Manufacturing issues trip up Novo on new therapy

Manufacturing issues are holding up approval of a new therapy, Novo Nordisk ($NVO) said in what was a small blemish on an otherwise upbeat earnings report for the Danish drugmaker. But it is the most recent example of how problems in a plant can turn into pressure on a pipeline.  

In its earnings release, Novo said that in June, the company received a Complete Response Letter (CRL) from the FDA saying that issues at a plant found during an inspection were holding up completion of the review for its recombinant factor XIII compound for a rare bleeding disorder. Novo did not delineate which plant or what issues. The company said, "Novo Nordisk is working closely with FDA to address the issues." It the second time Novo has received a CRL for the product. 

Novo spokesman Ken Inchausti said today in an email that the "observation was concerning sample sets used for training and certification of operators." He said all replies to the visual inspection findings were submitted on June 3. He would not say which plant was involved, only that it was not a U.S facility.

The denial this year followed a rejection in February 2012 for the product. Scientific Officer Mads Krogsgaard Thomsen in June told FierceBiotech the FDA has a low tolerance for safety and quality issues. "There is no doubt that the FDA has this safety-first principle. They have publicly stated that," Krogsgaard Thomsen said. "Which relates to [CDER chief] Janet Woodcock and her various divisions wanting to avoid, you can argue, future drug scandals. Because every time it falls back on the agency, so obviously they are very cautious. Whether they are even more cautious is difficult for me to say."

Novo is not the only drugmaker to have a drug application held recently because of unresolved manufacturing issues. In April the FDA told Allergan ($AGN) it was holding off approval of the company's new migraine treatment until problems at an inhaler plant were sorted out. In January, Impax Pharmaceuticals ($IPXL) said the FDA told it in a CRL that the company's plant in Hayward, CA, would require a satisfactory reinspection for issues outlined in a 2011 warning letter before it will approve Impax's NDA for an extended-release capsule formulation of carbidopa-levodopa for treating Parkinson's disease. That delay cost Impax a partnership with GlaxoSmithKline ($GSK) and led to Impax saying in June it would have to cut 10% of its workforce.

Novo's factor XIII is slated for a relatively small patient population, and the setback, while an issue the company felt was worth mentioning, did not spoil a generally upbeat earnings report. In fact the company said it expects 2013 sales to grow by 11% to 13%, with operating profits up 12% to 15%. That was an increase from its previous forecast that sales would grow 9% to 11% for the year.

- here's the earnings release (PDF)
- check out the transcript from Seeking Alpha

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