Crucell corporate brochure (PDF)

Crucell’s commitment to the world – Taking responsibility
R&D progress
Crucell invested heavily in the advancement and expansion of pipeline
programs in 2010. In line with our guidance to the financial market,
R&D expenses increased by more than a third to €100.0 million,
compared to €70.2 million in 2009. The rise was predominantly due
to an increase in clinical development spending, reflecting progress
in clinical trials and significant investments in our in-house product
development capabilities.
Development of our pipeline during 2010 was accelerated by a strategic
collaboration with Johnson & Johnson, signed in September 2009. Under
the terms of this agreement, Johnson & Johnson will finance a significant
part of Crucell’s existing R&D program aimed at discovery, development
and commercialization of a monoclonal antibody product for the universal
prevention and treatment of influenza. This program is based on Crucell’s
discovery of a new class of antibodies with the unprecedented ability
to neutralize a broad range of influenza virus strains.
The strategic collaboration also provided funding for four new discovery
programs in areas where Crucell’s innovative science and technologies
show significant potential to make an important difference to global
health. One of these was specified at the time the agreement was
signed, and two others were decided jointly by the collaboration
partners on the basis of exploratory work by Crucell’s Innovation
& Discovery Laboratory (I&DL) teams in the course of 2010.
In the first of the new discovery programs, Crucell scientists are using
the knowledge generated in our flu antibodies program to design
a vaccine with the potential to provide lifelong protection against
influenza, regardless of the causal virus strain. A universal flu vaccine
would eliminate the need to formulate new flu vaccines year after year,
and would at last provide a defense against a lethal new influenza
virus with pandemic potential. Work started on this exciting project
at the beginning of 2010.
The second discovery program, launched in June, focuses on the design
of a vaccine to prevent severe respiratory infections caused by all of the
most common strains of respiratory syncytial virus (RSV). Infants and
the elderly are especially vulnerable to life-threatening illness caused
by RSV, which currently claims an estimated 160,000 lives annually.
RSV-induced disease is the last major childhood illness for which no
preventive vaccine is available.
The third new discovery program, announced in November, targets the
development and commercialization of a therapeutic vaccine against
human papillomavirus (HPV). Around 250,000 men and women with
chronic HPV infection die each year.
Another R&D highlight during 2010 was the launch of Crucell’s in-house
FluCell program: a new frontier for seasonal influenza vaccines. Inflexal®
V, our current flu vaccine, is both highly effective and very well tolerated
thanks to its underlying virosomal technology. Now we are working
to combine this innovative approach to vaccine design with our highdensity
PER.C6® cell–based production system. This will enable us
to manufacture unlimited supplies of high-quality flu vaccine more
efficiently, more cost-effectively and starting earlier in the flu season.
The traditional production method grows the viruses used for flu vaccines
in chicken eggs—a slow and laborious method that does not lend itself
to high-volume manufacturing, as we saw during the recent pandemic.
The fact that we now have three influenza programs in the pipeline
illustrates Crucell’s approach to innovation. We seize opportunities
to make a difference in the near future while simultaneously working
towards breakthrough products that will take considerably longer
to develop, test and bring to market.
Investigational vaccines we already have in clinical trials made
important progress during 2010. For example, in May the recombinant
malaria vaccine Crucell is developing in collaboration with the US
National Institute of Allergy and Infectious Diseases entered a new
phase I trial in Burkina Faso, Africa. This is the first trial of the vaccine
in a population living in an area where malaria is endemic. In October,
we were delighted to announce the start of a new phase II clinical trial
of the tuberculosis vaccine we are developing together with the Aeras
Global TB Vaccine Foundation. The trial will evaluate the safety and
efficacy of this promising vaccine candidate in infants previously
immunized with Bacille Calmette Guérin (BCG) vaccine. BCG is the
only available TB vaccine, but has very limited efficacy.
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