Roche ($RHHBY) last week said it had resolved packaging issues that resulted in the interruption of supplies of its liquid Tamiflu flu fighter. But while the interruption lasted less than two weeks, the delay in delivery of product to the packaging facility couldn't have come at a worse time: at the beginning of the first quarter and right in the middle of the flu season. Last year, Tamiflu sales provided the Swiss drugmaker with a nice boost to first-quarter sales.
In an email last week, Tara Iannuccillo, a spokeswoman for Genentech, the Roche unit that makes Tamiflu, said the backup in supply had been overcome and that the company now anticipates "having sufficient supply of both the liquid and capsule forms of Tamiflu to meet demand for this flu season." She pointed out that there has been continuous supply of Tamiflu 75-mg capsules throughout the 2013-14 flu season.
In a new email Friday, Iannucillo explained that "for a two-week period our ability to package Tamiflu OS fell behind demand due to scheduling misalignments between the arrival of new product from Europe and its final packaging in the U.S."
The FDA also updated its drug shortage list to indicate the supply issue had been fixed. The FDA posted a shortage notice on Jan. 6 after Genentech notified it that demand for Tamiflu had thrown its packaging line behind and that there might be some spot shortages in certain parts of the country through mid-January. Whether any consumers came up empty-handed because of the supply delay was something that Genentech couldn't say.
"We have limited information regarding Tamiflu supply in specific local areas," Iannuccillo said in an email Thursday. "Given the widespread flu activity in 35 states nationally, there may be some instances where a local pharmacy may not have the liquid formulation of Tamiflu in stock." She explained that if consumers can't get the liquid form and need it, a healthcare professional can mix it up from capsules.
Lost sales for a product like Tamiflu are no small thing. Last year, Roche's impressive 13% leap in first-quarter sales was, in part, attributed to a tough flu season that resulted in an 84% growth in Tamiflu sales to $335 million. On the flip side, French drugmaker Sanofi ($SNY) in October reported that vaccine supply issues caused by problems at a plant in Canada was one of the factors undercutting its third quarter, both on the top line and bottom line. Its vaccines sales were off 7.2% to €1.3 billion ($1.8 billion) because of the "anomaly."
Roche has had to deal with shortages before, even suggesting there might be supply problems for its highly anticipated cancer drug Perjeta in 2012 just after it was approved by the FDA. It got that issue resolved quickly. At about the same time, the drugmaker ran into shortages of its osteoporosis drug Boniva because it had cut production in the expectation that sales of generic versions would reduce demand.
- here's the FDA shortage list
Roche's Genentech tells the FDA to expect a brief Tamiflu shortage
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Sanofi profits plummet as sales in China, Brazil suffer
Roche CEO says Genentech has resolved Perjeta production problems
Missed forecast by Roche leads to Boniva shortage