Novartis announces exclusive agreement to extend leadership in ophthalmology, leveraging novel anti-PDGF 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.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "to extend," "to receive," "if approved," "expected," "to be," "to commercialize," "will," "committed," "could," "commitment," "offers," "potentially," "expects," "to develop," "pipeline," "investigational," "designed to," "goal," or similar terms, or by express or implied discussions regarding potential marketing approvals for Fovista, RTH258, LFG316 or other investigational treatments in the Novartis medical retina pipeline, potential new indications or labeling for Lucentis or Lucentis pre-filled syringe, and potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Fovista, RTH258, LFG316 or any other investigational treatment in the Novartis medical retina pipeline will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that Lucentis or Lucentis pre-filled syringe will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, management's expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including ongoing pricing pressures; general economic and industry conditions; the company's ability to obtain or maintain proprietary intellectual property protection; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.