Nabi Receives Key Patent for Nicotine Vaccines, Enters Manufacturing Agreement with Diosynth

Nabi Biopharmaceuticals (Rockville, MD) has received a patent for treating and preventing nicotine addiction with NicVAX and related nicotine conjugate vaccines. The US Patent and Trademark office issued US Patent No. 7,776,620 entitled “Hapten-carrier conjugates for treating and preventing nicotine addiction,” for the exclusive use of methods for treating and preventing nicotine addiction with NicVAX and related nicotine vaccines. This patent runs through December 2018.
Nabi's patent portfolio for technology related to NicVAX encompasses a variety of issued and pending patents around the world, including five issued US patents related to both composition of matter and therapeutic methodology for treating and preventing nicotine addiction. Claims in these patents are directed to composition of matter, or conjugate vaccines that comprise a nicotine-like molecule linked to a carrier protein, as well as methods for the use of these conjugate vaccines to treat and prevent nicotine addiction.
Nabi also has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. (Research Triangle Park, NC) for the manufacture of drug substance integral to the production of NicVAX.
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.
Nicotine is a small molecule that, on 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. Preclinical 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 also may 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.