The fastest growing segment of the biological pharmaceutical market is in the treatment of chronic inflammatory conditions. These conditions are classically diseases of aging and consequentially are increasing as the population ages. This phenomena is not restricted to the Western affluent societies but is increasingly being manifested in the high growth Asian economies.
The fastest growth in disease prevalence are the auto-immune diseases of which Rheumatoid Arthritis is the most prevalent and largest in market size. There are a large number of auto-immune diseases not as prevalent as Rheumatoid Arthritis. The markets for these other auto-immune diseases is, at least in part, limited by the lack of availability of an effective treatment or drug.
Auto-immune diseases involve a chronic inflammation that causes the immune system to attack the host’s own healthy tissues. The immune system is the body’s defence mechanism against bacteria, viruses and ‘foreign’ substances generally. With auto-immune conditions the immune system’s ability to recognise the body’s "self" and to distinguish ‘foreign’ substances breaks down with the result that the immune system turns on itself and attacks the body. Rheumatoid arthritis is perhaps the best-known as well as the most prevalent auto-immune disease. There is, however, a range of such diseases including, among many others:
- Rheumatoid arthritis – which attacks the lining of the joints and causes inflammation and typically results in reduced mobility and loss of dexterity in addition to pain – a condition that is chronic, debilitating and progressive;
- Multiple sclerosis – in which the sheaths around the nerve fibers of the brain and spinal cord are damaged with adverse effects on motor control; and
- Psoriasis – in which the immune system mistakenly identifies areas of the skin as pathogens and reacts to accelerate skin cell replacement.
New Drug Development
A major issue with the use of proteins (or other biological drugs) is that the body eventually compensates for the induced metabolic imbalance. This generally requires the physician to move onto new or different drugs. Also, to date, existing biological drugs used for treating auto-immune diseases seem to work only in 50% to 70% of patients. This fact is both a medical problem and a commercial opportunity. Assuming each individual patient can continue with a biological drug even for five years, there is a need for new and better
drugs to supplant an existing drug over the remaining lifespan of the patient – typically somewhere between 20 and 40 years. The current immune suppressive drugs used in the treatment of auto-immune diseases have demonstrated some significant adverse side effects. Even though all immune suppressive drugs will have certain undesirable side effects - eg opportunistic infections – the preliminary public data from trials to date of the protein we are focusing on indicate a high level of safety. Although the current use of anti-tumour necrosis factor (TNF) for a selection of auto-immune diseases,is well established, there are still large resources devoted to finding other drugs to treat rheumatoid arthritis and other auto-immune diseases. Anti- tumour necrosis factor drugs are also coming off patent, and there are indications that generic antibodies are being developed in the US, Europe, and lately China, to enter this market. New drugs, under patent, will have a significantly longer life of premium pricing beyond that of the existing biological treatments.
Market Size & Opportunity
The prevalence of auto-immune diseases globally are conditions affecting many millions means that the market is, by definition, large not only in terms of patients treated but in terms of revenue generated. The top three biological auto-immune treatments generated a combined revenue of US$27.8b in 2013; these treatments (Humira, Enbrel & Remicade) were also the best-selling prescription drugs for all conditions – not just auto-immune diseases. Another antibody used in non-Hodgkins lymphoma, leukemia and auto-immune treatment, Rituxan, was sixth on the list with sales of $8.9 Billion in 2013.
Servatus targets development of biological drugs for chronic inflammatory and auto-immune diseases that work by new modes of action not currently fully utilised in modern medicine and which complement existing treatment strategies.