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GEN News Highlights : Oct 18, 2012

FDA Clears Vitreomacular Adhesion Drug

FDA approved ThromboGenics’ Jetrea® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). Clearance in the U.S. marks the first for a pharmacological agent for the condition. Regulatory review is ongoing in Europe. Jetrea is separately undergoing Phase II clinical evaluation in the treatment of diabetic retinopathy, and age-related macular degeneration.

The Phase III trial VMA program for ocriplasmin included two studies in the U.S. and Europe, involving 652 patients. Both studies met their primary endpoints of resolution of VMA at day 28. Jetrea is ThromboGenics’ lead drug candidate, and in March the firm inked a deal with Novartis’ Alcon business, for the commercialization of Jetrea outside the U.S. Under terms of the agreement Belgium-based Thrombogenics received €75 million (about $98 million) up front, and could be due to earn another €90 million (roughly $117 million) in potential near-term payments, plus additional milestones that could take total pre-royalties to €375 million ($490 million). The partners will also share the costs of developing Jetrea for a number of new vitreoretinal indications.

ThromboGenics’ early-stage pipeline also includes an anti-placental growth factor candidate (formerly TB-403), which is in development initially for the potential treatment of diabetic macular edema, and age-related macular degeneration. Back in June the firm and its partner BioInvent regained all global rights to the early clinical-stage anti-angiogenic antibody candidate from Roche, which had originally negotiated an exclusive global license the drug in 2008, and since carried out early clinical testing in patients with a range of solid tumors. The BioInvent-ThromboGenics partnership was established in 2004 to develop antibody-based drugs for the treatment of vascular indications and cancer.