Novartis’ generics business already holds European rights to dry powder inhaler-based generic combination therapy.

The Novartis generics business, Sandoz, negotiated expanded, rest-of-world (excluding the U.S.) rights to Vectura’s VR315 candidate combination therapy for asthma/COPD. Sandoz already holds European rights to the dry powder inhaler product.

The agreement follows just two days after Vectura announced licensing U.S. rights to VR315 to the U.S. division of an undisclosed pharma firm for $10 million up front. The latest arrangment with Novartis gives Sandoz rights in Japan, Canada, South America, and Australia.

Under terms of the RoW deal Sandoz will be responsible for development of VR315 in thes countries and for obtaining regulatory approvals. Vectura could be eligible for milestones and advanced prelaunch royalties of up to €8 million, €2.5 million of which are expected to be received by the end of September. The firm will also receive sales royalties and a margin on the commercial manufacture and supply of the dry powder inhaler delivery device.

Sandoz negotiated EU rights to VR315 delivered using Vectura’s GyroHaler® DPI device in March 2006, and acquired U.S. develpment rights later that year. However, the firm passed U.S. development and commercialization rights to the drug back to Vectura in March 2010. Sandoz also holds European rights to a second Vectura asthma/COPD product, VR632, which is delivered using the same device.

Vetura’s marketed product portfolio spans respiratory and nonrespiratory products partnered with Baxter, Recipharm, and Otsuka. The firm’s clinical pipeline is headed by the Phase III-stage, Novartis-partnered COPD candidates NVA237 (glycopyrronium bromide) and QVA149 (a combination of NVA237 and Novartis’ own indacaterol).

In April and June Vectura and Novartis reported positive data from two pivotal Phase III trials, Glow1 and Glow2, evaluating NVA237 in COPD patients. Novartis has previously confirmed plans to file for regulatory approval of NVA237 by the end of this year and for approval of QVA149 during 2012.

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