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B-I's manufacturing network prepped as Actavis rolls out Micardis generic

09-Jan-2014 - By Dan Stanton+
US FDA approves generic version of Boehringer-Ingelheim's Micardis
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Boehringer Ingelheim says it was well-prepared for the expiration of its blockbuster drug Micardis (telmisartan) with staff and capacity transfers as Actavis prepares to launch a generic version.

Net sales of Micardis - angiotensin II receptor blocker indicated for the treatment of hypertension - stood at €1.6bn ($2.2bn) in 2012, according to a Boehringer Ingelheim summary report, but earlier this week the drug lost its exclusivity in the US.

Yesterday Actavis received approval from the US Food and Drug Administration (FDA) on its generic version of the drug and with the firm intending to launch the product immediately, in-Pharmatechnologist.com spoke with Boehringer Ingelheim to see how it would affect operations.

“With our diverse portfolio, we have well-prepared for the loss of patent and introduction of generic telmisartan and we have made long term plans for related staff and capacity transfers within the company in that area,” said spokesperson Julia Meyer-Kleinmann.

She added: “We have for example arranged for transfers of production capacities from Ingelheim, Germany, to other European countries to allow the scale up of capacity in Ingelheim for new products from our therapeutic area range.”

She confirmed the German site would still manufacture Micardis in some capacity, along with continued production at a number of other sites across the globe, including Greece, Mexico, China and Japan.

One reason for this is though the loss of exclusivity began in 2012 and saw the patent lifted in the US on Tuesday, US sales for the year ending September 30 2013 accounted for only $274m and in other key markets the patent remains protected for a few more years. In Japan, for example, Micardis expires in 2017.

Furthermore, Meyer-Kleinmann said, in emerging markets - for example - sales of the drug are continuing to grow, with revenue generated by the product being reinvested to “support Boehringer Ingelheim’s extensive research and development programme in cardiovascular disease, metabolic disorders, oncology, respiratory and immunology.”

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