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.
Hikma in dispute with FDA over generic drug Advair
Hikma in dispute with FDA over generic drug Advair
Saudi POS spending jumps 28% in final week of Jan: SAMA
RIYADH: Saudi Arabia’s point-of-sale spending climbed sharply in the final week of January, rising nearly 28 percent from the previous week as consumer outlays increased across almost all sectors.
POS transactions reached SR16 billion ($4.27 billion) in the week ending Jan. 31, up 27.8 percent week on week, according to the Saudi Central Bank. Transaction volumes rose 16.5 percent to 248.8 million, reflecting stronger retail and service activity.
Spending on jewelry saw the biggest uptick at 55.5 percent to SR613.69 million, followed by laundry services which saw a 44.4 percent increase to SR62.83 million.
Expenditure on personal care rose 29.1 percent, while outlays on books and stationery increased 5.1 percent. Hotel spending climbed 7.4 percent to SR377.1 million.
Further gains were recorded across other categories. Spending in pharmacies and medical supplies rose 33.4 percent to SR259.19 million, while medical services increased 13.7 percent to SR515.44 million.
Food and beverage spending surged 38.6 percent to SR2.6 billion, accounting for the largest share of total POS value. Restaurants and cafes followed with a 20.4 percent increase to SR1.81 billion. Apparel and clothing spending rose 35.4 percent to SR1.33 billion, representing the third-largest share during the week.
The Kingdom’s key urban centers mirrored the national surge. Riyadh, which accounted for the largest share of total POS spending, saw a 22 percent rise to SR5.44 billion from SR4.46 billion the previous week. The number of transactions in the capital reached 78.6 million, up 13.8 percent week on week.
In Jeddah, transaction values increased 23.7 percent to SR2.16 billion, while Dammam reported a 22.2 percent rise to SR783.06 million.
POS data, tracked weekly by SAMA, provides an indicator of consumer spending trends and the ongoing growth of digital payments in Saudi Arabia.
The data also highlights the expanding reach of POS infrastructure, extending beyond major retail hubs to smaller cities and service sectors, supporting broader digital inclusion initiatives.
The growth of digital payment technologies aligns with Saudi Arabia’s Vision 2030 objectives, promoting electronic transactions and contributing to the Kingdom’s broader digital economy.
