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Novartis acquires rights to develop, commercialize new treatment for hyperphosphatemia in kidney dialysis patients

October 14, 2017

Novartis announced today that it has signed an agreement with SeBo GmbH of Germany to acquire the global rights for a novel oral phosphate binder in development for the treatment of elevated serum phosphate levels (hyperphosphatemia) in late- or end-stage renal disease patients.

Under the terms of the agreement, which were not disclosed, Novartis has obtained the rights to develop, manufacture and commercialize this compound for patients with chronic kidney disease or patients already on dialysis. The compound is currently in Phase I clinical development.

"This novel compound complements the expertise in kidney disease that we have established through our leadership in transplantation and has the potential to offer dialysis patients a new, more potent and convenient oral treatment option to help them manage the effects of dialysis and chronic kidney disease," said Thomas Ebeling, CEO of Novartis Pharma AG. "In our transplantation and immunology business, we are committed to providing patients with new and safe treatment options to help them live longer, healthier and more productive lives before and after organ transplantation."

Patients with chronic kidney disease, as well as those already on dialysis, have reduced phosphate excretion, which leads to elevated serum phosphate levels (hyperphoshatemia). This condition may lead to increased calcium-phosphate deposits that cause arteriosclerosis, which in turn raises the risk for coronary heart disease and stroke as well as bone disease.

Currently available treatments for hyperphosphatemia do not reliably achieve treatment standards set by kidney specialists to help patients effectively manage their disease. As a result, a need remains for novel, more efficient, convenient and tolerable treatment options that lower phosphate without raising calcium levels in the serum to values that are accepted by physicians in order to improve patient well being and possibly survival.

"We are strengthening our leading position in transplantation by expanding our focus to also offer therapeutic solutions for transplantation precursor diseases, such as chronic kidney disease, to patients and physicians," said Giacomo Di Nepi, Head of the Transplantation and Immunology Business Unit of Novartis Pharma AG.

At least 90% of dialysis patients receive chronic treatment for hyperphoshatemia, while an estimated 80% of patients with chronic kidney disease are also treated for this condition. Approximately 800,000 patients are estimated to have end-stage renal disease in Europe and the US, with the vast majority of them requiring dialysis. An equal number of patients are estimated to have late-stage chronic kidney disease and could eventually require dialysis.

Phosphate is primarily derived from dietary sources and is absorbed in the intestine. Hyperphosphatemia is generally caused by renal insufficiency when the kidneys are no longer able to filter excessive amounts of phosphate out of the blood. Elevated phosphate levels in the blood can lead to several serious conditions that include soft tissue calcification, kidney failure and heart disease. Another potential condition is hyperplasia of parathyroid glands with secondary hyperparathyroidism (HPT), which leads to bone disease. Acute hyperphosphatemia can also lead to hypocalcemia with tetany, seizures and arrhythmias.

The Novartis Transplantation and Immunology Business Unit is committed to helping the transplant community by developing and offering an innovative range of therapeutic products for use in the prevention of transplant organ rejection. Novartis is a global leader in this field of medicine, having helped to revolutionize organ transplantation over two decades ago by introducing SandimmuneŽ (cyclosporin).

The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "in development", "potential", or similar expressions, or by express or implied discussions regarding the potential development, regulatory approvals and commercialization of the oral phosphate binder which is the subject of this release. Such forward-looking statements 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 this product will be approved for sale in any market, or that this product will achieve any particular level of sale. Any such commercialization can be affected by, among other things, uncertainties relating to product development and clinical trials, including unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; as well as factors discussed in the Company's Form 20-F filed with the 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 described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world. For further information please consult novartis.

Contacts

John Gilardi
Novartis Global Media Relations
+41 61 324 3018 (direct)
+41 61 324 2200 (main)
john.gilardinovartis

Eric Althoff
Novartis Pharma Communications
+41 61 324 6392 (direct)
+41 79 593 4202 (mobile)
eric.althoffnovartis

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