Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

Sep 2 2010

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

Nicotine is a small molecule that, upon inhalation into the lungs, quickly passes into the bloodstream and subsequently reaches the brain by crossing the blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine receptors, resulting in the release of stimulants, such as dopamine, a chemical linked to pleasure and to addiction. NicVAX stimulates the immune system to produce antibodies that bind to nicotine, creating an antigen/antibody complex that is too large to cross the blood-brain barrier. In this way, NicVAX blocks nicotine from reaching these receptors in the brain, fewer stimulants are released, and the pleasurable, highly-addictive effects of nicotine are diminished, thereby making it easier to quit smoking. Pre-clinical and previous clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the nicotine antibodies circulate for long periods of time, Nabi believes NicVAX may also be effective in preventing smoking relapse and support long-term abstinence. This is a very important difference between NicVAX and existing anti-smoking treatment therapies. Relapse is a significant challenge facing smokers; with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.