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Biotech products represent 31% of
new launches in 1998
Biotechnology R&D has
at last begun to realise its potential, with 31% of first
world introductions
coming from the biotechnology sector in 1998.
New active substances (NASs)
totalled 45 in 1998, slightly down on the 1997 total of
50 NASs, but on a par with the previous two years of 44
and 45, respectively in 1996 and 1995.
Fourteen new active substances
were biotechnology products, representing 31% of introductions.
This is a marked increase over 1997 and 1996 when
11% and 16%, respectively, were biotechnology NASs, whereas
a decade earlier there was only one. Thus Biotechnology
drugs are gaining ground and are becoming an increasingly
important contributor to new product introductions and more
are about to be launched judging by recent biotech approvals
in the US.
Most of these NASs were introduced
in the US as their first world market and were developed
by US biotechnology companies. Six of the fourteen biotech
NASs are monoclonal antibodies.
Many of these drugs represent
important breakthroughs in their areas. Centocor's
Remicade (infliximab), which represented the first
new drug to be launched for Crohn's disease in several decades.
It also offered an important advance in that condition as
it is the only drug credited with being able to reduce the
number of fistulae in Crohn's patients.
ISIS Pharmaceuticals' Vitravene
(fomivirsen) was the first antisense agent to reach the
market, and is indicated for cytomegalovirus retinitis in
AIDS patients.
Immunex's Enbrel (etanercept),
offers promise to rheumatoid arthritis sufferers and acts
by clearing up the excess tumor necrosis factor that promotes
the inflammation process in these patients.
According to IMS HEALTH's
LifeCycle
service, most of the biotechnology drugs were introduced
in the US as their first market and by the end of 1998 had
not penetrated other world markets. A few, like Novartis'/Seragen's
Simulect (basiliximab), indicated for prophylaxis
of acute organ rejection in renal transplantation, were
first introduced in Switzerland in April 1998 and on the
market in several European countries the US and Brazil by
year end. Chiron's Regranex (becaplermin), was first
introduced in the US and later in 1998 reached Canada and
Puerto Rico. Zenapax (daclizumab) was introduced
in the US in January 1998 also for prevention of kidney
transplant rejection. It subsequently reached Switzerland,
Germany and Thailand by end 1998.
Although sales of these biotechnology
products are quite modest at present a number of biotechnology
NAS have made their way into the Top 50 new drugs introduced
over the last five years in terms of world dollar sales
- according to IMS HEALTH's Pharmaceutical
World Review. Reopro (abciximab), which was first
introduced in 1995, was ranked as the 13th best
selling NAS in 1998 with sales topping $300 million. Biogen's
Avonex (interferon beta-1a) commanded sales of $268
million in 1998.
Other biotechnology NASs ranked
in the top 50 included follitropin alfa, montelukast, zafirlukast,
insulin lispro and dornase alfa, all with sales well over
$100 million in 1998.
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