AKL4 Market Challenges

Leading OA treatments have been withdrawn from the global market due mainly to cardiovascular toxicity, though other toxicities such as gastrointestinal are also important.

Remaining treatment options are suspected to have the same toxicity and are subject to significant prescribing restrictions.

Large unmet need for treating pain

Although ~27% UK OA population (~1.8m) take drugs to relieve pain, neither oral nor topical NSAIDs alleviate all moderate/severe symptoms and opiates are inappropriate for long-term use. Agents that relieve pain rarely have structure modification benefits; in some cases they’re detrimental to the joint.

Rising Direct Costs

27 million Americans of all ages suffer from osteoarthritis with many progressing to joint replacement surgery. Osteoarthritis accounts for 55% of all arthritis related hospital admissions (632,000 in 2004, an increase of over 50% in less than 10 years). In the USA, in addition to drug – drug interactions, renal, cardiovascular and GI adverse events related to NSAID use are likely to exceed $4 billion.

Rising Indirect Costs

Indirect costs include those costs associated with loss of productivity, absenteeism, premature mortality and disability payments/benefits. In the USA it has been estimated that the cost of absenteeism alone exceeds $10 billion.

Extended Development Timelines

Adverse events and increasing concern for drug-drug interactions means that the next generation of OA treatments will likely need to demonstrate long term safety and minimal drug interactions, increasing typical time-to-market and reducing market attractiveness to developers.