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Annual Report 2015 Highlights

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Annual Report 2015
English PDF 14 MB

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Financial Report 2015
English PDF 5 MB

If you would like to download the pdf version of the Annual Report, please go to our Reporting Centre

Who we are

What we do

2015 highlights

4

FDA breakthrough therapy designations

25 million

patients treated with one of our top 25 selling medicines
  1. All growth rates in this report are at constant exchange rates (average 2014).

Message from our Chairman

2015 was a successful year for Roche.
Christoph Franz
Chairman of the Board

Message from our CEO

Diversity drives innovation.
Severin Schwan
Chief Executive Officer

Our innovation

Harnessing the immune system to fight cancer

9

cancer immunotherapy NMEs in clinical studies

Targeting the cancer-immunity cycle

Our immune system protects our body from cancer through a multi-step "cancer-immunity cycle". Click to explore how the 9 NMEs that we currently have in the clinic target one or more steps in the cancer-immunity cycle.1

Cancer immunity cycle

Click to explore

1

Release of cancer cell antigens

2

Cancer antigen presentation

Anti-CD40 (RG7876) is a fully human (IgG2) agonistic antibody against CD40. The antibody induces T cell-driven tumour killing by activation of CD40 on antigen-presenting cells which in turn prime T cells to attack the tumour.

3

Priming and activation

Anti-CEA IL2v FP (RG7813) is a targeted immunocytokine combining an engineered cytokine (IL2v) with an antibody against carcinoembryonic antigen (CEA), a protein expressed in several cancers.

Anti-OX40 (RG7888), a humanized monoclonal antibody, is designed to target OX40, a costimulatory receptor that is selectively expressed on the surface of antigen-experienced T cells. Anti-OX40 functions as an agonist antibody, which results in activation rather than blockade of the OX40 signaling pathway upon receptor binding.

aFAP-IL2v FP (RG7461) is a targeted immunocytokine combining an engineered interleukin-2 variant (IL2v) with an antibody against fibroblast activation protein (FAP), a protein expressed in several cancers.

4

Migration of T cells to tumours

5

Infiltration of T cells into tumours

6

Recognition of cancer cells

Anti-CEA/CD3 TCB (RG7802) is a bispecific antibody designed to simultaneously target carcinoembryonic antigen (CEA) expressed on tumour cells and the CD3 receptor present on T cells, triggering T cell activation, migration and tumour killing.

Anti-CD20/CD3 TCB (RG7828) is a full-length bisepcific antibody that targets CD20 on B cells and CD3 on T cells. It has a mode of action distinct from other CD20-directed antibody therapies, in that it is designed to recruit and activate cytotoxic T cells to kill malignant B cells.

7

Killing cancer cells

Anti-PDL1 (Atezolizumab, RG 7446) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Anti-CSF-1R (Emactuzumab, RG7155) is a humanized monoclonal antibody targeting colony stimulating factor-1 receptor (CSF-1R) designed to inhibit the CSF-1 mediated survival of tumour-promoting ‘M2’ macrophages without affecting tumour-killing ‘M1’ macrophages.

IDO inhibitor (RG6078) is a small-molecule investigational immunotherapy designed to inhibit IDO (indoleamine 2,3dioxygenase), a protein often overproduced by many cancer cells.

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  1. Chen DS., et al. Oncology Meets Immunology: The Cancer-Immunity Cycle, Immunity, 2013.

Advancing multiple sclerosis treatment

2.3 million

people worldwide are affected by multiple sclerosis 1

Multiple Sclerosis (MS) is a leading cause of non-traumatic disability in young people, usually striking between 20 and 40 years of age. 2

MS prevalence is highest in countries furthest from the equator3

Approximately 1 in 710 people in North America have MS1

Approximately 1 in 925 people in Europe have MS1

Approximately 1 in 1050 people in Australia have MS1

Ocrelizumab, a humanized monoclonal antibody targeted specifically against CD20-expressing B cells, is the first investigational medicine to have positive study results in both relapsing MS (RMS) and primary progressive (PPMS) MS.

