Tag Archives: INTERCEPT

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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. Rüesch, 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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Cerus Signs INTERCEPT Platelet Agreements With Two Key Blood Component Suppliers in Germany and Aust

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Cerus Signs INTERCEPT Platelet Agreements With Two Key Blood Component Suppliers in Germany and Austria

  • TILAK, University Clinics, Regional Hospital Innsbruck (LKI), one of the largest hospitals in Austria, signs one year agreement for Cerus’ INTERCEPT platelet system.
  • ZIT GmbH Hamburg (Zentralinstitut Hamburg), the largest in-house blood component supplier of the German Asklepios Group, signs four year agreement for the INTERCEPT Blood System for pathogen inactivation of platelet components.

CONCORD, Calif.–(BUSINESS WIRE)– Cerus Corporation (NAS: CERS) announced today that the TILAK, University Clinics, Regional Hospital Innsbruck (LKI) in Austria and ZIT GmbH Hamburg in Germany, signed one and four year purchase agreements, respectively, for the INTERCEPT Blood System for platelets.

LKI is one of the largest hospitals in Austria, with its Central Institute for Blood Transfusion supplying an estimated 6,000 platelet units annually to the federal state of Tyrol. LKI is the second facility in Austria to adopt INTERCEPT for platelets. Together with the General Hospital of Vienna (AKH), an estimated total of 12,000 platelet units, or 30% of the Austrian platelet market, could be treated with INTERCEPT. Implementation of the INTERCEPT platelet system at LKI is expected to start in March 2013.

ZIT Hamburg supplies roughly 10,000 platelet units annually and is the largest in-house blood component supplier to the Asklepios Group, one of the three largest operators of private hospitals in Germany. Implementation is expected to occur upon ZIT Hamburg’s receipt of regulatory approval from the Paul-Ehrlich-Institut to produce INTERCEPT-treated platelets.

“Considering the inherent limitations and increasing cost of the current testing strategies used for platelets, we believe the INTERCEPT Blood System for platelets offers a strong value proposition that combines patient safety with commercial benefits,” stated O. Schertges, CEO of the ZIT Hamburg.

“We believe the breadth of clinical and routine-use data for INTERCEPT platelets accumulated over the last 10 years may have positively influenced the decisions made by LKI and ZIT Hamburg,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. “It is this clinical experience and hemovigilance data that led to FDA‘s recent agreement to allow Cerus to proceed with a modular PMA submission for INTERCEPT platelets without the need to conduct another prospective clinical trial.”

ABOUT CERUS

Cerus Corporation is a biomedical products …read more
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Cerus Announces Proposed Public Offering of Common Stock

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Cerus Announces Proposed Public Offering of Common Stock

CONCORD, Calif.–(BUSINESS WIRE)– Cerus Corporation (NAS: CERS) today announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. Cerus also expects to grant the underwriters a 30-day option to purchase additional shares of common stock to cover overallotments, if any. Cerus anticipates using the net proceeds from the offering for clinical development and other research and development activities related to the INTERCEPT Blood System, preparatory activities for the potential commercialization of the INTERCEPT Blood System in the United States and elsewhere, and for other general corporate purposes, including regulatory activity, selling, general and administrative expenses and working capital. Cerus may also use a portion of the net proceeds from the offering to prepay the remaining outstanding indebtedness under its growth capital loan with Comerica Bank.

Cowen and Company, LLC is acting as sole book-running manager for the offering.

The securities described above are being offered by Cerus pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC“). A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC‘s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by calling 631-274-2806, or by faxing 631-254-7140.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

ABOUT CERUS

Cerus Corporation is a biomedical products company focused on enhancing blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate …read more
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