Roche Severin Schwann

Roche weathers tough year and looks to pipeline for 2011

pharmafile | February 3, 2011 | News story | Research and Development, Sales and Marketing 2010 pharma results, BRAF protein, GDC-0449, RG3616, RG7204, Roche, avastin, pertuzumab 

Roche is looking to its innovative late-stage pipeline to help it get back on track for the next financial year after a decline in sales for 2010.

Group sales fell 3% to CHF 47.47 billion ($50.6 billion) and pharma revenue was down by nearly 2% to CHF 37.05 billion.

The figures were skewed by sales of Tamiflu, which fell by 71%, or CHF 1.4 billion, after the H1N1 influenza pandemic petered out early last year.

But sales in Western markets also suffered twin blows from US healthcare reforms and austerity measures in Europe, leaving emerging markets to pick up some of the slack.

Roche’s oncology division saw the biggest growth across its pharmaceutical operations, with sales up 7% to CHF21.3 billion, accounting for over half of all the company’s pharma sales.

Speaking in London, Roche’s chief executive Severin Schwann remained optimistic about Roche’s future, saying that despite a “challenging year” which saw setbacks in its portfolio, the Swiss pharma firm still achieved “solid growth”.

The company did manage 4% year-on-year growth in its 2010 profits of CHF 8.9 billion, but this was partially achieved by making a 5% cut in R&D spending, which finished the year at CHF 9 billion.

Pascal Soriot, chief operating officer of Roche, said there had been not only headwinds but “cross winds” in 2010. “We look forward to the day when we can run with the winds again,” he added.

Avastin troubles

The source of one of these cross winds was Avastin’s use in metastatic breast cancer when in December the FDA asked for this indication to be removed after it was shown to be ineffective in phase III studies.

Roche declined to remove it voluntarily and said it would fight the US regulator’s decision.

Sales of its blockbuster were up globally by 9% to CHF 6.46 billion thanks in large part to growth in emerging markets – but sales in the US started to slide in the second half of 2010 after the publication of the new phase IV trial results.

2011 could prove even worse for the blockbuster, as a study in the Journal of the American Medical Association, published a day before Roche’s results, suggested Avastin in combination with chemotherapy was linked to a higher rate of life-threatening side effects against chemotherapy alone.

Roche has forecast that sales of Avastin may actually decrease in 2011 as a knock-on effect from the FDA’s decision, and downgraded its target for the drug from CHF 9 billion to between CHF 6-7 billion.

Outside its oncology franchise Roche remained strong, with arthritis drug Actemra making CHF 397 million following FDA approval in October and there was very healthy growth for ophthalmology drug Lucentis, whose sales were up 27% to CHF 1.5 billion.

Aside from Tamiflu, the biggest drop in revenue came from organ transplant treatment CellCept, which was down 15% to CHF1.29 billion as it continues to succumb to generic pressures.

Roche has forecast low single digit growth for 2011 as European price erosion and the US healthcare reforms continue to impact on sales for all pharma companies in the West.

2011 drug filings

Soriot said Roche were looking to file three key oncology drugs in 2011, including its melanoma drug RG7204, a BRAF inhibitor that has shown in phase II trials to extend median progression-free survival life by 6.2 months in a hard to treat cancer, and is forecast to be making $1 billion in peak sales.

The second is pertuzumab in combination with Roche’s Herceptin for first line treatment of both HER2+ and metastatic breast cancer.

The third filing Roche is hoping to make will be GDC-0449 (RG3616), its hedgehog pathway inhibitor for basal cell carcinoma, a rare slow growing form of skin cancer.

The company’s hope is that these three drugs will shore up a difficult year ahead for as it continues to focus on innovation to offset the even stronger headwinds of 2011.

Ben Adams

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