  1. Multiple Sclerosis International Federation. (2013): http://www.msif.org/about-us/advocacy/atlas/.
  2. National Institutes of Health-National Institute of Neurological Disorders and Stroke. (2015). Multiple Sclerosis: Hope Through Research. Available at: http://www.ninds.nih.gov/disorders/multiple_sclerosis/detail_multiple_sclerosis.htm#280373215
  3. Simpson S, et al. (2011) Latitude is significantly associated with the prevalence of multiple sclerosis: a meta-analysis. J Neurol Neurosurg Psychiatry, 82(10):1132-1141.
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Annual Report 2015 Highlights

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Annual Report 2015
English PDF 14 MB

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Financial Report 2015
English PDF 5 MB

If you would like to download the pdf version of the Annual Report, please go to our Reporting Centre

Who we are

Innovation: it's in our DNA. We have always worked across disciplines and geographies to drive scientific discovery and redefine what is possible to improve patients’ lives.

We are working on understanding how diseases differ down to the molecular level. So we can develop new tests and medicines that prevent, diagnose and treat diseases that matter and bring them to the patients who need them. With our combined strengths in diagnostics and pharmaceuticals, our personalized healthcare strategy aims to fit the right treatment to the right patient.

As the world’s largest biotech company, we develop breakthrough medicines, improving the standard-of-care across oncology, immunology, infectious diseases, ophthalmology and neuroscience. We are also the world leader in in vitro diagnostics. This track record allows us to build lasting and meaningful partnerships across the world with research academia and public healthcare institutions.

The founding families continue to hold the majority stake in the company. This stability allows for a tradition of sustainable thinking, so we can learn from setbacks and focus on lasting value for patients and society. We remain dedicated to the highest standards of quality, safety and integrity. Our legacy is based on respect for the individual, the communities and the world we live in.

What we do

We have a clear set of priorities aimed at achieving sustainable growth and delivering value to all of our stakeholders.

Focus on patients

We focus on developing innovative medicines and diagnostic tests that help patients live longer, better lives. Two-thirds of all diseases are either still not treated adequately or not treated at all. This medical need is enormous and better diagnostics and medicines can make a huge difference to the lives of millions of patients and their families.

Excellence in science

We strive to address unmet medical needs through excellence in science. Breakthroughs in science and technology increasingly allow us to find out precisely what is malfunctioning in the body and develop drugs to counter the problem. We focus on oncology, immunology, ophthalmology, infectious diseases and neuroscience, however we remain flexible and follow the science as new insights become available.

Personalised healthcare

We combine our strengths in pharmaceuticals and diagnostics to better fit treatments to patients. When genetic differences can be identified, the efficacy and safety of medicines can be improved enormously. To this end we have a companion diagnostic strategy for every molecule we develop.

Access to healthcare

We aim to bring our medicines and diagnostic tests to as many people in need as possible. Every healthcare system comes with different challenges and we customise solutions for individual markets. We work with many different local partners to reduce barriers to accessing healthcare and establish innovative, sustainable ways to bring effective and affordable healthcare to patients.

Great workplace

We are committed to constantly strengthening and maintaining an excellent workplace where every person feels valued and respected and can grow to his or her full potential. Our people make our business. They discover, develop and manufacture our products and ensure they reach the patients who need them. We believe that the key to our success lies in our ability to attract, retain and motivate a highly skilled and diverse workforce.

Sustainable value

We run our business in a way that is ethical and aims to create long-term value for all stakeholders. We want to create value through developing medical solutions and we aim for as many people to benefit from them as possible. We believe that our success lies in our ability to develop strategies where both industry and society benefit in a sustainable way.

We have also identified key material topics that affect our stakeholders and that are relevant for our long-term success, following a materiality analysis that was conducted in 2014 at the corporate level amongst our key stakeholders. As a result, we identified 21 material topics that stood out as highly relevant to us and to our key stakeholders, with a significant economic, environmental or social impact. These material topics are reflected in our business priorities and we have concrete actions related to them in our operational activities.

