| The
number of new active substances (NASs) launched on
the world market in 2000 plummeted to a 20-year low,
with only 38 NASs reaching the market. By the third
quarter of 2000, the picture was extremely bleak with
only 20 NASs launched.
A flurry of activity in the dying months of 2000 saw
numbers rally slightly to achieve 38 NASs, according
to editors reviewing IMS HEALTH's LifeCycle service
Drug
Launches, which monitors the launches of new products
in over 60 world markets. This 20-year low was only
six off the all time low of 32 NASs in 1979. There
were 46 NASs launched
in 1999.
US still dominates NAS first introductions
Just under half of the NASs (45%) were introduced
in the US as their first world market in 2000. Japan
was the first country of launch for 21%, and Europe
was the other main arena for first world introductions
of NASs, with Sweden and Germany achieving 8% each,
Spain achieving 5% and Austria, the Netherlands, Italy
and the UK each achieving 3%. Canada was the only
other country of first introduction, responsible for
3% of NASs.
New
Active Substances introduced 1996-2000
(by country of first launch)
|
Source:
World Review
Limited
market penetration
2000 was a lacklustre year for NASs, not just for
the dearth of launches but also based on NAS sales
by the year-end - none achieved sales of $100 million.
In the previous three years at least one of the NASs
had achieved blockbuster status (sales of >$500 million)
by year-end and many more had results in excess of
$100 million.
What happened to the "blast the market" philosophy
in 2000, where big multinationals aim to get their
new NASs in all major markets within months of the
first world launch?
Only ten out of the 38 NASs had reached a second market
by year-end 2000, and only six were available in more
than two markets.
Of the 17 NASs launched in the US as their first world
market, ten had not reached another market by year-end
2000. Four NASs were in two markets only. A further
three were available in more than five markets:
- UCB's
antiepileptic, levetiracetam (Keppra)
- Akzo
Nobel's ganirelix (Orgalutran), for prevention of
premature luteinizing hormone surges in women undergoing
controlled ovarian hyperstimulation
-
Celltech's anaesthetic levobupivacaine (Chirocaine)
None
of the eight NASs launched in Japan as their first
market had penetrated a further market by the end
of 2000.
Of the European first introductions, only three NASs
penetrated more than two markets by year-end 2000:
- AstraZeneca's
potential blockbuster, esomeprazole (Nexium), first
introduced in Sweden in August 2000, had reached
a further five European markets by the end of 2000
- Schering-Plough's
immunostimulating agent, PEG-interferon alfa-2B
(Viraferon PEG), which was first introduced in the
UK in June, was available in a further six European
markets as 2000 drew to a close
- Ferring's
atosiban (Tractocile), which made its market entrance
in Austria in April 2000, penetrated a further five
European markets.
Orphan drugs and niche markets limit sales potential
Single isomers of racemic drugs - three of
the drugs launched in 2000 were single isomers of
racemic drugs - levosimendan (Simdax), levetiracetam
(Keppra), and levobupivacaine (Chirocaine).
Orphan drugs - another reason for the poor
early sales performance of the 2000 NASs was that
many were orphan drugs or innovative drugs for niche
markets. The orphan drug Trisenox (arsenic trioxide)
was launched in the USA by Cell Therapeutics for treating
acute promyelocytic leukemia.
Innovative drugs for niche markets - Snow Brand's
Evoxac (cevimeline), a muscarinic M1-agonist, was
launched in the US for Sjogren's syndrome. Dusa Pharmaceuticals'
photosensitizer, 5-aminolevulinic acid (Levulan Kerstick)
was launched in the US for actinic keratosis. Brocacef's
Artecef (artemotil) was a new antimalarial launched
in the Netherlands.
Drug withdrawals - another factor was that
Glaxo SmithKline's irritable
bowel syndrome drug, Lotronex (alosetron), which
was expected to take the market by storm following
its launch in the US in March 2000, was withdrawn
in November 2000 following gastrointestinal safety
concerns. Ironically, its early potential was evident
and even with its withdrawal it was the best selling
NAS launched in 2000.
Blockbuster potential
Of the NASs launched within the last five years, only
20 drugs had become blockbusters by the end of 2000,
according to the recently published IMS HEALTH World
Review. Very few NASs achieve blockbuster status
in the year of launch. Notable exceptions have been
celecoxib (Celebrex), sildenafil (Viagra) and atorvastatin
(Lipitor). Six NASs have taken two years to achieve
blockbuster status, four have taken three years, five
have taken four years and a further two NASs took
the full five years according to results recently
released by IMS HEALTH.
| Number
of years for New Active Substances to Reach
Blockbuster Potential
| Blockbuster
|
Year
of First Launch |
Years
to Achieve Blockbuster Status |
| Celecoxib
|
1999
|
1
|
| Sildenafil
|
1998
|
1
|
| Atorvastatin
|
1997
|
1
|
| Rofecoxib
|
1999
|
2
|
| Rosiglitazone
|
1999
|
2
|
| Pioglitazone
|
1999
|
2
|
| Clopidogrel
|
1998
|
2
|
| Orlistat
|
1998
|
2
|
| Olanzapine
|
1996
|
2
|
| Etanercept
|
1998
|
3
|
| Raloxifene
|
1998
|
3
|
| Cerivastatin
|
1997
|
3
|
| Donepezil
|
1997
|
3
|
| Montelukast
|
1997
|
4
|
| Irbesartan
|
1997
|
4
|
| Candesartan
cilexetil |
1997
|
4
|
| Rabeprazole
|
1997
|
4
|
| Fexofenadine
|
1996
|
4
|
| Valsartan
|
1996
|
5
|
| Latanoprost
|
1996
|
5
|
|
Source:
MIDAS
Six rising stars tipped
All is not gloom! Out of the 38 NASs, six have been
tipped as potential blockbusters according to IMS
HEALTH's Pharma/Chemical
Horizons 2001 seminar. One of these is AstraZeneca's
esomeprazole (Nexium), a follow-up drug to its market
leader omeprazole (Prilosec/Losec).
And, NASs have got off to an excellent start in 2001
according to Drug Launches, with 12 launches in the
first three months... |
