07.14.15
Headquarters: Basel, Switzerland
twitter.com/Roche
www.roche.com
TOP SELLING DRUGS
Roche is one of the world’s largest biotech companies with medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. In 2014, the Roche Group invested nearly $10 billion in R&D and posted total revenue of $47 billion.
In Roche’s Pharmaceuticals division sales grew 4% at constant exchange rates to $37 billion with the oncology portfolio performing strongly (+5% CER), particularly medicines for HER2-positive breast cancer (+20%). Sales of new cancer products made a significant contribution, as did sales of Avastin, which were 6% higher. Immunology sales also grew, especially in the treatment of rheumatoid arthritis (RA), with Actemra/ RoActemra up 23% and MabThera/Rituxan (in RA) up 12%, as well as Xolair for chronic hives and allergic asthma, which grew 25%. Tamiflu sales soared (+54%) towards the end of the year as a result of the flu epidemic in the U.S. The company reported these sales helped to offset lower sales of oral chemotherapy drug Xeloda, which now has generic competition in key markets; and hepatitis medicine Pegasys, which faced competition from a new generation of treatments.
In the U.S., sales were 6% higher, with medicines for HER2-positive breast cancer driving growth (+27%), along with Tamiflu (+62%). Xolair and Avastin also grew significantly, up 25% and 6% respectively. Xolair was approved by the FDA to treat a form of chronic hives in 2014, which adds to its use in allergic asthma. Early uptake of Esbriet was very positive, the company reported, however, sales did not reflect demand, as patients in the U.S. are currently transitioning from a patient assistance program to normal commercial supply.
In Europe, 3% higher sales were driven by solid growth in Germany and the UK, particularly in sales of HER2-positive breast cancer medicines. In the UK there was also some stockpiling of Tamiflu. Ongoing pricing pressure had an impact on sales in a number of markets, but demand remained high.
Sales in the International region were 2% higher, with strong growth in Latin America, in particular Venezuela, Argentina and Brazil, as well as in Algeria. In Russia, sales declined significantly in the fourth quarter as a result of economic conditions, while sales in the Middle East were impacted by a change in distributor. In China, sales were 4% higher, with demand increasing in the fourth quarter, and continued strong growth for key products such as Herceptin and MabThera/Rituxan. Growth was negatively impacted by the base effect of strong Tamiflu sales in 2013, as well as competition for Tarceva.
In Japan, 7% higher sales were driven by strong demand for HER2-positive breast cancer medicines, as well as Avastin and Actemra, in particular for the subcutaneous form. In the osteoporosis segment, there was good sales growth for Edirol, as well as Bonviva. Early uptake was very strong for the newly approved Alecensa (alectinib) in ALK-positive lung cancer. The 2014 performance also reflected the continued increase in contribution from personalized healthcare. Sales of products with a companion diagnostic test on label now represent 23% of Pharmaceuticals division sales.
In Roche’s other division, Diagnostics, sales increased 6% to $11.5 billion. Professional Diagnostics, with 8% growth, was the main growth contributor led by its immunodiagnostics business. Sales of Molecular Diagnostics increased by 6%, with 8% growth in the underlying molecular businesses. Sales were 10% higher in Tissue Diagnostics and 1% higher in Diabetes Care. There was also positive early uptake for the new molecular laboratory testing systems, launched during the year, the cobas 6800 and the cobas 8800. Sales growth was driven by Asia–Pacific (+15%) and EMEA (+4%). Growth in Asia–Pacific was driven by a strong performance in China (+23%). Sales increased 4% in North America, 13% in Latin America and were flat in Japan.
Positive Pipeline
During the year, two new indications were approved for cancer medicine Avastin, platinum-resistant ovarian cancer and cervical cancer, while Gazyvaro was approved for the treatment of chronic lymphocytic leukemia in Europe. Esbriet, the newly acquired idiopathic lung fibrosis medicine, was granted FDA Breakthrough Therapy Designation in July and subsequently launched in October. The FDA also granted Breakthrough Therapy Designation for Lucentis in diabetic retinopathy and for a new cancer immunotherapy compound, anti- PDL1, in bladder cancer.