2015 Highlights

In 2015, sales grew strongly across our two divisions. Thanks to our strong business performance we are able to further enhance our innovation capabilities and deliver healthcare solutions which make a difference in patients’ lives.

Financial performance

 

​Read more about our financial performance

2015 Finance Report

Pharmaceuticals

CHF 37.3 bn

Pharmaceutical sales +5% growth1

Key growth-driving products in 2015 (CHF millions)

Diagnostics

CHF 10.8 bn

Diagnostics sales +6% growth1

Diagnostics top-selling products (CHF millions)

Pipeline

Sustainability

ROBECOSAM

Ranked as the most sustainable healthcare company by the Dow Jones Sustainability Indices for the 7th consecutive year

CDP

Recognised by CDP for our climate change mitigation strategy

  1. All growth rates in this report are at constant exchange rates (average 2014).

Remaining sustainably successful

Successful research and development of new tests and medicines and improving access to our medical solutions are key to the sustainable development of our business.

Dear Shareholders,

In 2015, sales grew strongly across our two divisions, Pharmaceuticals and Diagnostics. This enabled us to post net income of CHF 9.1 billion, despite the substantial appreciation of the Swiss franc. We owe this primarily to the dedication and passion of our 91,747 employees. And I thank each and every one!

Unfortunately 2015 will also stand out in our memories as a year of wars, terror and epidemics. Many of these events affected me personally because employees, former colleagues or friends were harmed and because I know some of the crisis regions very well. As the father of five children, I also ask myself how we can continue doing justice to future generations. In the past 25 years, the global economy has doubled in size, as has the global ecological footprint. The latter is now many times greater than our environment can bear in the longer term.

Against this background, I am encouraged by the 17 new ‘Sustainable Development Goals’ adopted by the Member States of the United Nations in September 2015. One of these goals is ‘Good health and wellbeing.’ As a global healthcare company, Roche can and will continue to contribute to achieving this goal. Our main contribution is developing tests and medicines to meet some of the most urgent medical needs.

This is an area in which diagnostics, in particular, is likely to play a more significant role in the future. It enables our health to be managed more effectively —from prevention through targeted therapy to the monitoring of chronic disorders—and there is still a lot of untapped potential here.

As part of our strategic focus on long-term success, we are also conducting research in fields where the probability of success is not particularly high but the medical need is all the greater. We want to drive the progress in medical options available to patients with neurological diseases. In this endeavour, we recently produced some strong results in trials investigating the treatment of multiple sclerosis.

Furthermore, we are encouraged by the opportunities opened up by information technology. Our aim is to turn the wealth of medical data into valuable knowledge to aid research and the selection of therapies for the individual patient. We were therefore delighted to have finalised our partnership agreements with Foundation Medicine and Flatiron Health in the field of oncology. These relationships should lead to further improvements in outcomes for cancer patients.

It is important to us that our therapies reach all of the patients who need them. In some countries the latest medicines and diagnostics are freely available, in others even the most basic things are lacking. Take the example of HIV/AIDS. It is not enough to distribute medicines at cost price if there are insufficient healthcare workers, facilities and diagnostic tools to administer the therapies correctly. We are working to overcome these hurdles in partnership with public and private stakeholders. Here, I would like to mention the HIV Global Access Programme that we have launched with partners such as UNAIDS, the Joint United Nations Programme on HIV/AIDS, and the Clinton Health Access Initiative. The aim of the programme is to provide certain low-income countries with long-term supplies of HIV viral load tests.

The question of access to new products inevitably has an ethical component too. We take this issue seriously and want to help patients gain access to our products, including in countries with low purchasing power. Roche is one of the first companies to have established a differentiated pricing policy in developing regions. In 2015, we advanced our access planning strategy, resulting in improved insights into specific regional and national challenges at the local level and tailored plans to address them.

