GlaxoSmithKline wins new reprieve as Hikma’s generic Advair delayed again

The timing of the arrival of generic Advair in the US is critical to GSK’s near-term earnings outlook. (Reuters)
Updated 12 March 2018
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GlaxoSmithKline wins new reprieve as Hikma’s generic Advair delayed again

LONDON: GlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after US regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug.
The Jordan-based firm said on Monday it expected to submit a response to the US Food and Drug Administration (FDA) with new clinical data in 2019.
Hikma’s partner on the project, Vectura, said this meant a potential approval and launch of the generic inhaled medication could come in 2020 if all goes well.
Shares in Hikma fell 1 percent in early trade, while Vectura lost 5 percent.
Hikma already faced a delay in US approval for its Advair generic in 2017, as did rival generics company Mylan, and last month a third Advair copy from Novartis’s Sandoz division also got knocked back by the FDA.
Hikma had disputed the FDA’s demand that it to conduct a fresh clinical endpoint study, but the agency upheld its original determination.
After Hikma and Mylan’s problems in 2017, most industry analysts expected the generic threat had been pushed back until mid-2018. 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.
The timing of the arrival of generic Advair in the United States is critical to GSK’s near-term earnings outlook. The drugmaker expects its 2018 earnings, at constant exchange rates, to be flat to down 3 percent if generic Advair launches in the US market by mid-year. Without generics, earnings would be up 4 to 7 percent.


Bahrain’s Mumtalakat starts marketing dollar sukuk

Updated 22 min 1 sec ago
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Bahrain’s Mumtalakat starts marketing dollar sukuk

  • Several international banks will handle the transaction
  • The bond is expected to be at least $500 million

DUBAI: Bahrain’s sovereign wealth fund Mumtalakat started marketing its planned five-year US dollar Islamic bonds, or sukuk, with an initial yield guidance of around 6.25 percent, a document issued by one of the banks leading the deal showed.
The sukuk, which is expected to price later on Wednesday, will be of benchmark size, which generally means upwards of $500 million.
BNP Paribas, Citi, HSBC, National Bank of Bahrain and Standard Chartered Bank have been hired to arrange the transaction.