the first of a new class of oral antidiabetic agents known as incretin enhancers. In the meantime, positive data have been reported from the most recent large-scale (Phase III) clinical trials. This new drug can be combined with several other antidiabetic agents, including insulin, or used alone. Another encouraging finding is that patients treated with Galvus showed no weight gain – in contrast to most other oral antidiabetics. The first regulatory filing for this product is planned in the US for the first half of 2006.

Also successful were the clinical trials for Rasilez (SPP100, aliskiren), the first in a new antihypertensive class called renin inhibitors. In these studies, Rasilez showed excellent tolerability and provided sustained 24-hour blood pressure control, thus also offering protection against dangerous early morning surges.

Further observation of patients with multiple sclerosis who were treated with FTY720 – a novel, experimental immunomodulator – substantiated the positive Phase II data. During treatment with this agent, inflammatory lesions in the brain resolved more rapidly, and relapse rates were significantly reduced over a 12-month follow-up period. However, these findings will need to be confirmed in additional studies before registration can be envisaged.

Unfortunately, the trial data for PTK787 – an agent designed to block new blood vessel formation (angiogenesis) in tumors – fell

short of expectations. The course of disease was only improved in one subgroup of patients with colorectal cancer who received this treatment. Whether this compound can ever be registered remains to be seen.

Clinical development of pitavastatin, a cholesterol-lowering compound licensed-in some years ago, has been terminated, as it proved less effective than had been hoped. We are thus reminded that while R&D is often fortunate enough to achieve breakthroughs that decisively improve the lives of thousands of patients, it is never immune to costly setbacks.

Access to medicine and drugs for needy patients, particularly in developing countries, remains an important concern. There is little public awareness of the fact that, since the UN Millennium Development Goals were proclaimed in 2000, multinational pharmaceutical companies have entered into more than 126 partnerships for the benefit of patients in developing nations. As a result of these initiatives, over 540 million treatments, worth in excess of USD 4.4 billion, have been provided to needy patients. These figures relate only to long-term programs and do not include assistance to patients in industrialized nations or disaster relief. Last year, taking all pro bono contributions into account, the total aid provided for patients in need by Novartis alone amounted to USD 696 million, with 6.5 million patients being treated. The main element of this commitment was the donation of medicines for the treatment

of leprosy, malaria, tuberculosis and chronic myeloid leukemia. On top of humanitarian considerations, this aid produces substantial economic benefits, as it may enable patients to start work again and support themselves and their families.

The pharmaceutical industry’s commitment to patients in developing countries exceeds that of any other industry sector worldwide. But it cannot succeed single-handedly. There is a fundamental need for effective action by governments that are primarily concerned with the welfare of their citizens, as well as for partnerships with international organizations and civil society.

The company’s tenth year of operations provides me with the opportunity for a brief review. In 1995, Ciba and Sandoz with a combined headcount of 134 000 posted total sales of around USD 27 billion (using today’s currency translation rates); in 2005, with just over 91 000 employees, sales reached USD 32 billion. In the initial postmerger years, spin-offs and disposals removed almost 50% of the 1995 total sales and a corresponding number of employees. This transformed the business portfolio dramatically.