Pharmacy News Article

May 01, 2009 (Datamonitor via COMTEX) Recently released data show that the Mirapex once-daily formulation was superior to placebo in early Parkinson's disease patients, and comparable with the thrice-daily version of the drug. With generic versions of Mirapex expected in early 2010, the development of this reformulation may be too late to prevent significant revenue loss for Boehringer Ingelheim.

In a double-blind, 18-week evaluation of the once-daily dopamine agonist pramipexole extended-release (ER) compared both to the Mirapex thrice-daily formulation pramipexole immediate-release (IR) and to placebo in 259 patients, pramipexole ER (8.1) was found to be superior to placebo (5.1) in early Parkinson's disease and possess comparable efficacy to pramipexole IR (8.4), according to the primary end-point of change in Unified Parkinson's Disease Rating Scale. In a longer-term study, efficacy was maintained between 18 and 33 weeks with the ER version.

Switching between pramipexole IR and the new formulation will be essential for the commercial success of pramipexole ER. With this in mind, Boehringer Ingelheim announced the results of a switching study in which patients were monitored prior to and after switching from pramipexole IR to pramipexole ER (or pramipexole IR as a control arm). A majority of 85.5% of patients switched successfully from pramipexole IR to ER in early Parkinson's disease.

A once-daily version would increase patient convenience and might facilitate improved compliance. Following the launch of GSK's Requip XL, a once-daily version of the dopamine agonist ropinirole, the development of an ER version of Mirapex is essential for Boehringer Ingelheim to maintain its market-leading position in Parkinson's disease. The company's Mirapex is currently the foremost brand indicated for the condition, with sales in excess of $550m across the seven major pharmaceutical markets (the US, Japan, France, Germany, Italy, Spain and the UK).

The availability of generic versions of Requip IR, launched in the same year as the once-daily reformulation, has mitigated the uptake of Requip XL in the US, despite the clear convenience advantage of once-daily dopamine agonists. A similar situation is expected to occur with pramipexole ER. An agreement with generics manufacturer Barr Pharmaceuticals will see generic versions of Mirapex enter the market in early 2010. This is likely to be prior to the launch of pramipexole ER, severely impeding uptake of the follow-on product.

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