Hikma plans new clinical study over generic Advair

Maricruz Casares
Marcha 13, 2018

U.S. regulators have upheld a prior decision rejecting Hikma and Vectura's generic formulation of GlaxoSmithKline's asthma and chronic obstructive pulmonary syndrome therapy Advair Diskus.

Shares in Hikma fell 1 percent in early trade, while Vectura lost 5 percent. The news marks a boost for the FTSE 100 drugmaker who has signalled that its near-term earnings outlook is contingent on the arrival of generic Advair in the US. Hikma's share price meanwhile has fallen deep into the red and is now 1.83 percent worse off at 882.00p.

The groups initiated the US Food and Drug Administration's dispute resolution process over the regulator's request for an additional clinical endpoint study, having addressed all other queries outlined in the Complete Response Letter issued last May.

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"In anticipation of this as one of the potential outcomes" Hikma said in a statement, "Hikma has already finalised the planning of a new clinical study and expects to start patient enrolment in the coming weeks".

The setback marks good news for GSK, which said in its full-year results last month that it expects its earnings to be flat to down three percent this year, if generic copies of its Advair inhaler hit the USA market by mid-year. Without generics, earnings would be up 4 to 7 percent. The latest snags mean GSK may enjoy more Advair profits for longer, although Mylan still has a chance to win a US green light for its version of generic Advair in 2018. "According to MarketBeat, the FTSE 100 drugmaker now has a consensus 'hold" rating and an average price target of 1,518.25p.

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