It is too bad this board is so quiet. GELX has had a bunch of good news since the last posting in January with a good earnings report, new formulation of RenaGel, and Welchol market approval / co-marketing agreement.
The biggest news, though, was the attached news regarding an article published in the New England Journal of Medicine. It validates the revolutionary effect of RenaGel binding phosphorus before it is absorbed without the use of calcium or aluminum. Calcium can be cheap (Tums) or prescription (PhosLo) and both are effective. The balance of the therapy can be tricky. Too little calcium supplementation leads to phosphate in the blood which will leach calcium out of the bones and lead to renal bone disease. It can also lead to secondary hyperparathyroidism. Taking too much calcium can lead to calcium deposits in the muscle and even worse in the arteries. 50% of dialysis patients die of cardiac problems and this is one contributing factor. Even the by-product of Ca x PO4 can build to toxic levels.
The other alternative before RenaGel was aluminum. Can lead to dementia and other nasty problems.
RenaGel binds phosphorus before it is absorbed, bypassing this whole problem. They seem to have problems with reimbursement and it is pretty expensive. Not sure if they are having Medicare problems since it is an oral compound or if something different. Anyway, this article should encourage faster adoption of the product.
I have been a shareholder since 1998 as I expected RenaGel to pick up a lot quicker. I continue to believe in their non-absorbed technology. Sales did not take off but this article may be the catalyst. I am sure investors will wait for the proof of sales rather than buying in anticipation as they have been burned once. This quarter's report may have been the first sign that this article is starting to have an effect.
-JAR
Thursday May 18, 8:18 am Eastern Time
Company Press Release
SOURCE: Genzyme General
Genzyme and GelTex Say Study Highlights Risks of Calcium for Dialysis Patients
Results Suggest Need For Calcium-Free Binders Such as Renagel(R)
CAMBRIDGE and WALTHAM, Mass., May 18 /PRNewswire/ -- Genzyme General (Nasdaq: GENZ <http://finance.yahoo.com/q?s=genz&d=t> - news </n/g/genz.html>) and GelTex Pharmaceuticals Inc. (Nasdaq: GELX <http://finance.yahoo.com/q?s=gelx&d=t> - news </n/g/gelx.html>) said today that a new study showing dramatic coronary artery calcification in young adult dialysis patients provides evidence of the need for changes in the current management of phosphorus and calcium in the treatment of end-stage renal disease.
The study, published in today's New England Journal of Medicine, found that nearly 90 percent of adults in their twenties undergoing dialysis had signs of coronary artery calcification, a form of cardiovascular disease in which calcium deposits in the blood vessels of the heart. One of several factors linked with this calcification was the ingestion of calcium through calcium-containing phosphate binders. Patients in the study with coronary artery calcification had nearly twice the daily intake of calcium through phosphate-binding agents, compared to patients who showed no signs of calcification. These patients also had higher serum phosphorus levels, higher calcium-phosphorus ion product levels, and had been on dialysis for a longer period of time.
``This study highlights the importance of Renagel, which allows clinicians to control phosphorus levels in their hemodialysis patients without the use of calcium,'' said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. ``We hope and expect that this study will prompt physicians to re-examine their use of calcium-containing phosphate binding agents.''
Patients on dialysis are at high risk for elevated phosphorus and calcium levels. If left untreated, the combination of high phosphorus and calcium can lead to cardiac and other soft tissue calcification, renal bone disease and death. Nearly all patients on dialysis take a phosphate binder to control the level of phosphorus in the blood. Eighty percent of these patients are currently on a calcium-based binder. Renagel® (sevelamer hydrochloride), launched 16 months ago and marketed by Genzyme under a joint venture with GelTex Pharmaceuticals Inc., is the first calcium-free, aluminium-free phosphate binder available to patients with end-stage renal disease. Neither Genzyme nor GelTex sponsored the UCLA study.
``This study's findings coincide with our growing concern surrounding the amount of calcium we are now giving our patients and the need for a calcium- free alternative to bind phosphorus,'' said Sharon Moe, M.D., Assistant Professor of Medicine at Indiana University.
While cardiovascular disease and coronary artery calcification have been shown to be common in adults receiving dialysis, little had been known about its prevalence in younger dialysis patients prior to the publication of today's study. The results indicate that coronary artery calcification is markedly higher in men and women less than 30 years of age undergoing dialysis than in volunteers of the same age and sex with normal renal function. Fourteen of the 16 dialysis patients between the ages of 20 and 30 showed signs of coronary artery calcification, while no patients under the age of 20 had evidence of calcification. Calcification of the coronary arteries doubled within two years in patients who showed signs of calcification at the beginning of the study. Only five percent of healthy volunteers showed any signs of the disease.
``Based on this study's findings, physicians caring for dialysis patients may want to reconsider the use of large doses of calcium-containing medications in patients who are treated with dialysis,'' said Dr. William Goodman, MD of UCLA's School of Medicine and the study's lead author.
Mark Skaletsky, chairman and chief executive officer of GelTex Pharmaceuticals, said: ``This study adds to the growing body of literature linking excessive calcium intake, phosphorus, and calcium-phosphorus levels with severe cardiac consequences for dialysis patients. Genzyme and GelTex are currently funding clinical studies and other research that we hope will provide additional insight and solutions to this widespread problem.''
Renagel was introduced in the United States in late 1998 and is also available in Europe, Canada, and Israel.
Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of products in development focused on the treatment of rare genetic disorders. Genzyme General is a division of the biotechnology company Genzyme Corporation.
GelTex Pharmaceuticals Inc. develops polymer-based, non-absorbed pharmaceuticals that selectively bind and eliminate target substances from the intestinal tract resulting in systemic medical benefit.
This press release contains forward-looking statements, including statements about the anticipated reactions of physicians to the study results, the estimated number of dialysis patients taking calcium-based phosphate binders, the anticipated benefits of additional clinical studies and research, and the estimated extent of the problem of cardiac calcification. Actual results may materially differ due to numerous factors, including without limitation the actual results of the additional clinical studies and research, decisions by regulatory authorities, and the accuracy of the companies' information about the number of dialysis patients on calcium-based binders and the incidence of cardiac calcification in the dialysis patient population.
Renagel® (sevelamer hydrochloride) is indicated for reduction of serum phosphorus in patients with end-stage renal disease (ESRD). The safety and efficacy in ESRD patients not on hemodialysis have not been studied. Renagel® is contraindicated in patients with hypophosphatemia or bowel obstruction. The drug should be used with caution in patients with swallowing or severe gastrointestinal motility disorders or major GI surgery. In a placebo-controlled study adverse events were similar to placebo. The most common treatment-emergent adverse events in a phase 3 crossover study were not dose related and included diarrhea, infection, and pain. There is a possibility that Renagel® may bind concomitantly administered drugs and decrease their bioavailability. When administering any oral drug, for which alteration in blood levels could have a clinically significant effect the drug should be administered at least 1 hour before or 3 hours after Renagel®. For more information on Renagel® please refer to the product's package insert.
SOURCE: Genzyme General |
