
| Werner Henrich |
Dr. Anthony Man |
| Chairman of the Board |
Chief Executive Officer |
Dear Shareholders,
This year was remarkable for the number of high impact
company milestones achieved that signal our transition
from a pure research & development organization to
a fully integrated biopharmaceutical company. Our
successes in 2007 bring us much closer to making our
innovative drugs available to patients and health care
providers alike.
Completion of pivotal phase III clinical trial programs in
2007 enabled two of Basilea’s portfolio compounds to
move forward into regulatory review in the USA, Europe,
Switzerland and Canada. We anticipate completing the
review process in several countries during 2008 putting us
firmly on the path of product commercialization.
Positive results from three phase III trials with ceftobiprole,
our novel hospital antibiotic, were announced in 2007. In
May, we and our collaboration partner Johnson & Johnson
filed the first registration dossier for the treatment of complicated
skin infections with the U.S. (FDA) and then with
the European health authorities (EMEA) in June. Regulatory
filings were additionally made in Canada and Switzerland
where an accelerated assessment was granted.
The clinical trial data from patients with serious community
and hospital-acquired pneumonia will also be filed with
regulatory authorities as potential additional indications.
Alitretinoin, our second late stage portfolio molecule,
was also highly successful in clinical studies. Patients with
chronic hand eczema who do not respond to topical
steroid treatment have significant work or social disabilities
and no approved treatments. We are developing
alitretinoin specifically for these patients and have completed
three phase III studies that all confirmed the efficacy
and safety profile of alitretinoin in these patients.
Regulatory submissions were filed in Europe, Switzerland
and Canada and a new clinical study is planned for the
US in 2008.
Basilea’s continued R&D innovation, with new programs
against resistant Gram-negative bacteria and oncology,
received international recognition at key scientific congresses.
These programs address high medical need and
represent significant future business opportunities. As
ever, our research efforts receive solid support from our
research center in China.
Our 2007 financial results reflect a sound cash position,
judicious investment in key value driving activities and
tight cost control. Additional capital raised in March
2007 is funding ongoing R&D programs, production of
commercial product supplies and the essential commercial
infrastructure to support successful product launches
over the next few years.
Our achievements of 2007 have provided a solid springboard
for commercializing products and as a result we
have been successful in attracting talented and experienced
individuals to build our international commercial
organization. Assuming timely completion of several regulatory
reviews on both ceftobiprole and alitretinoin,
we anticipate marketing authorizations and potential
product launches to begin in 2008.
We would like to thank our stakeholders for all their contributions
in 2007 in bringing our innovative drugs closer
to the market and look forward to a challenging year as
we build a hospital and specialty biopharmaceutical
business.
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Werner Henrich
Chairman of the Board |
|
Dr. Anthony Man Chief Executive Officer |