We are aware that in the world’s poorest countries, patents can present a hurdle to the provision of basic medical care. This is why we do not register and enforce patent rights in these countries. In more affluent countries, however, patents create the incentives needed for high-risk investments. Once a patent has expired, society benefits too because important medicines become permanently available at a reduced cost. I am proud that 29 of the medicines we have developed now feature on the World Health Organisation Essential Medicines List, among them life-saving antibiotics, malaria and cancer medicines.

As an innovative healthcare company, we regard sustainability as both a responsibility and a growth driver. Recent recognition demonstrates that our efforts here are successful. Roche is the only healthcare company to have been awarded the maximum score by the non-profit organisation CDP (formerly the Carbon Disclosure Project) in its leading ranking of companies’ responses to climate change. And for the seventh time in a row, Roche has been identified as the most sustainable healthcare company in the Dow Jones Sustainability Indices.

These awards do not mean that we are satisfied with the status quo. We must renew our efforts every day so that we can stay ahead of the game and live up to our strong commitment to being a sustainable company. That applies to everything we do.

Ladies and gentlemen, I look forward to welcoming you at the 98th Annual General Meeting (AGM) of Roche Holding Ltd on 1 March 2016. I would like to take this opportunity to mention two important items from the agenda.

In light of our strong performance and positive outlook, the Board of Directors is proposing a dividend increase to CHF 8.10 per share and nonvoting equity security. Subject to your approval, this will be the 29th dividend increase in as many years.

In addition to the re-election of existing members, the AGM will see some changes on the Board of Directors. As you are already aware, Dame DeAnne Julius, a member of the Board of Directors since 2002, and Professor Dr Beatrice Weder di Mauro, a Board member since 2006, have decided not to stand for re-election in 2016. Both have made extraordinarily valuable contributions over many years to the company’s successful development. On behalf of the Roche Board of Directors, I would like to extend our sincerest thanks to them.

I am delighted to be able to propose Julie Brown and Dr Claudia Süssmuth Dyckerhoff as new members of the Board of Directors. Both have a wealth of international management experience. As Chief Financial Officer of the British medical technology company Smith & Nephew, Julie Brown has extensive knowledge of sales and finance in the healthcare industry. Claudia Süssmuth Dyckerhoff is currently a Senior Partner at the consulting firm of McKinsey and Company, where she is Leader of the Healthcare Systems & Services Practice in Asia.

Since the company was founded nearly 120 years ago, Roche has always questioned the status quo and set new standards.

It is a great pleasure for me to be part of such an innovative company. And I can assure you that we will continue to do everything in our power to ensure that your company continues to deliver scientific excellence for the benefit of patients in the future.

I would like to thank you, our shareholders, for your confidence in our company.

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Christoph Franz
Chairman of the Board

A great year for our pipeline

2015 was a successful year, as we made great strides innovating medicines for patients with difficult-to-treat diseases including multiple sclerosis, different types of cancer and hemophilia A.

Dear Shareholders,

In a year that contained many highlights, one that particularly stood out for me was without question the phase III results which we presented on our investigational medicine ocrelizumab in multiple sclerosis. This is a devastating disease and current treatments vary in benefit and patients need better options. We have the potential to improve this situation, particularly in the primary progressive form of this chronic disease, for which no effective treatments are yet available.

In oncology, we made significant advances with our cancer immunotherapy portfolio, obtaining positive outcomes for bladder and lung cancer in pivotal trials of our lead candidate atezolizumab. We are really encouraged by the improved, sustained outcomes we are seeing for cancer patients and are investing strongly in this promising treatment approach. We are studying more than 20 investigational cancer immunotherapy medicines, nine of which are in clinical trials.

These scientific successes have been made possible by a solid financial foundation, which was further strengthened in 2015. With sales increasing by 5%1, the Group's core earnings per share for 2015 were 7%2 higher than in the previous year. These positive results can be attributed to the continuing strength of our underlying business.

In the Pharmaceuticals Division, oncology and immunology contributed significantly to sales growth of 5%. Following our acquisition of InterMune in 2014, I am particularly pleased to report that Esbriet —a treatment for the fatal condition of idiopathic pulmonary fibrosis—is showing very good growth. Another highlight in 2015 was the approval of Cotellic in combination with Zelboraf for the treatment of advanced melanoma in both the US and Europe.

