Astellas forms partnership with ClearPath to build vaccine portfolio

Japanese pharmaceutical firm Astellas Pharma and ClearPath Development Company of Rockville, MD, US have announced a partnership to form a portfolio of development companies focused on vaccines targeting infectious diseases.

The partnership will 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, for respiratory syncytial virus (RSV) through completion of a Phase IIb human proof-of-concept study.

Under the new partnership agreement, Astellas received exclusive rights to acquire RSVC as well as further develop and commercialise the vaccine.

'This partnership highlights our commitment to build a global vaccine business and represents a highly efficient model for bringing innovative vaccines to market,' said Kenji Yasukawa, Senior Vice President and Chief Strategy Officer at 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. There is no vaccine available for this virus.

This partnership highlights our commitment to build a global vaccine business

'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, Chairman, ClearPath Development Company.

Mymetics will collaborate with RSVC on the development of the vaccine, with Toon Stegmann, CSO of Mymetics, remaining engaged on pre-clinical activities including non-clinical evaluation, formulation development, and manufacturing. RSVC's development team is led by George Siber, a recognised vaccine expert with more than 35 years' experience. From 1996 to 2007, he 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.

For its technology for RSV, Mymetics could receive upfront and post proof-of-concept milestone payments of up to US$82m, as well as double-digit 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.

ClearPath is a subsidiary of RRD International and works with biopharmaceutical companies to expand product pipeline opportunities with complementary development and finance capabilities.