Vectura and Hikma to develop US asthma generic

Vectura and Hikma have extended their partnership, signing an agreement to develop a generic of GlaxoSmithKline’s asthma drug, Serevent, for the US market.

The product is codenamed VR730, and Hikma will be responsible for the clinical development, manufacture and commercialisation of the salmeterol generic, delivered via Vectura’s dry powder inhaler.

Hikma’s US subsidiary, West-Ward Pharmaceuticals, formerly Boehringer Ingelheim’s US generic business, Roxane, will be responsible for development.

Vectura will complete the formulation development of the generic long-acting beta agonist, which will be largely funded by Hikma.

Vectura will receive a $375,000 up front and future filing, approval and launch milestone payments totalling up to $1.125 million.

Based in Wiltshire in the UK, Vectura will also get a share of future profits once Hikma has recovered certain costs from a pivotal clinical trial.

The two companies have already partnered to produce VR315, a generic version of GSK’s Advair/Seretide (fluticasone+salmeterol), and VR506, a generic, inhaled monotherapy for asthma.

Vectura earlier this year merged with UK-based respiratory drugs firm, Skyepharma in a deal worth $441 million.

The Serevent deal is also good news for Hikma, which in a trading update earlier this month said it expects revenues to grow 35% this year to around $2 billion in constant currency.

In its injectables business, Hikma said a good mix of products will generate operating profit margins of 39%, up from the 38% previously anticipated.

Respiratory drugs have in the past proved difficult to copy, due to the challenges of producing an effective drug/device combination.

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