Roche reports further accelerated sales growth in third quarter

RocheThe Roche Group recorded sustained strong sales growth in the first nine months of 2009. Group sales grew 11% in local currencies (9% in Swiss francs; 4% in US dollars) to 36.4 billion Swiss francs. The Pharmaceuticals Division’s sales increased 12% in local currencies (11% in Swiss francs; 6% in US dollars) to 29.0 billion Swiss francs, maintaining growth at twice the global market rate. The Diagnostics Division also continued to outpace market growth, with sales up 8% in local currencies (4% in Swiss francs; -1% in US dollars) to 7.4 billion Swiss francs.

Sales by the Pharmaceuticals Division in the first nine months rose 12% in local currencies (11% in Swiss francs, 6% in US dollars) to 29.0 billion Swiss francs, or double the global pharmaceuticals market growth rate (6%)2. Excluding Tamiflu, the division's sales increased 6%, in line with global market growth, driven by strong demand for Avastin, Herceptin, MabThera/Rituxan, Lucentis, Pegasys and Mircera. The worldwide spread of the pandemic A (H1N1) 2009 influenza virus led to exceptionally strong demand for Tamiflu in the second and third quarters.

The division recorded above-market sales increases in all regions, led by Japan and Europe/Rest of World3 (RoW). Solid growth of Avastin, Lucentis and other key products, together with strong growth of Tamiflu, more than offset lower sales of CellCept and Boniva in the United States and the impact of the voluntary withdrawal of Raptiva from the US market in 2009. Sales by Chugai in Japan increased strongly due to demand for Tamiflu, Avastin, Herceptin and Actemra. Sales in Europe/RoW were driven by demand for Tamiflu, Avastin, Herceptin and MabThera/Rituxan.

Global sales of the antiinfluenza medicine Tamiflu (oseltamivir) totalled 2.0 billion Swiss francs in the first nine months, an increase of 362%, or 1,576 million francs, over the same period last year. This exceptional growth was driven by substantially increased demand in the second and third quarters from governments and in the retail pharmacy sector during the current pandemic A (H1N1) 2009 influenza virus ('swine flu') outbreak. Sales for pandemic stockpiling amounted to 1,380 million francs in the first nine months. Sales of Tamiflu in the third quarter totalled 994 million francs, compared with 101 million francs in the third quarter of 2008. Based on current estimates, Roche expects full-year sales of Tamiflu of around 2.7 billion francs in 2009 and about 700 million francs in 2010. This is, however, difficult to predict and will depend on levels of infection due to the pandemic A (H1N1) virus and seasonal influenza strains in the coming northern hemisphere winter, as well as government orders in the fourth quarter. Roche is working with the World Health Organization and governments worldwide to support pandemic preparedness and supply Tamiflu to patients in need.

The Roche Group's key cancer medications continued to show solid growth through the third quarter. Nine-month sales of Avastin (bevacizumab), for advanced colorectal, breast, lung and kidney cancer, and for relapsed glioblastoma (a type of brain tumour), rose 26% to 4.7 billion Swiss francs. Sustained growth in all regions was driven primarily by continued uptake in colorectal, breast and lung cancer. Uptake in Japan, where Avastin is currently approved for advanced colorectal cancer, remains particularly strong. Rollout of Avastin in the United States in the recently approved indications relapsed glioblastoma and advanced renal cell carcinoma is progressing according to plan. Herceptin (trastuzumab), for HER2-positive breast cancer, is experiencing particularly strong growth in Japan and emerging markets. Sales in the first nine months advanced 9% to 4.0 billion Swiss francs. Overall sales (oncology and autoimmune diseases) of MabThera/Rituxan (rituximab), for non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and rheumatoid arthritis (RA), rose 8% to 4.6 billion Swiss francs. Growth in the oncology segment is being driven by uptake in CLL following approval in the EU earlier in the year. Sales in the RA segment are being driven mainly by increasing use of MabThera/Rituxan in patients with an inadequate response to a single tumour necrosis factor (TNF) inhibitor in the EU and multiple TNF inhibitors in the US. Sales of Xeloda (capecitabine) and Tarceva (erlotinib) increased 11% and 10%, respectively, to 952 million and 962 million Swiss francs. Sales of Xeloda, for colorectal, stomach and breast cancer, were driven primarily by strong gains in the United States, Japan and China. Sales of Tarceva, for advanced lung and pancreatic cancer, were driven by strong growth in Western Europe and Japan, with additional contributions from CEMAI and Asia–Pacific countries.

US sales of Lucentis (ranibizumab), for wet age-related macular degeneration (AMD), increased 21% to 869 million Swiss francs compared with the prior-year period. Solid growth was driven primarily by an increase in the number of Lucentis injections administered to patients in the first and second year of treatment, growth in the number of patients treated for wet AMD and continued improvement in market conditions compared with the first nine months of 2008.

Sales of Pegasys (peginterferon alfa-2a), for hepatitis B and C, rose 11% to 1.3 billion Swiss francs. Growth was driven by continued demand in emerging markets and market-share gains worldwide.

