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New Dosing Recommendations Approved for Sirolimus in High Immunologic Risk Renal Transplant Patients

Madison, N.J., February 2, 2007 – Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), today announced that the U.S. Food and Drug Administration (FDA) has approved new dosing recommendations for its immunosuppressant drug sirolimus (Rapamune).

Rapamune is the first and only kidney transplant therapeutic with dosing recommendations specifically for the treatment of high immunologic risk renal transplant recipients.

In high immunologic risk patients, it is recommended that a Rapamune-based regimen be used in combination with cyclosporine (CsA) and corticosteroids for the first year following transplantation. The new dosing recommendations for Rapamune also allow for use in combination with antibody induction therapy in this population. High immunologic risk patients have a greater likelihood of developing acute rejection than low to moderate risk kidney transplant recipients.

High immunologic risk patients are defined as transplant recipients who are Black; and/or repeat renal transplant recipients who lost a previous kidney transplant for immunologic reasons; and/or patients with high-panel reactive antibodies (PRA). For patients with high PRA, it is more difficult to find a compatible organ donor.

“Preventing acute rejection is the highest priority for both physicians and their patients during the first year following kidney transplantation. The new labeling for Rapamune is significant because it provides a needed treatment option for high immunologic risk renal transplant recipients,” says John F. Neylan, M.D., Vice President, Clinical Research and Development, Transplant Immunology/Internal Medicine of Wyeth Pharmaceuticals. “Wyeth remains committed to improving outcomes in renal transplant patients.”

In the clinical trial of high immunologic risk patients, patient survival at 12 months was 94.6 percent. The incidence of biopsy-confirmed acute rejection (BCAR) was 17.4 percent during the first 12 months post-transplant, and the majority of the episodes of acute rejection were mild in severity. Of those receiving Rapamune plus CsA in the trial, 88.4 percent also received antibody induction therapy. The safety and efficacy of this combination in high risk patients has not been studied beyond one year. After the first year following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient.

High Immunologic Risk Population
Black kidney transplant recipients represent the largest segment of the high immunologic risk population. According to the Organ Procurement and Transplant Network (OPTN), approximately 91 percent of white kidney transplant recipients have a fully functioning kidney one year post-transplant versus approximately 89 percent of Black recipients. This gap grows steadily over time. By five years post-transplant, only 60 percent of Black kidney transplant recipients have a fully functioning kidney, versus 72 percent of white recipients. Black kidney transplant recipients are more likely than white kidney transplant recipients to experience acute rejection.

“There are many barriers to successful kidney transplantation for Black and repeat recipients,” says Joe Vassalotti, M.D., the National Kidney Foundation’s Chief Medical Officer. “The Foundation believes that it is extremely important to have options in preventing and treating acute rejection for these high risk patients.”

Pivotal Study Description
The new labeling was based on clinical data indicating that a Rapamune-based regimen, when initiated post-transplant in combination with CsA, is efficacious in preventing acute rejection in high immunologic risk renal transplant recipients.

The study was conducted at 35 centers in the United States. A total of 224 patients received a transplant and at least one dose of Rapamune (sirolimus) and cyclosporine and was comprised of 77.2 percent Black patients, 24.1 percent repeat renal transplant recipients, and 13.5 percent patients with high PRA. Efficacy was assessed with the following endpoints, measured at 12 months: efficacy failure (defined as the first occurrence of biopsy-confirmed acute rejection, graft loss, or death), first occurrence of graft loss or death, and renal function.

About Rapamune
Rapamune (sirolimus) is in a novel class of immunosuppressant agents called mammalian target of rapamycin (mTOR) inhibitors, a key regulatory enzyme involved in cell growth and survival. Rapamune® works by arresting T cell development early in the cell cycle, resulting in inhibition of lymphocyte proliferation. Rapamune® inhibits the mTOR pathway and avoids the calcineurin pathway. It is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. For more information please visit http://www.rapamune.com.

Source: Wyeth Pharmaceuticals

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