Clinical trial data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer was one of the highlights of 2014. The results showed that adding Perjeta to Herceptin and chemotherapy, increased survival time for previously untreated patients to an unprecedented almost five years. Clinical trial results for cobimetinib combined with Zelboraf in advanced melanoma (tested against Zelboraf alone), were also announced during the year, showing that treatment with the combination halved the risk of the disease worsening. Roche now has over 30 different combination therapies in its oncology pipeline.
Phase III studies of bitopertin for schizophrenia did not meet primary endpoints, and a Phase III study of gantenerumab in early-stage Alzheimer’s disease was discontinued after a pre-planned futility analysis.
Cancer immunotherapy is a key focus area for Roche, with seven investigational medicines in five types of cancer currently in development. Roche’s most advanced investigational medicine in this area, anti-PDL1, showed promising early results in combination with Avastin in renal cell carcinoma, as well as positive early data in other solid tumors. Roche also reported positive news from two Phase III studies of Avastin in HER2- negative breast cancer, a very aggressive and common form of breast cancer.
In hemophilia A, early data on ACE910, an innovative bispecific antibody, showed an encouraging reduction in bleeding rates for all patients on the trial. Lampalizumab, the first potential treatment for geographic atrophy, initiated Phase III trials in September. Development of onartuzumab was discontinued in advanced MET-positive non-small cell lung cancer, as it failed to show clinically meaningful efficacy.
Building Capabilities with Strategic Acquisitions
During the year, Roche made a number of targeted acquisitions to complement its current product portfolio in both divisions, but only some of those in Pharmaceuticals are highlighted here. The largest deal was Roche’s acquisition of InterMune for $8.3 billion. The acquisition broadens Roche’s respiratory portfolio globally with InterMune’s lead drug pirfenidone, approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada, and is under regulatory review in the U.S. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs.
Also, Genentech, a member of the Roche Group, acquired Seragon Pharmaceuticals, a privately held biotechnology company based in San Diego, CA, for $725 million, plus additional payments of up to $1 billion based on milestone achievements. With this acquisition, Genentech obtained rights to Seragon’s entire portfolio of investigational next-generation oral selective estrogen receptor degraders (SERDs), for the potential treatment of hormone receptor-positive breast cancer. The acquisition of the Phase I program offers a potential new approach for hormone receptor-positive breast cancer.
Roche also acquired Santaris Pharma, a privately held Denmark-based biopharma company for $250 million in cash up front and additional payments of as much as $200 million based on certain milestones. Santaris’ Locked Nucleic Acid (LNA) platform is focused on the discovery and development of RNA-targeting therapeutics, a new class of medicines with the potential to address hard to treat diseases. Roche plans to maintain Santaris’ operations in Denmark, where the existing site will be renamed Roche Innovation Center Copenhagen. The acquisition combines Santaris Pharma’s next-generation antisense technology and LNA expertise with Roche’s deep experience in disease biology, chemistry, drug safety, drug formulation, delivery, and development.
In 2014 Roche entered into several clinical supply agreements. With Infinity Pharmaceuticals it started a master clinical supply agreement under which Roche will supply Gazyva (obinutuzumab) to Infinity for planned clinical studies to evaluate the combination of Gazyva and duvelisib (IPI-145), Infinity’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with hematologic malignancies.
Pharmacyclics and Roche entered into a master clinical drug supply agreement to evaluate the safety, tolerability and efficacy of IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor, in combination with GAZYVA (obinutuzumab), a new CD20-directed antibody in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Pharmacyclics will initially conduct a Phase III study in CLL/SLL, and plans to evaluate the combination for NHL. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. Both products are approved for the treatment of CLL. The use of these products in combination is investigational.