In the Diagnostics Division, the launch of new cobas instruments marks the achievement of a milestone in automated, integrated laboratory diagnostics. These new systems permit substantially higher test throughput and greater flexibility. They thus provide an important benefit for healthcare providers, who are constantly striving for efficiency gains. The laboratory business contributed substantially to the Diagnostics Division's 6% sales growth.

Roche is also facilitating and improving laboratory work in tissue sample staining, which is central to the study and correct diagnosis of cancer. With its full automation and excellent staining quality, the newly launched Ventana HE 600 system enables pathologists to work with even greater safety, accuracy and efficiency.

We continued to make good progress with our product pipeline, with five major approvals and four FDA breakthrough therapy designations on our medicines. This is testament to the high level of innovation we are achieving in our research and development activities, which, with Genentech, Chugai and various external alliances, reflect a broad range of approaches and ideas. Take, for example, the early development phase results for emicizumab (ACE910)—a medicine developed by Chugai for the prophylactic treatment of people 12 years or older with hemophilia A—which are sufficiently promising for us to start a pivotal phase III programme.

We also received approval from the FDA for Alecensa (alectinib) for the treatment of a specific form of lung cancer. This medicine was created by Chugai and approved in Japan in 2014. Roche has simultaneously developed a companion diagnostic test to identify those patients who could benefit the most from Alecensa.

Lung cancer is just one example of a disease where a better understanding of the molecular processes in cancer cells has shed light on many possible different causes. Analysis of this molecular information is already yielding insights that are important both for research and development purposes and for the targeted treatment of patients. For Roche, innovation also means simplifying diagnostics for patients. By investing in research into blood-based cancer tests, also known as liquid biopsies, and developing the cobas EGFR Mutation Test v2, Roche is helping to minimise the need for intensive and stressful surgical procedures to collect tumour tissue samples.

Meaningful use of the large amounts of data from test results and clinical practice is set to take on an even more important role. This is why we are involved in pilot projects and partnerships such as those with Foundation Medicine and Flatiron Health, using high-quality healthcare data and advanced analytics to improve both the development of medicines and the scientific basis for treatment decisions.

We will only be able to realise these plans if we continue developing our business sustainably. An important part of our strategy is to improve patient access to our innovative tests and medicines.

Improving health outcomes requires all stakeholders —public and private—to work closely together to achieve sustainable solutions. I am convinced that together we will succeed in improving quality healthcare globally, while continuing to incentivize true medical innovation.

At Roche, each and every one of our 91,747 employees is committed to medical innovation which truly makes a difference to patients. As an innovation-driven company, our employees play a central role in our success. Encouraging diversity is an essential part of fostering new ways of thinking, challenging the status quo and finding new solutions.

Our talent management strategy is focused on giving our employees the opportunity to develop professionally and personally by gaining experience in different roles and countries. As a global company, with increasing activities in emerging markets, diversity in people and experience is becoming increasingly valuable.

I would like to thank all our employees for their personal contributions, and you, our shareholders, for your continued confidence in Roche.

For the current year, we expect sales to grow low-to-mid-single digit at constant exchange rates. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. We expect to further increase our dividend in Swiss francs.

I remain very confident about Roche's long-term future. With science and medicine progressing at an unprecedented rate, and thanks to the new data analysis techniques available to us, we will continue to be in a strong position to develop new medicines and diagnostic tests for better patient care.

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Severin Schwan
Chief Executive Officer

  1. All growth rates in this report are at constant exchange rates (average 2014).
  2. This increase excludes the one-time benefit of CHF 428 million before tax related to the divestment of filgrastim rights in 2014.

Our innovation

Harnessing the immune system to fight cancer

Cancer cells use ‘cellular camouflage’ to avoid being attacked by our immune system. For a long time, it was unclear why cancer cells were going undetected, but scientists, including experts across the Roche Group, are unraveling the mystery of how cancer evades the immune system while it starts, grows and spreads. We are using that knowledge to develop medicines that harness the body’s immune system to fight cancer.

