PIZZODIGINO
Pacifico
Nicox titolo contrarian ? Le borse scendono e lei sale (come oggi) ?
Press Release |
Nicox’s Partner Ocumension Obtains Positive Phase 3 Clinical Trial Results for ZERVIATE® in China |
Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced positive results in a Chinese Phase 3 clinical trial of ZERVIATE® (cetirizine ophthalmic solution), 0.24%, run by its Chinese partner, Ocumension Therapeutics. ZERVIATE was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name EMADINE®. ZERVIATE was found to be non-inferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. ZERVIATE was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate. This clinical trial is required for Ocumension to be able to submit a New Drug Application (NDA) for approval to commercialize ZERVIATE in China. “The successful completion of this clinical trial is an important step towards commercialization of ZERVIATE in China and we congratulate our partner, Ocumension, on its swift execution. Ocumension is able to use Nicox’s data previously generated on ZERVIATE in the United States, supplemented with this clinical trial, to support their application for approval of ZERVIATE” said Gavin Spencer, Chief Business Officer of Nicox. “We look forward to seeing ZERVIATE on the market in China, as well as the territories in the Far East where Ocumension has licensed the rights, and we continue to collaborate with our other partners to obtain approval for ZERVIATE in multiple geographies.” ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC®, and is currently commercialized in the U.S. for ocular itching associated with allergic conjunctivitis. The prescription market for allergic conjunctivitis products in China is expected to grow to almost $0.5 billion by 2030. Clinical Trial Design This was a randomized, observer-masked, Phase 3 clinical trial to evaluate the safety and efficacy of ZERVIATE (cetirizine ophthalmic solution), 0.24% dosed twice daily compared to emedastine difumarate ophthalmic solution, 0.05% dosed twice daily in Chinese patients with allergic conjunctivitis. The treatment period was 14 days and the primary efficacy endpoint was a non-inferiority analysis of the change from baseline in the itching score within the 24 hours prior to the Day 14 visit. A total of 296 patients were randomized across multiple clinical sites in China. ZERVIATE Partnerships ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets. Nicox may potentially receive sales milestones of up to US$17.2 million together with royalties of between 5% and 9% of net sales of ZERVIATE by Ocumension. ZERVIATE is commercialized in the U.S. by our exclusive U.S. partner Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd of Japan, and is also exclusively licensed to Samil Pharmaceutical in South Korea, to ITROM Pharmaceutical Group in certain Gulf and Arab markets, and to Laboratorios Grin in Mexico. |
Informazioni che meriterebbero naturalmente un'altra mania..
ma tra la notizia catastrofica (…) e la quasi certa presenza di un DCA presente sul valore di mantenerlo a un valore basso per poterlo riacquistare in seguito.. dovremo ancora aspettare…
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l sanzioni alla Russia rischiano di essere un boomerang mostruoso per le economie occidentali.....l'ultimo default della Russia nel 1998 ha mandato in tilt Wall Street a causa di fallimenti delle banche esposte con il debito russo....mi auguro che certe persone che comandano nella finanza mondiale abbiano fatto bene i conti....o ancor peggio proprio perchè l han fatti che alcuni vogliono la fine del mondo come lo conosciamo noi.