Novartis AGNVS entered into a licensing agreement with Spark Therapeutics to develop, register and commercialize Luxturna (voretigene neparvovec) in markets outside the United States.
We note Luxturna was approved in the United States on Dec 19, 2017 as one-time gene therapy to restore functional vision in children and adult patients with biallelic mutations of the RPE65 (retinal pigment epithelial 65 kDa protein) gene.
The market authorization application was filed with the European Medicines Agency on July 31, 2017.
Novartis will make an upfront payment as well as pay milestones and royalties to Spark Therapeutics. Meanwhile, Spark Therapeutics will retain exclusive rights for Luxturna in the United States and will retain responsibility for obtaining approval in Europe. Spark Therapeutics will also be responsible for the supply of Luxturna under a separate manufacturing and supply agreement with Novartis.
We remind investors that the FDA approved Novartis' breakthrough gene transfer treatment, Kymriah suspension for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse. Kymriah has been launched in the United States.
Earlier in the week, Novartis reported encouraging results for the fourth quarter wherein results beat both earnings and sales estimates on strong performance of Cosentyx and Entresto. Psoriasis Cosentyx achieved multi-blockbuster drug status in 2017 on the back of strong growth of three approved indications while Entresto's sales benefited from continued access improvements and expansion of sales force in the United States.
The generic division, Sandoz also combatted pricing pressure strongly buoyed by launches of Rixathon, the biosimilar version of Roche Holdings, Inc.'s RHHBY Rituxan (rituximab) and Erelzi, the biosimilar of Amgen, Inc.'s AMGN Enbrel in EU. The proposed biosimilar version of AbbVie. Inc.'s ABBV Humira (adalimumab) has also been accepted for review by the FDA.
Meanwhile, the strategic decision on Alcon to retain the business or separation via capital market transactions such as a spin-off or an initial public offering has been postponed. The company believes that the Alcon division has revived well for now and hence a decision on a possible spin-off will be taken in 2019. The recent approvals of Kymriah and Kisqali will further boost the oncology portfolio and drive growth.
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