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July 25, 2006

July 25- July 31

July 26th: STERIS Corporation Announces FDA Market Clearance of Reliance(TM) Endoscope Processing System

STERIS Corporation (NYSE: STE ) today announced that the United States Food and Drug Administration (FDA) has given the Company clearance to market its Reliance(TM) Endoscope Processing System (EPS). The innovative technology of the Reliance EPS addresses significant unmet reprocessing needs within the gastrointestinal (GI) departments of hospitals and surgery centers, including enhanced patient and staff safety, improved quality through an automated, consistent and repeatable process, and increased productivity from faster total reprocessing time.

The Reliance(TM) Endoscope Processing System is an automated, self-contained system specifically designed to achieve high-level disinfection of heat-sensitive instruments using a patented, dry oxidative chemistry. Through uniquely designed interior, medical instruments such as GI endoscopes, bronchoscopes and associated accessories can be rapidly connected in the system, which reduces set-up time. The system can also reprocess two scopes within 30 minutes.

The Company expects to begin offering Reliance EPS in the U.S. market immediately. Reliance EPS is already being successfully marketed in Canada, Australia and certain European countries. Marketing and launch costs for the U.S. market are expected to result in the introduction of the product being neutral to earnings in fiscal 2007, and accretive to earnings in future years as sales accelerate.

The mission of STERIS Corporation is to provide a healthier today and safer tomorrow through knowledgeable people and innovative infection prevention, decontamination and health science technologies, products and services. The Company's more than 5,000 dedicated employees around the world work together to supply a broad array of solutions by offering a combination of equipment, consumables and services to healthcare, pharmaceutical, industrial and government customers.

31st July: St. Jude Medical and Boston Scientific Settle Patent Litigation

St. Jude Medical, Inc. (NYSE:STJ ) and Boston Scientific Corporation today announced that they have entered into an agreement that resolves four previously disclosed patent litigation matters pending between the companies and certain of their affiliates.

Under the settlement, St. Jude Medical and Boston Scientific have also agreed to limit how two previously disclosed patent cases, though not resolved, will be pursued.

St. Jude Medical and Boston Scientific have also agreed to a patent cross license involving the companies' cardiac rhythm management patent portfolios, and a separate cross license of certain patents held by each of their affiliates related to neuromodulation.

"We are pleased to have reached these agreements, which eliminate much of the expense and uncertainty associated with the litigation and enable the company to focus its resources and attention on providing patients with life-saving products," said St. Jude Medical Chairman, President and Chief Executive Officer Daniel J. Starks.

"We are pleased to have reached a reasonable commercial settlement of the lawsuits between Boston Scientific and St. Jude Medical," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We are also pleased to have reached agreement on additional cross licenses, which will help reduce the possibility of future patent disputes between our companies. This is very welcome news, which we believe will benefit both companies and offer physicians and patients continued access to a broad range of treatment alternatives."

St. Jude Medical and Boston Scientific each will be filing a Form 8-K with the U.S. Securities and Exchange Commission that provides additional detail concerning the settlement agreement and license agreements.

July 31st: FDA Announces Framework for Moving Emergency Contraception Medication to Over-the-Counter Status

FDA announced today it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option. The Agency and the Sponsor will discuss the Sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older.

FDA and the Sponsor have agreed to meet immediately to discuss the approvability of the Sponsor's amended application and the framework by which this medicine can be made available over-the-counter.  The Agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks.

Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills—only in the case of Plan B—each pill contains a higher dose and the product has a different dosing regimen.  Like other birth control pills, Plan B is currently available to all women as a prescription drug. 

In the letter to Duramed, the Agency communicated its plan to  proceed working with the Sponsor in order to move Plan B from prescription only to over-the-counter status for woman ages 18 and older.  The steps FDA has taken with respect to this application and the letter it issued to the Sponsor of Plan B today underscores FDA's commitment to public health and safety.

This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor's amended application.  Foremost in the Agency's concerns is to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use.  The Acting Commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step in moving the Agency's broad and critical agenda forward.

 

 

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