Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. (Diosynth) for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.
Under the agreement, Diosynth will produce the Drug Substance AMNic-rEPA. The Drug Substance is produced by conjugating nicotine hapten, which is sourced from another contract manufacturing organization, with the carrier protein, rEPA, produced at Diosynth. The resulting Drug Substance is then combined with an adjuvant and filled in syringes at a filling facility to produce NicVAX. The term of the agreement is for five years from the effective date of the agreement with provisions for supply extension beyond the initial term. In collaboration with Nabi, Diosynth has already validated the NicVAX manufacturing process and produced commercial-scale lots of NicVAX Drug Substance under contract for Nabi.
"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," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "We are pleased to enter into this agreement with Diosynth, an experienced manufacturer of licensed biological products with a regulatory approved facility and available capacity to perform bulk manufacture of the NicVAX Drug Substance."
How NicVAX Works