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To optimize profitability of
marketed drugs it is essential to build on market share,
and to prepare for patent expiry. Strategies include constant
monitoring of patients and prescribers to optimize sales
and marketing campaigns, and continuing research on the
product to identify opportunities to extend its life.
After launching a drug, it is
not just sales into pharmacies and prescriptions written
in each country that need to be monitored. Detailed information
on individual marketplaces increases the chances of marketing
success through increased market transparency, more efficient
sales management and more accurate target doctor group definition.
Studying the performance of therapies
in doctor specialty groups enables the identification of
such target doctor groups, which is one of the most important
factors for ensuring lasting market success. Marketing resources
can then be focused on areas with a high concentration of
this specialty.
A company needs to be aware of
patient demographics, while knowledge of co-diagnoses can
also be valuable in the marketing of the drug. In addition,
medical data can be used in identifying opportunities to
extend the life of a product, through, for example, developing
new indications.
Understanding the depression
market
Antidepressants were the world’s
third-largest therapy class in 2000, according to IMS HEALTH’s
World
Review. Sales amounted
to $13.4 billion, up 18% from 1999. To capture or protect
a share of this competitive market requires a detailed understanding
of the doctors and patients involved.
Depression affects about twice
as many women as men in developed countries. According to
Medical Dynamics, the percentage of female patients treated
for depression was around 70% of the total in the US, France,
Spain and Italy.
The number of prescriptions written
for depressive episodes peaks in the US for patients in
the 45-49 age range. In Spain, however, the level of prescriptions
seems to remain relatively stable after the age range of
35-39.
Prescribing physicians
Doctor specialty data provides
an insight into the prescribing of doctors in primary care
by highlighting the different approaches used in managing
diseases. Medical Dynamics shows that in the US, prescriptions
for depressive episodes are spread broadly among doctor
groupings, although psychiatrists account for over a quarter
of prescriptions written.
In Spain, prescriptions for depressive
episodes are more restricted to general practice. Prescriptions
by paediatricians are negligible, unlike in the US, where
paediatricians account for 2% of prescriptions for depressive
episodes. Medical
Dynamics gathers data
directly from doctors practicing primary care, and records
the treatment given to a patient at each consultation.
Co-diagnosis in depression
Co-diagnosis occurs when a doctor
diagnoses several conditions during the same consultation.
There is a high proportion of co-diagnoses in the diagnoses
of depressive episodes, representing over 35% of the total,
in both the US and Spain, with marginally more co-diagnosis
in the US.
According to Medical Dynamics,
for both countries the three top co-diagnoses in the 12
months to June 2000 were:
- hypertension
- chronic ischaemic cardiac
disorder
- sleep disorders
This information is important,
as some antidepressants cannot be taken with other types
of medications given to treat these secondary disorders.
Protecting sales
Even when a drug is successful
in gaining a large share of a market, it still has to face
the challenge of new competitors, which intensifies when
it loses its market exclusivity.
Prozac’s global market share
has been declining since 1995, because of new drugs and
more recently as a result of generic competition in certain
markets. This falling market share is a natural part of
a product's life cycle. Basically, Prozac is suffering
from old age. With Prozac’s market
exclusivity in the USA
expected to expire in
2001, and further new drugs nearing the market, competition
in the depression market is intense.
Although it has fallen down
the best-seller list, Prozac was still the world's sixth-biggest
selling prescription drug, with sales of $2.3 billion, for
the 12 months to February 2001, according to IMS HEALTH's
MIDAS
sales system. However, the effect
of the loss of market exclusivity on Prozac’s sales
in the UK was dramatic.
The Prozac story in the UK
The plunge in Prozac sales in
the UK resulted from the expiry of its Supplementary
Protection Certificate
(SPC) in the UK in January
2000, and the ensuing arrival of generic forms of fluoxetine.
Within a year, generic fluoxetine sales exceeded
£43 million (at ex-manufacturer level), overtaking sales
of the original product. By mid-2001, Prozac had lost 80%
of its sales in the UK.
Antidepressant
market development in the UK
1988–2000 at ex-manufacturer
prices
Source: MIDAS
Antidepressant patent expiry
in the US
Lilly’s Prozac is expected to
lose its market exclusivity in the US market, which represents
two-thirds of global antidepressant sales, in August 2001,
and several other antidepressants will soon follow. There
will be some important patent expiries in the US depression
market affecting leading US corporations during 2001–2007.
According to Generic
Planning, most severely
affected will be Lilly and Pfizer.
Competition in the generic
antidepressant market will also hot up in Europe, following
the European approval of Synthon’s generic version of paroxetine
(GlaxoSmithKline's Paxil/Seroxat) in May 2001. Eight
countries mutually approved the product, with the first
marketing authorization being granted in Denmark in October
2000.
Fighting back
One way to defend a brand name
drug is reformulation. By doing this, a company can
develop better products, build a franchise, and limit the
impact of generics.
Prozac Weekly was approved
by the FDA in February 2001 for the continuation treatment
phase of major depressive disorder. It contains 90mg of
fluoxetine with an enteric coating that delays release into
the bloodstream. This formulation takes advantage of the
protective effects provided by fluoxetine's naturally long
half-life, allowing Prozac Weekly to be administered just
once a week.
A new indication for a
product can also be used to expand the market base. Therefore,
while a branded product’s share may not change much, or
may decrease due to the number of generic entries in the
market, volume is not as heavily affected. Typical added
indications
being explored for antidepressants
include obsessive compulsive disorder, panic disorders and
other anxiety/stress conditions.
Rebranding a product
– giving a new brand name to a molecule – and introducing
it in a new market is another tactic that expands the overall
market base for the molecule.
Bupropion, used in GSK’s Wellbutrin
SR, was introduced as Zyban for smoking
cessation
in 1997. This rebranding
added a lot of value to the molecule; during Zyban’s first
12 months on the market, it achieved sales of $124 million,
boosting Glaxo’s bupropion sales by 25%.
In July 2000, the FDA approved
Lilly’s Sarafem for the treatment of premenstrual
dysphoric disorder (PMDD). Sarafem contains fluoxetine hydrochloride,
the same active ingredient found in Prozac. Lilly stated
that: "the additional trademark will help with educational
efforts for this largely under-recognized disorder while
reducing confusion about the differences between depression
and PMDD". Sarafem was the first prescription medication
indicated for the treatment of PMDD in the US.
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