Teva under investigation for marketing practices
pharmafile | February 12, 2014 | News story | Sales and Marketing | Azilect, Copaxone, Teva, fines, generics
Teva Pharmaceuticals is under investigation by US authorities for sales and marketing activity around two of its drugs – including multi-billion-selling multiple sclerosis treatment Copaxone.
The company, whose HQ is in Israel, received a civil investigative demand from the US Justice Department for documents and information related to Copaxone, which is soon to lose its US patent, and Parkinson’s Disease brand Azilect.
Teva says it is currently gathering the documents which have been requested by the authorities and is “fully cooperating in responding to the subpoena”.
A spokesperson for the firm did not want to go into details, telling Pharmafile: “Given that this is a pending matter, we are unable to comment further at this time.”
Pharma has been no stranger to financial punishment for wrongdoing in recent years, the most recent of which being Johnson & Johnson’s $2.2 billion fine for promoting antipsychotic drug Risperdal off-label.
In 2012, GlaxoSmithKline was hit with $3 billion in fraud charges, the largest fine of its kind in US history, for off-label promotion of antidepressants Paxil and Wellbutrin and for withholding important safety information about diabetes drug Avandia.
There is no indication of how much money – if any – Teva could stand to lose on the result of the latest Justice Department investigation, but Copaxone has a key place in Teva’s operation, racking up global revenues last year of $4.3 billion.
This is more than half of the money which Teva’s specialty segment brought in. The drug is set to lose around $500 million to generic erosion this year, but Teva was handed a small reprieve last month when a high dose form of the medicine was approved by the FDA, with a 16-year patent.
The US market is particularly important for Copaxone, with sales up 11% to $3.2 billion, as a result of increases in both price and volume.
Outside the US the drug saw an increase of 2% to $1.1 billion, due to an upswing in some European countries.
Azilect is far smaller beer for Teva, but its sales jumped 12% to $371 million last year, with global in-market revenues up 17% to $493 million “primarily due to increased demand in the US and Europe as well as a price increase in the US”, according to the firm.
In all, Teva’s turnover from generics medicines was $9.9 billion in 2013, down 5% on the $10.4 billion in 2012, and representing 49% of the group’s total revenue.
The US accounted for generics revenue of $4.2 billion – a year-on-year drop of 5% again.
Specialty medicines – the segment in which Copaxone and Azilect sit – saw revenue rise 3% to $8.4 billion, $6 billion of which was in the US, an increase of 3% compared to 2012.
Adam Hill
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