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Dear Fellow Shareholders:
Penwest has a clear, well defined growth strategy: to leverage
our strength in drug delivery and drug formulation to develop a portfolio
of products targeting disorders of the nervous system. Our current
development pipeline includes products for the treatment of pain,
epilepsy, Parkinson's disease, spasticity and edema. We are continually
evaluating new growth opportunities, both internally and externally.
During 2006, we made important progress in pursuit of that
strategy. Our key accomplishments included the approval and
launch of Opana ERŪ by Endo Pharmaceuticals, development of our
internal pipeline and enhancement of our organizational capabilities
and processes.
Launch of Opana ER
Penwest reached an important milestone
in June with the FDA's approval of Opana ER and the launch by Endo
of this valuable new product for the treatment of moderate to severe
chronic pain. Since this product was launched in the second half of
2006, prescriptions have been steadily increasing. Initial feedback
on Opana ER has been favorable, and Endo has invested significant
resources in the sales and marketing of the product.
We expect that our involvement with Endo and Opana ER will
continue in the future as we seek to fully leverage the value of this
product as a global franchise through commercialization with an international partner. We have a successful relationship with Endo,
and we will continue to pursue opportunities to create value together.
Progress on Our Pipeline
As we build our internal portfolio,
we are both advancing the product candidates currently in our
pipeline and generating new product concepts. We plan to continue
to focus primarily on products that can be developed using a
505(b)(2) regulatory strategy because we believe it enables us
to move more quickly by focusing on improved formulations of
products that have previously been approved by the FDA.
We placed strong emphasis on building our pipeline in 2006 and
setting the stage for a busy clinical year in 2007. We plan to advance
nalbuphine ER, a compound we are developing for moderate chronic
pain into a Phase II study, and continue formulation studies on
torsemide ER, a once daily treatment for edema resulting from congestive
heart failure, in 2007. Our upcoming trials on nalbuphine ER are
designed to explore whether it is an effective treatment for chronic pain,
while the studies of torsemide will focus on optimizing the formulation.
In 2006, we also completed extensive formulation work and
Phase I studies on several earlier-stage compounds in our portfolio.
We are hopeful that we can advance one or two of these compounds
into Phase II trials by the end of 2007.
In addition to developing our internal pipeline, we continually
evaluate opportunities to in-license new technologies and product
candidates to augment our portfolio. In 2006, we initiated work on
compounds utilizing novel drug delivery technologies accessed through
collaborations. We believe this is a good way to expand our product
opportunities, diversify our technology risk and, importantly, develop
products that fulfill unmet medical needs. In addition, we are exploring
possible collaborations with companies that own new chemical entities
in early stage development that relate to the treatment of specific
neurological diseases, and need our expertise in drug formulation
and clinical development to advance the product candidates.
Enhanced Organizational
Capabilities
In 2006, we continued
to strengthen our organization
to establish the end-to-end capabilities
necessary for effectively
executing our growth strategy.
This initiative involved, among
other things, bringing on board a
number of talented people with
pharmaceutical development and
clinical expertise, developing a
disciplined process for evaluating
new product concepts and utilizing project management tools to
efficiently execute the development of our pipeline.
In addition, we expanded our Board of Directors to enhance
its ability to support the growth and transition of Penwest. We were
pleased to begin 2007 by welcoming to the Board Dr. David Meeker,
President of the Lysosomal Storage Diseases Therapeutics unit
of Genzyme Corporation. We believe Dr. Meeker's knowledge and
experience in clinical development and regulatory strategy will be
invaluable as we move forward.
Priorities for 2007
Penwest spent 2006 creating momentum,
a theme you will see reflected in this annual report. We expect that
these efforts will accelerate the pace of our growth. Our primary
focus in 2007 is on the disciplined execution of our clinical development
programs. Given the risks inherent in drug development, we
recognize that we will not be successful with every product candidate.
However, we are confident that we have the organizational
strengths and processes in place to grow our company with the
creativity and discipline it takes to be successful.
I look forward to keeping all of you apprised of our progress
going forward. Thank you for your continued support.
Sincerely,
Jennifer L. Good
President and Chief Executive Officer
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