Data from a number of Roche clinical studies presented in the last 18 months reveal that cancer immunotherapies show extraordinary promise where other treatments have previously failed. When treated with the most advanced cancer immunotherapies, some patients with terminal cancers have lived for extensively longer periods of time compared to benefit from classical treatment.

We now have more than 20 cancer immunotherapies in research and development, with 9 compounds currently being tested in clinical studies and multiple combinations under investigation. Our comprehensive cancer immunotherapy programme covers a total of more than 40 trials underway in lung, kidney and breast cancer.

Ultimately, we expect cancer immunotherapy to spawn a new era in oncology with the development of therapies that transform deadly cancers into chronic diseases with which patients can live with for a long time.

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A special opportunity to have an impact — as a scientist and a physician.
Dr Dan Chen, Cancer Immunotherapy Franchise Head, Global Product Development Oncology
Expand to read the full story

The immune system fighting cancer

My own experience with cancer helps me to empathise with patients.

As a scientist, I’ve always been fascinated by the potential of harnessing the body’s own immune system to fight cancer. I am really encouraged by the progress we are making in this area at Roche in realising that potential. I’m trained as a medical oncologist, and I have seen many patients fight bravely against cancer. During those desperate times, I have been their doctor, their counsellor and often their friend. And I have watched most of them lose the battle.

I myself have had a personal glimpse into how difficult a journey this fight can be. In 2008, I was informed that the MRI I had on my back showed a two cm tumour in my spine. The tumour crushed the nerves in my spine, putting me in pain so excruciating that it frightened my children.

Work helped me to focus my mind, and my spirit during that year and a half. I never missed a day during my treatment, which was tough at times. Due to the location of the tumour, we weren’t able to get a biopsy, so I also had to come to grips with the uncertainty of whether I was going to live or die.

Today with our investigational cancer immunotherapies, I see a real opportunity to have an impact.

There are many opportunities for cancer cells to ‘camouflage’ themselves and escape the immune response. However, by leading the understanding of how the immune system works in cancer, we are rapidly developing even newer ways to help the immune system recognise and fight cancer. New insights are occurring in cancer immunotherapy every day now. It is an amazing time to be in this field, and my job is a special opportunity to have an impact both as a scientist and a physician.

Targeting the cancer-immunity cycle

Our immune system protects our body from cancer through what we now understand is a multi-step cancer-immunity cycle. We have learned that tumours can disrupt the cycle by disabling, hiding from and co-opting the immune response at several points along the way. The goal of cancer immunotherapy research is to identify, understand and counteract a tumour’s ability to suppress the immune response. Our scientists are focused on inhibiting the diverse mechanisms a tumour can use to sabotage the immune system and also on stimulating the immune response against cancer.

Atezolizumab

Atezolizumab is an investigational antibody designed to fight tumours by blocking the PD-L1 protein. PD-L1 is produced on the surface of both tumour and immune cells and is believed to act as a stop sign that blocks immune cells from recognising, attacking and destroying cancer cells. More than a dozen different tumour types have hijacked this PD-L1 to PD-1 interaction. Atezolizumab removes this cellular camouflage in such tumours, allowing the immune cells to attack the tumours.

All atezolizumab studies include the evaluation of an investigational immunohistochemistry test developed in-house that uses a specific antibody to measure PD-L1 expression on both tumour cells and infiltrating immune cells. We believe that having diagnostic information is important so that physicians and patients have the opportunity to incorporate all available information into their treatment decisions.
In the US, the FDA granted Breakthrough Therapy Designation for atezolizumab for the treatment of metastatic urothelial carcinoma and non-small cell lung cancer.
There are currently 11 ongoing or planned phase III studies with atezolizumab across several types of lung, kidney, breast and bladder cancer.

Atezolizumab in lung cancer

Atezolizumab in bladder cancer

Advancing multiple sclerosis treatment

2.3 million

people worldwide are affected by multiple sclerosis 1

A disease of the central nervous system, multiple sclerosis (MS) is a chronic disease in which the immune system abnormally attacks the insulation and support around the nerve cells in the brain, spinal cord and optic nerves, causing inflammation and damage.

