Production glitch exhausts Keryx supply of kidney drug Auryxia

Keryx Biopharmaceuticals ($KERX), which was already dealing with slow uptake of its kidney drug Auryxia, now has a bigger issue with which to deal: No product to sell.

The Boston-based drug company Monday announced that reserves of the drug have been depleted as its contract manufacturer has dealt with a production glitch and that it does not expect to have fresh batches of Auryxia until Q4. It said that current inventories of the hyperphosphatemia med are not sufficient to ensure uninterrupted patient access to the drug.

“We take our responsibility to patients and the treating community very seriously and recognize the impact this interruption of supply will cause for patients and their healthcare providers,” Greg Madison, Keryx CEO, said in an announcement.

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The company said that because of a problem in converting the active ingredient into a finished form, the contract manufacturer has been getting “variable yields.” The drugmaker said it is the process of getting a second manufacturer approved but that the FDA is not slated to make a decision about that until mid-November.

The notice came as the drugmaker Monday reported Q2 results which included $8.3 million sales of the hyperphosphatemia med Auryxia, compared with $5.6 million sales for the drug in Q1. The company withdrew its guidance for the year and its shares plummeted 35.87%, closing at $4.72 Monday.

“Although we are withdrawing our financial guidance for 2016, we believe we are well positioned financially to manage through this interruption in supply of Auryxia,” CFO Scott Holmes said in a statement. The company said it has $155.8 million in cash and cash equivalents on hand.

The FDA approved the Auryxia in September 2014. It competes with Sanofi’s ($SNY) Renvela, which dominates the market and had Q1 sales of  $208 million, although that was off 7.4%. Keryx is hoping to get approval this year for a second indication to treat iron deficiency anemia in adult patients with non-dialysis-dependent chronic kidney disease.

- here’s the release

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Keryx anemia med Auryxia trounces placebo in study aimed at big new use
Auryxia differentiation strategy, check. Next, Keryx has to persuade prescribers


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