- (The Times via NewsPoints Desk)

Hikma takes sharp intake of breath after inhaler setback - (The Times via NewsPoints Desk)

  • Hikma Pharmaceuticals cut its full-year sales forecast by as much as $200 million, to between $2 billion and $2.1 billion, after it was forced to delay launching its generic version of GlaxoSmithKline's Advair for asthma and chronic obstructive pulmonary disease, reported The Times.

  • The FDA issued Hikma a complete response letter last week indicating that significant amendments would have to be made to the company's application and that its version of the drug is unlikely to be approved this year.

  • Hikma said it was reviewing the FDA's letter and would provide an update on its filing "as soon as practicable."

  • The company lowered the revenue forecast for its generics business to about $670 million this year, down from about $800 million in March, when it had said that Advair was likely to be launched in the second half of the year and that profits from the generics business would "significantly improve in 2017."

  • James Vane-Tempest, an analyst at Jefferies, said "if this environment persists…with any delays to new launches, we could see further potential downside."

  • Meanwhile, Cantor Fitzgerald analysts suggested Hikma "is more than just an Advair generic," citing strong performance from the company's sterile injectables and its branded products businesses.

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