Tag Archives: Supplement No

Swissmedic and Swiss Red Cross Present National Haemovigilance Data Showing Favourable Safety Profil

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Swissmedic and Swiss Red Cross Present National Haemovigilance Data Showing Favourable Safety Profile for INTERCEPT-Treated Platelet Components

CONCORD, Calif.–(BUSINESS WIRE)– Cerus Corporation (NAS: CERS) announced today the results of a haemovigilance study reflecting two years of experience with routine transfusion of 62,500 INTERCEPT-treated platelet components recently presented by Swissmedic and the Swiss Red Cross at the 15th International Haemovigilance Seminar (IHS) in Brussels, Belgium.

“Swiss haemovigilance data from transfusion of INTERCEPT-treated platelet components support the favourable safety profile of this pathogen inactivated blood product compared with conventional platelets,” said Dr. Markus Jutzi, Haemovigilance, Swissmedic, Swiss Agency of Therapeutic Products. “As expected, in routine use, we observed that INTERCEPT-treated platelet components prevented septic transfusion reactions. Furthermore, we detected no increased risk for pulmonary adverse events. The introduction of the INTERCEPT procedure also obviated the need for gamma irradiation.”

The INTERCEPT Blood System for platelets was introduced into routine use in Switzerland in 2011, where reporting of transfusion-related adverse events is mandatory. The cumulative haemovigilance data allowed for comparison of risks associated with transfusion of conventional platelet components (during 2009-2011) and INTERCEPT-treated platelet components (during 2011-2012).

As presented at IHS, Dres. RĂ¼esch, Jutzi and colleagues observed no change in platelet or red blood cell utilization between the two periods. There were fewer reports of non-infectious transfusion reactions in general (1:400) as well as of severe (grade 3, 4) transfusion reactions (1:10,000) with INTERCEPT-treated platelet components compared to conventional platelet components (1:300 and 1:3,000, respectively). There were no instances of septic reactions reported with INTERCEPT-treated platelet components, compared to 4 septic reactions, including 1 fatality, with conventional platelet components. Additionally, fewer and less severe transfusion reactions with respiratory symptoms were reported for INTERCEPT-treated platelet components.

“We are very pleased by the improvements in transfusion safety documented by the Swiss haemovigilance data after the adoption of the INTERCEPT Blood System for platelets, and these results are consistent with the 6-year experience in France reported by the ANSM haemovigilance system,” said Dr. Laurence Corash, Cerus’ chief medical officer. “Cerus’ goal is to enable transfusion services to deliver safe and effective blood products to patients, and we are proud to work with countries such as Switzerland in this effort.”

The poster presentation (“Two years experience with pathogen inactivation for platelet concentrates in Switzerland“) is available for download on the Swissmedic website at http://www.swissmedic.ch/marktueberwachung/00159/00160/00437/index.html.

The poster abstract has been published as P-11 in Blood Transfusion, Supplement No. 1, February 2013, ISSN 1723-2007 and is available for download at …read more
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Heinz Announces Successful Completion of its Consent Solicitation with Respect to 7.125% Guaranteed

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Heinz Announces Successful Completion of its Consent Solicitation with Respect to 7.125% Guaranteed Notes Due 2039

PITTSBURGH–(BUSINESS WIRE)– H.J. Heinz Company (NYS: HNZ) (“Heinz”) announced today that its subsidiary H.J. Heinz Finance Company (“Heinz Finance“) has received the consents necessary to effect certain amendments (the “Amendments”) to the 7.125% Guaranteed Notes Due 2039 (CUSIP No. 42307T AH1) issued by Heinz Finance and fully, unconditionally and irrevocably guaranteed by Heinz (the “Notes”).

The Amendments (a) amend the definition of “Change of Control” contained in the Notes and (b) add a definition of “Permitted Holder” to the Notes. The effect of the Amendments is to waive Heinz Finance‘s obligation under the Notes to make a change of control offer to repurchase the Notes at 101% of the principal amount thereof, plus accrued and unpaid interest, upon consummation of Heinz’s pending merger with Hawk Acquisition Sub, Inc., an entity affiliated with Berkshire Hathaway Inc. and 3G Capital Partners Ltd. (the “Merger”), and to make certain other changes to the definition of “Change of Control”. The effectiveness of the Amendments is not a condition to the completion of the Merger, although the Merger remains subject to shareholder and regulatory approvals and other customary closing conditions.

Heinz Finance received the consents of holders of a majority of the aggregate principal amount of the Notes prior to the expiration time of 5:00 p.m., New York City time, on March 21, 2013. As a result, Heinz Finance, Heinz and The Bank of New York Mellon (“the Trustee”) have entered into the First Supplemental Indenture to the Indenture, dated as of July 6, 2001, by and among Heinz Finance, Heinz, as guarantor, and the Trustee, which effects the Amendments.

Heinz Finance will make cash payments of $10.00 for each $1,000 in aggregate principal amount of Notes for which a consent was validly delivered in accordance with the terms and conditions of the Consent Solicitation Statement, dated March 13, 2013, as amended by Supplement No. 1 to the Consent Solicitation Statement, dated March 18, 2013.

This announcement is for informational purposes only and is neither an offer to sell nor a solicitation of an offer to buy any Notes or any other securities. This announcement is also not a solicitation of consents with respect to the Amendments or any securities.

Cautionary Statement Regarding Forward-Looking Statements

This press release and our other public pronouncements contain forward-looking …read more
Source: FULL ARTICLE at DailyFinance