In a highly competitive, price-sensitive market, sales of the renal anemia medication Mircera (methoxy polyethylene glycol-epoetin beta), which is now available in more than 80 countries worldwide, rose 296% to 123 million Swiss francs in the first nine months. Growth is being driven primarily by the success of the product in the predialysis segment. Combined sales of the Group’s established anemia medicines, Roche’s NeoRecormon and Chugai’s Epogin (epoetin beta), declined 9% to 1.2 billion Swiss francs. The decline in NeoRecormon sales of 12% was due mainly to price erosion. The more moderate reduction in sales of Epogin in Japan (-2%) reflects stabilisation of the product's market share despite continued strong competition.

Sales of CellCept (mycophenolate mofetil), for the prevention of solid organ transplant rejection, decreased 14% compared with the year-earlier period to 1.3 billion Swiss francs. As expected, in the second and third quarters sales fell sharply year-on-year as a result of the expiry of the product’s US patent in May. The erosion of US sales through generic competition was partly offset by continued solid growth elsewhere, especially in Latin America and China.

Sales uptake of the novel rheumatoid arthritis (RA) medicine RoActemra (tocilizumab, known as Actemra outside Europe) in its initial European launch markets has been strong, and the response from physicians is very encouraging. Actemra/RoActemra is now available in eight EU countries, including Germany, as well as Switzerland, India, Brazil and several other countries worldwide. RoActemra is scheduled for launch in additional key EU markets by the end of the year. In Japan, where Actemra was approved for RA in adults and for related pediatric indications in April 2008, market penetration is progressing well.

Product development highlights
In the third quarter of 2009 the Pharmaceuticals Division gained a number of major regulatory approvals and filed important new marketing applications. In July the EU authorities approved the use of Avastin in combination with docetaxel, a commonly used chemotherapy, in the first-line treatment of metastatic breast cancer. The expanded indication, which follows EU approval for combined Avastin and paclitaxel in 2007, means that more patients can benefit from Avastin-based treatment options. In August the US Food and Drug Administration (FDA) approved Avastin in combination with interferon alfa-2a for the treatment of metastatic renal cell carcinoma, the most common type of kidney cancer. In September Roche received EU approval for the use of MabThera in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), the most common form of the disease in adults. In July the FDA designated for priority review two supplemental Biologics License Applications (sBLAs) submitted by Genentech and Biogen Idec, for approval of Rituxan plus standard chemotherapy in previously untreated or treated CLL. In September Chugai received approval in Japan for additional indications for Xeloda and Avastin. Xeloda can now be used in combination with oxaliplatin chemotherapy, with or without Avastin, in the first- or second-line treatment of patients with metastatic colorectal cancer.

In July the FDA accepted Roche's resubmission for its US marketing application for Actemra for rheumatoid arthritis. This follows the FDA's complete response in September 2008 and subsequent discussions with Roche. The FDA has designated a six-month review timeline for the resubmission. Also in July, Chugai filed a marketing application with the Japanese authorities for approval of Mircera (currently known in Japan by its project code, RG744) for renal anemia. In September Roche filed an application with the EU’s European Medicines Agency to expand the marketing authorisation for RoActemra to include inhibition of the progression of joint damage and improvement of physical function in patients with rheumatoid arthritis. The filing follows positive two-year data from the phase III LITHE trial.

Also in September Roche submitted an application to the EU health authorities to expand approval for Herceptin to include treatment of advanced HER2-positive stomach cancer. The filing is based on the results of the international phase III ToGA trial. In mid-September Chugai filed a marketing application in Japan for approval of Tarceva in the additional indication of pancreatic cancer.

So far this year the division has reported positive results from nine major phase III clinical trials with the potential to significantly expand the use of key products. In July the Group announced the results of two phase III studies, BRAVO and CRUISE, which showed that Lucentis improved vision in patients with swelling in the retina (macular edema) due to branch retinal vein and central retinal vein occlusion, respectively. The data will be used to support a planned supplemental Biologics License Application to the US FDA for Lucentis in retinal vein occlusion.

In September Roche, Genentech and Biogen Idec announced results from an international phase III study (PRIMA), showing that MabThera/Rituxan maintenance therapy can significantly increase the time until the disease progresses in newly-treated patients with advanced follicular lymphoma, a common type of non-Hodgkin's lymphoma. Because PRIMA met its endpoint during a pre-planned interim analysis, the study was stopped early on the recommendation of an independent data and safety monitoring board. Data from the trial will be filed with EU and US health authorities to extend the current label for MabThera/Rituxan.

In addition, two new studies published in September reported increased survival rates in patients with avian flu (H5N1) and severe seasonal flu who were treated with Tamiflu: in the first of these observational studies 53% of patients with H5N1 infection survived when treated with Tamiflu, compared with 12% of untreated patients; the second trial showed that the death rate was reduced by 37% in high-risk patients with severe seasonal flu who received Tamiflu, compared with no treatment.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80’000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: