Madrid, 30 June 2009. Laboratorios Farmacéuticos Rovi (ROVI) announced today its initial agreement to use the proprietary, recombinant virus-like-particle (VLP) vaccine technology of Novavax, Inc. ROVI will use the VLP technology to create a comprehensive influenza vaccine solution for the Spanish government under a new 60 million-Euro program sponsored and led by the Spanish Ministry of Health and other government groups to develop pandemic and seasonal flu vaccines and establish its only in-border facility. This program, which was announced today by Spanish health officials, is being launched to develop safe and effective flu vaccines to serve the entire population of Spain.
Under separate agreements that are in the process of being completed by both companies, ROVI will receive exclusive licenses to Novavax’s portable VLP vaccine technology to commercialize flu vaccines in Spain and Portugal, and non-exclusive licenses in Europe, Latin America and Africa. Furthermore, under a stock purchase agreement executed today, ROVI has committed to make a $3 million (US) equity investment in Novavax at $2.74 per share, a 10% premium to the June 29, 2009 closing bid price on the NASDAQ global markets.
A non-profit Foundation, jointly sponsored by ROVI and the Spanish authorities, will be formed and funded with a 25 million euro credit line from the Spanish government, to support phase III clinical development and other studies necessary to achieve marketing authorization of the VLP influenza vaccines in the European Union in 2012. This credit line offers very favorable conditions for ROVI: (i) 0% interest rate and (ii) a repayment calendar of 15 years with (iii) a 3 year grace period. These conditions will allow ROVI to repay the credit line using the cash generated by the sales of the vaccine.
In addition, the State of Andalucía will support ROVI in building a new VLP vaccine plant in the city of Granada and bring it on-line in 2012. The plant, with certain licensed manufacturing rights from Novavax, is expected to have enough manufacturing capacity to service Spain and other parts of Europe, Latin America, and Africa. Details of the commercial terms between ROVI and Novavax will be announced after the definitive agreements are finalized and are expected to include milestones and royalties. Milestones will be feasible once the commercialization of the flu vaccine has begun.
Juan López-Belmonte Encina, ROVI CEO, commented: “The pandemic flu vaccine business is currently a key part of the strategy of ROVI, and we are committed to the business as one of the future growth drivers for the company. We are entering a new world of high technology and complex processes, but we are confident that our knowledge in this area along with Novavax's extensive experience will enable us to fight on the front line against the devastating affects of influenza virus infection.”
Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated:“Today’s contemplated partnership with ROVI and the Spanish government will enable funding to support development and registration of VLP-based influenza vaccines in the European Union and possibly other countries, including the United States. Through this partnership, the goal to supply influenza vaccines for all Spanish citizens from domestic production should be achieved in year 2012.”
About ROVI
ROVI is a fully integrated, profitable Spanish specialty pharmaceutical company engaged in the research, development, in-licensing, manufacturing and marketing of small molecule and specialty biologic drugs. The Company has a diversified portfolio of products that it markets in Spain through its specialized sales force, calling on specialist physicians, hospitals and pharmacies. ROVI’s portfolio of 23 principal marketed products is currently anchored by the internally-developed,second generation low molecular weight heparin, bemiparin. ROVI’s research and development pipeline is focused primarily on addressing currently unmet medical needs by developing new LMWH-based products and expanding applications for its existing LMWH-based products. ROVI manufactures the active biological ingredient (bemiparin) for its principal proprietary product and product candidates and the injectable pharmaceutical products developed by its in-house research team, and utilizes its state-of-the-art filling and packaging capabilities to provide a broad array of toll manufacturing services to leading international pharmaceutical companies, primarily in the area of pre-filled syringes.
About NOVAVAX
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biotechnology company creating novel vaccines, including H1N1, to address a broad range of infectious diseases worldwide using advanced proprietary virus-like-particle (VLP) technology. The company produces these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches. VLPs are designed to induce protective immune responses without generating infection since they are not made from a live virus and contain no genetic material in their inner core. The Company is currently conducting Phase 2 clinical studies of a seasonal flu vaccine and recently announced a research agreement with the National Institutes of Health to evaluate a VLPbased vaccine against the novel H1N1 influenza strain. The company also plans to initiate a seasonal flu vaccine study in elderly subjects later this year. Additional information about Novavax is available at www.novavax.com and in the company’s various filings with the Securities and Exchange Commission.