Renagel/Renvela

[SarahK]

Has a firm date been established for Renagel being removed from the market? How urgently do patients need to move to Renvela?

[diana.papshev]

At this point, it doesn't appear that a specific timetable has been set by Genzyme. In the July 2008 Earnings Call, the following statement was made by the President of the Renal devision: "we would like to get to a point where Renvela is the product that we are selling globally in the market and replace Renagel. Exactly how long that takes is still to be determined. But there are a number of triggers..." (Link to full transcript)

The decision when to pull Renagel off the market will probably largely depend on how fast patients are switched and the declining rate of new scripts for Renagel.

[chantell.reagan]

The unofficial word on the street is that Renagel will be pulled off the market by the end of 2009/beginning of 2010, but the exact date has not been set yet.

[Nochmar]

I think the biggest tell to Renagel's withdrawal will be to look when the marketing changes over to Renvela. They'll need to establish the new name and be satisfied they'll retain the market share before they'll pull Renagel.

[chantell.reagan]

The latest update is that Genzyme is working to transition all patients from Renagel to Renvela by September 30. In addition, Renvela will get a new indication in mid-2009 for the treatment of hyperphosphatemic chronic kidney disease patients who are not on dialysis. A new powder formulation will be launched mid-2009 for the control of serum phosphorus in chronic kidney disease patients on dialysis.

Source: News article 1/09

[drsherry]

Not sure if this is helpful, but I came across the following on Renal Business Today (http://www.renalbusiness.com/hotnews/genzyme-transitions-to-renvela.html#)

CAMBRIDGE, Mass.—Genzyme Corp. said Jan. 14 that it’s working with physicians to transition all U.S. patients on the phosphate binder Renagel to Renvela by Sept. 30.

Renvela was launched in March 2008 and is a next-generation version of Renagel, which Genzyme said is the most-prescribed phosphate binder in the United States.

“We developed Renvela because we are committed to improving the care of kidney disease patients,” said Dan Regan, senior vice president of Genzyme’s U.S. renal business. “We believe that Renvela is the best option for patients who need a phosphate binder, and this is why we are working to fully transition all appropriate patients to this treatment.”

Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed treatment approved for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela, however, has a carbonate buffer.

Renagel and Renvela are protected by the same core patents, which expire in 2014, according to Genzyme. The company added that Renvela has comparable managed care coverage to Renagel, and is widely available through the majority of commercial insurance and Medicare Part D plans.

In addition, Genzyme said it is continuing to work with the U.S. Food and Drug Administration toward a label expansion in mid-2009 for Renvela to include the treatment of hyperphosphatemic chronic kidney disease patients who are not on dialysis.

Renvela and Renagel are both currently available in tablet form, and Genzyme said it anticipates that it will launch a powder form of Renvela in the United States in mid-2009 for the control of serum phosphorus in chronic kidney disease patients on dialysis.

The Renvela powder formulation will provide an additional therapeutic option for physicians and a no-pill phosphate binder option for patients, according to Genzyme. European approval of Renvela is also expected by the middle of this year, and Genzyme is pursuing approvals in other markets internationally.

[chantell.reagan]

The word on the street is that Genzyme changed their strategy with regards to Renagel, and it will continue to be available (at least for the near-term). Upon inquiry, Genzyme stated that there is no firm discontinuation date, as they will be continuing to work with physicians to transition patients to Renvela. If the transition is not completed by 2010, this issue will be interesting from a formulary management perspective, particularly for Medicare Part D, where the 2010 Reference Formulary File does not include Renagel.