Nabi Biopharmaceuticals signed a five-year agreement with Diosynth for the commercial manufacture of a component of its Phase III-stage nicotine addiction vaccine, NicVax. Diosynth will produce AMNic-rEPA by conjugating the carrier protein rEPA, which it produces, to the nicotine hapten sourced from another CMO. The final NicVax product is generated by combining AMNic-rEPA with adjuvant. Nabi says Diosynth has already validated the NicVAX manufacturing process and generated commercial-scale lots of the NicVax drug substance.
“This agreement is an important and exciting step in the event that the Phase III trials for NicVax are positive and we subsequently receive regulatory approval,” comments Raafat Fahim, Ph.D., president and CEO at Nabi.
GlaxoSmithKline Biologicals has an option to take on an exclusive worldwide license to NicVax through an agreement finalized between the companies in March. Under terms of the deal Nabi received $40 million up front from GSK. In addition to its option to the NicVax product, GSK also has a license to develop next-generation nicotine vaccines using Nabi’s IP. The latter could receive up to $460 million in potential option fees and regulatory, development and sales milestones for NicVAX and follow-on nicotine vaccines.
A week after signing the deal with GSK, Nabi confirmed starting the second of two pivotal Phase III trials with NicVax. The Phase III program is being carried out under an FDA Special Protocol Assessment. The firm has also received two tranches of NIAID funding to support the vaccine’s development. Most recently, in September 2009, the NIAID awarded Nabi a $10 million grant to support initiation of the Phase III NicVax trial program.