诺华(Novartis)5月19日与Ophthotech公司签署一份授权及商业化协议，获得眼科药物Fovista(抗PDGF适配体)在美国以外地区的独家销售权利。Fovista是在研抗PDGF产品在临床开发中走的最远的药物，如果获批，将成为这一类药物中首个上市的新药，用于湿性AMD的治疗。

　　根据协议条款，Ophthotech公司将会收到一笔2亿美元的即刻付款，以及一笔可能达1.3亿

　　美元的潜在近期里程碑付款。此外，Fovista获得美国以外监管批准并上市后，Ophthotech还将获得高达7亿美元的监管和销售里程碑款项，同时将有资格获得产品在美国以外地区销售的特许权使用费。

　　目前，Ophthotech正在调查Fovista联合标准的抗VEGF药物(包括Regenero公司的Eylea，罗氏的Avastin和Lucentis)，用于湿性年龄相关性黄斑变性(wet-AMD)患者的治疗。诺华也将开发Fovista与其专有的抗VEGF药物的复方药。Ophthotech拥有Fovista在美国的商业化权利

　　Fovista提供了一种新的作用机制，有望解决进一步改善视力的未获满足的医疗需求，并可能延缓病情的进展。在数个II期临床研究中，Fovista联合Lucentis显著地改善了湿性AMD患者的基线视力，且与Lucentis相比，组合疗法未见新的安全信号。

　　诺华视网膜医疗管线中，处于后期临床开发的药物，还包括新一代抗VEGF药物RTH258(用于湿性AMD治疗)，LFG316(用于干性AMD治疗)(生物谷Bioon.com)

　　英文原文：Novartis announces exclusive agreement to extend leadership in ophthalmology, leveraging novel anti-PGDF therapy Fovista®

　　Novartis acquires exclusive ex-US rights to Fovista from Ophthotech; upfront payment of USD 200 million plus potential future recruitment and other milestone payments; additionally Ophthotech to receive royalties on ex-US Fovista sales

　　Fovista is the most advanced anti-PDGF technology in development, and if approved, is expected to be first to market in this class of therapies for wet AMD

　　Novartis to commercialize Fovista outside the US as stand-alone treatment and as a co-formulation with a Novartis proprietary anti-VEGF product

　　Basel, May 19, 2014 - Novartis announced today the signing of a licensing and commercialization agreement with Ophthotech Corporation (Ophthotech) for the exclusive rights to market Fovista® (anti-PDGF aptamer) outside the United States. Under the financial terms of the agreement, Ophthotech will receive an immediate payment of an upfront fee of USD 200 million plus potential future recruitment and other milestone payments. In addition, Ophthotech is eligible to receive royalties on ex-US Fovista® sales. Fovista is being studied in combination with anti-VEGF agents for patients suffering from wet age-related macular degeneration (wet AMD). Novartis will also develop a co-formulation of Fovista with a Novartis proprietary anti-VEGF treatment. Ophthotech will hold the marketing rights to Fovista in the United States.

　　"Novartis is committed to addressing key unmet needs in medical retina. Fovista in combination with currently available anti-VEGF treatments could further improve outcomes of patients suffering from avoidable vision loss," said David Epstein, Division Head, Novartis Pharmaceuticals. "If approved, Fovista is expected to be the first to market in this class of therapies for wet AMD confirming our commitment and leadership in the ophthalmology space."

　　Fovista offers a new mechanism of action to address unmet need to further improve visual acuity and potentially slow disease progression. In Phase II clinical studies, combination therapy of Fovista and Lucentis® (ranibizumab) significantly improved baseline visual acuity in wet AMD patients. No new safety signals were observed with Fovista / Lucentis adjunctive therapy as compared to Lucentis monotherapy.

　　Novartis expects to develop Fovista and the co-formulation in its proprietary, innovative pre-filled syringe as part of this agreement.

　　About Novartis in Ophthalmology

　　Novartis, through its Alcon and Pharmaceuticals Divisions, is the global leader and partner for physicians in medical retina, and as such, offers the industry's most comprehensive portfolio of innovative retina products to support professionals to help achieve the best possible patient outcomes.

　　Novartis medical retina pipeline includes investigational treatments in late-stage clinical development such as RTH258 for wet AMD (next generation anti-VEGF), and LFG316 for the treatment of dry AMD. Novartis holds the marketing rights for Fovista (anti-PDGF aptamer) outside the United States. Ophthotech Corporation holds the marketing rights to Fovista in the United States.

　　About Lucentis® (ranibizumab)

　　Lucentis was designed to save sight and has demonstrated transformational efficacy with individualized dosing in its licensed indications. As an antibody fragment with a short systemic half-life, Lucentis was specifically designed, developed, formulated and licensed for ocular conditions, and is manufactured to the highest standards for intra-ocular use.

　　Lucentis is licensed in more than 100 countries, for the treatment of wet age-related macular degeneration (wet AMD), visual impairment due to diabetic macular edema (DME) and for visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including both branch- and central-RVO. Also, Lucentis is licensed in more than 60 countries, not including the US, for the treatment of patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). In most countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.

　　Lucentis has a well-established safety profile supported by 43 sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 2.4 million patient-treatment years of exposure since its launch in the United States in 2006.

　　Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.