Date: 2014-05-19
Type of information: Licensing agreement
Compound: Fovista®
Company: Novartis (Switzerland) Ophthotech (USA - NY)
Therapeutic area:
Type agreement: licensing commercialisation
Action mechanism: Fovista® is an anti-PDGF aptamer. It is designed to target platelet derived growth factor (PDGF) in combination with anti-VEGF drugs to disrupt the formation of abnormal new blood vessels in wet AMD. Fovista®binds to and inhibits PDGF expression, causing the loss or stripping of pericytes, leaving the endothelial cells unprotected and highly vulnerable to the effects of anti-VEGF therapy. Clinical data have shown that administration of Fovista® 1.5mg in combination with anti-VEGF drugs is likely to inhibit new blood vessel growth in patients with wet AMD more effectively than anti-VEGF monotherapy and may also enhance neovascular regression.
Disease:
Details: * On May 19, 2014, Novartis announced the signing of a licensing and commercialization agreement with Ophthotech for the exclusive rights to market Fovista® (anti-PDGF aptamer) outside the United States. 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. 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.
Financial terms: Under the financial terms of the agreement, Ophthotech will receive an immediate payment of an upfront fee of $ 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).
Latest news: * On September 8, 2014, Ophthotech announced that it has achieved a $50 million enrollment milestone payment from Novartis Pharma AG as part of the ex-US licensing and commercialization agreement between the two companies focused on the treatment of wet age-related macular degeneration (AMD). This enrollment milestone payment from Novartis was triggered as a result of Ophthotech reaching the first enrollment goal under the agreement in its pivotal, multi-national Fovista® Phase 3 clinical program and is the first of a total of $130 million in potential enrollment-based milestones under the agreement. Fovista®, Ophthotech's anti-platelet-derived growth factor (PDGF) compound, is being studied in combination with anti-vascular endothelial growth factor (VEGF) therapy for the treatment of wet AMD. Under the agreement signed in May 2014, Ophthotech granted Novartis exclusive rights to commercialize Fovista® in markets outside the United States, with Ophthotech retaining sole rights to commercialize Fovista® in the United States. Potential payments to Ophthotech under the agreement could total over $1 billion in upfront and milestone payments, not including future royalties on ex-US Fovista® sales. Ophthotech received an upfront payment of $200 million upon execution of the agreement and Fovista® Phase 3 enrollment-based milestones could total $130 million of which $50 million has now been achieved by the Company. Ophthotech is eligible to receive contingent future ex-US marketing approval milestones totaling up to $300 million and ex-US sales milestones up to $400 million. In addition, Ophthotech is entitled to receive royalties on ex-US Fovista® sales. Fovista® is the most advanced anti-PDGF agent in development for the treatment of wet AMD and, if approved, Ophthotech expects it to be first to market in this class of therapies for wet AMD. In connection with the receipt of this $50.0 million milestone payment, the Company expects to recognize approximately $40.1 million as revenue during the three months ended September 30, 2014. The remaining $9.9 million is expected to be deferred and recognized as revenue on a proportional performance basis through 2017.
