Genzyme Corporation (Nasdaq: GENZ) announced that the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has adopted a positive opinion for the marketing authorization of the new phosphate binder Renvela® (sevelamer carbonate) for use in patients with chronic kidney disease (CKD), including patients not on dialysis, with serum phosphorous levels > 1.78 mmol/L (5.5 mg/dL).
Genzyme’s filing in Europe for Renvela includes both tablet and powder formulations for the control of serum phosphorus in adult hyperphosphatemic CKD patients. The CHMP opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The European Commission generally follows the advice of the CHMP, but is not obligated to do so. A decision from the European Commission is expected at the end of May.
“Upon approval this will represent a significant addition to the treatment options available to nephrologists,” said Professor Markus Ketteler, Professor of Medicine and Clinical Nephrologist, Klinikum Coburg, Academic Teaching Hospital of the University of Würzburg, Germany. “Physicians will hopefully soon have an approved non-absorbed, calcium-free phosphate binder to use with hyperphosphatemic patients, regardless of their dialysis status, with the added flexibility of a powder formulation.”
“We are delighted with this positive opinion,” said John P. Butler, President, Cardiometabolic & Renal, at Genzyme. “If confirmed by the European Commission, this will be the first phosphate binder for patients not on dialysis approved through the centralized procedure. This is an acknowledgement of the value Renvela is expected to bring to patients with CKD.”
Renvela is a next-generation version of Renagel® (sevelamer hydrochloride), a calcium-free, metal-free, non-absorbed phosphate binder, and has the added benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within recommended KDOQI1 range.
In the United States, Genzyme launched Renvela in its tablet formulation for patients with CKD on dialysis in March 2008. The company is also seeking FDA approvals of the powder formulation and for the treatment of hyperphosphatemic CKD patients not on dialysis.
Elevated serum phosphorus levels are common in patients with CKD because phosphorus is not easily filtered by the diseased kidneys and therefore builds up in the body. This can lead to calcification of tissues, and increased risk of cardiovascular mortality. Controlling serum phosphorus is therefore an important element in the care of patients with CKD.
About Renvela and Renagel
Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride) are currently the only phosphate binders available that do not contain either calcium or a metal. Sevelamer, the active moiety in both Renagel and Renvela, has an established safety profile and is not systematically absorbed. It is used by more than 350,000 patients worldwide.
Renvela and Renagel are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation or major GI tract surgery. Common adverse events reported with sevelamer include vomiting, nausea, diarrhea, dyspepsia, abdominal pain, and constipation. Other events reported include pruritus, rash, fecal impaction, and intestinal obstruction. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take sevelamer. Patients should be informed to take sevelamer with meals and to adhere to their prescribed diets.
One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements regarding Genzyme’s future business plans and strategies, including without limitation: the anticipated receipt of marketing authorization for Renvela from the European Commission and the expected timing thereof; and the potential receipt of FDA approval of the powder formulation of Renvela and for use in CKD patients not on dialysis. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: whether the European Commission approves Renvela and the actual timing of the decision; whether the FDA approves the powder formulation of Renvela; whether the FDA approves the use of Renvela in CKD patients not on dialysis; and the risks and uncertainties described in Genzyme’s SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption “Risk Factors” in Genzyme’s Annual Report on Form 10-K for the period ended December 31, 2008. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today’s date and Genzyme undertakes no obligation to update or revise the statements.
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1 The National Kidney Foundation’s 2003 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Bone Metabolism and Disease in CKD recommend sevelamer as a first-line treatment option to control phosphorus.