Bayer had originally hoped to launch the high dose formulation over the fourth quarter this year as part of the drive to protect its Betaferon franchise. However, results from the company's clinical trials revealed that the 500mcg dose wasn't any better than the established 250mcg dose or fellow MS drug Copaxone (glatiramer acetate). The firm's BEYOND study (Betaferon Efficacy Yielding Outcomes of a New Dose) was the largest clinical study to be carried out on MS, with over 2,200 patients enrolled on the trial. Unfortunately for the company, the higher dose formulation "did not show statistically significant superiority," and as such the results "do not support regulatory filing for the 500mcg dose."
The intangible assets from the BEYOND project will be devalued as a result of yesterday's news, with the firm estimating a €152m charge to be recognised in the third quarter financial results (due to be announced next Tuesday). With Betaferon representing Bayer's best-selling product (pulling in €500m over the first half of the year) the company is actively pursuing lifecycle management initiatives to try and protect the revenue stream from the MS drug.
While the double-dose formulation was one of the company's projects in this vein, the loss of which will surely be a disappointment to the German pharma, the company is using the results of the trial to push the 250mcg formulation: "The trial showed that the standard Betaferon dose of 250mcg is the optimal Betaferon dose to prescribe for treatment naïve patients," a Bayer spokesperson told in-PharmaTechnologist.com, whilst emphasising that the patients receiving the 250mcg dose on the BEYOND trial showed the lowest drop-out rate compared to the 500mcg dose and the Copaxone patients.
"Bayer will continue to invest in lifecycle management programmes, including enhancing the Betaferon application system as well as long term follow-up programmes." An earlier study of Betaferon demonstrated that early treatment with the drug could reduce patients' risk of permanent disability due to MS events by 40 per cent over three years compared to conventional treatment.
The company is also in the midst of developing its "next generation" MS treatment in the form of the humanised monoclonal antibody alemtuzumab, already approved to treat chronic lymphatic leukaemia. At present, however, the company is perhaps unusual in that it has not embarked on plans to develop an oral MS treatment, unlike many of its competitors.
Bayer was unwilling to provide any insight into whether it might consider developing an oral formulation now that the double-dose Betaferon option has vanished, but considering the first of its competitors' oral formulations are due to start hitting the market by 2009, the company may have to find an alternative revenue buffer fairly swiftly.