Ophthotech, a privately held biopharmaceutical company, has raised $175 million to finance a global phase III clinical program of its lead compound Fovista, an anti-platelet-derived growth factor (PDGF), in combination with anti-VEGF therapy for the treatment of neovascular age-related macular degeneration (wet AMD). The multi-national phase III trial is expected to begin in the third quarter of 2013 and enroll nearly 1,900 patients in more than 200 centers worldwide.
The financing of $175 million consists of $125 million from Novo, a private limited liability company, in exchange for royalties on Fovista sales. The remaining $50 million is in the form of a Series C preferred stock financing from Novo and current venture investors in Ophthotech. The royalty and Series C funding is structured in three equal tranches, the first of which has closed.
"We are excited to lead this very large financing to drive phase III development of Fovista," said Henrik Gürtler, CEO of Novo. "Ophthotech is well positioned to bring this important drug rapidly to market, based on the strength of phase IIb results and the proven medical, regulatory and commercial capabilities of its management team."
In a large, randomized, controlled phase IIb study reported last year, Fovista in combination with Lucentis (ranibizumab injection) demonstrated superior efficacy over Lucentis monotherapy in patients with wet AMD. Patients receiving the combination of Fovista (1.5mg) and Lucentis gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (p=0.019), representing a 62% additional benefit. No significant safety issues were observed for either treatment group in the trial.
To accelerate the clinical development of Fovista, Ophthotech has also expanded its management team. David R. Guyer, MD, the company's chairman of the board since its inception, has accepted the position of CEO, and Samir Patel, MD, co-founder and current president of Ophthotech, has been appointed to the additional role of vice chairman of the board. Under the new management structure, Guyer will direct the company's corporate and financial strategy, while Patel will focus fully on clinical development.