Source: IMS LifeCycle New Product Focus
The US still far exceeds all other single
countries in terms of first launches of NASs, accounting
for just under 35%. The US also accounted for the highest
percentage of NASs in terms of R&D country, with 32%
of all launches.
Japanese
outlook improving?
Japan
has seen its share of first launches plummet to scarcely
5% in 2004; in 1999, Japan accounted for 19% of first
launches. In the previous decade, Japan dominated first
launches with 30-40%, but most of the NASs were domestic
products (me-toos) with no international potential, while
the small handful of international NASs that surfaced
often took 10 years or more to penetrate the US and European
markets. In the 2004 crop of Japanese first launches,
all four products appear to have international potential
and they are predicted to reach international markets
in the next few years. Many of the Japanese first launches
in the previous decade are no longer viable in the Japanese
market and quite a number are no longer on sale. In 2004
Japan fared better, with 16% of NASs developed by Japanese
companies.
Sea
change in world order
What
is remarkable in 2004 is the emergence of innovative new
drugs from China. In 2004 China introduced two leading
edge biotechnology NASs. One is a new antisense drug,
Gendicine, from SiBiono Genetech, for the treatment
of head and neck cancer; the other is ABCream,
a topical monoclonal antibody against interleukin-8 for
psoriasis,
marketed by Anogen in China. Is this trend likely to be
sustained or even grow? According to IMS
LifeCycle R&Dfocus, there were two
NASs registered in China by March 2005, which bodes well
for the rest of the year.
More
NASs are also emerging from Central and Eastern European
countries, such as Bulgaria and Russia, and from South
Korea. In 2004 two NASs were launched in Russia as their
first market and one in Bulgaria. South Korea has consistently
launched an NAS each year for the last four years. In
2004, Chong Kun Dang introduced Camtobell (belotecan)
in South Korea for the treatment of ovarian and lung cancers.
South Korea has long been associated with the development
of new antibiotics, in particular fluoroquinolones,
but over recent years R&Dfocus has seen new
biotechnology companies emerging in South Korea, namely
CrystalGenomics, WelGene, Ahn-Gook and ViroMed, which
have expertise in other therapy areas.
Biotech
NASs still not 50% of total
Of
the 31 NASs first introduced in 2004, eight were biotechnology
drugs, representing 26% of launches. Biotech NASs have
made up 20-30% of NAS launches over the last few years
- still far short of the 50% predicted by leading scientists
three years ago.
According
to IMS
World Review 2005, 23 NASs launched over the last
five years have reached blockbuster status - sales of
more than $500 million in 2004; 20% of these are biotech
products. Indeed, two anticancer
monoclonal antibodies launched for the first time
in 2004, ImClone Systems, Bristol-Myers Squibb and Merck
KGaA's Erbitux (cetuximab), and Genentech and Roche's
Avastin (bevacizumab), made it into the top 50
NASs launched over the last five years, with sales of
$299 million and $262 million respectively.
Licensing
features strongly
The
majority of NASs take 9-15 years from initial research
to reaching the market, according to the New Product Focus
annual review. Once again, in general biotech drugs tend
to have shorter lead times, although one monoclonal antibody
took 15 years.
Length
of time to market
Source:
IMS LifeCycle
Only
nine of the 31 NASs were not subject to at least one licensing
deal, according to R&Dfocus. It is interesting to
note that first licensing still appeared to occur during
late stages of drug development – Phase II to registered/approved
– though a few NASs were first licensed out at the
preclinical stage.
Development
stage at first licensing
Source:
R&Dfocus
When one reviews all licensing deals, there is a definite
peak in licensing activity at the Phase II stage, and
many deals are also done while the drug is awaiting approval.
Licensing out will continue to be of major importance
for new NASs for many years, but it is likely that deals
will be brokered between the new emerging innovative markets
and all other regions much more frequently.
Development
stage at licensing
Source:
R&Dfocus
Questions
still remain: when will we see the emergence of new innovative
drugs from India,
and will the promising R&D pipelines from Chinese
and South Korean innovators take centre stage in world
NAS introductions?
This
article was written by Irene Buggle, Executive Editor
of the IMS LifeCycle publications. For further
information on LifeCycle or any of its constituent publications,
please contact Stephanie Earle via e-mail or call
+44 207 393 5515.
