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Utibron Neohaler

Novartis AG

Drug Names(s): NVA237 (AD237)/QAB149, glycopyrronium bromide/indacaterol, LAMA-LABA, Ultibro Breezhaler (EU), Ulunar Breezhaler (EU), R03AL04, Xoterna Breezhaler (EU), QVA149, Loftair, Sequadra

Description: QVA149 is an inhaled combination of the long-acting muscarinic antagonist NVA237 and the long acting, rapid onset beta-2 agonist QAB149 given once daily.

The first generation delivery device for QVA149 is the CONCEPT1 inhaler.

Deal Structure: NVA237 was developed through a joint venture between Vectura and Arakis (now a wholly owned subsidiary of Sosei). The co-development agreement between the two was signed in late 2000; all revenues are shared equally. NVA237 was licensed to Novartis on April 12, 2005.

Under the terms of the Novartis agreement, Vectura and Arakis each received an initial payment of $15 million (7.9 million) in April 2005. Clinical, regulatory and commercialisation milestones will be payable upon the achievement of pre-agreed targets, which could total up to $172.5 million for each company for bothmonotherapy and combination products. The initialpayment and potential milestones therefore total up to $375 million.

In addition, royalties on product sales will be paid for the monotherapy (NVA237) and the combination product (NVA237/QAB149). If a third combination product is developed by Novartis using NVA237, further milestones and royalties may be payable on that product.

Novartis and...See full deal structure in Biomedtracker

Partners: Vectura Group Sosei Co., Ltd Pfizer Inc. Lupin Limited


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