VISUfarma. This amendment results in a net income of €2.8 million.
• In August, Nicox completed a financing through a reserved capital increase of ordinary shares of the Company with a specific category of investors. Gross proceeds from the financing were €26.3 million, and net proceeds were €24.5 million.
• In August, Nicox’s licensee Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) announced that it submitted a response to the U.S. Food and Drug Administration’s (FDA) Complete Response Letter (CRL), also received in August, concerning the New Drug Application (NDA) for VYZULTATM2 (latanoprostene bunod ophthalmic solution), 0.024% for intraocular pressure lowering in patients with open angle glaucoma or ocular hypertension. The CRL from the FDA referred to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida. The NDA had been resubmitted to the FDA by Bausch + Lomb in February 2016 following receipt of a previous CRL. Neither CRL issued to Bausch + Lomb mentioned any efficacy or safety issues with respect to the NDA for VYZULTATM, nor any additional clinical trials for the approval of the NDA.

Development Update
Following an update on the manufacturing timelines for the NCX 4251 formulation, the IND application to support a Phase 2 clinical study is now expected to be submitted in H2 2018. NCX 4251 is a novel formulation of fluticasone propionate being developed for the first time as a topical treatment for acute exacerbation of blepharitis.

The IND application to support a Phase 2 clinical study with NCX 470 is expected to be submitted in H1 2018. NCX 470 is a novel NO-donating bimatoprost analog in development for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Q3 2017 Financial Highlights
The Group had cash and cash equivalents of €47.1 million (including gross proceeds from the August 2017 financing) as of September 30, 2017, compared to €20.4 million as of June 30, 2017. The Group recorded no revenues for the third quarter 2017 because the non-refundable $6 million payment received from Eyevance is not immediately recognizable as revenue accordingly to IFRS accounting principles.

Notes:
1. ZERVIATETM is the tradename approved for cetirizine ophthalmic solution, 0.24%
2. VYZULTATM is the provisionally approved tradename for latanoprostene bunod ophthalmic solution, 0.024%

 

[guly]

mi sto facendo grosse risate,per fortuna questo non e' un crollo,il prezzo tuttosommato e' in un range da 9 a 10.
complimenti per le previsioni e complimenti a traderman anche che viene definito esperto e uno che ha capito tutto e non vedeva motivi per il crollo.
COMPLIMENTI ora forse la aspetto verso i 7,50 euro.

 

[viralic]

mi sto facendo grosse risate,per fortuna questo non e' un crollo,il prezzo tuttosommato e' in un range da 9 a 10.
complimenti per le previsioni e complimenti a traderman anche che viene definito esperto e uno che ha capito tutto e non vedeva motivi per il crollo.
COMPLIMENTI ora forse la aspetto verso i 7,50 euro.

Anche 5 euro !!