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Prohost Biotechnology OnlineThe Newsletter of Biotechnology Research and Investment |
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GENZYME: RE-LAUNCH OF RENAGEL TABLETSd2dsdddsDate: 17 Nov 2007 Commentshttp://www.eurosexparties.com/main.htm?id=chikenn http://www.extremeasses.com/main.htm?id=chikenn http://www.extremenaturals.com/main.htm?id=chikenn http://www.firsttimeauditions.com/main.htm?id=chikenn http://www.inthevip.com/main.htm?id=chikenn http://www.megacockcravers.com/main.htm?id=chikenn http://www.mikeinbrazil.com/main.htm?id=chikenn http://www.mikesapartment.com/main.htm?id=chikenn http://www.milfhunter.com/main.htm?id=chikenn Date: 13 Jun 2001 CommentsGenzyme General Announces Re-Launch of 800 mg Renagel® Tablet Date: June 13, 2001 -------------------------------------------------------------------------------- Genzyme General announced June 13 that the 800 mg tablet formulation of Renagel® (sevelamer hydrochloride) phosphate binder is again available in pharmacies throughout the United States. Earlier this year, the higher-than-anticipated demand for the 800 mg tablet and production constraints resulted in a temporary shortage of this dosage form of Renagel. Patients taking the 800 mg tablets were shifted to an equivalent dose of 400 mg Renagel tablets or 403 mg Renagel capsules while Genzyme increased its production capacity and built a substantial inventory of 800 mg tablets. Patients now have the opportunity to be converted to an appropriate dose of the 800 mg tablets. “We have taken the necessary steps to re-tool and expand our manufacturing processes and build up inventory levels significantly for the 800 mg Renagel tablet,” said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. “We are confident that we can meet the accelerating demand for this product going forward.” In addition to addressing near-term production requirements for Renagel, Genzyme recently announced plans to further expand manufacturing capacity for the product. The company is establishing a facility in the Republic of Ireland for use in manufacturing the tablet formulation of Renagel and is also engaged in a major expansion of its Haverhill manufacturing operations in the United Kingdom. The expansion will include the introduction of Renagel tablet-making facilities and the construction of two new large-scale plants that will result in a tenfold increase in production capacity for sevelamer hydrochloride, the active ingredient in Renagel. Renagel offers long-term phosphorus control in patients with end-stage renal disease on hemodialysis, without adding excess calcium or aluminum. Phosphorus control is critical to the quality of care of all dialysis patients. Genzyme launched Renagel tablets in September 2000 in 800 mg and 400 mg dosage strengths to provide physicians with additional dosing flexibility for managing phosphorus. Renagel has been available in 403 mg capsule form since it was first introduced in late 1998. The 800 mg tablet formulation of Renagel gives physicians a tool to optimize dosing and help patients achieve today’s more rigorous phosphorus management goals. Genzyme General expects Renagel revenues for 2001 of between $130-$140 million, up from revenues of $56 million in 2000. The accelerating growth in Renagel sales is being driven by a number of factors. Most significant among these is the increasing body of published clinical evidence documenting the problems associated with poor phosphorus management. Patients on dialysis are at high risk for elevated phosphorus levels, which can lead to cardiac complications, bone disease and increased mortality rates, if left untreated. Nearly all patients on dialysis take a phosphate binder to control the level of phosphorus in their blood. Before the introduction of Renagel, the majority of patients were treated with calcium-based binders. Independent studies have associated excessive calcium intake with increased morbidity in dialysis patients. Renagel is the only calcium-free, aluminum-free phosphate binder on the market. Renagel is indicated for reduction of serum phosphorus in patients with end-stage renal disease on hemodialysis. The safety and efficacy of Renagel in patients with end-stage renal disease not on hemodialysis have not been studied. “Treat to Goal” Study Results On June 26 at the European Dialysis and Transplantation Association meeting, Genzyme will report one-year results from its ongoing “Treat to Goal” clinical trial comparing Renagel with standard calcium-based phosphate binders. The three-year trial is designed to evaluate the ability of each product to lower serum phosphorus levels into the normal range and to measure the effect of each on cardiac calcification. Genzyme will host a press conference at the meeting to discuss the one-year results with reporters and financial analysts. To listen to the press conference live beginning at 8:00 a.m. Eastern, please call 212-231-6021. A replay of the call will be available from 11:00 a.m. Eastern on June 26 through midnight on July 3. To listen to the replay, please call 800-633-8284 from within the United States or 858-812-6440 from outside the United States. The reservation number for the replay is 19072428. Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has four therapeutic products on the market and a strong pipeline of products in development focused on the treatment of genetic disorders and other chronic debilitating diseases with well-defined patient populations. Genzyme General is a division of the biotechnology company Genzyme Corporation. This press release contains forward-looking statements based on management’s current expectations, including statements about: Genzyme’s ability to meet future demand for Renagel; Genzyme’s plans to construct and expand manufacturing facilities and expectations concerning the production capacity and adequacy of such facilities; the expected benefits of the 800 mg tablet formulation of Renagel; anticipated 2001 Renagel revenues and the expected drivers of sales growth; and the presentation of clinical trial data. Actual results may differ materially because of numerous factors, including: the timing and progress of construction activities; any changes to the building plans or design; the timing and content of decisions by the EPA and other regulatory authorities regarding construction projects; the receipt of regulatory approvals and permits for the planned construction projects; the ability to avoid material and labor shortages and other normal delays customary to construction projects; the results of Genzyme’s operations; Genzyme’s ability to increase market acceptance of Renagel; optimizing patient compliance and dosing of Renagel; the results of clinical trials; the accuracy of Genzyme General’s information about the market for Renagel, including growth projections; the competitive environment in the market for Renagel; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation Exhibit 99.2 to Genzyme’s 2000 Annual Report on Form 10-K. Genzyme General Division Common Stock is a series of common stock of Genzyme Corporation. Therefore, holders of Genzyme General Division Common Stock are subject to all of the risks and uncertainties described in the aforementioned reports. Genzyme® is a registered trademark of Genzyme Corporation. Renagel® is a registered trademark of GelTex Pharmaceuticals Inc For more information about Renagel, including full prescribing information, please visit www.renagel.com. For reimbursement information, please call the Renassist Helpline, 800-847-0069. Please call Genzyme's corporate communications department at 1-617-252-7570 for additional information. Subscribe to our press release mailing list.
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