Celldex Therapeutics and Roche formed a pact to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex’s CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1), Roche’s investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma.
Also of note, Roche expanded its partnership with DKSH Business Unit Healthcare, a market expansion services provider with a focus on Asia. DKSH is currently managing Roche’s entire supply chain operations for pharmaceutical products and distribution to hospitals, clinics and pharmacies in Cambodia, Hong Kong, Laos, Malaysia, Myanmar, Thailand and Vietnam. Now DKSH and Roche will work together in Singapore for the first time.
twitter.com/Roche
www.roche.com
Headcount: | 88,509 | |
Year Established: | 1896 | |
Total Revenues: | $47,961 | (+1%) |
Pharma Revenues: | $37,082 | (+1%) |
Net Income: | $9,635 | (-16%) |
R&D: | $9,006 | (+2%) |
TOP SELLING DRUGS
Drug | Indication | 2014 Sales | (+/-%) |
MabThera/Rituxan | rheumatoid arthritis | $6,973 | 2% |
Avastin | breast cancer | $6,485 | 6% |
Herceptin | breast cancer | $6,341 | 7% |
Lucentis | macular degeneraton | $1719 | 2% |
Tarceva | lung cancer | $1,306 | -1% |
Actemra/RoActemra | rheumatoid arthritis | $1,237 | 23% |
Pegasys | hepatitis C | $1,026 | -20% |
Xolair | asthma | $985 | 25% |
Tamiflu | influenza | $969 | 54% |
Perjeta | breast cancer | $928 | 189% |
Roche is one of the world’s largest biotech companies with medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. In 2014, the Roche Group invested nearly $10 billion in R&D and posted total revenue of $47 billion.
In Roche’s Pharmaceuticals division sales grew 4% at constant exchange rates to $37 billion with the oncology portfolio performing strongly (+5% CER), particularly medicines for HER2-positive breast cancer (+20%). Sales of new cancer products made a significant contribution, as did sales of Avastin, which were 6% higher. Immunology sales also grew, especially in the treatment of rheumatoid arthritis (RA), with Actemra/ RoActemra up 23% and MabThera/Rituxan (in RA) up 12%, as well as Xolair for chronic hives and allergic asthma, which grew 25%. Tamiflu sales soared (+54%) towards the end of the year as a result of the flu epidemic in the U.S. The company reported these sales helped to offset lower sales of oral chemotherapy drug Xeloda, which now has generic competition in key markets; and hepatitis medicine Pegasys, which faced competition from a new generation of treatments.
In the U.S., sales were 6% higher, with medicines for HER2-positive breast cancer driving growth (+27%), along with Tamiflu (+62%). Xolair and Avastin also grew significantly, up 25% and 6% respectively. Xolair was approved by the FDA to treat a form of chronic hives in 2014, which adds to its use in allergic asthma. Early uptake of Esbriet was very positive, the company reported, however, sales did not reflect demand, as patients in the U.S. are currently transitioning from a patient assistance program to normal commercial supply.
In Europe, 3% higher sales were driven by solid growth in Germany and the UK, particularly in sales of HER2-positive breast cancer medicines. In the UK there was also some stockpiling of Tamiflu. Ongoing pricing pressure had an impact on sales in a number of markets, but demand remained high.
Sales in the International region were 2% higher, with strong growth in Latin America, in particular Venezuela, Argentina and Brazil, as well as in Algeria. In Russia, sales declined significantly in the fourth quarter as a result of economic conditions, while sales in the Middle East were impacted by a change in distributor. In China, sales were 4% higher, with demand increasing in the fourth quarter, and continued strong growth for key products such as Herceptin and MabThera/Rituxan. Growth was negatively impacted by the base effect of strong Tamiflu sales in 2013, as well as competition for Tarceva.
