Crucell will not be able to terminate agreement with Shantha and regains full rights to influenza vaccine FluCell.

Crucell and Sanofi Pasteur have decided to restructure their long-standing partnership. Crucell will waive its right to terminate an existing license agreement with Sanofi Pasteur’s subsidiary Shantha Biotechnics for the development of pediatric vaccines based on Haemophilus influenzae b. This termination right was triggered by the acquisition of Shantha by Sanofi Pasteur in July 2009.
Additionally, Sanofi Pasteur will return to Crucell commercial rights held under an exclusive license agreement for the development and commercialization of a cell-based seasonal influenza vaccine FluCell. The vaccine is based on Crucell’s PER.C6® technology. The original license deal was inked in December 2003 and left Crucell with marketing rights for FluCell in Japan only.

With the return of the worldwide marketing rights, Crucell will assume full responsibility for the FluCell program. The firm says that it will commence immediately with the development of a cell-based influenza vaccine.

In April 2005, Sanofi Pasteur with Crucell as a subcontractor received a $97 million contract from the HHS for clinical development of FluCell. Phase II studies in healthy adults were initiated in the U.S. in November 2007. In the third quarter of 2008, Crucell obtained a milestone fee from Sanofi Pasteur for progress of the Phase II trials.

“Combining our intensified PER.C6® production system with our proven virosomal technology creates an exciting new method to produce an influenza vaccine both at large scale and very competitive cost levels,” says Crucell’s CMO, Jerald Sadoff. “I am confident that we will be able to accelerate this program and expect to apply for licensure in 2014.”

Together with its Taiwanese partner Adimmune, the firm has successfully increased the availability of flu antigen for Inflexal® V, a virosomal adjuvanted influenza vaccine, according to Crucell’s CEO, Ronald Brus. In 2009, the company reports that it distributed more than 115 million vaccine doses in more than 100 countries around the world, with 97% of doses going to developing countries. Crucell also supplies vaccines to UNICEF.

Crucell was reportedly the first manufacturer to launch a fully liquid vaccine that protects against five important childhood diseases. Since the launch of this pentavalent vaccine Quinvaxem® in 2006, over 130 million doses have been sold in more than 50 GAVI (Global Alliance for Vaccines and Immunization) countries. Other vaccines in Crucell’s portfolio include a vaccine against hepatitis B and travel vaccines including an oral typhoid vaccine, an oral cholera vaccine, and the only aluminum-free hepatitis A vaccine on the market, the firm notes.

The company is also developing other products on its PER.C6 production technology. The platform is also licensed to other companies including CSL, DSM Biologics, GSK, Johnson & Johnson, Merck & Co, Novartis, sanofi-aventis, and Wyeth.

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