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Seebri Neohaler

Novartis AG

Drug Names(s): 0AD 237, glycopyrrolate, glycopyrronium bromide, Seebri Breezhaler (EU), Enurev Breezhaler, Tovanor Breezhaler (EU), NVA237

Description: NVA237 is a long-acting muscarinic antagonist (LAMA). It consists of a dry powder inhaler formulation of glycopyrronium bromide, an existing off-patent compound that has been marketed for other indications, but has never before been licensed for the treatment of COPD in the US or EU. Inhaled muscarinic antagonists block the effect of acetylcholine at its muscarinic receptor, leading to airway smooth muscle relaxation and bronchodilation.

The first generation delivery device for NVA237 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 both monotherapy and combination products. The initial payment 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...See full deal structure in Biomedtracker

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


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