In Japan, 7% higher sales were driven by strong demand for HER2-positive breast cancer medicines, as well as Avastin and Actemra, in particular for the subcutaneous form. In the osteoporosis segment, there was good sales growth for Edirol, as well as Bonviva. Early uptake was very strong for the newly approved Alecensa (alectinib) in ALK-positive lung cancer. The 2014 performance also reflected the continued increase in contribution from personalized healthcare. Sales of products with a companion diagnostic test on label now represent 23% of Pharmaceuticals division sales.
In Roche’s other division, Diagnostics, sales increased 6% to $11.5 billion. Professional Diagnostics, with 8% growth, was the main growth contributor led by its immunodiagnostics business. Sales of Molecular Diagnostics increased by 6%, with 8% growth in the underlying molecular businesses. Sales were 10% higher in Tissue Diagnostics and 1% higher in Diabetes Care. There was also positive early uptake for the new molecular laboratory testing systems, launched during the year, the cobas 6800 and the cobas 8800. Sales growth was driven by Asia–Pacific (+15%) and EMEA (+4%). Growth in Asia–Pacific was driven by a strong performance in China (+23%). Sales increased 4% in North America, 13% in Latin America and were flat in Japan.
Positive Pipeline
During the year, two new indications were approved for cancer medicine Avastin, platinum-resistant ovarian cancer and cervical cancer, while Gazyvaro was approved for the treatment of chronic lymphocytic leukemia in Europe. Esbriet, the newly acquired idiopathic lung fibrosis medicine, was granted FDA Breakthrough Therapy Designation in July and subsequently launched in October. The FDA also granted Breakthrough Therapy Designation for Lucentis in diabetic retinopathy and for a new cancer immunotherapy compound, anti- PDL1, in bladder cancer.
Clinical trial data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer was one of the highlights of 2014. The results showed that adding Perjeta to Herceptin and chemotherapy, increased survival time for previously untreated patients to an unprecedented almost five years. Clinical trial results for cobimetinib combined with Zelboraf in advanced melanoma (tested against Zelboraf alone), were also announced during the year, showing that treatment with the combination halved the risk of the disease worsening. Roche now has over 30 different combination therapies in its oncology pipeline.
Phase III studies of bitopertin for schizophrenia did not meet primary endpoints, and a Phase III study of gantenerumab in early-stage Alzheimer’s disease was discontinued after a pre-planned futility analysis.
Cancer immunotherapy is a key focus area for Roche, with seven investigational medicines in five types of cancer currently in development. Roche’s most advanced investigational medicine in this area, anti-PDL1, showed promising early results in combination with Avastin in renal cell carcinoma, as well as positive early data in other solid tumors. Roche also reported positive news from two Phase III studies of Avastin in HER2- negative breast cancer, a very aggressive and common form of breast cancer.
In hemophilia A, early data on ACE910, an innovative bispecific antibody, showed an encouraging reduction in bleeding rates for all patients on the trial. Lampalizumab, the first potential treatment for geographic atrophy, initiated Phase III trials in September. Development of onartuzumab was discontinued in advanced MET-positive non-small cell lung cancer, as it failed to show clinically meaningful efficacy.
Building Capabilities with Strategic Acquisitions
During the year, Roche made a number of targeted acquisitions to complement its current product portfolio in both divisions, but only some of those in Pharmaceuticals are highlighted here. The largest deal was Roche’s acquisition of InterMune for $8.3 billion. The acquisition broadens Roche’s respiratory portfolio globally with InterMune’s lead drug pirfenidone, approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada, and is under regulatory review in the U.S. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs.
Also, Genentech, a member of the Roche Group, acquired Seragon Pharmaceuticals, a privately held biotechnology company based in San Diego, CA, for $725 million, plus additional payments of up to $1 billion based on milestone achievements. With this acquisition, Genentech obtained rights to Seragon’s entire portfolio of investigational next-generation oral selective estrogen receptor degraders (SERDs), for the potential treatment of hormone receptor-positive breast cancer. The acquisition of the Phase I program offers a potential new approach for hormone receptor-positive breast cancer.
