Orthogen presents cox- II inhibitor alternative
shown the emergence of autologous bioengineered proteins as a
viable alternative to the cox-II inhibitor class. The class of drug
was blighted with severe side effects, which resulted in the drug
taken off worldwide markets in 2004.
After the failure of cox II inhibitors such as Vioxx (rofecoxib), osteoarthritis patients and their doctors are faced with a lack of alternative therapies. In the race to find a solution, biologicals have emerged as a candidate to supplant pharmaceutical blockbusters such as Vioxx.
A spokeswoman for Orthogen told DrugResearcher.com: "Orthokine-therapy originated from research in the role of cytokines in pain and inflammation."
"The therapy involves administering knee-injections of IL-1Ra protein, obtained from the patient's blood. Since it is an autologous process there are no allergic reactions with minimal side effects," she added.
The basic idea for the development of this therapy was the fact that interleukin-1 (IL-1) plays a key role in the pathology of osteoarthritis or intervertebral disc degeneration/prolaps. The biological antagonist, interleukin-1 receptor antagonist (IL-1Ra), intervenes in the physiological mechanism of these diseases.
Interleukin-1-receptor antagonist (IL-1Ra) is naturally present in the blood. However, this antagonist is produced and extracted in higher concentrations with the production of Orthokine. To do this, blood is taken from the patient with a special syringe.
"The problem with conventional osteoarthritis-therapies such as painkillers, steroids and hyaluronic acid is that they act on the symptoms but leave the underlying causes of the disease untouched," said Orthogen CEO Peter Wehling.
"In contrast Orthokine acts on the causal mechanism of arthritis and prevents further cartilage degeneration in the joints. Orthokine could potentially become the new standard arthritis therapy," he added.
Ten to 20 per cent of the western population suffers from joint and spinal disorders. The therapies for these disorders are most expensive after circulatory and digestive diseases with a high market potential.
According to official government statistics, orthopaedic disorders cost €25 billion annually in Germany alone and approximately one-third of this amount is accounted by osteoarthritis. For many years now, musculoskeletal disorders have been the number one cause of work disability and the consequent economic loss in Germany.
Orthogen believes that it may well earn revenues in the two-digit millions in the coming years, considering the fact that Merck was earning $2.5 billion annually worldwide from its Vioxx painkiller.
Vioxx (rofecoxib), used by millions worldwide to treat arthritis was withdrawn from the market last September after comprehensive clinical data confirmed long-established concerns that the treatment increased the risk of heart attacks and strokes.
Its withdrawal sent a powerful message regarding safety over similar drugs in the same class. Aside from the immediate impact of losing Vioxx revenues which at their height reached $2.8 billion (€2.18bn) a year, the US company is also facing lawsuit and legal charges which some analysts have predicted could reach the double-digit billion dollar level.
According to Datamonitor, the worldwide market for arthritis preparations is expected to increase from its current level of $21 billion to $26 billion in 2010.
