Key Developments: Cerus Corp (CERS.O)
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Latest Key Developments
Cerus Corporation To Collaborate With French National Transfusion Service On INTERCEPT Red Blood Cell Development
Cerus Corporation announced that it has entered into a collaborative agreement with France's national transfusion service, the Etablissement Français du Sang (EFS), for the development of the Company's INTERCEPT Blood System for red blood cells. Terms of the agreement call for the EFS to co-invest by contributing its facilities, personnel and resources in support of clinical and commercial product development, validation, and both CE mark and French regulatory approvals. In return, EFS has certain royalty rights on future product revenue. The EFS plans to conduct the collaboration at four regional EFS establishments in France, with candidate locations including Strasbourg, Besançon, St-Etienne, Tours, Montpelier, and Marseille.
Cerus Corporation Reports Positive Outcome Of Phase 1 Clinical Trial Of INTERCEPT Red Blood Cells
Cerus Corporation announced that its Phase 1 trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75% of treated cells continued to circulate 24 hours following transfusion. The INTERCEPT red blood cell system is a pathogen inactivation treatment the company is developing to protect against transmission of infectious diseases through red blood cell transfusions. An estimated 70 million units of red blood cells are transfused worldwide each year. The randomized, single-blind, controlled, multi-center Phase 1 clinical trial of the INTERCEPT red blood cell system included 27 healthy subjects at two clinical trial centers. Each subject received two transfusions of the subject's own red blood cells, one INTERCEPT-treated, and the other a control not treated for pathogen inactivation. The primary endpoint of the clinical trial, a mean INTERCEPT red blood cell recovery of greater than 75 percent at 24 hours post-transfusion, was met. The INTERCEPT red blood cells had a recovery of 88% compared to 90% for control red blood cells, and both INTERCEPT-treated and control red blood cells met the criteria for red blood cell recovery recommended by the U.S. Food and Drug Administration. The half-life of the red blood cells was also evaluated, and INTERCEPT-treated red cells were within the established reference range of 28 to 35 days.
Cerus Corporation Reports Positive Outcome In European Study Of 7-Day INTERCEPT Platelets
Cerus Corporation announced that INTERCEPT-treated platelet components were found to be effective for patient support following extended six and seven day storage in a clinical study conducted at four sites in Europe. These data further confirm the safety and therapeutic efficacy of platelets treated with the INTERCEPT Blood System, a pathogen inactivation treatment designed to protect against transfusion-transmitted diseases.
Cerus Corporation Receives FDA Blood Products Advisory Committee Guidance For Proposed INTERCEPT Blood System Phase III Trial Design
Cerus Corporation announced that the United States Food And Drug Administration (FDA)'s Blood Products Advisory Committee (BPAC) rendered a positive opinion on the proposed hemostatic efficacy and safety endpoints for a potential United States Phase III clinical trial of the INTERCEPT Blood System for platelets. The Committee disagreed with the safety margins for the trial proposed by Cerus, and recommended that the trial design include more stringent safety margins for comparing INTERCEPT-treated platelets and conventional platelets. In addition, the Committee rendered a positive opinion on a proposed pathway forward in which successful completion of the proposed Phase III trial would be followed by a post-marketing randomized control study and concurrent staged roll-out of the product. The proposed Phase III clinical trial is designed as a randomized, double-blinded, non-inferiority trial to assess the hemostatic efficacy and safety of routine use of INTERCEPT-treated platelets compared to platelets prepared with conventional processes. The proposed primary efficacy endpoint is number of days of Grade 2 bleeding (World Health Organization scale), and the proposed primary safety endpoint is the incidence of acute lung injury (ALI).
Cerus Corporation Announces Pricing of Common Stock and Warrant Offering
Cerus Corporation announced that it has entered into definitive agreements with selected investors to sell 6,000,000 units, with each unit consisting of one share of the Company`s common stock and a warrant to purchase 0.4 of a share of the Company`s common stock for gross proceeds of approximately $13.2 million in a registered direct offering. The Company estimates that net proceeds from the offering will be approximately $12.2 million, after deducting placement agent fees and estimated offering expenses. The investors have agreed to purchase the units at a purchase price of $2.20 per unit. The warrants, which represent the right to acquire an aggregate of up to 2,400,000 shares of the Company`s common stock, will have a five-year term from the date of issuance, will be exercisable beginning six months after the date of issuance and will be exercisable at a price of $2.90 per share. The transaction is expected to close on or about August 25, 2009. The net proceeds from the transaction are expected to be used for working capital and general corporate purposes. Cowen and Company, LLC, a subsidiary of Cowen Group, Inc., acted as the exclusive placement agent for the transaction.
Cerus Corporation's INTERCEPT Blood System For Platelets Receives Swiss Approval
Cerus Corporation announced that the Swiss regulatory body, Swissmedic, has approved the use of platelet components treated with Cerus' INTERCEPT Blood System. The approval extends permitted storage time for platelets to seven days with INTERCEPT treatment, compared to five days without treatment. The regulatory review process by Swissmedic is similar to the regulatory processes in France (Afssaps) and Germany (Paul Ehrlich Institute), in which INTERCEPT treated blood components have been approved as a biologic for patient use.
Cerus Corporation and Grifols S.A. To Collaborate On INTERCEPT Red Cell Kit Development
Cerus Corporation and a subsidiary of Grifols S.A. announced that the two companies have entered into an agreement to collaborate on the development of red blood cell treatment sets for use in the INTERCEPT Blood System. The agreement calls for Laboratorios Grifols to provide their technical expertise and resources for the development of commercial kit manufacturing, and also establishes the parties` joint commitment to a future commercial manufacturing contract. The INTERCEPT red blood cell system, currently in Phase I trials, is being developed to inactivate a broad range of pathogens that may contaminate donated blood.
Cerus Corporation and Grifols SA Extend Blood System Distribution to Italy-DJ
Dow Jones reported that Cerus Corporation and Grifols SA entered into an agreement extending Grifols' INTERCEPT platelet and plasma distribution territory to include Italy. The INTERCEPT Blood System inactivates a broad range of viruses, bacteria and parasites that may contaminate donated blood components, including emerging pathogens such as West Nile virus, Chikungunya and influenza virus. Under terms of this new agreement, Grifols SA will sell, deploy and support the INTERCEPT Blood System in Italy. In 2007, both companies entered a similar distribution agreement for Spain and Portugal, and in 2008 the territory was expanded to include Chile.
Cerus Corporation Receives CE Mark Approval To Extend Platelet Treatment Range Of Its INTERCEPT Blood System
Cerus Corporation announced that it has received CE Mark approval to extend the platelet treatment range of its INTERCEPT Blood System, resulting in enhanced compatibility with all commonly used platelet collection methods, and in particular with practices prevalent in Eastern Europe, the Middle East and Africa.
Cerus Corporation Appoints Kevin D. Green As Principal Financial Officer-Form 8-K
Cerus Corporation reported in its Form 8-K that on April 24, 2009, the Board of Directors appointed Kevin D. Green, to serve as the Company's Principal Financial Officer effective as of May 1, 2009.
UPDATE 1-Cerus in development deal for blood safety system
BANGALORE, Feb 9 (Reuters) - Blood safety products maker Cerus Corp said it entered into an agreement with France's national blood transfusion service to develop its Intercept red blood cell system.
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