BEN VENUE DETERMINES SIGNIFICANT REMEDIATION REQUIRED AT ITS BEDFORD, OHIO FACILITIES

“NORTH” FACILITY MAY NOT BE AVAILABLE FOR MFG OF STERILE INJECTABLES BEFORE 4th QUARTER 2012

COMMENT

Ben Venue Laboratories issued an early “Christmas gift” press release on Friday, December 23 wherein they announced the decision to extend the voluntary suspension of manufacturing at its Bedford, OH facility.  Ben Venue has determined that it can no longer both manufacture and remediate simultaneously and must focus on manufacturing issues.  Major reconstruction that may require upwards of nine months is possible. 

Ben Venue Laboratories, Inc. Update on Drug Manufacturing

Bedford, OH – December 23, 2011 – Ben Venue Laboratories, Inc., (“Ben Venue”) has announced its decision to extend the voluntary suspension of manufacturing at its Bedford, OH facility, originally announced on November 19, in order to uphold its commitment to providing the highest attention to quality and product safety, and to permit the implementation of lasting corrective actions. The original suspension took place after an internal review indicated that routine preventive maintenance and requalification of some manufacturing equipment was overdue. These issues have also been noted in recent inspection findings by the FDA, EMA, and other global regulatory agencies. Ben Venue continues to conduct a site-wide assessment in order to fully understand the potential impact and implement any appropriate corrective actions that may be needed as quickly as possible to ensure that healthcare providers and patients have access to the medicines they need.

Ben Venue has been working with global regulatory agencies over the past few years to balance the need to continue supplying patients and healthcare professionals with safe and effective critical medicines while addressing manufacturing and quality-related issues. However, Ben Venue is now in a position where it can no longer continue to manufacture and remediate simultaneously and must direct its focus on addressing manufacturing-related issues.

Ben Venue’s operation in Bedford, OH is one of the largest sterile injectable facilities in the world, with aseptic filling, lyophilization and cytotoxic manufacturing in four factories. Due to the distinct technologies and manufacturing processes in each of Ben Venue’s factories, issues are being addressed separately. As we address the facility and equipment issues in each factory, we will resume production, likely one line at a time. We are now working to restore some manufacturing in the first quarter of 2012, and will provide updates as they become available.

A substantial investment of time and resources will be required to make necessary improvements in the North facility, where several sterile injectable drugs currently in short supply are manufactured. The facility requires major reconstruction that may take up to nine months to complete. We anticipate that no products manufactured in the North facility will be available to patients and healthcare professionals before the fourth quarter of 2012. It should be noted that these expectations are based on our current plans and may be revised in the future.

As many of the products that Ben Venue produces are critical to patient care, the impact of our inability to produce these products weighs heavily on us. Our highest priority is to resume manufacturing and delivery of safe and effective products, and we are committed to working as quickly as possible to resolve the issues that have affected production.

We will provide periodic updates on our website as progress is made and additional information becomes available. Questions regarding this notice can be directed to our Bedford Laboratories Client Services Team at 1.800.562.4797 – Monday – Friday, 8am – 5pm EST.

Ben Venue Laboratories, Inc. Temporarily Suspends Manufacturing and Distribution of Drug Products

November 19, 2011 – Ben Venue Laboratories, Inc, (“Ben Venue”) has voluntarily and temporarily suspended manufacture and distribution of products produced in its Bedford, OH facility.

A recent internal review of documentation indicated that routine preventive maintenance and requalification of some manufacturing equipment did not occur at the specified time interval, and is overdue.  To uphold our commitment to quality and product safety, Ben Venue is completing a site-wide assessment in order to fully understand the potential impact, if any, and implement any appropriate corrective actions that may be needed as quickly as possible to ensure that healthcare providers and patients have access to the medicines they need. 

Ben Venue has notified the global regulatory agencies of this voluntary preventive measure and is assessing stock levels and anticipated demand to minimize impact to product supply in the market place.  The U.S. Food and Drug Administration has been and will continue to work closely with Ben Venue to address these issues and help resume manufacturing and distribution of products as soon as possible. 

Ben Venue is committed to providing pharmaceutical products that improve the health and quality of life of patients. As a provider of many medically-necessary drugs, including several products for which we are the sole-source manufacturer, we recognize the importance of ensuring that healthcare professionals and patients have access to the products they need, when they need them, with the highest attention to quality and product safety.

Questions regarding this notice can be directed to our Bedford Laboratories Client Services Team at 1.800.562.4797 – Monday – Friday, 8am – 5pm EST.