Hikma in dispute with FDA over generic drug Advair

Hikma Pharmaceuticals plans to launch a generic copy of GlaxoSmithKline’s popular lung drug Advair in the US. (Reuters)
Updated 09 November 2017
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Hikma in dispute with FDA over generic drug Advair

LONDON: Hikma Pharmaceuticals is in dispute with the Food and Drug Administration (FDA) over plans to launch a generic copy of GlaxoSmithKline’s popular lung drug Advair in the US, the drugmaker said on Thursday, when trimming 2017 revenue guidance for its generics business for a third time.
The dispute between the Jordan-based firm, its partner Vectura and the US FDA, delays any eventual approval of the generic version of the drug.
Hikma, which makes and markets branded and non-branded generic and injectable drugs, said it expected revenue of around $600 million and a core operating margin in the low single-digits from its generics business.
In August it had lowered its generics revenue guidance by $50 million to about $620 million citing higher pricing pressures in the industry, having slashed it to $670 million from an initial $800 million last November.
The company, which has been hit by higher price erosion levels than the rest of the industry, has been re-negotiating its contracts with suppliers and third-party vendors to cut costs to try to boost profitability.
“We expect these market conditions to persist in 2018 and are actively pursuing new commercial opportunities and focusing on the execution of our pipeline to help offset continuing price erosion across the industry,” it said in a statement. The company, which cut its full-year guidance in May to the range of $2 billion-$2.1 billion from $2.2 billion, said in August that it expected 2017 revenue to be at the lower end of the range at $2 billion.
Hikma reiterated its 2017 revenue expectations on Thursday.
Hikma’s lower guidance in May followed a decision by US regulators not to approve its generic version of GlaxoSmithKline’s blockbuster lung drug Advair, citing “major” issues with the application.
Hikma said it expected the dispute process with the FDA to be completed in the first quarter of 2018.


Philippine central bank holds overnight borrowing rate steady

Updated 13 December 2018
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Philippine central bank holds overnight borrowing rate steady

  • The Bangko Sentral ng Pilipinas left the rate on its overnight reverse repurchase facility unchanged at 4.75 percent

MANILA: The Philippine central bank held its benchmark interest rate steady on Thursday, as expected, in line with the outlook for the inflation rate to cool.
The Bangko Sentral ng Pilipinas left the rate on its overnight reverse repurchase facility unchanged at 4.75 percent, as predicted by 11 out of 13 analysts in a Reuters poll.
The central bank raised rates by a total 175 basis points at the past five consecutive meetings to tame inflation, which eased for the first time in nearly a year in November to 6.0 percent.