Plant issues cost Lilly, Boehringer Ingelheim a drug approval

The FDA has been on a campaign to convince drugmakers that quality is good for patients and good for business. By default, then, the reverse is true--lack of quality is bad for business. That was abundantly clear Wednesday when the FDA held off approval of a new Eli Lilly ($LLY) diabetes drug until partner Boehringer Ingelheim fixes problems at a plant that last year was slapped with a warning letter.

The diabetes drug development partners said on Wednesday that they had received a complete response letter from the FDA citing "previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured." The two said they were "committed to working with the FDA" so that empagliflozin can be available as soon as possible.

This is a particularly big setback for Lilly, which has promised it will capture "several" new drug approvals this year to make up for its dearth of approvals and flagging revenues. The rejection comes only weeks after Lilly's copycat version of Sanofi's ($SNY) market-dominant Lantus was put on hold by a lawsuit the French drugmaker filed claiming patent infringement. That may delay launch of Lilly's biosimilar until the middle of 2016.

In May 2013, the FDA sent Boehringer Ingelheim a warning letter for its plant in Ingelheim am Rhein taking the company to task for not properly investigating the appearance of large particles contaminating batches of an active pharmaceutical ingredient it manufactured there. The German drugmaker responded that it took the warning very seriously and pointed out that the plant had passed 22 inspections over 5 years.

That is not to say that Boehringer Ingelheim has not seen the contents of a warning letter before. In fact, it closed its Ben Venue contract manufacturing operation in Bedford, OH, at the end of the year, deciding the upside for the facility was not worth the additional expense it faced. The drugmaker in January 2012 had signed a consent decree with the agency for that plant which had issued 40 product recalls from 2002 until the plant voluntarily closed in November 2011.

The warning letter for Boehringer Ingelheim's plant in Germany stems from problems in 2008 and 2009, but inspectors did not let the company off the hook. It criticized the drugmaker for not investigating the source of the particles, some of them as large as 3 mm, and then even using the affected API to make finished capsules. The warning letter said it was not until 2012 that the company finally took "comprehensive corrections to mitigate the presence of foreign particles" in the API.

Lilly is in the midst of expanding several manufacturing plants in anticipation of growing sales from its diabetes drug franchise, but the earliest of those projects don't come online until 2016.

- here's the release