Roche also acquired Santaris Pharma, a privately held Denmark-based biopharma company for $250 million in cash up front and additional payments of as much as $200 million based on certain milestones. Santaris’ Locked Nucleic Acid (LNA) platform is focused on the discovery and development of RNA-targeting therapeutics, a new class of medicines with the potential to address hard to treat diseases. Roche plans to maintain Santaris’ operations in Denmark, where the existing site will be renamed Roche Innovation Center Copenhagen. The acquisition combines Santaris Pharma’s next-generation antisense technology and LNA expertise with Roche’s deep experience in disease biology, chemistry, drug safety, drug formulation, delivery, and development.
In 2014 Roche entered into several clinical supply agreements. With Infinity Pharmaceuticals it started a master clinical supply agreement under which Roche will supply Gazyva (obinutuzumab) to Infinity for planned clinical studies to evaluate the combination of Gazyva and duvelisib (IPI-145), Infinity’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with hematologic malignancies.
Pharmacyclics and Roche entered into a master clinical drug supply agreement to evaluate the safety, tolerability and efficacy of IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor, in combination with GAZYVA (obinutuzumab), a new CD20-directed antibody in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Pharmacyclics will initially conduct a Phase III study in CLL/SLL, and plans to evaluate the combination for NHL. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. Both products are approved for the treatment of CLL. The use of these products in combination is investigational.
Celldex Therapeutics and Roche formed a pact to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex’s CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1), Roche’s investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma.
Also of note, Roche expanded its partnership with DKSH Business Unit Healthcare, a market expansion services provider with a focus on Asia. DKSH is currently managing Roche’s entire supply chain operations for pharmaceutical products and distribution to hospitals, clinics and pharmacies in Cambodia, Hong Kong, Laos, Malaysia, Myanmar, Thailand and Vietnam. Now DKSH and Roche will work together in Singapore for the first time.
Roche announced plans during the year to expand and upgrade its manufacturing facilities at its headquarters in Basel, Switzerland, as part of the company’s ongoing efforts to expand its biologics manufacturing network. Roche said it is investing approximately $135 million to build new facilities at its Basel headquarters and upgrade existing production operations, including a new facility for small-molecules, which is expected to be operational by 3Q16, and the expansion of an existing facility for investigational drugs and approved products, which the company expects to be operational this June. The company is also investing approximately $880 million to expand its biologics manufacturing, including a new antibody-drug conjugate (ADC) production facility in Basel for Kadcyla, its first approved ADC, as well as eight ADCs under development. The company will also expand biologic manufacturing capacity at its U.S. facilities in Vacaville and Oceanside, CA, as well as operations in Penzberg, Germany. The expansion project is expected to add approximately 500 jobs. |
Roche has had a strong start to 2015 and is clearly not planning to take its foot off the pedal. Its oncology and immunology portfolio is underpinned by solid growth in HER2-positive breast cancer treatment, and having secured FDA approval for Avastin plus chemotherapy for advanced cervical cancer in 4Q14, Roche has maintained its stronghold in oncology. Immuno-diagnostics are also thriving, maintaining Roche’s well-developed diagnostics arm. Investment in the Far East and Asia is also high on the drug maker’s list. With the announcement of the development of a new 450 million Swiss Franc manufacturing facility in the Suzhou area of China, there is a clear indication of maintaining its leadership position in the region where there is a growing demand for diagnostic products. The site should be fully operational by 2018. Roche has also suffered under the Cancer Drug Fund (CDF) in the UK by the loss of Avastin, however by some quirk of fate the £90,000 a year Kadcyla remains available, which has certainly provided financial relief. Roche’s recent acquisitions include German-based Signature Diagnostics, a next generation sequencing (NGS) diagnostics company and Trophos, a French-based biotechnology company. Very focused in oncology, they have also teamed up with Meifi and Fedora to dabble in antibiotic resistance. —Adele Graham-King |