BEDFORD LABS

Ben Venue Laboratories, Inc. (Ben Venue) of Bedford, Ohio, has decided to cease production by the end of 2013. Despite the ongoing support of the U.S. Food and Drug Administration (FDA), the tremendous dedication of employees, and significant investments in facility upgrades, the company cannot return to sustainable production. Although interim controls implemented to assure product quality have been effective to date, in the long term, they are not sustainable. The magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable. Given the age and condition of some of our facilities, combined with the findings from our third-party current Good Manufacturing Practice (cGMP) experts and ongoing remediation needs, Ben Venue projects, in addition to the more than $350 million invested to date, significant additional cumulative operating losses of approximately $700 million over the next five years. The effort, magnitude of investment, and additional years required to remediate the facility before Ben Venue can return to sustainable production is not feasible. Ben Venue understands the importance of the drugs the company produces, and will work to help ensure that these critical medicines continue to reach the patients who need them. The closure will affect all of Ben Venue’s employees (approximately 1,100) over a phased reduction starting this month and continuing into 2014 as Ben Venue executes wind-down activities. Boehringer Ingelheim recognizes the importance of Bedford Laboratories, Ben Venue’s generic sterile injectables business, and is exploring strategic options to try to continue the supply of these products to patients. Ben Venue has notified the FDA of this difficult decision, and is diligently working to minimize the potential impacts this decision may have on patients, providers and employees.