MS is a leading cause of non-traumatic disability in young people, usually striking between 20 and 40 years of age.2

Patients with relapsing disease, the most common form, have attacks or periods of time when symptoms flare. Those with the primary progressive form, which affect about 10% of MS patients, suffer from a disability which continuously worsens after the onset of the disease, but typically without distinct relapses or periods of remission.

There is no cure for MS, but various treatment approaches are available with varying degrees of benefit to patients.

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It was teamwork, perseverance and ingenuity that enabled us to meet our goal.
Rita Wong, Head of US Global Biologics, Manufacturing Science and Technology Drug Product
Expand to read the full story

Double-blind by design

All this hard work was definitely worth it.

I am an intensely curious person, and ‘why?’ is one of my favourite words. So, it was natural for me to become a scientist. That inquisitiveness helped me for almost a decade of working on an investigational medicine being studied in patients with multiple sclerosis (MS).

I joined Genentech in 1987 right out of college and was hired into the formulation development group. Simply stated, we ensure the active ingredient in our medicines remains stable and usable. I began working on the formulation of an investigational medicine in 2006. Four years later, I was appointed Technical Development Leader just prior to the phase III trials.

Roche clinicians wanted to increase the scientific rigour of the phase III trials by comparing our investigational medicine with a standard of care medicine approved for the treatment of MS. Both arms were 'double-blinded', meaning that neither patients nor clinicians knew whether they received placebo or the investigational medicine.

My Technical Development Team supplied the materials for these clinical trials. For the first study arm, we scaled up production, and produced a placebo formulation identical in appearance for administration.

For the second arm, we purchased drug that was a standard of care medicine approved for the treatment of MS. But how could we develop a placebo that looked like the marketed comparator drug, which came in a syringe, multiple doses and different presentations? This had never been done before at Roche. And we only had six months before the start of the trials.

I formed a tight-knit subteam to develop the comparator placebo. We first broke down the active comparator into their component parts to design the comparator placebo. Then we leveraged our external manufacturing network to produce the placebo syringes, which had to meet the same strict requirements for human injection as our drug.

We faced many obstacles and the merciless ticking of the clock. It was teamwork and perseverance that enabled us to succeed in producing the comparator placebo on time. We set a high bar that allowed us to produce compelling comparative clinical data in the context of a well characterised active comparator.

In 2014, I took on my current position, but kept an eye on the clinical trials. The results convinced me that all the hard work was worth it.

Ocrelizumab

In 2015, we presented the results from three phase III clinical studies on our investigational medicine ocrelizumab in MS which provide hope for a new paradigm in treatment.

For more than a decade our scientists have pioneered the concept that selectively targeting a component of the immune system, the CD20-positive B cell, may be an effective therapeutic approach for people with MS.

While this concept was not widely accepted in the medical community, our scientists conducted in-depth research and followed-up development programmes with a long-term view and commitment. With the development of ocrelizumab, a humanized monoclonal antibody targeted specifically against CD20-expressing B cells, the hypothesis that B cells are central to the pathogenesis of relapsing MS has been confirmed. Ocrelizumab is the first investigational medicine to show positive study results in both primary progressive and relapsing forms of MS, which affects approximately 95% of people with MS at the time of diagnosis.

​Read more about the results of the OPERA I, OPERA II and ORATORIO clinical studies

Read more about what Roche is doing in Multiple Sclerosis

Roche will submit the ocrelizumab data to global regulatory authorities for both forms of multiple sclerosis in 2016.

  1. Multiple Sclerosis International Federation. (2013): http://www.msif.org/about-us/advocacy/atlas/
  2. National Institutes of Health-National Institute of Neurological Disorders and Stroke. (2015). Multiple Sclerosis: Hope Through Research. Available at: http://www.ninds.nih.gov/disorders/multiple_sclerosis/detail_multiple_sclerosis.htm#280373215

Tags: Innovation