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Biopharmaceuticals FDA

 News Release - April 22, 2010

Novartis Receives US FDA Approval for Zortress(R) (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients

Zortress offers kidney transplant recipients a new option for preventing organ rejection and preserving kidney function with reduced doses of cyclosporine

Preventing organ rejection while reducing the side effects of treatment regimens containing cyclosporine is a major challenge in kidney transplantation

Zortress inhibits the proliferation of cells that play a key role in transplant rejection

First approved outside the US over six years ago as Certican®, everolimus is an established transplant immunosuppressant therapy in more than 70 countries

EAST HANOVER, N.J., April 22 -- (Healthcare Sales & Marketing Network) -- The US Food and Drug Administration (FDA) has approved Zortress® (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids.

Under the brand name Certican®, everolimus is already an established part of the immunosuppressive regimen for transplant patients in more than 70 countries outside the US.

"For patients who require a kidney transplant, the limited availability of organs underscores the urgent need for effective medicines that can help protect the survival of the transplanted organ for the patient," said David Epstein, Division Head of Novartis Pharmaceuticals. "Our commitment to transplant patients exceeds 25 years, and Zortress is the latest addition to our growing portfolio. This includes five medications that enable clinicians to provide various treatment options to help manage their individual kidney transplant patients."

FDA approval of Zortress was based on results from the largest single Phase III registration study ever conducted in kidney transplant recipients. In the study, Zortress prevented acute organ rejection and preserved kidney function while allowing, on average, 60% lower doses of the CNI cyclosporine to be used compared with the control regimen of mycophenolic acid (MPA) with full dose cyclosporine and corticosteroids. Use of Zortress led to a reduction in CNI-associated side effects while maintaining good efficacy.

Calcineurin inhibitors, which are part of the typical immunosuppressive regimen, have been associated with injury to the kidneys and, when used in a combination-immunosuppressant regimen, increase the risk of infections and malignant tumors.

Following transplantation, immunosuppressive medicines are required to protect the transplanted organ from being rejected by the recipient's immune system. Antigen-activated T cells play a key role in transplant rejection by recognizing foreign substances and multiplying in an attempt to protect the body. Zortress acts as an immunosuppressant by binding to a protein called mammalian target of rapamycin (mTOR) and preventing the proliferation of these antigen-activated T cells.

"Transplant recipients require lifelong immunosuppression, so there is a critical need for treatment regimens that protect the transplanted kidney, and also reduce the side effects and infections associated with calcineurin inhibitors," said Diane M. Cibrik, MD, Associate Professor of Medicine and Medical Director of Transplant Clinical Research Trials at the University of Michigan. "Based on its different mode of action, Zortress offers the ability to reduce calcineurin inhibitors, and may help to address this unmet need."

In 2009, an estimated 16,800 kidney transplants were performed in the US, and an estimated 4,500 kidney transplant candidates died while awaiting organ donation. As of March 2010, there were more than 83,000 patients awaiting kidney transplantation in the US.

Organ survival rates one year after a successful kidney transplant range from 89% when the organ comes from a deceased donor to 95% when the donor is living. However, percentages drop five years after transplantation with survival rates of approximately 67% and 80% respectively.

Zortress has been approved in the US with a Risk Evaluation and Mitigation Strategy (REMS) to help guide patients and healthcare providers on the safe use and risks of Zortress following kidney transplantation. The approved REMS includes a medication guide, a communications plan and a timetable for submission of assessments.

Important Safety Information for Zortress (everolimus) tablets

Increased susceptibility to infection and possible development of malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of transplant patients should use everolimus. Reduced doses of cyclosporine are required for use in combination with everolimus in order to reduce nephrotoxicity. There is an increased incidence of kidney graft thrombosis.

Potential serious adverse events associated with Zortress include lymphoma and other malignancies, serious infections, angioedema, wound healing/fluid accumulation, hyperlipidemia, proteinuria, polyoma virus infections, interactions with strong inhibitors and inducers of CYP3A4, non-infectious pneumonitis, thrombotic microangiopathy / thrombotic thrombocytopenia purpura / hemolytic uremic syndrome, new onset diabetes after transplantation and male infertility. Live immunizations should be avoided.

The most common (greater than or equal to 20%) adverse events are peripheral edema, constipation, hypertension, nausea, anemia, urinary tract infection and hyperlipidemia. Events such as peripheral edema, dyslipidemia and hyperlipidemia were at least 5% higher in patients given Zortress with reduced-dose cyclosporine than in those given mycophenolic acid and full-dose cyclosporine.

About Zortress (everolimus)

Zortress is indicated for the prophylaxis of organ rejection in adult patients at low-to-moderate immunologic risk receiving a kidney transplant. Zortress is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and corticosteroids. Therapeutic drug monitoring of Zortress and cyclosporine is recommended for all patients receiving these products.

Everolimus is also available in different dosage strengths under the brand name Afinitor® for the treatment of advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. Afinitor was approved in the US in 2009.

About Novartis Transplant Medicines

As a company committed to research, development and the marketing of therapies that improve health, ease suffering and enhance patients' quality of life, Novartis is a leader in transplantation and immunology. With the discovery and introduction of cyclosporine more than 25 years ago, Novartis has contributed to improving treatment options for transplant patients and now has the broadest portfolio of immunosuppressants on the market.

Full prescribing information for Novartis products is available at


The foregoing release contains forward-looking statements that can be identified by terminology such as "commitment," "risk," "may," "potential," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for medicines containing the active ingredient everolimus or regarding potential future revenues from everolimus. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that everolimus will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that everolimus will achieve any particular levels of revenue in the future. In particular, management's expectations regarding everolimus could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit

Source: Novartis

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