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Astellas To Form Strategic Partnership With ClearPath To Build Vaccine Portfolio

In-license Vaccine Technology for Respiratory Syncytial Virus (RSV) from Mymetics

TOKYO, ROCKVILLE, Md. and EPALINGES, Switzerland, Jan. 6, 2014 /PRNewswire/ -- Astellas Pharma Inc. (Astellas) and ClearPath Development Company (ClearPath) announced today a strategic partnership to form a portfolio of development companies focused on vaccines targeting infectious diseases.  The partnership was established to support Astellas' goal of building a global vaccine franchise and launched its first company, RSV Corporation (RSVC), in December 2013.  Astellas will fund RSVC's development of a virosome vaccine technology, licensed from Mymetics Corporation (Mymetics - OTC BB: MYMX), for respiratory syncytial virus (RSV) through completion of a Phase 2b human proof-of-concept study.  Based on the strategic partnership, Astellas received exclusive rights to acquire RSVC as well as further develop and commercialize the vaccine product.

"This partnership highlights our commitment to build a global vaccine business and represents a highly efficient model for bringing innovative vaccines to market.  It is also a unique opportunity for Astellas to utilize external cutting edge science and technology to enhance our ability to generate innovative drugs, as part of the "Reshaping Research Framework" program announced in May, 2013," said Kenji Yasukawa, Senior Vice President and Chief Strategy Officer, Astellas. 

RSV is a respiratory pathogen which infects patients of all ages.  The infection can be especially severe in infants and older adults with chronic pulmonary or cardiovascular disease.  Each year the virus infects 64 million people and is responsible for 160,000 deaths worldwide.  Currently, there is no vaccine available for this virus.

"Together we are harnessing our collective resources to accelerate development of this promising, early stage asset and will replicate this scalable, outcome driven model across future portfolio companies," said Chuck Finn, PhD, Chairman, ClearPath Development Company. 

Mymetics will collaborate with RSVC on the development of the vaccine, with Toon Stegmann PhD, CSO of Mymetics, remaining engaged on pre-clinical activities including nonclinical evaluation, formulation development, and manufacturing.  RSVC's development team is led by George Siber, MD, a recognized vaccine expert with more than 35 years experience.  From 1996 to 2007, Dr. Siber was Executive Vice President and Chief Scientific Officer of Wyeth Vaccines Research where he oversaw the approval and marketing of six childhood vaccines including Prevnar, Meningitec, Rotashield and FluMist.  

"The financial backing and commercial experience of Astellas combined with ClearPath's development expertise and our continued program involvement are unique factors which all work to increase the likelihood of success," said Ronald Kempers, CEO, Mymetics.  "We anticipate RSV will be the first of many vaccine constructs that can be generated from our proprietary 2nd generation virosome platform." 

For its technology for RSV, Mymetics could receive upfront and post proof-of-concept milestone payments up to $82 million, as well as double digits royalties and other payments. 

The virosome vaccine consists of membrane nanoparticles containing the native key viral surface proteins that are targets of the immune system, but lack the genetic material required to cause infection. In pre-clinical testing, it generated powerful immune responses and strong protection against RSV. Virosome-based vaccines have a proven track record of safety and efficacy for the prevention of other infections including influenza.

About Astellas Pharma Inc.:
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology (including Transplantation) and Infectious diseases, Oncology, Neuroscience and DM Complications and Kidney diseases. For more information on Astellas Pharma Inc., please visit the company website at www.astellas.com/en.

About ClearPath Development Company: ClearPath Development Company, a subsidiary of RRD International, works with leading biopharmaceutical companies to expand product pipeline opportunities with complementary development and finance capabilities. Its business model provides biopharmaceutical companies with an alternative mechanism for accelerating product development.  This model is highly capital-efficient for development of early-stage assets, enables accelerated development for existing company assets and external assets under consideration for in-licensing, and helps de-risk development projects with tailored financing structures. For more information, visit www.clearpathdevco.com.

About Mymetics Corporation:
Mymetics Corporation is a Swiss-based biotechnology company registered in the US (OTC BB: MYMX) developing next-generation preventative vaccines for infectious diseases. The company's vaccines are designed to induce protection against early transmission and infection, focusing on the mucosal immune response as a first-line defense, which, for some pathogens, may be essential for the development of an effective prophylactic vaccine. The Mymetics pipeline also includes vaccines to prevent influenza (intranasally administered), HIV-1 and malaria. Please visit www.mymetics.com.

Forward-looking statements
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements, which are identified by the words "believe," "expect," "anticipate," "intend," "plan" and similar expressions. The statements contained herein which are not based on historical facts are forward-looking statements that involve known and unknown risks and uncertainties that could significantly affect our actual results, performance or achievements in the future and, accordingly, such actual results, performance or achievements may materially differ from those expressed or implied in any forward-looking statements made by or on our behalf. These risks and uncertainties include, but are not limited to, risks associated with our ability to successfully develop and protect our intellectual property, our ability to successfully develop our vaccine candidates, our ability to raise additional capital to fund future operations and compliance with applicable laws and changes in such laws and the administration of such laws. See Mymetics' most recent Form 10-K for a discussion of such risks, uncertainties and other factors. Readers are cautioned not to place undue reliance on these forward- looking statements which speak only as of the date the statements were made.

SOURCE Astellas Pharma Inc. and ClearPath Development Company and Mymetics Corporation

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