|
Even as the number of overweight people grows, a clear winner
has yet to emerge in the race to develop safe and effective
obesity treatments. With billions of dollars in sales up for
grabs from around 35 million obese Americans and tens of millions
elsewhere, the company that can develop and market a safe,
effective treatment to help people lose weight knows it will
be on to a winner.
However, will long-term weight loss ever be as simple as popping
a pill and, if so, at what cost to the health of the patient
and the finances of the healthcare industry?
A complex issue
In scientific terms, obesity occurs when an individual's calorie
intake exceeds the amount of energy he or she burns. Evidence
suggests that many factors may contribute to obesity. These
include:
- Genetic factors - obesity tends to run in families and
growing evidence points to heredity as a strong determining
factor
- Environmental factors - lifestyle factors such as what
a person eats and how active he/she is play a significant
role
- Psychological factors - many people eat in response
to negative emotions such as boredom, sadness, or anger
- Illnesses - hypothyroidism, Cushing's syndrome and
depression cause around 1% of obesity
Challenges for pharmaceutical companies
Obesity has been declared by the World Health Organization
(WHO) as the largest global chronic health problem in adults.
Associated with chronic medical conditions like diabetes,
heart disease, hypertension, stroke and cancer, obesity is
estimated to occur in one in three American adults and five
to 10 million people in each of France, Germany and the UK.
Today's increasingly sedentary lifestyle, combined with higher
disposable incomes to spend on convenience food, has contributed
to the rapidly rising prevalence of obesity. The costs of
treating obesity or obesity-related disorders are almost as
high as the costs of treating cancer, accounting for between
5% and 10% of healthcare costs in the industrialised countries.
A 'cure' for obesity is highly sought after. However a drug
such as Roche's Xenical (orlistat) or Knoll's (BASF) Meridia
(sibutramine, also known as Reductil) cannot fulfill its true
potential until:
- The possibility of a pharmaceutical treatment for obesity
becomes more widely accepted
- Consumers see obesity as a health issue and not just
as a cosmetic concern
- The view that some obese people could benefit from
certain drugs - going beyond changes in exercise and eating
habits - is embraced by the medical profession and patients
alike
The problem is that some weight control drugs that have hit
the market carry the risk of unpleasant or even dangerous
side effects. Others have proved to be only partially effective
as they also involve harsh dietary regimes that patients have
been unable to follow for long. Additionally, many doctors
are reluctant to prescribe drugs to help patients lose weight
when dieting and exercise may provide the best 'cure'.
Ban in European Union
In April 2000, the European Commission (EC), on the advice
of the European Medicines Evaluation Agency (EMEA), took the
decision, after years of heated debate, to end the marketing
of anorectic drugs in the European Union, effective April
2001.
The EMEA pointed out that anorectic drugs, such as amfepramone,
phentermine, clobenzorex and mefenorex, are often ineffective
and have been associated with serious side effects, such as
pulmonary hypertension and deformation of the heart valves.
Following a challenge to the EC's initial decision, on August
7 the European Court instructed the Commission that its action
be suspended until the Court reaches a final decision.
Even before the EC's decision, however, the market for antiobesity
products in the EU had begun to decline, after being boosted
substantially by the launch of Xenical in 1998. Doubts over
the safety of anorectic drugs may have contributed to this
decline in the European market.
Source: MIDAS
The pipeline…
According to R&Dfocus,
there are several drugs in development for the potential treatment
of obesity:
- Zoloft (sertraline), marketed mainly as an antidepressant,
is currently in Phase III trials evaluating its potential
as an anorectic
- Axokine, a second generation ciliary neurotrophic factor
has entered into Phase II trials to assess its safety
and efficacy in 175 severely obese patients
- SR 141716 was reported in 1999 to be in Phase IIb trials
investigating the agent's potential in obesity using 20
healthy obese patients. It is thought to reduce hunger
and calorific intake of carbohydrates and fat
- Ecopipam, a dopamine D1/D5 receptor antagonist, is in
Phase II trials assessing its use as an obesity management
therapy following previous Phase I/II evaluation of the
agent in the treatment of schizophrenia
- Amgen is developing a second-generation leptin molecule
for the treatment of obesity. Preliminary results suggest
it is superior to native leptin for obesity
|
Selected
Products in Late Phase Trials for the Treatment of
Obesity
|
|
Product
|
Phase
|
Leading
Corporation
|
Action
|
| Zoloft
(sertraline) |
Marketed/Phase
III |
Pfizer |
5-HT
reuptake inhibitor |
| Axokine |
Phase
II |
Regeneron |
neurotrophic
factor |
| SR
141716 |
Phase
II |
Sanofi-Synthelabo |
cannabinoid
antagonist |
| ecopipam |
Phase
II |
Schering-Plough |
dopamine
antagonist |
| leptin
(second generation) |
Phase
II |
Amgen |
biotechnology |
Source: R&Dfocus
|
