New Hope for Organ Transplant Patients in Egypt

• Novartis TRANSFORM confirms strong efficacy of EVEROLIMUS-based regimen with lower exposure to nephrotoxic calcineurin inhibitor (CNI)¹
• The Novartis study is the largest de novo interventional study in renal transplantation including more than 2,000 kidney transplant patients in 42 different countries²
• “H2307” is one of the largest liver transplant trials with living donor population

Egypt, November 24, 2017 – The Egyptian Society of Nephrology and Transplantation, the Egyptian Transplantation Society and Novartis held a press conference today to announce the positive results of an international study and mark new hope for organ transplant patients.

Almost all kidney transplant recipients receive immunosuppressive therapy to help prevent rejection of the new organ. However, with increased use of immunosuppressive drugs, like calcineurin inhibitor (CNI), comes an increased chance of infection. The findings, which were presented at the press conference, showcased new phase IV data that confirms the strong efficacy of an EVEROLIMUS-based regimen in kidney transplant patients with lower exposure to CNI. Moreover CNIs are known to be nephrotoxic and linked to cardiovascular morbidities or the development of malignancies in the long term⁴. Data shows that due to CNI complications, only 50% of renal transplant patients survive more than 10 years after transplantation³.

“At Novartis, we discover new ways to improve people’s lives and harness the power of science to address some of society’s most challenging healthcare issues,” said Dr. Basyouni Abuseif, Country President of Novartis Egypt. “Novartis has made substantial contributions to the development of immunosuppressants and continues its investment to deliver innovative transplant-patient care solutions.”

“Kidney disease represents a significant healthcare challenge in Egypt, with 60,000 patients on dialysis as opposed to the nearly 1,500 patients that receive transplants every year,” noted Prof. Gamal Saadi, Professor of Internal Medicine and Nephrology at Cairo University and President of International Federation of Kidney Foundation and the Egyptian Society of Nephrology and Transplantation, “We must take further steps to emphasize the transplant option as it offers better outcomes than living with dialysis.”

“Kidney transplantation provides high-quality-life years to patients with irreversible kidney failure,” said Prof. Omar El Khashaab, Professor of Renal Medicine, Cairo University and former President of Egyptian Society of Nephrology and Transplantation, “What was a very risky and limited treatment option 50 years ago is now a routine clinical practice around the world. However, there remains margin for improving the kidney transplant patient journey to be optimized.”

Professor Refaat Kamel, President Elect of the Middle East Society of Organ Transplantation and Council Member of the LDLT Study Group discusses the increasingly emerging need for transplantation in Egypt and noted that “there’s a strong tendency from the state to encourage the transfer of organs from newly deceased donors. In the next 10 years, 100,000 liver transplant surgeries will be needed- yet only around 4,000 have been performed in the last 16 years. Despite the government’s tremendous efforts in eradicating the Hepatitis C Virus, hepatic malignancies are still the main challenge and the cause for around 25% of liver transplantations in Egypt.”

“It is critically important that transplant patients undergo regular follow-up to ensure early detection of any complications that can be properly managed, and take corrective actions,” said Prof. Maher Fouad, Professor of Renal Medicine at Cairo University and President of the Transplantation Chapter of the Egyptian Society for Nephrology and Transplantation. “It is vital that patients commit to a strictly tailored lifestyle and keep an eye on potential comorbidities, like diabetes or hypertension, as they negatively affect kidney functions. Immunosuppression protocol selection is tailored to each patient depending on several factors like age, the degree of compatibility between him and the donor, and the kidney efficiency after transplantation.”

“The Mansoura Kidney Center was honored to participate in the international TRANSFORM trial with 25 living related transplant patients – and our results matched the global findings,” said Professor Mohamed Adel Bakr, Emeritus Professor of Nephrology, Urology and Nephrology Center in Mansoura, Egypt, “Since the start of the transplant program in Mansoura, our aim has been to improve patients’ quality of life with a focus on short-term, one-year outcomes. We have since changed our mindset to focus on long-term outcomes, to guarantee better quality of life and fewer side effects and immunosuppressant-driven outcomes. This was the base for developing the TRANSFORM study to use Everolimus-based protocol that allows reducing CNI dosage. The TRANSFORM study include 2000 patient with a 2 years follow up, with a composite efficacy endpoint that strengthens the reliability of the study. The results of the fourth phase were announced at the European Society for Organ Transplantation (ESOT) Conference in Barcelona last September and the full results will be announced through a series of conferences held during 2017-2018 along with.”

“Egypt is a leader in live donation liver transplants around the world. That’s why the inclusion of Ain Shams University in the trial was critically important to understanding and improving long-term outcomes for Egyptian patients,” said Professor Mahmoud El Meteini, Professor of Hepatobiliary Surgery and Dean of Faculty of Medicine and Head of the Liver Transplant Program, Ain Shams University, “The importance of this truly global study is the inclusion of living donors – for the first time – across 13 countries, including here in Egypt. We are very pleased with the results and look forward to better quality of life for liver transplant patients.”

“The TRANSFORM study is the largest de novo interventional study ever conducted in renal transplantation, with over 2,000 kidney transplant patients recruited across 195 sites in 42 countries,” said Prof. Federeico Oppenheimer, Transplant Nephrologist and Director of the Nephrology & Urology Institute at the Hospital Clinic in Barcelona.

“Results from the landmark H2307 trial will significantly improve long-term outcomes for liver transplant recipients. These results are a true treatment paradigm in terms of the long-term prevention of complications in efforts to maximize graft survival– which is critically important for improved quality of life. Post-transplant immunosuppression management will definitely change in Egypt and around whole world,” said Prof. Marina Berenguer, Consultant Hepatologist at La Fe University Hospital in Valencia, Spain.

“The need for liver transplantation in Egypt is yet not fulfilled due to the many challenges we are facing. Several milestones have been achieved as a result of the huge efforts invested by the government in the past few years, however the awareness of Egyptians about cadaveric and donation concepts needs immediate focus and attention,” added El Meteini.

About the TRANSFORM study

TRANSFORM (Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRoliMus-based regimen) is the largest de novo interventional study ever conducted in renal transplantation. TRANSFORM (NCT01950819) is a 24 month, multi-center, randomized open-label study trial involving 2,037 kidney transplant patients conducted at 195 sites across 42 countries. The study met its primary endpoint at month 12. TRANSFORM will continue to investigate long term graft functions and overall patient morbidities.

The primary aim of TRANSFORM is to evaluate overall graft outcomes of de novo concentration-controlled EVEROLIMUS, plus reduced levels of CNI, as compared to current standard of care, being MPA plus standard dose CNI by utilizing a novel binary composite endpoint of eGFR (<50 mL/min/1.73 m2, MDRD4 formula) or tBPAR.

The key secondary aim is to evaluate EVEROLIMUS with reduced exposure CNI compared to MPA plus standard exposure CNI at 12 months and 24 months post-transplantation with respect to the traditional regulatory endpoint, namely composite efficacy failure rate of (treated biopsy proven acute rejection (tBPAR), graft loss or death).

TRANSFORM also assesses the evolution of renal function over time, explores the incidence of de novo donor-specific antibodies (DSA) as well as the development of Chronic Allograft Nephropathy (CAN)/IFTA (Interstitial Fibrosis/Tubular Atrophy).

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit https://www.novartis.com/.

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Novartis Egypt Media Relations: [email protected]