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Biotechnology
drugs are making a major contribution to the new active
substances (NASs) launched worldwide, according to the IMS
HEALTH LifeCycle
service. Of the 37 NASs launched in 2001, over 30% were
biotechnology products.
While
the trend continues to show fewer NASs launched overall
- 37 in 2001 versus 39 in 2000,
heralding a new 20-year low for NASs - biotechnology NASs
continue to increase their franchise of the world market.
New
Active substances by year of launch
Source:
LifeCycle
This
trend is set to increase momentum over the next ten years
according to William Haseltine, Chairman and CEO of Human
Genome Sciences, speaking at the Economist's 8th Annual
Pharmaceutical Conference, entitled "Rethinking the
Formula!" held in London in February 2002.
Haseltine
predicts that over 50% of NASs in the next 10-15 years will
be the result of antibody research. Part of the reason for
this is the much shorter development times MAbs require
compared to conventional NASs. He claims that 6-7 years
could easily be shaved off the development time for MAbs.
In recent
years there has been an increase in the R&D time for
conventional NASs due to the slowing down of approval times
by the FDA and the insistence on larger and more expensive
clinical
trials. Running parallel with this, according to Haseltine,
was that development
costs for monoclonal antibodies would be also much lower,
as trials would be more targeted. He also pointed out that
because human MAbs are natural proteins, they are not toxic
to the body and are thus safer.
Another
very important consideration is that the longer life expectancy
has increased the likelihood of patients needing multiple
drug treatments, so drug interactions are an increasing
problem. MAbs, in Haseltine's view, will obviously circumvent
this problem. Professor Trevor Jones, Director General of
the ABPI, however, also speaking at the conference, suggested
that clinical trials are unlikely to be reduced significantly
in size in the near to medium future as the FDA would still
insist on large trials to ensure that side-effect potential
is fully explored.
Number
of MAbs Launched by year
Source: LifeCycle R&Dfocus
According
to IMS's LifeCycle service, 1998
was a bumper year for new monoclonal antibodies reaching
the world stage, but in the last two years only a single
MAb NAS has reached the market.
Since
the launch of the first, murine, MAb in 1986, there has
been a stream of both therapeutic and diagnostic MAbs introduced.
MAbs have been developed for a range of diseases including
many types of cancers, organ rejection, rheumatoid
arthritis,
Crohn's disease, and cardiac complications during transluminal
coronary angioplasty.
New
MAbs about to hit the market are extending the disease spectrum
further. Novartis/Genentech/Tanox's injectable anti-asthma
product, Xolair (omalizumab), is at the registration
stage, whilst Genentech/Xoma's MAb Xanelim (efalizumab)
is in phase III for psoriasis.
Though both products have faced setbacks and delays, Xanelim
entered phase II trials in rheumatoid arthritis in April
2002.
Monoclonal
antibodies by Phase of Development
Source: LifeCycle R&Dfocus
Two
marketed monoclonal antibodies are rapidly approaching blockbuster
status according to IMS Pharma/Chemical Horizons 2002
presentations. Centocor's (Johnson & Johnson) Remicade
(infliximab), for Crohn's disease (licensed to Schering-Plough
and Tanabe Seiyaku), had sales topping $0.75 billion in
2001, while IDEC/Genentech’s Rituxan (sold outside
the US as MabThera by Roche and also licensed to
Zenyaku Kogyo), saw sales approach $0.75 billion in 2001;
it is indicated for non-Hodgkin’s lymphoma.
Sales
of Rituxan/MabThera by Year
Source: IMS
World Review 2002
Franz
Humer, Chairman and CEO of Roche, speaking at the Economist
Pharmaceutical Conference, predicted the growth in the development
of genomics/proteomics
diagnostics
being developed some way ahead of new therapeutics. These
diagnostics will identify the subpopulation of the disease
group who will benefit from the drug. Diagnostics, in Humer's
opinion, will be a major growth area for the industry within
the next decade.
This
was echoed by Richard Simpson, Head of Investor Relations
at Roche, in an interview with IMS
Company Profiles,
recently. He believes that genomics/proteomics diagnostics
will be commonplace within 3-4 years and that similar therapeutics
will be the norm within 6-8 years.
The
changes in the R&D paradigm will require considerable
alterations within the industry to take full advantage of
the opportunities. How the industry refocuses its people
and resources will be a major factor in its success.
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