Isis Pharmaceuticals, Inc. Form 10K - page 55

If we fail to compete effectively, our drugs, including KYNAMRO, ISIS-APOCIIIRx, ISIS-SMNRx and
ISIS-TTRRx , will not contribute significant revenues.
Our competitors engage in drug discovery throughout the world, are numerous, and include, among others,
major pharmaceutical companies and specialized biopharmaceutical firms. Other companies engage in developing
antisense technology. Our competitors may succeed in developing drugs that are:
• priced lower than our drugs;
• safer than our drugs;
• more effective than our drugs; or
• more convenient to use than our drugs.
These competitive developments could make our drugs, including KYNAMRO, ISIS-APOCIIIRx,
ISIS-SMNRx and ISIS-TTRRx, obsolete or non-competitive.
Certain of our partners are pursuing other technologies or developing other drugs either on their own or in
collaboration with others, including our competitors, to treat the same diseases our own collaborative programs
target. Competition may negatively impact a partner’s focus on and commitment to our drugs and, as a result,
could delay or otherwise negatively affect the commercialization of our drugs, including KYNAMRO, which is
approved, ISIS-APOCIIIRx, ISIS-SMN Rx and ISIS-TTRRx.
Many of our competitors have substantially greater financial, technical and human resources than we do. In
addition, many of these competitors have significantly greater experience than we do in conducting preclinical
testing and human clinical studies of new pharmaceutical products and in obtaining FDAand other regulatory
approvals of such products. Accordingly, our competitors may succeed in obtaining regulatory approval for
products earlier than we do. Marketing and sales capability is another factor relevant to the competitive position
of our drugs, and we will rely on our partners to provide this capability.
Regarding KYNAMRO, some competitors are pursuing a development or commercialization strategy that
competes with our strategy for KYNAMRO. Other companies are currently developing products that could
compete with KYNAMRO. Products such as microsomal triglyceride transfer protein inhibitors, or MTP
inhibitors, and other lipid lowering drugs other companies are developing or commercializing could potentially
compete with KYNAMRO. For example, Aegerion Pharmaceuticals, Inc. received approval from the FDAand
the EuropeanMedicines Agency to market its MTP inhibitor, lomitapide, as an adjunct to a low-fat diet and other
lipid-lowering treatments in patients with HoFH. Our revenues and financial position could suffer if KYNAMRO
cannot compete effectively in the marketplace.
There are several pharmaceutical and biotechnology companies engaged in the development or
commercialization of products against targets that are also targets of products in our development pipeline. For
example, drugs like tafamadis, diflunisal, and patisiran could compete with ISIS-TTRRx, drugs like Glybera,
pradigastat and CAT-2003 could compete with ISIS-APOCIIIRx, and RG7800 and olesoxime and the other
products that may emerge from early development programs designed to treat patients with SMAcould compete
with ISIS-SMNRx.
KYNAMRO is, and, following approval any of our other drugs, including ISIS-APOCIIIRx, ISIS-SMN Rx
and ISIS-TTRRx, could be, subject to regulatory limitations.
Following approval of a drug, we and our partners must comply with comprehensive government regulations
regarding the manufacture, marketing and distribution of drug products. We or our partners may not obtain the
labeling claims necessary or desirable for successfully commercializing our drug products, including our
approved drug, KYNAMRO, and our drugs in development including: ISIS-APOCIIIRx, ISIS-SMNRx and
ISIS-TTRRx.
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