Savient Pharmaceuticals (SVNT)

Sales and Marketing

If the BLA for KRYSTEXXA receives FDA approval, we may seek to commercialize KRYSTEXXA ourselves, or collaborate with a third party to commercialize KRYSTEXXA in the United States. We would expect to collaborate with a third party in any event to commercialize KRYSTEXXA outside of the United States.

If we commercialize KRYSTEXXA in the United States ourselves, rheumatologists will be our primary target audience for our marketing and sales activities relating to KRYSTEXXA. Although the majority of gout patients are seen in primary care settings, the most difficult cases are typically referred to rheumatologists. There are approximately 4,500 rheumatologists in the United States. Administration of biologic therapy via intravenous infusion is well-established in clinical practice in the rheumatology setting as there are two widely used pharmaceutical products used for the treatment of rheumatoid arthritis that are administered via intravenous infusion. The key opinion leaders in the gout field are rheumatologists, many of whom have been involved in the clinical development program for KRYSTEXXA.

A subset of nephrologists see a high volume of complicated gout patients, due to co-morbidity of gout with renal disease, and the use of calcineurin inhibitors (which exacerbate hyperuricemia) in kidney transplant recipients. Nephrologists mainly administer infused therapies in the hospital setting. If we commercialize KRYSTEXXA ourselves in the United States, we plan to target these approximately 1,000 specialized nephrologists who we have determined have potential for adoption of KRYSTEXXA.

Infusion nurses play a critical role for any infused product because they both perform the administration and are with the patient throughout the entire time of the infusion, providing a potential educational channel to patients. If we commercialize KRYSTEXXA ourselves in the United States, we also plan to target infusion nurses for field force calls.

We do not currently have an existing field force as we do not actively promote any products at this time. In preparation for the launch of KRYSTEXXA, we have conducted field force sizing analyses based on these target audiences and presently believe that a field force of 60 specialty representatives will be adequate and cost-effective for launch. If we commercialize KRYSTEXXA ourselves in the United States, in hiring these specialty representatives, our hiring criteria will stress experience in selling infused biologics, especially in the rheumatology field. We have already begun hiring efforts for an experienced sales management team, and expect to identify and interview specialty representatives in the months leading up to a possible FDA approval. We are also in the process of hiring a staff of corporate account directors to manage relationships with key payor organizations. We plan to time these hires so that our commitments increase only as our expectations regarding BLA approval become more certain.

Sales and Marketing

If the BLA for KRYSTEXXA receives FDA approval, we may seek to commercialize KRYSTEXXA ourselves, or collaborate with a third party to commercialize KRYSTEXXA in the United States. We would expect to collaborate with a third party in any event to commercialize KRYSTEXXA outside of the United States.

If we commercialize KRYSTEXXA in the United States ourselves, rheumatologists will be our primary target audience for our marketing and sales activities relating to KRYSTEXXA. Although the majority of gout patients are seen in primary care settings, the most difficult cases are typically referred to
rheumatologists. There are approximately 4,500 rheumatologists in the United States. Administration of biologic therapy via intravenous infusion is well-established in clinical practice in the rheumatology setting as there are two widely used pharmaceutical products used for the treatment of rheumatoid arthritis that
are administered via intravenous infusion. The key opinion leaders in the gout field are rheumatologists, many of whom have been involved in the clinical development program for KRYSTEXXA.

A subset of nephrologists see a high volume of complicated gout patients, due to co-morbidity of gout with renal disease, and the use of calcineurin inhibitors (which exacerbate hyperuricemia) in kidney transplant recipients. Nephrologists mainly administer infused therapies in the hospital setting. If we
commercialize KRYSTEXXA ourselves in the United States, we plan to target these approximately 1,000 specialized nephrologists who we have determined have potential for adoption of KRYSTEXXA.

Infusion nurses play a critical role for any infused product because they both perform the administration and are with the patient throughout the entire time of the infusion, providing a potential educational channel to patients. If we commercialize KRYSTEXXA ourselves in the United States, we also plan to
target infusion nurses for field force calls.

We
do not currently have an existing field force as we do not actively promote
any products at this time. In preparation for the launch of KRYSTEXXA,
we have conducted field force sizing analyses based on these target audiences
and presently believe that a field force of 60 specialty representatives
will be adequate and cost-effective for launch. If we commercialize KRYSTEXXA ourselves
in the United States, in hiring these specialty representatives, our hiring
criteria will stress experience in selling infused biologics, especially
in the rheumatology field. We have already begun hiring efforts for an experienced
sales management team, and expect to identify and interview specialty representatives
in the months leading up to a possible FDA approval. We are also in the process
of hiring a staff of corporate account directors to manage relationships
with key payor organizations. We plan to time these hires so that our commitments
increase only as our expectations regarding BLA approval become more certain.