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Hikma and Vectura ally on Ellipta rivals

Executive Summary

Hikma has announced a global development and marketing collaboration deal with Vectura aimed at developing generic versions of GlaxoSmlithKline’s (GSK’s) Ellipta respiratory portfolio. The agreement on rivals to Ellipta – which builds on an existing collaboration between the two firms to develop a generic version of GSK’s Advair Diskus (fluticasone/salmeterol) – will use Vectura’s proprietary ‘open-inhale-close’ dry-powder inhaler device.

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Hikma’s Latest Advair Setback Pushes It Closer To Rivals

Hikma has received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.

Hikma Awaits Advair Opportunity

Hikma still sees a substantial opportunity in the generic Advair Diskus market once it makes it to market, according to CEO Siggi Olafsson, while rivals to GSK’s Ellipta range will also be coming into focus several years down the line. Meanwhile, nasal sprays gained through deals with Insys and Glenmark will aid in efforts to differentiate the firm’s non-injectables business in the US.

Hikma Addresses Advair Issues In US

Hikma has submitted a response to the US FDA addressing all outstanding deficiencies in its application for a generic version of GlaxoSmithKline’s Advair Diskus.

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