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“I was in my early 40s when I
was diagnosed with prostate cancer. As a registered nurse
caring for men with prostate cancer, I knew I had to make
some serious decisions. As part of my treatment, chemotherapy
which included Novantrone® offered me as much hope as
possible in my fight against this disease. It has now been
two years and several months and there is no detectable cancer
and I am happy to say that I am feeling good…”
Philip Bacon
Cancer Survivor
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“Eating is something we do every day
without thinking about it; however, when going through my chemotherapy
treatments the sores in my mouth were so painful, it was difficult
to do the simplest of things like swallow. Gelclair® helped
me get through my treatments by allowing me to eat and drink…it
was an essential part to my recovery.”
Edward Mastellone
Cancer Survivor |
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Around
our two marketed oncology products, Novantrone® and Gelclair®,
we have now been able to assemble a quality commercial operation
in the United States. Obtaining the marketing rights to these
products has been an essential step in the process of becoming
a fully integrated oncology franchise and allows us to be well
prepared for the potential launch of Tarceva™ in the United
States. |
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Novantrone® is a synthetic antineoplastic anthracenedione used
intravenously as an anti-cancer agent. The FDA approved the product
in 1987 for acute nonlymphocytic leukemia (ANLL) and in 1996 for
the relief of pain associated with hormone-refractory prostate cancer
(HRPC), or prostate cancer that no longer responds to hormone therapy.
It was also registered for multiple sclerosis (MS) indications in
October 2000. In March 2003, OSI entered into an agreement with
Serono to market and promote Novantrone® in the oncology marketplace
in the United States. To support sales of Novantrone®, the company
has built a core commercial operation  comprising
approximately 60 sales, marketing, medical affairs, commercial planning
and support personnel including an approximately 30 person sales
force. We have also successfully executed the re-launch of Novantrone®
and are actively selling the product across the country. Commissions
through our first two quarters of promotion exceeded our estimates
and we expect to generate in excess of $30 million in commission
revenues in 2004.
An estimated 300,000 cancer patients in the United States suffer
from oral mucositis, an inflammation and ulceration of the surface
of the mouth and throat commonly associated with cancer treatment.
Patients receiving high-dose chemotherapy and/or radiation therapy
often perceive oral mucositis as the
most debilitating toxicity associated with their therapy. In addition,
many patients indicate that they receive either no symptom control
or only a marginal improvement of their symptoms with current treatment.
Symptoms of oral mucositis may include painful ulcerations, redness,
and swelling in the mouth.  More
severe symptoms include extreme pain that may prevent the patient
from eating and pose a serious risk of infection resulting in the
interruption of cancer therapy. The problem has been a significant
unmet need in the management of a cancer patient’s health
and well-being.
We obtained our second marketed product, Gelclair®, from our
acquisition of Cell Pathways. We believe that Gelclair® could
be widely used by oncology patients suffering from chemotherapy-
or radiotherapy-induced mucositis, as well as any other patient
with mucosal oral lesions. Gelclair® is a bioadherent oral gel
indicated for the management and relief of oral pain. It provides
rapid and durable oral pain relief by adhering to the mucosal surface
of the mouth, forming a protective barrier over the mouth and throat,
shielding and soothing the exposed and sensitized nerves. We estimate
that the product has the potential to grow to an annual net revenue
stream in excess of $25 million per year to OSI over the next five
years.
The additions of Novantrone® and Gelclair® to our portfolio
represent major steps forward as we continue our mission of building
a first-class oncology franchise.
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