The U.S. Food and Drug Administration has extended by six months a deadline for STERIS (NYSE:STE) to support customers transitioning from its System 1 sterilizer, for which the FDA revoked approval two years ago.
Under terms of the new agreement, some System 1 customers can continue to purchase a consumable sterilant used by the system until Aug. 2, 2012, according to a regulatory filing by Mentor, Ohio-based STERIS. The previous deadline was Feb. 2, 2012.
To be eligible, customers must have placed orders for products to replace all remaining System 1s in their possession and have provided a properly completed “certificate of transition,” according to a letter to customers from STERIS that details the agreement.
“STERIS recently requested the extension because we believe it is in the best interest of our customers to aid their transition and allow additional time for the installation of alternative processing technologies,” company spokesman Stephen Norton said.
The System 1 is a liquid chemical sterilizing system used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments.
The FDA revoked its approval for the System 1 after it found in December 2009 that STERIS had made so many changes to the device over the years that the agency hadn’t cleared the modified version of the device. STERIS began shipping the replacement device, the System 1E, in December 2010.
However, sales of the System 1E have been disappointing, as STERIS continues to wait for the FDA to approve an accessory part that’s optional to run the system, but considered important by some customers.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
STERIS said it anticipates that the newly granted extension will not “materially impact” total System 1E shipments, but that shipments of as many as 1,000 units could shift from fiscal 2012 to fiscal 2013, according to the regulatory document.
