Key Developments For Cerus Corp
Cerus Corp (CERS.O) (Consolidated Issue listed on NASDAQ Global Market)
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.
